CLINICAL GUIDELINE FOR THE ELIMINATION OF MOTHER-TO-CHILD TRANSMISSION OF HIV AND CONGENITAL SYPHILIS IN LATIN AMERICA AND THE CARIBBEAN
S A L U O T R E P
O P A P H S O
N I O D V I M U N
Latin American Center for Perinatology Women and Reproductive Health CLAP/WR
Scientific Publication CLAP/WR Nº 1570-02 Clinical Guideline for the Elimination of Mother-to-Child Transmission of HIV and Congenital Syphilis in Latin America and the Caribbean
2011
5
/$7,1$0(5,&$1&(17(5)253(5,1$72/2*< :20(1$1'5(352'8&7,9(+($/7+ &/$3:5 PAHO Headquarters Library — Catalog at source González H, Serruya S ed. “ Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean”. Montevideo: CLAP/WR, 2011 (PAHO/FCH/HI/06-09.E) ISBN: 978-92-75-12991-3
Title II. Series
1 Congenital Syphilis 2 Sexually Transmitted Diseases 3 Vertically Transmitted Disease 4 Mother and Child Relations 5 HIV Infections 6 The Caribbean Region 7 Latin America NLM WC161
http://www.paho.org/iniciativadeeliminacion Website CLAP/WR: http//www.new.paho.org/clap VHL - WOMEN MATERNAL AND PERINATAL: http://perinatal.bvsalud.org Latin American Center for Perinatology / Women and Reproductive Health - CLAP/WR Pan American Health Organization / World Health Organization - PAHO/WHO
P.O. Box 627, 11000 Montevideo, Uruguay Telephone: +598 2 487 2929, Fax: +598 2 487 2593 [email protected] CLINICAL GUIDELINES FOR THE ELIMINATION OF MOTHER TO CHILD TRANSMISSION OF HIV AND CONGENITAL SYPHILIS IN LATIN AMERICA AND THE CARIBBEAN
“GUÍA CLÍNICA PARA LA ELIMINACIÓN DE LA TRANSMISIÓN MATERNOINFANTIL DEL VIH Y DE LA SÍFILIS CONGÉNITA EN AMÉRICA LATINA Y EL CARIBE”.
Scientific publication CLAP/WR 1570-02 2011 The Pan American Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full.
Applications and inquiries should be addressed to the VIH/AIDS Unit, Pan American Health Organization, Washington, DC, USA, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available.
© Pan American Health Organization, 2011
Publications of the Pan American Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights are reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the Pan American Health Organization concerning the status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the Pan American Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
The opinions expressed in this document are the sole responsibility of its authors. The secretariat and consultants have made all the efforts possible to ensure that the indications and doses stated in this document are correct, and generally recommended by the health authorities and medical literature.
Nevertheless, readers are suggested to consult the recommendations and information regularly provided by the authorities and manufacturers.
Editors Raúl González Montero, PAHO Suzanne Jacob Serruya, CLAP/WR/PAHO Coordinators Ricardo Fescina, CLAP/WR/PAHO Kathleen Israel, HI/FCH/OPS
Listing of the Group of Latin American and Caribbean Experts for the Adaptation of the Regional Guidelines (GELAC) (in alphabetical order)
Dulce Almonte, REDOVIH/REDLAT, Dominican Republic Mónica Alonso, PAHO Tania Corpeño Olivas, MINSA, Nicaragua Bremen De Mucio, CLAP/WR/PAHO Marie Deschamps GHEISKO, Haiti Hernando Estrada, Heres Salud I.PS., Colombia Carlos Falistocco, Medical advisor, National Program Against Human Retroviruses, Argentina Odalys García, Ministry of Health, Honduras Perry Gomez MOH, The Bahamas June Holdip, CFNI/PAHO/WHO Yira Ibarra Head of the National Program Against HIV/AIDS, Panama Beryl Irons CAREC/PAHO Noreen Jack PHCO/PAHO Andre Jolicoeur, UNICEF Osvaldo Lorenzo, DIGECITSS, Dominican Republic Denis Padgett, IHSS/UNAH, Honduras Russel Pierre UWI, Mona, Jamaica Leah-Mari Richards UNFPA Maria Dillion Remy Tobago Regional Health Authority, Trinidad and Tobago Margaret Ann St. John MOH, Barbados Omar Sued, PAHO Mauro Texeira, GCTH, Brazil Victor Vallejo Sandoval, COPRECOS, Peru Patricia Vasquez San Juan de Dios Hospital, CONASIDA Advisory Committee, Chile Ana Visconti Ministry of Health, Uruguay
We thank Dr. Jorge Lattner, an expert on infectious diseases at the Fernández Hospital, Argentina, for the initial review of the draft version of this document of this document and Dr. Bilali Camara for its initial coordination.
All the contents in the guideline were updated in May 2009, and the prevention of congenital syphilis was integrated as a joint strategy. This work was conducted by:
José Ramón Espinoza UNICEF Bertha Gómez PAHO Raúl González Montero PAHO Noreen Jack PHCO/PAHO Cecilia Sánchez Bodas TACRO/UNICEF Suzanne Jacob Serruya CLAP/WR/PAHO Omar Sued PAHO
Generations free of HIV and congenital syphilis 4 INDEX Contents
1. INTRODUCTION ...... 9 1. 1. Epidemiology & Background ...... 9 1.2. Objectives of the clinical guideline ...... 14 1.3. Goals, indicators and program objectives of the “Initiative for the Elimination of Mother-To-Child Transmission of HIV and Congenital Syphilis in Latin America and the Caribbean” ...... 15 2. OPERATIONAL DEFINITIONS ...... 16 3. INTERVENTIONS FOR THE PRIMARY PREVENTION OF HIV AND SYPHILIS ...... 20 3.1. Perinatal Electronic System ...... 20 3.2. Primary prevention of HIV and syphilis in pregnant and non pregnant women ...... 22 3.3. Preventing unwanted pregnancies ...... 22 3.4. Pre Conception Counseling in HIV+ women ...... 23 4. DIAGNOSIS ...... 25 4.1. Diagnosis of maternal syphilis ...... 25 4.1.1. Clinical ...... 25 4.1.2. Laboratory tests for the diagnosis of syphilis ...... 27 4.2. Diagnosis of congenital syphilis ...... 30 4.2.1. Clinical ...... 30 4.2.2. Serological Diagnosis ...... 32 4.3. Diagnosing the mother’s HIV infection ...... 32 4.3.1. Clinical Diagnosis ...... 33 4.3.2. Serological Diagnosis ...... 33 4.4. Diagnosis of HIV infection in children ...... 34 4.4.1 Polymerase Chain Reaction for the detection of viral DNA ...... 35 4.4.2 Viral RNA detection ...... 36 5. CLINICAL MANAGEMENT ...... 37 5.1. Syphilis ...... 37 5.1.1. Treatment of maternal syphilis ...... 37 5.1.2. Treating children with congenital syphilis ...... 39 5.2. HIV INFECTION ...... 40 5.2.1. Clinical and immunologic evaluation of HIV+ pregnant women: indication to start ARVT ...... 40 5.2.2. Women that get pregnant while on ARVT ...... 43 5.2.3. Antiretroviral MTCTP prophylaxis ...... 45 5.2.4. Type of delivery and indication of caesarean section ...... 49 5.2.5. Recommendations on how to feed the newborn ...... 51 5.2.6. Safety of ARVT in pregnant women and children ...... 53 5.2.7. Drug resistance following HIV MTCP ...... 58
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 5 6. CHILD MONITORING ...... 62 6.1 Systematic immunizations of the HIV-exposed child within the first months of life ...... 64 6.1.2 BCG immunization (187) ...... 65 6.2 Follow-Up Schedule ...... 66 7. SPECIAL CONSIDERATIONS ...... 71 7.1. Pregnant women with HIV and active tuberculosis ...... 71 7.2. Pregnant women with HIV and hepatitis ...... 72 7.3. Pregnant women with HIV and anaemia ...... 73 7.4. Treating IDU pregnant women ...... 73 7.5. Women with primary HIV-infection during pregnancy ...... 75 8. ANNEXES ...... 76 9. BIBLIOGRAPHY ...... 87
Generations free of HIV and congenital syphilis 6 ACRONYMS & ABBREVIATIONS
A3TC Lamivudine ABC Abacavir AC Antenatal Care AFASS Affordable, Feasible, Acceptable, Sustainable and Safe. Acronym used by the WHO to describe under what circumstances milk formula can be recommended to replace breastfeeding. AIDS Acquired Immune Deficiency Syndrome ARV Antiretroviral ARVT High Efficacy Combined Antiretroviral Therapy ATV/r Atazanavir / ritonavir AZT Azidotimidine (zidovudine) CAH Child & Adolescence Health CDC Centers for Disease Control and Prevention CLAP/WM Latin American Center for Perinatology, Women & Reproductive Health CS Congenital Syphilis CSF Cerebro Spinal Fluid D4T Stavudine ddl Didanosine DNA Deoxyribonucleic Acid du-NVP Single dose nevirapine ECS Elimination of Congenital Syphilis EFV Efavirenz ELISA Enzyme Linked Immunoabsorbent Assay fAPV/r Fosamprenavir / ritonavir FTA-Abs Fluorescence Treponemic Absortion of Antibodies FTC Emtricitabine GUS Genital Ulcer Syndrome HALY Handicap-Adjusted Life Years HBV Hepatitis B Virus HCV Hepatitis C Virus HIV Human Immune Deficiency Virus IDV Indinavir IgE Immunoglobulin E IgM Immunoglobulin M IU International Units LAC Latin America and the Caribbean LB Live birth, LPV/r Lopinavir / ritonavir
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 7 MCH Maternal & Child Health MDGs Millennium Development Goals MHA-TP MicroHaemagglutination Assay for Antibodies to Treponema pallidum MSM Men that have sex with men MTCT Mother-to-Child Transmission MTCT Prevention of Mother-To-Child Transmission of HIV NFV Nelfinavir NNRTI Non Nucleoside Reverse Transcriptase Inhibitor NRTI Nucleoside Reverse Transcriptase Inhibitor NVP Nevirapine ORT Opiate Replacement Therapy PAHO Pan American Health Organization PCR Polymerase Chain Reaction PECS Program for the Elimination of Congenital Syphilis PI Protease Inhibitor PVL Plasma Viral Load RIF Rifampin RNA Ribonucleic Acid RPR Rapid Plasma Reaginine SQV/r Saquinavir / ritonavir SRH Sexual & Reproductive Health STI Sexually Transmitted Infections TB Tuberculosis TDF Tenofovir TPHA Treponema pallidum haemagglutination assay TP-PA Treponema pallidum particle agglutination UNGASS United Nations General Assembly Special Session on VIH/AIDS UNICEF United Nations Children’s Fund USR Unheated serum reagin VDRL Veneral Disease Research Laboratory VT Vertical Transmission WHO World Health Organization
Generations free of HIV and congenital syphilis 8 1. INTRODUCTION
1.1. Epidemiology & Background 7KH+,9 +XPDQ,PPXQH'H¿FLHQF\9LUXV SDQGHPLFLVRQHRIWKHPRVWVHULRXV JOREDO KHDOWK FULVHV 2YHU PLOOLRQ SHRSOH KDYH VXFFXPEHG WR$,'6 VLQFH WKH RFFXUUHQFHRIWKHGLVHDVH2IWKHPLOOLRQSHRSOHZLWKWKH+,9YLUXVJOREDOO\DV RI'HFHPEHUDOPRVWPLOOLRQOLYHGLQ/DWLQ$PHULFDDQGWKH&DULEEHDQ +,9LQIHFWLRQLVDFFRXQWDEOHIRUDVLJQL¿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¿UVW ZHHNV RI OLIH REVWHWULF LQWHUYHQWLRQV VXFK DV VFKHGXOHGFHVDUHDQVHFWLRQ SODQQHGEHIRUHWKHRQVHW RI ODERUDQG WKHUXSWXUHRI PHPEUDQHV DQGWKHDYRLGDQFHRIEUHDVWIHHGLQJE\+,9PRWKHUV 6\SKLOLVLVVWLOODVHULRXVSXEOLFKHDOWKLVVXH LWLVFDOFXODWHGWKDWHYHU\\HDUWKHUHDUH RYHUPLOOLRQQHZLQIHFWLRQVE\7UHSRQHPDSDOOLGXPDQGPRUHWKDQPLOOLRQ RFFXULQSUHJQDQWZRPHQ,WLVLPSRUWDQWWRKLJKOLJKWWKDWWKH/$&UHJLRQH[KLELWV WKHKLJKHVWPDWHUQDOV\SKLOLVUDWHLQWKHZRUOG WKH:+2HVWLPDWHGLWUHDFKHG EHWZHHQ DQG 7KDW ¿JXUH VXJJHVWV WKDW WKHUH PD\ EH DSSUR[LPDWHO\
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 9 JHVWDWLRQDOFDVHVLQWKH$PHULFDV QRWLQFOXGLQJWKH86$DQG&DQDGD WKXV FDXVLQJIURPWRFDVHVRIFRQJHQLWDOV\SKLOLV &6 \HDUO\ ,QPRVW FDVHVWKHLQIHFWLRQLVWUDQVPLWWHGWRWKHIHWXV W\SLFDOO\EHWZHHQSUHJQDQF\ZHHNV DQG DQGLWLVIDWDOLQRIWKHFDVHV 7KHSUHYDOHQFHRIPDWHUQDO V\SKLOLVYDULHVVLJQL¿FDQWO\DFURVVWKHFRXQWULHVLQWKHUHJLRQ)RULQVWDQFHLQ LWZDVLQ$UJHQWLQDLQ+DLWL DQGLQ%ROLYLD *LYHQ WKH LQFUHDVLQJ SUHYDOHQFH RI FRQJHQLWDO V\SKLOLV DQG WKH DSSDUHQW ODFN RI DZDUHQHVVE\KHDOWKFDUHSURIHVVLRQDOVDQGFRPPXQLW\DVDZKROHWKH³;;,93DQ $PHULFDQ+HDOWK&RQIHUHQFH´FDOOHGIRUWKHHOLPLQDWLRQRIFRQJHQLWDOV\SKLOLV (&6 DVDSXEOLFKHDOWKSUREOHPLQWKH$PHULFDVLQ 7KLVOHGWRWKHGHYHORSPHQW RI WKH ³3ODQ RI $FWLRQ IRU WKH (OLPLQDWLRQ RI &RQJHQLWDO 6\SKLOLV´ DW 3$+2¶V WK([HFXWLYH&RPPLWWHH¶V0HHWLQJLQ 7KDWGRFXPHQWHVWDEOLVKHGWKH GH¿QLWLRQVRIFRQJHQLWDOV\SKLOLV &6 DQGWKHQHHGWRHOLPLQDWHLWDVDSXEOLFKHDOWK LVVXHDVZHOODVWKHVWUDWHJLHVDQGPHWKRGVDJUHHGWRPHHWWKRVHREMHFWLYHV ,Q 3$+2LQFOXGHG WKH (&6 LQ LWV ZRUNLQJ SODQ DQG FDOOHG IRU WHFKQLFDO FRQVXOWDWLRQ WR LGHQWLI\ WKH UHFRPPHQGDWLRQV QHHGHG WR LPSOHPHQW WKLV LQLWLDWLYH WKRVH UHFRPPHQGDWLRQV DUH FRPSLOHG LQ WKH GRFXPHQW ³(OLPLQDWLRQ RI FRQJHQLWDOV\SKLOLVLQ/DWLQ$PHULFDDQGWKH&DULEEHDQ5HIHUHQFH)UDPHZRUNIRU LWV,PSOHPHQWDWLRQ´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³*OREDO6WUDWHJ\ IRUWKH3UHYHQWLRQDQG&RQWURORI6H[XDOO\7UDQVPLWWHG,QIHFWLRQV´ 7KH :+2 UHFHQWO\ SXEOLVKHG DQRWKHU GRFXPHQW SURYLGLQJ WKH UDWLRQDOH DQG WKH QDWLRQDODQGLQWHUQDWLRQDOVWUDWHJLHVIRUWKH(&6NQRZQDVWKH³*OREDO(OLPLQDWLRQ RI&RQJHQLWDO6\SKLOLV 5DWLRQDOHDQG6WUDWHJ\IRU$FWLRQ³ 7KHVWUDWHJ\IROORZV IRXUJXLGHOLQHVWKDWVKRXOGEHDGDSWHGWRHDFKFRXQWU\¶VVHWWLQJVWREHLQWHJUDWHG KRUL]RQWDOO\ LQWR 0 &+ SURJUDPPHV DQG VHUYLFHV LQFOXGLQJ D WR HQVXUH WKH SROLWLFDOFRPPLWPHQWDQGYLVLELOLW\RIWKHSUREOHP E WRLPSURYHDFFHVVWRDTXDOLW\ PRWKHUDQGFKLOGKHDOWKVHUYLFH F WRVFUHHQDOOWKHSUHJQDQWZRPHQDQGWRWUHDWDOO
Generations free of HIV and congenital syphilis 10 WKRVHDIIHFWHGDQGG WRHVWDEOLVKHSLGHPLRORJLFDOVXUYHLOODQFHV\VWHPVPRQLWRULQJ DQGHYDOXDWLRQ:KHQWKLVVWUDWHJ\ZDVFRPSDUHGZLWKVHYHUDOQDWLRQDOSURJUDPVWKH PRVWIUHTXHQWEDUULHUVEHFDPHDSSDUHQWDVGLGWKHQHHGWRZRUNZLWKJRYHUQPHQWV WR LPSURYH ZRPHQ¶V DFFHVV WR VHURORJ\ WHVWLQJ WR GHYHORS UHFRPPHQGDWLRQV RU VSHFL¿FQDWLRQDOWHFKQLFDOJXLGHOLQHVDQGWRLPSURYHWKHVXUYHLOODQFHV\VWHPVWREH VXFFHVVIXOLQ(6& ,QUHFHQW\HDUVWKHUHKDVEHHQDQXQSUHFHGHQWHGSROLWLFDODQGVRFLDOPRELOL]DWLRQLQ UHVSRQVHWRWKH+,9SDQGHPLFZLWKQHZIXQGLQJRSSRUWXQLWLHVDQGDSXEOLFKHDOWK DSSURDFKLQFOXGLQJWKHSURJUDPVIRUWKHSUHYHQWLRQRIPRWKHUWRFKLOGWUDQVPLVVLRQ 07&7 7KHVHSURJUDPVKDYHSURYHQWREHIHDVLEOHDQGFRVWHIIHFWLYHHYHQLQPRVW ORZDQGPHGLXPLQFRPHFRXQWULHVWKDWKDYHQRWUHDFKHGWKHREMHFWLYHVDGRSWHGE\ WKH8QLWHG1DWLRQV*HQHUDO$VVHPEO\¶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¿F LQWHUYHQWLRQ SDFNDJH KDV EHHQ LGHQWL¿HG WR SUHYHQW WKH +,9 LQIHFWHGPRWKHUIURPWUDQVPLWWLQJWKHLQIHFWLRQWRKHUFKLOG,WLQFOXGHVWKH XVHRIDQWLUHWURYLUDOGUXJVWKHHOHFWLRQRIDVDIHUW\SHRIGHOLYHU\DVZHOO DVDGYLFHRQFKLOGIHHGLQJ G &DUHWKHUDS\DQGVXSSRUWWRZRPHQOLYLQJZLWK+,9WKHLUFKLOGUHQDQG IDPLOLHV
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 11 7KHUHLQIRUFHPHQWRIOLQNDJHVEHWZHHQWKHSURJUDPVDLPHGDWSUHYHQWLQJ+,907&7 WKHFDUHDQGVXSSRUWVHUYLFHVIRU+,9LQIHFWHGZRPHQWKHLUFKLOGUHQDQGIDPLOLHVZLOO HQVXUHWKDWZRPHQKDYHDFFHVVWRWKHVHUYLFHVWKH\QHHG/LNHZLVHWKHLPSURYHPHQW RIWKHPRWKHUV¶VXUYLYDODQGTXDOLW\RIOLIHZLOOUHVXOWLQWKHLUFKLOGUHQ¶VEHQH¿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¶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³,QLWLDWLYH IRU WKH HOLPLQDWLRQ RI PRWKHUWRFKLOGWUDQVPLVVLRQRI+,9DQGFRQJHQLWDOV\SKLOLVLQ/DWLQ$PHULFDDQGWKH &DULEEHDQ´DVVXPLQJWKDWWKHLQWHJUDWLRQRIERWKDFWLRQVZLOO\LHOGEHWWHURXWFRPHV WKDQLIHDFKZHUHDGGUHVVHGVHSDUDWHO\7KHFRQFHSWXDOIUDPHZRUNRIWKH,QLWLDWLYHLV GHVFULEHGLQWKHGRFXPHQW 5HJLRQDO,QLWLDWLYHIRUWKH(OLPLQDWLRQRI0RWKHU7R&KLOG 7UDQVPLVVLRQRI+,9DQG&RQJHQLWDO6\SKLOLVLQ/DWLQ$PHULFDDQGWKH&DULEEHDQ 3$+26HSWHPEHU
Generations free of HIV and congenital syphilis 12 7KHPDVWHUOLQHVDUHVKRZQLQ)LJXUH )LJXUD
5HJLRQDO,QLWLDWLYHIRUWKH(OLPLQDWLRQRI0RWKHUWR&KLOG7UDQ VPLVVLRQRI+,9 DQG&RQJHQLWDO6\SKLOLVLQ/DWLQ$PHULFDDQGWKH&DULEEHDQ &21&(378$/)5$0(:25. 9,6,21 /,1(62)$&7,21 352*5$0$7,&2%-(&7,9(6 5(68/76 7$5*(7
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
*8,',1*35,1&,3/(6 XQLYHUVDODFFHVVSULPDU\FDUHIRFXVRQXVHUFRXQWU\GULYHQUHJLRQDOSHUVSHFWLYHSDUWQHUVKLSVDQGFRPPXQLW\ LQYROYHPHQWKXPDQULJKWVIRFXVLQWHUFXOWXUDODQGJHQGHUSHUVSHFWLYH
7KH ³(OLPLQDWLRQ ,QLWLDWLYH´ VHHNV WR LQWHJUDWH DQWHQDWDO FDUH ZLWK WKH SUHYHQWLRQ RI WKH WUDQVPLVVLRQ RI +,9 DQG FRQJHQLWDO V\SKLOLV DQG RWKHU YHUWLFDOO\ WUDQVPLWWHG GLVHDVHV LPSURYLQJ DFFHVV WR 65+ WKH V\VWHPDWLF SURYLVLRQRIFRXQVHOOLQJDQG+,9DQGV\SKLOLVVFUHHQLQJWRDOOSUHJQDQWZRPHQ WKHXVHRI$597WRSUHYHQW07&7WRDOOZRPHQZLWK+,9$59SURSK\OD[LV WRWKHFKLOGGXULQJWKH¿UVWZHHNVRIOLIHHDUO\DQGDGHTXDWHWKHUDS\WRZRPHQ ZLWKV\SKLOLVLGHQWL¿HGGXULQJSUHJQDQF\DQGSURYLVLRQRIFKLOGQXWULWLRQDGYLFH DQGVXSSRUWUHFRPPHQGLQJWKHUHSODFHPHQWRIEUHDVWIHHGLQJIRUPLONIRUPXOD ZKHQWKH$)$66FRQGLWLRQVDUHPHW
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 13 1.2. Objectives of the clinical guidelines
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
Generations free of HIV and congenital syphilis 14 1.3. Goals, indicators and program objectives of the “Initiative for the Elimination of Mother-To-Child Transmission of HIV and Congenital Syphilis in Latin America and the Caribbean”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¿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
&DULEEHDQ FRXQWULHV FRQVLGHU RQH WKLUG RXWSXW LQGLFDWRU UHGXFLQJ WKH LQFLGHQFH RI +,9 PRWKHUWRFKLOG WUDQVPLVVLRQWRFDVHVSHUOLYHELUWKVRUOHVV
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 15 2. OPERATIONAL DEFINITIONS
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¿YH YLVLWV WKH¿UVWEHLQJEHIRUHWKHWKZHHN VXI¿FHWRSURYLGHJRRGTXDOLW\RI FDUHDVORQJDVHDFKLQFOXGHVWKHNH\LQWHUYHQWLRQVSURSRVHG 3ODVPDYLUDOORDG 7KH39/UHIHUVWRWKHGHWHFWLRQDQGTXDQWL¿FDWLRQRI+,9YLUDO51$LQSODVPD ,WLVXVXDOO\H[SUHVVHGDVQXPEHURIFRSLHVPO &RLQIHFWLRQ &RLQIHFWLRQLPSOLHVWKHSUHVHQFHRIDQRWKHUUHOHYDQWLQIHFWLRQLQDSHUVRQZLWK +,9 XVXDOO\WXEHUFXORVLVV\SKLOLVRUFKURQLFYLUDOKHSDWLWLV7KHUHLVDVHWRI LQIHFWLRQVWUDQVPLWWHGLQWKHSHULQDWDOSHULRG IRUIXUWKHULQIRUPDWLRQUHIHUWRWKH &/$3:0 KDQGERRN RQ SHULQDWDO LQIHFWLRQV WUDQVPLWWHG IURP PRWKHU WR FKLOG 6HURORJLFDO7HVWLQJ (VWDEOLVKLQJ WKH GLDJQRVLV RI DQ LQIHFWLRQ EDVHG RQ WKH SUHVHQFH RI VSHFL¿F DQWLERGLHVLQSODVPD
Generations free of HIV and congenital syphilis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¿HVYLUDOSDUWLFOHV R 9LUDOFXOWXUH &XOWXUHRIWKHYLUXVLQFHOOOLQHV R 'HWHFWLRQRIDQWLJHQSZKLFKGHWHFWVWKDWDQWLJHQLQSODVPD (OLPLQDWLRQ (OLPLQDWLRQLVWKHUHGXFWLRQRIWKHPRWKHUWRFKLOG+,9WUDQVPLVVLRQWRRUOHVV DQGWKHUHGXFWLRQRIWKHLQFLGHQFHRIFRQJHQLWDOV\SKLOLV VWLOOELUWKVLQFOXGHG WR FDVHVRUOHVVWKDQELUWKV $QWLUHWURYLUDO'UXJV 'UXJVVSHFL¿FDOO\GHVLJQHGWRLQKLELWWKHUHSOLFDWLRQRI+,9LQWKHKXPDQERG\ 0LON)RUPXOD 3UHSDUDWLRQVSULPDULO\REWDLQHGIURPFRZPLONDQGPDQLSXODWHGWRPLPLFWKH QXWULHQWVDQGROLJRHOHPHQWVSUHVHQWLQKXPDQPLON7KH\DUHXVHGWRIHHGWKH QHZERUQZKHQEUHDVWIHHGLQJLVHLWKHUQRWSRVVLEOHRUFRQWUDLQGLFDWHG
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean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¶VLPPXQRORJLFDOVWDWXV 0DWHUQDORUJHVWDWLRQDOV\SKLOLV $Q\ ZRPDQ GXULQJ SUHJQDQF\ RU SXHUSHULXP RU ZLWK D UHFHQW VSRQWDQHRXV DERUWLRQWKDWSUHVHQWVFOLQLFDOHYLGHQFH IRUH[DPSOH FKDQFUHV\SKLOLWLFURVHROD ÀDWZDUWV RUVHURORJLFDOHYLGHQFHRIV\SKLOLV &RQJHQLWDO6\SKLOLV DQ\RIWKHVFHQDULRVEHORZ R 1HZERUQ VWLOOERUQ RU VSRQWDQHRXV DERUWLRQ RI D ZRPDQ ZLWK PDWHUQDO V\SKLOLVWKDWKDGQRWUHFHLYHGDSSURSULDWHWUHDWPHQW R &KLOGZLWK9'5/RU535WLWHUVIRXUWLPHVKLJKHUWKDQPDWHUQDO HTXLYDOHQW WRWZRGLOXWLRQVLHZRPHQFKLOG R &KLOG ZLWK FOLQLFDO PDQLIHVWDWLRQV VXJJHVWLYH RI FRQJHQLWDO V\SKLOLV DQG SRVLWLYHVHURORJ\UHJDUGOHVVRIWKHWLWHU R 3URGXFWRIJHVWDWLRQRUSODFHQWDZLWKHYLGHQFHRI7SDOOLGXPLQIHFWLRQLQ KLVWRORJLFDOVWXGLHV $597 +LJKHI¿FDF\FRPELQHGWKHUDS\IRU+,9LQIHFWLRQ 6LPXOWDQHRXVXVHRIDWOHDVWWKUHH$59V$WSUHVHQWPRQRRUELWKHUDS\KDYHQR UROHLQWKHWKHUDS\RI+,9LQIHFWLRQ
Generations free of HIV and congenital syphilis 18 +,9 7KHKXPDQLPPXQHGH¿FLHQF\YLUXVLVDQLQIHFWLRXVDJHQWWKDWDWWDFNVWKH LPPXQHV\VWHPSULPDULO\WKHZKLWHEORRGFHOOV 7O\PSKRF\WHV DQGFDXVHV WKHDFTXLUHGLPPXQHGH¿FLHQF\V\QGURPH $,'6 9DOXHDQGGHJUHHRIVWUHQJWKRIHYLGHQFHEDVHGUHFRPPHQGDWLRQV 7KH UHFRPPHQGDWLRQV PDGH LQ WKLV GRFXPHQW DUH EDVHG RQ WKH HYLGHQFH REWDLQHGWKURXJKFRQWUROOHGDQGUDQGRPL]HGFOLQLFDOWULDOV IRUWKHLVVXHVQRW UHODWHGWRWKHUDSLHVWKH\DUHEDVHGRQKLJKTXDOLW\VFLHQWL¿FVWXGLHVGDWDIURP REVHUYDWLRQDOFRKRUWVDQGZKHQWKHUHLVQRHYLGHQFHRUZKHQWKHH[LVWLQJ HYLGHQFHLVQRWHQRXJKLWLVEDVHGRQWKHRSLQLRQRIH[SHUWV7KHYDOXHRI UHFRPPHQGDWLRQVLVVXPPDUL]HGLQWKH&KDUWEHORZ &KDUW 9DOXHDQGJUDGHRIVWUHQJWKRIDVFLHQWL¿FHYLGHQFHEDVHGUHFRPPHQGDWLRQ
/HYHORI /HYHORIHYLGHQFHWRVXSSRUWWKH UHFRPPHQGDWLRQ UHFRPPHQGDWLRQV ,$WOHDVWRQHUDQGRPL]HGFRQWUROOHGWULDO $5HFRPPHQGHG ZLWKSURJUDPPDWLFODERUDWRU\RUFOLQLFDO 6KRXOGEH DVVHVVPHQWFULWHULD IROORZHG ,,$WOHDVWRQHKLJKTXDOLW\VWXG\RUVHYHUDO VXI¿FLHQWVWXGLHVZLWKSURJUDPPDWLF ODERUDWRU\RUFOLQLFDODVVHVVPHQWFULWHULD %7REHFRQVLGHUHG ,,,2EVHUYDWLRQDOFRKRUWGDWD RQHRUPRUH DSSOLFDEOHLQPRVW SURSHUO\GHVLJQHGDQDO\WLFDORUFDVHFRQWURO VLWXDWLRQV VWXGLHV$VVHVVFDVHVDQGFRQWUROV
,9([SHUWRSLQLRQEDVHGRQWKHDVVHVVPHQWRI &2SWLRQDO RWKHUWHVWV
6RXUFH $GDSWHG IURP ´7KH %ULWLVK +,9$VVRFLDWLRQ %+,9$ WUHDWPHQW JXLGHOLQHV IRU ´ 5R 'HYHORSLQJ DQ HYLGHQFHEDVHG JXLGH WR FRPPXQLW\ SUHYHQWLYH VHUYLFHV ² PHWKRGV :+2 (YLGHQFH1HWZRUN (%0JXLGHOLQHV HYLGHQFHEDVHGPHGLFLQH
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 19 3. INTERVENTIONS FOR THE PRIMARY PREVENTION OF HIV AND SYPHILIS
3.1. Perinatal Electronic System 7KH3HULQDWDO&OLQLFDOUHFRUGLVWKHPRVWYDOXDEOHVRXUFHRIGDWDDYDLODEOHWRWKH KHDOWKWHDPHLWKHUWRNQRZWKHFKDUDFWHULVWLFVRIWKHXVHUVWRHYDOXDWHWKHUHVXOWVRI WKHFDUHSURYLGHGDQGWRFRQGXFWDEURDGUDQJHRIRSHUDWLRQDOUHVHDUFK7KLVUHTXLUHV XVHUIULHQGO\PHFKDQLVPVWKDWIDFLOLWDWHWKHUDSLGVWRUDJHDQGUHWULHYDORIWKHGDWDVR WKH\FDQEHXVHGE\WKHKHDOWKFDUHSURYLGHUVWKHPVHOYHV 7R DGGUHVV WKRVH QHHGV &/$3:53$+2:+2 KDV GHYHORSHG WKH 3HULQDWDO (OHFWURQLF 6\VWHP 6,3 ZKLFK FRQWHPSODWHV DOO WKH DERYHPHQWLRQHG LVVXHV ,W FRQVLVWV RI WKH 3HULQDWDO &OLQLFDO 5HFRUG 3&5 WKH 3HULQDWDO&DUG 3& DQG WKH &RPSXWHUL]HG6\VWHPZLWKVRIWZDUHGHVLJQHGWRSURFHVVWKHLQIRUPDWLRQ ,QDVLQJOHSDJHWKH3&5SXWVWRJHWKHUDVHWRIGDWDRQZKLFKWKHUHLVXQLYHUVDO FRQVHQVXV VXPPDUL]LQJ WKH PLQLPDO LQIRUPDWLRQ LQGLVSHQVDEOH IRU WKH DGHTXDWH FDUHRIWKHSUHJQDQWZRPDQDQGKHUQHZERUQ7KH3&5VHUYHVDVDURDGPDS LWLV LQH[SHQVLYHDQGXVHUIULHQGO\ 7KH SDJH LV EURNHQ GRZQ LQWR VHYHUDO VHFWLRQV WKDW FRQWDLQ WKH GRFXPHQWDWLRQ RQ REVWHWULF HYHQWV DQG GDWD RQ WKH QHZERUQ LQ WKH LPPHGLDWH QHRQDWDO SHULRG $OPRVWDOOWKHTXHVWLRQVLQWKHOLVWRQO\UHTXLUHFORVHGDQVZHUV7KHOD\RXWVHHNV WRIDFLOLWDWHWKHV\VWHPDWLFDQGWLPHO\FROOHFWLRQRIGDWD7KH,QVWUXFWLRQV0DQXDO &/$3:53XEOLFDWLRQ KHOSVHQVXUHWKHXQLIRUPLW\RIWKHUHFRUGVHQWHUHG LQDOOWKHFDVHV 7KH 3&5 FRQWDLQV WKH NH\ GDWD UHTXLUHG IRU WKH PDQDJHPHQW RI PRVW ORZULVN FDVHV 7KHZD\GDWDDUHWUDGLWLRQDOO\SURFHVVHGUHVXOWVLQWKHGHYHORSPHQWRIDQQXDOVWDWLVWLFV WKDWDUHUDUHO\DYDLODEOHWRWKHKHDOWKFDUHSURYLGHUVWKDWJHQHUDWHGWKHLQLWLDOGDWDLQD WLPHO\PDQQHU,WLVIUHTXHQWO\WKHFDVHWKDWE\WKHWLPHWKRVHVWDWLVWLFV¿QDOO\UHDFK WKHPWKHLQIRUPDWLRQFRQWDLQHGWKHUHIDLOVWRPHHWWKHKHDOWKFDUHSURYLGHUV¶QHHGV SUHYHQWLQJWKHPIURPEHQH¿WLQJIURPWKH³IHHGEDFN´WKDWLVLQGLVSHQVDEOHIRUWKH HYDOXDWLRQDQGLPSURYHPHQWRIWKHLUSHUIRUPDQFH7KH3HULQDWDO(OHFWURQLF6\VWHP DGGUHVVHGWKLVLVVXHE\GHYHORSLQJGDWDSURFHVVLQJVRIWZDUHWKDWDOORZVWKHVWDIIDW WKHFHQWHURULJLQDWLQJWKHGDWDWRXVHWKHLURZQLQIRUPDWLRQ
Generations free of HIV and congenital syphilis 20 7KHRSHUDWRUPD\HQWHUWKH3&5GDWDE\¿OOLQJWKHIDFVLPLOHSDJHWKDWDSSHDUVLQWKH FRPSXWHUQRWUHTXLULQJVSHFL¿FRUH[WHQVLYHWUDLQLQJ7KDWZLOOHQDEOHWKH&HQWHU LWVHOIWRSURFHVVDQGDQDO\]HLWVRZQGDWDDQGWKHKHDOWKVWDIIZLOOEHDEOHWRDFFHVV WKHLQIRUPDWLRQZKHQLWLVQHHGHGIDFLOLWDWLQJWKHHYDOXDWLRQRIFDUHDQGGHFLVLRQ PDNLQJ 7KHSURFHVVHGGDWDUHVXOWLQDVHWRIGRFXPHQWVWKDWVXPPDUL]HWKHFHQWHU¶VDFWLYLW\ LQDJLYHQSHULRGDQGWKH\PD\DOVREHHOHPHQWVWREHXVHGIRUIXUWKHUUHVHDUFK 7KH PRVW VDOLHQW FKDUDFWHULVWLFV RI WKH V\VWHP PD\ EH VXPPDUL]HG LQ WKH LWHPV EHORZ 7KH ORFDO SURFHVVLQJ RI GDWD ZLWK WKHVH SURJUDPV VWUHQJWKHQV WKH VHOI HYDOXDWLRQFDSDFLW\RISHULQDWDOFDUHWKURXJKWKHDQDO\VLVRIWKHGDWDDWWKH VDPHKHDOWKFDUHFHQWHU ,WFUHDWHVDZDUHQHVVDPRQJWKHVWDIIRQWKHLPSRUWDQFHRIKDYLQJFRPSUHKHQVLYH GRFXPHQWDWLRQRIWKHKHDOWKUHODWHGDFWLRQVDQGREVHUYDWLRQV ,WIDFLOLWDWHVLQWUDDQGH[WUDLQVWLWXWLRQDOFRPPXQLFDWLRQVIDYRUVFRPSOLDQFH ZLWKVWDQGDUGVUHFRUGVWKHOHJDOO\UHOHYDQWGDWDDQGIDFLOLWDWHVDXGLWLQJ ,WVHUYHVDVWKHEDVLVIRUWKHSODQQLQJRIFDUHSURYLGLQJWKHGDWDUHTXLUHGWR LGHQWLI\WKHSRSXODWLRQHYDOXDWHFDUHFDWHJRUL]HWKHSUREOHPVDQGFRQGXFW WKHRSHUDWLRQDOUHVHDUFK 7KHGDWDEDVHVFDQEHFRQVROLGDWHGDQGDQDO\]HGDWDQDWLRQDOOHYHOWRGHVFULEHWKH VWDWXVRIYDULRXVLQGLFDWRUVLQWLPHSHUJHRJUDSKLFDODUHDVVHUYLFHQHWZRUNVRURWKHU FKDUDFWHULVWLFVRIWKHVSHFL¿FSRSXODWLRQVPDNLQJWKH6,3DYHU\XVHIXOLQVWUXPHQWIRU WKHVXUYHLOODQFHRIPDWHUQDODQGQHRQDWDOHYHQWVDQGIRUWKHHYDOXDWLRQRISURJUDPV DWDQDWLRQDOOHYHO
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 21 7R IDFLOLWDWH WKHVH SURFHVVHV &/$3:03$+2:+2 KDV SUHSDUHG D SUDFWLFH JXLGHOLQH WR PDQDJH WKH 3HULQDWDO (OHFWURQLF 6\VWHP WR VWUHQJWKHQ WKH FDSDFLWLHV RI WKH VWDII DW WKH KHDOWK FDUH FHQWHUV WR PDNH WKH PRVW RI WKH GDWD DYDLODEOH KWWS ZZZSDKRRUJFODS
3.2. Primary prevention of HIV and syphilis in pregnant and non pregnant women
7KHHIIRUWVIRUWKHSUHYHQWLRQRI+,9DQGFRQJHQLWDOV\SKLOLVDUHPRUHHIIHFWLYHLIWKH\ DUHIXOO\LQWHJUDWHGLQWRWKHH[LVWLQJPRWKHUDQGFKLOGDQGIDPLO\SODQQLQJVHUYLFHV 7KHPRWKHUDQGFKLOGVHUYLFHVPXVWEHFDSDEOHRILPSOHPHQWLQJLQWHUYHQWLRQVWR SUHYHQWWKHWUDQVPLVVLRQRIV\SKLOLVDQG+,9IURPWKHPRWKHUWRWKHQHZERUQ ,Q WKH FRQWH[W RI WKH PRWKHUWRFKLOG WUDQVPLVVLRQ RI +,9 DQG V\SKLOLV SULPDU\ SUHYHQWLRQVKRXOGVSHFL¿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
3.3. Preventing unwanted pregnancies
)DPLO\ SODQQLQJ FRXQVHOLQJ PXVW EH LQWHJUDWHG LQ DOO WKH SKDVHV RI WKHUDS\ DQG FDUHRI+,9LQFOXGLQJSUHDQGSRVWWHVWLQJDQGORQJWHUPIROORZXS:RPHQZLWK
Generations free of HIV and congenital syphilis 22 +,9PXVWUHFHLYHFRXQVHOLQJWRHQDEOHWKHPWRFKRRVHWKHFRQWUDFHSWLYHPHWKRGV WKDW EHVW VXLW WKHLU VWDWXV DQG QHHGV WDNLQJ LQWR DFFRXQW WKH VWDJH RI WKH GLVHDVH DQGWKHUDS\DVZHOODVWKHLUSHUVRQDOSUHIHUHQFHVOLIHVW\OH5HJDUGOHVVWKHPHWKRG FKRVHQWKHLQIRUPDWLRQRQWKHWUDQVPLVVLRQRI+,9DQG67,VDQGWKHGXDOSURWHFWLRQ UHTXLUHGVKRXOGEHKLJKOLJKWHGGXULQJWKHIDPLO\SODQQLQJFRXQVHOLQJ 7KHFRQVLVWHQWXVHRIFRQGRPVVKRXOGEHSURPRWHGDPRQJDOOZRPHQZLWK+,9 7KH SURJUDPV PXVW KDYH GDWD DYDLODEOH WR JXLGH ZRPHQ ZLWK +,9 RQ WKH EHVW FRQWUDFHSWLYHFKRLFHVWREHXVHGLQFRPELQDWLRQZLWKWKHFRQGRPEDVHGRQWKHEHVW VFLHQWL¿FHYLGHQFHDYDLODEOH7KLVLQIRUPDWLRQPXVWFRQWDLQWKHUHFRPPHQGDWLRQV EHORZ :RPHQDWFKLOGEHDULQJDJHZLWK+,9FDQXVH,8'VIRUFRQWUDFHSWLRQXW DOZD\VDVVRFLDWHGZLWKFRQGRPV +RUPRQHEDVHGFRQWUDFHSWLYHVDUHQRWUHVWULFWHGLQFOXGLQJFRPELQHGRUDO FRQWUDFHSWLYHV SLOOV FRQWDLQLQJ SURJHVWHURQH DORQH FRPELQHG LQMHFWLRQ FRQWUDFHSWLYHVPHGUR[\SURJHVWHURQHDFHWDWHSDWFKHVFRPELQHGSDWFKHV DQGYDJLQDOULQJ,QDOOFDVHVSRWHQWLDOGUXJLQWHUDFWLRQVPXVWEHERUQHLQ PLQG 3.4. Pre Conception Counseling in HIV+ women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¿FDQWQXPEHURIRUJDQLVPVPD\EHSUHVHQWLQWKHJHQLWDOÀ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
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 23 ZRPDQ¶VF\FOH:KHQERWKPHPEHUVRIWKHFRXSOHDUH+,9 UHLQIHFWLRQZLWK GLIIHUHQWVWUDLQVLVDOVRDFRQFHUQ FRQVHTXHQWO\XQSURWHFWHGLQWHUFRXUVHVKRXOGEH GLVFRXUDJHGWRSUHYHQWWKLVULVN
Generations free of HIV and congenital syphilis 24 4. DIAGNOSIS 4.1. Diagnosis of maternal syphilis
4.1.1. Clinical 6\SKLOLV LV DQ LQIHFWLRXV GLVHDVH FDXVHG E\ 7UHSRQHPD SDOOLGXP LW LV WUDQVPLWWHGVH[XDOO\DQGDFURVVWKHSODFHQWD LWVFRXUVHLVFKURQLFDQGLWLV GLVWULEXWHG ZRUOGZLGH $W SUHVHQW WKH WUDQVIXVLRQUHODWHG URXWH LV DOPRVW QRQH[LVWHQW6H[XDOWUDQVPLVVLRQRFFXUVZKHQWKHFDXVDWLYHDJHQWLVLQRFXODWHG WKURXJKGLVUXSWLRQV DEUDVLRQV RIWKHVNLQRUPXFRVDUHVXOWLQJIURPWKHPLFUR WUDXPDWKDWPD\RFFXUGXULQJWKHVH[XDOLQWHUFRXUVH WKRVHGLVUXSWLRQVZLOO VXEVHTXHQWO\OHDGWRHURVLRQVDQG¿QDOO\WRXOFHUV,IWKHGLVHDVHLVQRWWUHDWHG GXULQJ WKH DFXWH SKDVH LW WXUQV LQWR D FKURQLF FRQGLWLRQ ZLWK SRWHQWLDOO\ VHULRXVPDQLIHVWDWLRQV &OLQLFDOSLFWXUH&OLQLFDOPDQLIHVWDWLRQVRIV\SKLOLVDUHJURXSHGLQWRSHULRGV EDVHGRQWKHLUWLPHRIRFFXUUHQFH D 3ULPDU\V\SKLOLV 7KH KDOOPDUN RI WKLV SHULRG LV WKH VRFDOOHG ³FKDQFUH´ ZKLFK DSSHDUV DIWHU DQ LQFXEDWLRQSHULRG RI DSSUR[LPDWHO\ ZHHNV GD\V 7KH FKDQFUHLVWKHLQLWLDOPDQLIHVWDWLRQRIV\SKLOLVDQGLWLVORFDWHGDWWKHVLWH RI LQRFXODWLRQ RI WKH WUHSRQHPD ,W LV D SDLQOHVV DQG FOHDUFXW HURVLRQ ZLWKURXQGRURYDOUDLVHGULPVDQGDQLQGXUDWHGEDVH,QZRPHQLWPD\ EHGLI¿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
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 25 7KRVHOHVLRQVPD\ODVWIURPDIHZGD\VWRZHHNVDQGWKH\¿QDOO\UHVROYH VSRQWDQHRXVO\ LQ XS WR RQH IRXUWK RI WKH SDWLHQWV KRZHYHU WKH\ PD\ UHFXUVHYHUDOWLPHVWKURXJKRXWWKH¿UVW\HDU&RQG\ORPDODWDVDUHDQRWKHU PDQLIHVWDWLRQRIVHFRQGDU\V\SKLOLV WKH\FDQEHIRXQGLQWKHSHULDQDODUHD JURLQVJHQLWDOLDDQGD[\OOD LQJHQHUDOWHUPVWKH\WHQGWRRFFXURQDQ\ IROGVZKHUHWKHUHLVPRLVWXUHDQGPDFHUDWLRQ OHVLRQVDUHDOVRIRXQGLQWKH RUDOPXFRVD UHGRURIIZKLWHZHOOGH¿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
Generations free of HIV and congenital syphilis 26 ,QYROYHPHQW RI WKH QHUYRXV V\VWHP PD\ EH DOUHDG\ SUHVHQW GXULQJHDUO\ V\SKLOLV DV D UHVXOW RI YDVFXODU LPSDLUPHQW WKLV PD\ EH HYLGHQFHG DV PHQLQJLWLVVHL]XUHVP\HORSDWK\FUDQLDOQHUYHLPSDLUPHQWRUH\HGLVHDVH /DWH QHXURV\SKLOLV UHSUHVHQWV WKH PDQLIHVWDWLRQV DVVRFLDWHG ZLWK FKURQLF V\SKLOLVDQGLWLQFOXGHVGHPHQWLDWDEHVGRUVDOLVSDUHVLVVHQVRULDODWD[LD VSKLQFWHUG\VIXQFWLRQHWF
4.1.2. Laboratory tests for the diagnosis of syphilis D 6HURORJLFDO7HVWLQJ $OO SUHJQDQW ZRPHQ VKRXOG XQGHUJR VHURORJ\ VFUHHQLQJ DW WKHLU ¿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¶V FOLQLFDOUHFRUG'XULQJSUHJQDQF\WKHSUHJQDQWZRPDQ¶VWKHUDS\LVMXVW DVLPSRUWDQWDVKHUVH[XDOSDUWQHU¶V)DLOXUHWRWUHDWWKHFRXSOHLVWKHPDLQ VRXUFHRIUHLQIHFWLRQGXULQJSUHJQDQF\ &RXQVHOLQJVKRXOGEHSURYLGHGDWDOOYLVLWVWRUHGXFHWKHULVNRIDFTXLULQJ V\SKLOLVRU+,9GXULQJSUHJQDQF\
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 27 )LJXUH$OJRULWKPIRUWKHGLDJQRVLVDQGPDQDJHPHQWRI+,9DQGV\SKLOLVLQIHFWLRQ
:RPHQVHHNLQJFDUH :RPHQVHHNLQJFDUHDIWHUODERUVWDUWV IRUSUHJQDQF\FRQWURO ZLWKQRSUHYLRXVSUHJQDQF\YLVLWV
3URYLGHV\VWHPDWLFFRXQVHOLQJ 3URYLGHV\VWHPDWLFFRXQVHOLQJ DQGUDSLGWHVWLQJIRU+,9DQGV\SKLOLV DQGUDSLGWHVWLQJIRU+,9DQGV\SKLOLV
1HJDWLYHVHURORJ\ 3RVLWLYHVHURORJ\ 3RVLWLYHUDSLGWHVW 1HJDWLYH VHURORJ\ +,9DQG 5HSHDW +,9 6\SKLOLV V\SKLOLV +,9DQG 6WDUW07&73LQWUD 7UHDWPHQW SULPDU\ V\SKLOLV DQGSRVWSDUWXP RIZRPDQ SUHYHQWLRQ VHURORJLHV FRPSRQHQWV DQGULVN LQWKHWKLUG KHUFRQWDFWV 3ULPDU\ DVVHVVPHQW WULPHVWHU 3URJUDPWKH DQGQHRQDWH SUHYHQWLRQ 6\SKLOLV HYDOXDWLRQRI 3HQLFLOOLQ $597DQGVHURORJ\ 1HJDWLYHVHURORJ\ +,9 RIWKHSDUWQHUV WKHUDS\ 6WDUW$597 WRPRWKHU 3ULPDU\SUHYHQWLRQ DQGFRQWDFWV
&/$3:03$+2:+2KDVLQFRUSRUDWHGWKHSRVVLELOLW\RIUHFRUGLQJWZRFRQWUROV IRUWKHVFUHHQLQJRIV\SKLOLVLQWKH3HULQDWDO&OLQLFDO5HFRUGFRQVLVWHQWZLWKWKHEHVW HYLGHQFHDYDLODEOHDQGLQNHHSLQJZLWKPRVWVWDQGDUGJXLGHOLQHVLQWKHUHJLRQ7KH ¿UVWWHVWPXVWEHSHUIRUPHGXSRQWKHSDWLHQW¶VLQLWLDOSUHVHQWDWLRQDWWKH¿UVWYLVLW EHIRUH:HHN DQGWKHQH[WVKRXOGEHDWWKHWKLUGWULPHVWHU)LJXUH )LJXUH 'LDJQRVLVDQGWKHUDS\¿OHLQWKH3HULQDWDO&OLQLFDO5HFRUG
6<3+,/,6'LDJQRVLVDQG 7UHDWPHQW 7HVW 7UHDWPHQW 7UHDW QRWUHSRQpPLF WUHSRQpPLF SDUWQHU QG QG QD QR \HV QG QD QR \HV ZHHNV ZHHNV ZN QG QD ZHHNV ZHHNV ZN QR \HV QG QG QD QR \HV QG QD QG QD
7KHVHURORJLFDOGLDJQRVLVRIV\SKLOLVLVEDVHGRQWUHSRQHPLFDQGQRQWUHSRQHPLFWHVWV
Generations free of HIV and congenital syphilis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¿FPRUHFRPSOH[DQGFRVWO\WHVWV WKH\LQFOXGH 73+$ 7UHSRQHPDSDOOLGXPKDHPDJJOXWLQDWLRQDVVD\ 733$ 7UHSRQHPD SDOOLGXP SDUWLFOH DJJOXWLQDWLRQ 0+$73 PLFUR KDHPDJJOXWLQDWLRQ DVVD\ IRU DQWLERGLHV WR 7UHSRQHPD SDOOLGXP DQG )7$$EV ÀXRUHVFHQW WUHSRQHPDODQWLERG\DEVRUSWLRQ 7KH\DUHXVHGWRFRQ¿UPWKHUHVXOWRI DQRQWUHSRQHPLFWHVW7KHPRVWIUHTXHQWO\XVHGWHFKQLTXHVDUH0+$73 DQG)7$$EV 7KHVHWHVWVUHPDLQSRVLWLYHUHJDUGOHVVRIWKHUDS\DQGIDOVHSRVLWLYHVPD\ EHVHHQ OHVVWKDQ LQRWKHUGLVHDVHFDXVHGE\VSLURFKHWHV OHSWRVSLURVLV /\PH¶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¿FLW\DQGWKHUHDUHVRPHFRPSDULVRQVWXGLHVDQG VWXGLHV WKDW PHDVXUH WKHLU FRVWHIIHFWLYHQHVV7KH\ DUH HVSHFLDOO\ XVHIXO ZKHQ QR VWDQGDUG WUHSRQHPLF WHVWV DUH DYDLODEOH :KHQ WKH UDSLG WHVWV DUHSRVLWLYHWKHSDWLHQWPXVWXQGHUJRQRQWUHSRQHPLFWHVWVWKDWDOORZWKH HYDOXDWLRQRIWKHUHVSRQVHWRWKHUDS\E\TXDQWLI\LQJWKDWUHVSRQVH
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 29 E 2WKHUODERUDWRU\WHVWLQJIRUWKHGLDJQRVLVLIV\SKLOLV 8QGHUVSHFLDOFLUFXPVWDQFHVWKHUHDUHRWKHUWHFKQLTXHVWKDWPD\EHXVHIXO DVZHOO DOWKRXJKWKH\DUHXVXDOO\PRUHFRPSOH[DQGOHVVHDVLO\DYDLODEOH DW KHDOWK FDUH FHQWHUV 7KHVH LQFOXGH WKH GDUN ¿HOG H[DPLQDWLRQ ZLWK LPPXQRÀXRUHVFHQFHRIWKHH[XGDWHVLQWKHOHVLRQVKLVWRORJ\RU3&5 &KDUW5HVXOWDQGLQWHUSUHWDWLRQRIWKHVHURORJ\WHVWLQJ 5HVXOW ,QWHUSUHWDWLRQ
17 $EVHQFHRILQIHFWLRQ,IH[SRVXUHLVYHU\UHFHQWLWLV 7 UHFRPPHQGHGWRUHSHDWWKHWHVWV
17 $FWLYHLQIHFWLRQHVSHFLDOO\ZKHQWKHQRQWUHSRQHPLFWHVWWLWHUV DUHKLJK ! /RZWLWHUVPD\UHÀHFWDQROGV\SKLOLVWKDWZDV 7 DOUHDG\WUHDWHG 17 8VXDOO\DQROGLQDFWLYHV\SKLOLVWKDWZDVDOUHDG\WUHDWHG 7 ([FHSWLRQDOO\LWPD\EHDIDOVHSRVLWLYHWUHSRQHPLFWHVW ,WLVUHFRPPHQGHGWRUHSHDWWHVWLQJXVLQJDGLIIHUHQW 17 WUHSRQHPLFPHWKRG LILWLVVWLOOQHJDWLYHWKHQWKHUHVXOWRIWKH 7 QRQWUHSRQHPLFWHVWLVDIDOVHSRVLWLYHDQGWKHFRQFOXVLRQLV WKDWWKHUHLVQRLQIHFWLRQ
17 1RQWUHSRQHPLFWHVW7 WUHSRQHPLFWHVW
4.2. Diagnosis of congenital syphilis 4.2.1. Clinical 7UHSRQHPDSDOOLGXPLVSUHVHQWLQEORRGDWHDUO\VWDJHVDQGLWFDQEHWUDQVPLWWHG WRWKHIHWXV3DVVDJHWKURXJKWKHSODFHQWDXVXDOO\RFFXUVEHWZHHQ:HHNV DQGRISUHJQDQF\DOWKRXJKWKHUHDUHFDVHVUHSRUWHGDVHDUO\DVRQ:HHN $SUHJQDQWZRPDQ¶VRGGVRIWUDQVPLWWLQJWKHGLVHDVHWRWKHIHWXVGHSHQGVRQ WKHSKDVHRILQIHFWLRQEHLQJ GXULQJWKH¿UVW\HDURIWKHGLVHDVHZKHQ WKHUHKDVEHHQQRWKHUDS\DQGWKHQGURSSLQJDWODWHUVWDJHV7KHSURJQRVLVRI FKLOGUHQLQIHFWHGZLWKV\SKLOLVLQXWHUXVLVQRWZHOOHVWDEOLVKHGEXWWKHUDWHRI QHJDWLYHHYHQWVLVHVWLPDWHGWRUDQJHIURPWRLQFOXGLQJDERUWLRQ VWLOOELUWKORZELUWKZHLJKWSUHPDWXULW\DQGQHRQDWDOLQIHFWLRQ
Generations free of HIV and congenital syphilis 30 $OOWKHFKLOGUHQERUQWRPRWKHUVWKDWSUHVHQWHGZLWKV\SKLOLVGXULQJSUHJQDQF\ PXVWEHWHVWHGWRGHWHUPLQHZKHWKHUWKH\VKRZHYLGHQFHRIWKHGLVHDVH 7KHSURFHGXUHVEHORZDUHUHFRPPHQGHGLQDOOFDVHV 3DWKRORJLFDOH[DPLQDWLRQRIWKHSODFHQWD &RPSOHWHSK\VLFDOH[DPLQDWLRQWRLQFOXGHWKHDFWLYHVHDUFKRIWKHOHVLRQV GLVFXVVHGIXUWKHURQ 6HURORJLFDOWHVWLQJ 'DUN¿HOGH[DPLQDWLRQRIWKHFKLOG¶VVHFUHWLRQV ,QWKHFDVHVWKDWPHHWWKHGH¿QLWLRQRIFRQJHQLWDOV\SKLOLVWKHUHFRPPHQGHG WHVWLQJLQFOXGHVDOXPEDUSXQFWXUHWRHYDOXDWHWKH9'5/F\WRORJ\DQG SK\VLFRFKHPLFDOWHVWRIWKHFHUHEURVSLQDOÀXLG &6) 7KLVVKRXOGEHGRQH ZKHQWKHDSSURSULDWHFRQGLWLRQVIRUWKHSURFHGXUHDUHPHW,IWKHOXPEDU WDSLVQRWIHDVLEOHDQGWKHUHLVDVXVSLFLRQRIQHXURORJLFDOLQYROYHPHQWWKH FKLOGPXVWEHWUHDWHGDVLILWZHUHDFDVHRIQHXURV\SKLOLV 2WKHU WHVWV VKRXOG EH FRQVLGHUHG EDVHG RQ WKHLU DYDLODELOLW\ DQG RQ WKH FOLQLFDO VXVSLFLRQ HJ ORQJ ERQH UDGLRJUDSKV RU FKHVW ;UD\V OLYHU IXQFWLRQWHVWVQHXURORJLFDOXOWUDVRXQGHYDOXDWLRQHWF
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
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 31 &16PDQLIHVWDWLRQV DVHSWLFPHQLQJLWLV3DUURW¶VSVHXGRSDUDO\VLV (\HPDQLIHVWDWLRQV FKRULRUHWLQLWLVUHWLQLWLV 2WKHU¿QGLQJV IHYHUKHPRUUKDJLFUKLQRUKHDSDQFUHDWLWLVMDXQGLFH LQÀDPPDWLRQRIWKHJDVWURLQWHVWLQDOWUDFWK\SRSLWXLWDULVPP\RFDUGLWLV +\GURSVIHWDOLV 0DQLIHVWDWLRQVVXJJHVWLQJODWHFRQJHQLWDOV\SKLOLV +XWFKLQVRQ¶VWHHWK ,QWHUVWLWLDONHUDWLWLV 6DGGOHQRVH RO\PSLDQIRUHKHDG *XPPDVRQIHHW ,QYROYHPHQWRIWKH61& PHQWDOUHWDUGDWLRQK\GURFHSKDOXVVHL]XUHV GHDIQHVVDQGEOLQGQHVV 2VWHRDUWLFXODUOHVLRQV &OXWWRQ¶VMRLQWVVDEHUWLELDERQHJXPPDVEHOO VKDSHGVFDSXOD +LJKSDODWHSURWUXGLQJPDQGLEOHPLFURJQDWLDSHULRUDO¿VVXUHV
4.2.2. Serological Diagnosis $V ,J* DQWLERGLHV JR WKURXJK WKH SODFHQWD ERWK WUHSRQHPLF DQG QRQ WUHSRQHPLFWHVWVFDQEHSRVLWLYHZKHQPRWKHUVKDYHV\SKLOLV,QWKHVHFDVHV LWLVUHFRPPHQGHGWRFRQGXFWDVLPXOWDQHRXVDVVHVVPHQWRI9'5/RU535 WRPRWKHUDQGFKLOG WKHXVHRIFRUGEORRGVKRXOGEHDYRLGHGEHFDXVHRIWKH SRWHQWLDO FRQWDPLQDWLRQ ZLWK PDWHUQDO EORRG DQG WR FRQVLGHU SRVLWLYH DQ\ FKLOGZKRVHWLWHUVDUHIRXUIROGWKHLUPRWKHUV¶ IRUH[DPSOHDWLWHURILQWKH PRWKHUDQGLQWKHFKLOG LWLVKRZHYHULPSRUWDQWWRUHPHPEHUWKDW ORZHUWLWHUVGRQRWIXOO\UXOHRXWWKHGLDJQRVLVRIFRQJHQLWDOV\SKLOLV
4.3. Diagnosing the mother’s HIV infection &RXQVHOLQJDQG+,9WHVWLQJDUHDFULWLFDOFRPSRQHQWRIWKH07&73SURJUDPV DQGWKH\DUHNH\IRUWKHLGHQWL¿FDWLRQRIWKHZRPHQWKDWUHTXLUHPHGLFDOFDUH DQG$597 RU 07&7 SUHYHQWLRQ LQWHUYHQWLRQV 3UHJQDQW ZRPHQ PXVW DOVR UHFHLYHLQIRUPDWLRQDQGFRXQVHOLQJRQWKHV\SKLOLVDQG+,9WHVWV$OOSUHJQDQW ZRPHQPXVWXQGHUJRVHURORJLFDOVFUHHQLQJDWWKHLU¿UVWDQWHQDWDOYLVLW,IWKH\ DUHQHJDWLYHWKH\PXVWEHUHSHDWHGLQWKHWKLUGWULPHVWHUDQGDWFKLOGELUWK
Generations free of HIV and congenital syphilis 32 :KHQWKHWHVWUHVXOWVDUHQRWDYDLODEOHEHIRUHGHOLYHU\ IRULQVWDQFHEHFDXVH WKH\ GLG QRW UHFHLYH DQWHQDWDO FDUH FRXQVHOLQJ DQG +,9 WHVWLQJ LGHDOO\ DUDSLGWHVW GXULQJGHOLYHU\RULPPHGLDWHO\DIWHUFKLOGELUWKIDFLOLWDWHWKH SURYLVLRQ RI WKH LQWUDSDUWXP DQG SRVWSDUWXP FRPSRQHQWV RI WKH 07&73 LQWHUYHQWLRQV DQG WKH UDSLG V\SKLOLV WHVW SHUPLWV WKH QHRQDWH¶V HDUO\ WKHUDS\ +HQFHWKHQHHGWRUHLQIRUFHWKHFDSDFLW\WRRIIHUV\VWHPDWLFFRXQVHOLQJDQG +,9DQGV\SKLOLVWHVWVDWDOOFHQWHUVWKDWSURYLGHFDUHWRSUHJQDQWZRPHQDQG ZRPHQDWFKLOGEHDULQJDJHHYHQDWWKHWLPHRIGHOLYHU\6SHFLDOFDUHPXVW EHJLYHQWRWKHZRPHQSUHVHQWLQJZLWKQHJDWLYHVHURORJLHVSURYLGLQJWKHP SULPDU\SUHYHQWLRQVHUYLFHVSDUWLFXODUO\GXULQJSUHJQDQF\DQGODFWDWLRQ ,IWKHUHVXOWVDUHSRVLWLYHWKHZRPDQ¶VVH[XDOFRQWDFWVVKRXOGEHRIIHUHG FRXQVHOLQJDQGVHURORJLFDOWHVWLQJ+,9WHVWVVKRXOGDOZD\VEHSHUIRUPHG ZLWK FRXQVHOLQJ UHVSHFWLQJ FRQ¿GHQWLDOLW\ DQG RQO\ DIWHU REWDLQLQJ WKH SHUVRQ¶VFRQVHQW
4.3.1. Clinical Diagnosis +,9LQIHFWLRQPD\EHDV\PSWRPDWLFIRUVHYHUDO\HDUVIROORZLQJWKHLQIHFWLRQ E\WKHYLUXV$,'6V\PSWRPVRFFXUZKHQWKH&'FRXQWVGURSDQGSDYH WKHZD\IRUDQRSSRUWXQLVWLFLQIHFWLRQ0RVWSUHJQDQWZRPHQZLWKDQ+,9 LQIHFWLRQWKDWVHHNDQWHQDWDOFDUHDUHDV\PSWRPDWLFDQGWKH\PD\QRWEH DZDUHWKDWWKH\KDYHDQ+,9LQIHFWLRQ
4.3.2. Serological Diagnosis +,9WHVWVGHWHFWDQWLERGLHVRUYLUDOPDUNHUVSURGXFHGGXULQJ+,9LQIHFWLRQ LQEORRGRUERG\ÀXLGV0RVW+,9WHVWVUHO\RQWKHGHWHFWLRQRIDQWLERGLHV LQEORRGDQGWKH\GRQRWGHWHFWWKHYLUXVLWVHOI7KLVPHDQVWKDWDWWLPHV SHRSOHUHFHQWO\LQIHFWHGPD\EHUHSRUWHGDV+,9 EHFDXVHRIWKLVSHULRG NQRZQDVWKH³ZLQGRZSHULRG´7KHUHIRUHQHJDWLYHWHVWVQHHGWREHUHSHDWHG ZHHNVDIWHUWKHH[SRVXUH 6HURORJLFDOWHVWVWKDWGHWHFW+,9DQWLERGLHVDUHXVXDOO\EURNHQGRZQLQWR WZRFDWHJRULHV VFUHHQLQJDQGFRQ¿UPDWLRQWHVWV
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 33 D 6FUHHQLQJWHVWV 6FUHHQLQJWHVWVDUHKLJKO\VHQVLWLYHEXWWKH\PD\RFFDVLRQDOO\SUHVHQWIDOVH SRVLWLYHUHVXOWVKHQFHUHTXLULQJFRQ¿UPDWLRQ (Q]\PH/LQNHG,PPXQRDEVRUEHQW$VVD\ (/,6$LVWKHWHVWPRVWIUHTXHQWO\ XVHGWHVWWRGHWHFW+,9DQWLERGLHV7KHIRUPDWKDVEHHQJUDGXDOO\LPSURYHG VLQFHLWVLQWURGXFWLRQ)RXUWKJHQHUDWLRQ+,9WHVWVSHUPLWWRGHWHFWERWK YLUDODQWLERGLHVDQGDQWLJHQV 5DSLG +,9 WHVWV WKHVH DUH VLPSOH WHVWV WKDW GR QRW UHTXLUH VSHFL¿F HTXLSPHQW WKHLUVHQVLWLYLW\DQGVSHFL¿FLW\DUHVLPLODUWR(/,6$IRUWKH VHURORJLFDO GLDJQRVLV RI +,9 LQIHFWLRQ7KHVH WHVWV SHUPLW WR REWDLQ WKH UHVXOWVLQDIHZPLQXWHV E &RQ¿UPDWLRQWHVWV &RQ¿UPDWLRQ WHVWV DUH GHVLJQHG WR SURYLGH D KLJKHU VHQVLWLYLW\ WKDQ WKH VFUHHQLQJWHVWV 7KH:HVWHUQ%ORW :% LVXVHGDVDFRQ¿UPDWLRQWHVWDQGLWLVFRQVLGHUHG WKHJROGVWDQGDUGWRFRQ¿UPWKHSUHVHQFHRIDQWLERGLHVDJDLQVW+,97KH FRPELQDWLRQ RI (/,6$ DQG :% DUH FRQVLGHUHG WKH DOJRULWKP IRU WKH VHURORJLFDOGLDJQRVLVRI+,9 7KHUHDUHVHYHUDOFRQ¿UPDWRU\WHVWVVXFKDV/,$RU,),
6HHDOJRULWKPIRUWKHGLDJQRVLVDQGPDQDJHPHQW RI+,9DQGV\SKLOLVLQIHFWLRQLQ¿JSDJH
4.4. Diagnosis of HIV infection in children
7KHGLDJQRVLVRI+,9LQIHFWLRQLQWKHQHZERUQQHHGVWREHGRQHZLWKLQWKH¿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
Generations free of HIV and congenital syphilis 34 7KHYLURORJLFDOWHVWVSUHIHUUHGIRUFOLQLFDOXVHIRUWKHGLDJQRVLVRI+,9LQIHFWLRQ LQ FKLOGUHQ XQGHU \HDU RI DJH DUH YLUDO ORDG +,9 51$ DQG '1$ 3&5 7KHVH WHVWVLPSO\WKHGHWHFWLRQRISDUWRIWKH+,9¶VJHQRPHDUHWKH\DUHGH¿QLWLYHIRUWKH GLDJQRVLVRI+,9LQIHFWLRQ 7KHFXOWXUHRI+,9RUWKHGHWHFWLRQRIDQWLJHQSDUHPRUHFRVWO\SURFHGXUHVDQG WKH\HQWDLOKLJKHUULVNVWRWKHODERUDWRU\VWDIIVRWKH\DUHQRWUHFRPPHQGHGRWKHU WKDQLQWKHUHVHDUFKFRQWH[WV ,WLVWRQRWHWKDWZKHQFKLOGUHQDFTXLUHWKHLQIHFWLRQDWFKLOGELUWKWKH+,9JHQRPH DVVD\PD\EHQHJDWLYHWKH¿UVWZHHNVRIOLIH7KHYLURORJLFDOGLDJQRVLVLVUHFRPPHQGHG DWZHHNVRIOLIHZKHQWKHVHQVLWLYLW\RIWKLVWHVWUHDFKHV 7RHVWDEOLVKWKH GLDJQRVLVSRVLWLYHWHVWVUHTXLUHFRQ¿UPDWLRQZLWKDVHFRQGYLUDOWHVW7KHFKLOGUHQ H[SRVHG WR +,9 WKDW KDG D QHJDWLYH WHVW DQG ZHUH EUHDVWIHG E\ WKH PRWKHU PXVW XQGHUJRQHZYLURORJLFDOWHVWVZHHNVDIWHUZHDQLQJ )RUFRQVLGHUDWLRQVRQWKHGLDJQRVLVRIFKLOGUHQROGHUWKDQPRQWKVVHH³$QWLUHWURYLUDO 7KHUDS\RI+,9,QIHFWLRQLQ&KLOGUHQ,Q/DWLQ$PHULFDDQGWKH&DULEEHDQ 7RZDUG 8QLYHUVDO$FFHVV´
4.4.1 Polymerase Chain Reaction for the detection of viral DNA 7KLVWHVWGHWHFWVWKH+,9¶VSURYLUDO'1$LQWKHSHULSKHUDOEORRGPRQRQXFOHDU FHOOVDQGLWVKRZVWKDW+,9KDVEHHQSHUPDQHQWO\HPEHGGHGLQWRWKHFKLOG¶V O\PSKRF\WH JHQRPH ,W UHTXLUHV WKH XVH RI SULPHUV FDSDEOH RI DPSOLI\LQJ WKH YDULRXV VXEW\SHV RI +,9 ,W ZLOO UHPDLQ SRVLWLYH HYHQ DIWHU WKH PRWKHU DQGQHRQDWHUHFHLYHFRPELQHG$5977KHVHQVLWLYLW\RID3&5WHVWIRUWKH GHWHFWLRQRIWKHYLUDO'1$ +,9'1$3&5 SHUIRUPHGZLWKLQWKH¿UVW KRXUVRIOLIHLV EXWLWLQFUHDVHVXSWR! DIWHUZHHNV,QRWKHU VHWWLQJVWKH¿UVWYLURORJLFDOWHVWLVUHFRPPHQGHGDWZHHNVWRDOORZIRUDQ HDUOLHUGLDJQRVLV
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 35 4.4.2 Viral RNA detection
7KLVWHVWGHWHFWVWKH+,951$LQSODVPDGLUHFWO\UHÀHFWLQJWKHGHJUHHRI YLUDOUHSOLFDWLRQDQGLWLVMXVWDVVHQVLWLYHDVWKH+,9'1$3&5IRUWKHHDUO\ GHWHFWLRQRI+,9LQIHFWLRQLQH[SRVHGFKLOGUHQ,WVVHQVLWLYLW\LVWKH ¿UVWZHHNEXWUDLVHVWR DWWKHDJHRIPRQWKV 7KHVSHFL¿FLW\ KDVEHHQUHSRUWHGWREHVLPLODUWRWKH'1$3&5WHVWLQYLUHPLDVZLWK+,9 51$ WKDW H[FHHG FRSLHVPO EXW WKLV DVSHFW VKRXOG EH LQWHUSUHWHG ZLWKFDXWLRQLQFKLOGUHQERUQWRPRWKHUVWKDWZHUHRQ$597XQWLOWKHHQG RI JHVWDWLRQ DQG QHRQDWHV WKDW UHFHLYH FRPELQHG$597 EHFDXVH WKH YLUDO SODVPDORDG 93/ FRXOGEHQHJDWLYHDVDFRQVHTXHQFHRIWKHDQWLUHWURYLUDO WKHUDS\7KHDVVHVVPHQWVKRXOGEHFRQGXFWHGDWOHDVWZHHNWRGD\VDIWHU GLVFRQWLQXLQJQHRQDWDODQWLUHWURYLUDOSURSK\OD[LV
)LJXUH$OJRULWKPIRUWKHGLDJQRVLVRI+,9LQIHFWLRQLQFKLOGUHQ
&KLOGRIDQ+,9LQIHFWHGPRWKHU
1REUHDVWIHHGLQJ %UHDVWIHHGLQJ
PRQWKV !PRQWKV
9LURORJ\WHVWLQJ &RQYHQWLRQDO &RQGXFWUHJXODU DWZHHNV VHURORJ\WHVWLQJ YLURORJ\WHVWLQJ 6FUHHQLQJWHVW GXULQJ 3RVLWLYH 1HJDWLYH IROORZHGE\ EUHDVWIHHGLQJ FRQILUPHGWHVW WKHODVWWHVWVKRXOG &RQILUPDIWHU 5HSHDWDW EHGRQHZHHNV ZHHN PRQWKVLI 3RVLWLYH 1HJDWLYH DIWHUDEVROXWH LWLVDYDLODEOH ZHDQLQJ 3RVLWLYH 1HJDWLYH 5HSRUW 5HSRUW 3RVLWLYH 1HJDWLYH 5HSRUWQHJDWLYH 5HSRUW 3RVLWLYH 5HFRPPHQG (/,6$DWPRQWK
,QWKHFDVHRIDQLQFRPSDWLEOHUHVXOW IRUH[DPSOHDQHJDWLYHUHVXOWDIWHUDSRVLWLYHUHVXOWRUD SRVLWLYHUHVXOWDIWHUDQHJDWLYHRQH DQHZVDPSOHLVUHTXLUHGIRUFRQ¿UPDWLRQ
Generations free of HIV and congenital syphilis 36 5. CLINICAL MANAGEMENT
5.1. Syphilis
5.1.1. Treatment of maternal syphilis 7KHWKHUDS\RIV\SKLOLVLQWKHSUHJQDQWZRPDQVKRXOGEHVWDUWHGLPPHGLDWHO\ DIWHUREWDLQLQJWKHUHVXOWRIDSRVLWLYHVFUHHQLQJWHVWSUHIHUDEO\DWWKH¿UVW OHYHORIFDUHXQOHVVWKHZRPDQ¶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
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 37 0DQDJLQJSDWLHQWVZLWKDSRWHQWLDODOOHUJ\WRSHQLFLOOLQ 7KHUHDUHQRDOWHUQDWLYHVWRSHQLFLOOLQZLWKSURYHQHI¿FDF\IRUWKHWUHDWPHQW RIQHXURV\SKLOLVFRQJHQLWDOV\SKLOLVV\SKLOLVLQSUHJQDQWZRPHQDQG+,9 SDWLHQWV 2Q WKH RWKHU KDQG UHSHDWLQJ WKH DGPLQLVWUDWLRQ RI SHQLFLOOLQ WR D SDWLHQW ZLWK SUHYLRXV KLVWRU\ RI DOOHUJ\ PLJKW FDXVH VHYHUH DQG LPPHGLDWH UHDFWLRQV ,WLVHVWLPDWHGWKDWRIWKHSHRSOHWKDWUHSRUWVHYHUHDOOHUJLFUHDFWLRQVWR SHQLFLOOLQFRQWLQXHWREHDOOHUJLF:LWKWLPHPRVWRIWKHPZLOOVWRSSURGXFLQJ SHQLFLOOLQVSHFL¿F(LPPXQRJOREXOLQV,ILWZHUHSRVVLEOHWRGHWHUPLQHWKDWWKH VSHFL¿F,J(VKDYHFOHDUHGWKHVHSHRSOHFRXOGEHWUHDWHGZLWKSHQLFLOOLQVDIHO\ 7KHUHDUHVNLQWHVWVZLWKPDMRUDQGPLQRUGHWHUPLQDQWVIRUSHQLFLOOLQDOOHUJ\ WKDWFRXOGHIIHFWLYHO\LGHQWLI\WKHSHRSOHDWDKLJKULVNRIGHYHORSLQJDUHDFWLRQ DJDLQVWSHQLFLOOLQ
'HVHQVLWL]DWLRQ 7KH SDWLHQWV ZLWK D SRVLWLYH WHVW WR DQ\ RI WKH SHQLFLOOLQ GHWHUPLQDQWV FDQ EHGHVHQVLWL]HG7KHSURFHVVLVUHODWLYHO\VDIHEXWFXPEHUVRPHDQGLWPD\ EH GRQH RUDOO\ RU LQWUDYHQRXVO\ &KDUW HYHQ ZKHQ WKH WZR IRUPV RI GHVHQVLWL]DWLRQKDYHQRWEHHQFRPSDUHGWKHRUDOIRUPVHHPVWREHVDIHUDQG HDVLHU'HVHQVLWL]DWLRQPXVWEHXQGHUWDNHQDWKRVSLWDOVHWWLQJVVLQFHDOWKRXJK WKH\DUHUDUHDOOHUJLFUHDFWLRQVPD\RFFXU7KHSURFHGXUHPD\EHFRPSOHWHGLQ IRXUKRXUVDIWHUZKLFKWKHSDWLHQWLVDGPLQLVWHUHGWKH¿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
Generations free of HIV and congenital syphilis 38 &KDUW 3URWRFROIRURUDOGHVHQVLWL]DWLRQIRUSDWLHQWVZLWKDSRVLWLYHVNLQWHVW
3HQLFLOOLQ9 $PRXQW $FFXPXODWHGGRVH VXVSHQVLRQ ,8P, POO ,8 ,8
2EVHUYDWLRQSHULRG PLQXWHVEHIRUHWKHSDUHQWHUDODGPLQLVWUDWLRQRISHQLFLOOLQ 6RXUFH :HQGHO *2 -U 6WDUN %- -DPLVRQ 5% 0HOLQD 5' 6XOOLYDQ 7- 3HQLFLOOLQ DOOHUJ\ DQG GHVHQVLWL]DWLRQLQVHULRXVLQIHFWLRQVGXULQJSUHJQDQF\1(QJO-0HG 7KHLQWHUYDOEHWZHHQGRVHVLVPLQXWHV WLPHHODSVHGKRXUVDQGPLQXWHV DFFXPXODWHGGRVH PLOOLRQXQLWV 7KHVSHFLÀFDPRXQWRI SHQLFLOOLQLVGLOXWHGLQDSSUR[LPDWHO\PORI ZDWHUDQGWKHQJLYHQRUDOO\
5.1.2. Treating children with congenital syphilis $OOWKHFKLOGUHQZLWKWKHIHDWXUHVEHORZ &OLQLFDOHYLGHQFHRIFRQJHQLWDOV\SKLOLV $V\QWRPDWLF EXW ZKRVH PRWKHU GLG QRW UHFHLYH DGHTXDWH WKHUDS\ IRU PDWHUQDOV\SKLOLV
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 39 $V\QWRPDWLFDQGZKRVHPRWKHUZDVDGHTXDWHO\WUHDWHGEXWZKRSUHVHQWV 535RU9'5/WLWHUVKLJKHU IROG WKDQWKHPRWKHU¶V $V\QWRPDWLFDQGZKRVHPRWKHUZDVDGHTXDWHN\WUHDWHGEXWWKHUHDUHQR TXDQWL¿HGWLWHUVWRFRPSDUHZLWKWKHPRWKHU¶V 7KH\PXVWUHFHLYHWKHUDS\ZLWKDTXRXVFU\VWDOOLQHSHQLFLOOLQ* XQLWV .JHYHU\KRXUV .JGD\ WKH¿UVWGD\VRIDJHFRQWLQXLQJWKHQ ZLWK XQLWVNJ HYHU\ KRXUV NJGD\ XQWLO GD\V DUH FRPSOHWHG,QWKHFDVHRIFKLOGUHQWKDWSUHVHQWHGQHXURORJLFDOPDQLIHVWDWLRQV WKHUDS\PXVWEHPDLQWDLQHGIRUGD\V,IQHXURV\SKLOLVKDVEHHQUXOHGRXWDQ DOWHUQDWLYHWKHUDS\PD\EHFRQVLGHUHGZLWK,0SURFDLQHSHQLFLOOLQDWD XNJGRVHDWVLQJOHGDLO\GRVHVIRUWRGD\V 7KHDV\PSWRPDWLFFKLOGUHQERUQIURPPRWKHUVZLWKV\SKLOLVWUHDWHGDGHTXDWHO\ DQGZKRVH535RU9'5/WLWHUVDUHVLPLODURUORZHUWKDQWKHPRWKHU¶VVKRXOG UHFHLYHRQHVLQJOHGRVHRIEHQ]DWKLQHSHQLFLOOLQ*DWXQLWVNJUHJDUGOHVV RIWKHWKHUDS\UHFHLYHGE\WKHPRWKHUDQGZLWKRXWDQ\IXUWKHUWHVWLQJ
5.2. HIV INFECTION
5.2.1. Clinical and immunologic evaluation of HIV+ pregnant women: indication to start ARVT :KHQDSUHJQDQWZRPDQLVIRXQGWREH+,9KHUFOLQLFDOVWDWXVDQG&' FRXQWPXVWEHHYDOXDWHGWRGHWHUPLQHWKHULJKWPRPHQWWRVWDUWWKHUDS\ 7KHYLUDOORDGWHVWLVDYDLODEOHLQPRVWFRXQWULHVLQWKHUHJLRQ,WLVQRW FRQVLGHUHGLQGLVSHQVDEOHEHIRUHVWDUWLQJWKHUDS\EXWZKHQLWLVDYDLODEOH LW SURYLGHV VLJQL¿FDQW LQIRUPDWLRQ WKDW ZLOO EHFRPH UHOHYDQW DW IROORZ XS7KHYLUDOORDGSHUPLWVWRHYDOXDWHWKHHI¿FDF\RIWKHUDS\DQGZKHQ LWLVKLJKHUWKDQFRSLHVPODWWKHHQGRISUHJQDQF\LWVXSSRUWVWKH GHFLVLRQIRUGHOLYHU\E\HOHFWLYHFHVDUHDQVHFWLRQ ,I WKH ZRPDQ PHHWV WKH FOLQLFDO DQGRU LPPXQRORJLFDO FULWHULD WR VWDUW WKHUDS\VKHVKRXOGEHVWDUWHGRQ$597DVVRRQDVSRVVLEOH,IWKHZRPDQ LVQRWHOLJLEOHWRLQLWLDWHIRUWKHUDS\EHFDXVHRIKHURZQKHDOWKVKHVKRXOG EHVWDUWHGRQ$597DVSURSK\OD[LVRI07&7RI+,9DVVRRQDVSRVVLEOH DIWHU:HHN ,QSUHJQDQWZRPHQ$597SURWHFWVWKHPRWKHUDQGKXJHO\UHGXFHVWKHULVN RI07&7SDUWLFXODUO\LQFDVHVRIDGYDQFHGLVHDVH7KHLVVXHVWKDWPXVW
Generations free of HIV and congenital syphilis 40 EHWDNHQLQWRDFFRXQWZKHQVWDUWLQJ$597LQFOXGHWKHIHWXV¶VJHVWDWLRQDO DJHWKHSRWHQWLDOHIIHFWVRILQWUDXWHULQHH[SRVXUHWRGUXJVDQGWKHDGYHUVH HIIHFWVRI$597LQWKHSUHJQDQWZRPDQ7KHREMHFWLYHRI$597LVWRIXOO\ VXSSUHVVWKHYLUDOORDGWRDYRLGWKHULVNRIWUDQVPLVVLRQDQGPLQLPL]HWKH ULVNRIRFFXUUHQFHRI$59UHVLVWDQFH 7KH¿UVWOLQHJXLGHOLQHUHFRPPHQGHGIRUWKHSUHJQDQWZRPHQWKDWUHTXLUH WKHUDS\DQGSUHVHQWZLWKOHVVWKDQ&'FHOOVPP LV EDVHG RQ WZR 157,V XVXDOO\$=77& ZLWK193 ,WLVWRQRWHWKDWLQZRPHQSUHVHQWLQJZLWKPRUHWKDQ&'FHOOVPP WKHXVHRI193PD\EHDVVRFLDWHGZLWKDKLJKHUWR[LFLW\$OWKRXJKWKHUH DUHVHYHUDORSWLRQVDYDLODEOHLQWKDWVFHQDULR3,VDUHWKHSUHIHUUHGFKRLFH RWKHUDOWHUQDWLYHVLQFOXGHXVLQJ193XQGHUFORVHPRQLWRULQJRIWKHSDWLHQW WKH¿UVWZHHNVRIWKHUDS\RUWRFKRRVHDUHJLPHQZLWK157,V7KH 157,JXLGHOLQHKDVSURYHQWREHOHVVHIIHFWLYHVRLWVXVHPXVWEHOLPLWHG WRVSHFLDOVLWXDWLRQV
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¿UVWOLQHUHJLPHQ7KHG7GG,FRPELQDWLRQLVFRQWUDLQGLFDWHGLQSUHJQDQF\ GXHWRWKHLQFUHDVHGULVNRIPDWHUQDOGHDWKDVDUHVXOWRIODFWLFDFLGRVLVDQG OLYHUIDLOXUH *LYHQWKHODFNRILQIRUPDWLRQRQWKHXVHRI7') QXFOHRWLGHDQDORJ LQ SUHJQDQF\DQGWKHFRQFHUQRYHUSRWHQWLDOGHOHWHULRXVHIIHFWVRQWKHIHWDO
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 41 ERQHV 7') PXVW EH FRQVLGHUHG D FRPSRQHQW RI WKH LQLWLDO $597 IRU SUHJQDQWZRPHQZKHQRWKHURSWLRQVDUHQRWDYDLODEOH
E &KRRVLQJWKH1RQ1XFOHRWLGH5HYHUVH7UDQVFULSWDVH,QKLELWRU 193LVWKH1157,RIFKRLFHIRU$597GXULQJSUHJQDQF\EHFDXVHRIWKH FRQVLGHUDEOH H[SHULHQFH DYDLODEOH RI LWV XVH LQ SUHJQDQW ZRPHQ DQG LWV HI¿FDF\UHGXFLQJ07&76SHFLDODWWHQWLRQPXVWEHSDLGWRLWVSRWHQWLDO WR[LFLW\HVSHFLDOO\KHSDWLWLVLQZRPHQWKDWVWDUW$597ZLWKDO\PSKRF\WH FRXQWRIRYHU&'PP :KHQ$597LVVWDUWHGZLWK193LQDSUHJQDQWZRPDQZLWKD&'FRXQW KLJKHUWKDQPPLWLVDGYLVDEOHWRPRQLWRUFORVHO\ERWKFOLQLFDODQG ODERUDWRU\SDUDPHWHUVGXULQJWKH¿UVWZHHNVRIWKHUDS\0RUHRYHUWKH ZRPDQVKRXOGEHLQIRUPHGDERXWWKHV\PSWRPVWKDWZDUUDQWXUJHQWFDUH MDXQGLFHVNLQUDVKIHYHURUDEGRPLQDOSDLQ VFKHGXOLQJPRUHIUHTXHQW YLVLWVGXULQJWKH¿UVWZHHNVRIWKHUDS\ HYHU\WZRZHHNV DQGDVVHVVWKH OLYHUHQ]\PHVDWEDVHOLQHDQGGXULQJWKH¿UVWZHHNV IRUH[DPSOHDW ZHHNVDQG LQFDVHRIRFFXUUHQFHRIV\PSWRPV,IOLYHUHQ]\PHV UHDFKJUDGHRU $/7RU$67!WLPHVWKHLUXSSHUQRUPDOOLPLW ZLWKQR RWKHUSRWHQWLDOFDXVH193VKRXOGEHGLVFRQWLQXHGSHUPDQHQWO\FKDQJLQJ LWIRUDQRWKHUDQWLUHWURYLUDO193VKRXOGDOVREHGLVFRQWLQXHGLIWKHSDWLHQW VKRZVV\PSWRPVRIOLYHUWR[LFLW\DQGWKHUHLVQRDFFHVVODERUDWRU\WHVWV RULIWKHSDWLHQWSUHVHQWVZLWKDVHYHUHVNLQUDVK ()9 VKRXOG QRW EH XVHG GXULQJ WKH ¿UVW WULPHVWHU RI SUHJQDQF\ H[FHSW XQGHUH[FHSWLRQDOFRQGLWLRQVZKHQWKHEHQH¿WMXVWL¿HVWKHSRWHQWLDOULVNWR WKHIHWXVVXFKDVIRULQVWDQFHZKHQWKHUHDUHQRRWKHUWKHUDSHXWLFRSWLRQV DYDLODEOHDQGWKHZRPDQPHHWVWKHFULWHULDIRUVHYHUHGLVHDVH
Generations free of HIV and congenital syphilis 42 5HFRPPHQGDWLRQVIRUVWDUWLQJ$59WKHUDS\LQZRPHQ $OOSUHJQDQWZRPHQZLWK$59LQGLFDWLRQVKRXOGUHFHLYH$597 $,, $597PXVWEHVWDUWHGDVVRRQDVWKHFOLQLFDORULPPXQRORJLFDO LQGLFDWLRQKDVEHHQGH¿QHG $,9 :RPHQQRWUHTXLULQJ$597IRUWKHLURZQKHDOWKZLOOEHVWDUWHGRQ $597UHJDUGOHVVRIWKHLUFOLQLFDOVWDWXVDQGLPPXQHFRXQWDVVRRQ DVSRVVLEOHDIWHUZHHNRISUHJQDQF\DVDQ+,907&7SURSK\ODFWLF PHDVXUH $,, 7KH¿UVWOLQH$597SODQVSUHIHUUHGIRUSUHJQDQWZRPHQDUH $=77& 193RU$=77&3, /39URU649U $,, 3ODQLQFOXGLQJ3, 3ODQLQFOXGLQJ193RQO\LIDFORVHFOLQLFDODQGDQDO\WLFDOWHVWLQJ FDQEHDVVXUHGIRUWKHQH[WZHHNV 3ODQZLWK157,V *XLGHOLQHVZLWK157,VDUHOHVVSRZHUIXOWKDQ 3,RU,117EDVHGSODQV &RQVLGHUXVLQJ7')DVDFRPSRQHQWRIWKHLQLWLDO$597RQO\ZKHQ WKHUHDUHQRRWKHUDOWHUQDWLYHVDYDLODEOHRUZKHQWKHH[LVWLQJRQHVDUH FRQWUDLQGLFDWHG &,9
5.2.2. Women that get pregnant while on ARVT 7KH SULPDU\ FRQFHUQ ZLWK ZRPHQ WKDW JHW SUHJQDQW ZKLOH RQ$597 LV WR PDLQWDLQ WKHLU KHDOWK VWDWXV DQG WR HQVXUH WKH\ UHFHLYH DQ DGHTXDWH WUHDWPHQW,WLVWKHQQHFHVVDU\WRHYDOXDWHWKHJHVWDWLRQDODJHWKHZRPDQ¶V FOLQLFDOVWDWXVDQGWKHQHHGWRPDNHDGMXVWPHQWVWRKHUWKHUDS\ :KHQ SUHJQDQF\ LV GHWHFWHG LQ WKH ¿UVW WULPHVWHU WKH SRWHQWLDO ULVNV DQG EHQH¿WV RI DQWLUHWURYLUDO GUXJV ERWK IRU WKH ZRPDQ DQG WKH FKLOG¶V IXWXUH WKH ULVN RI 07&7 DQG WKRVH ULVNV UHVXOWLQJ IURP LQWUDXWHULQH H[SRVXUH RI$59V QHHG WR EH FRQVLGHUHG ,Q WKH 86$ WKH UHJLVWU\ RI PRWKHUVWKDWUHFHLYHG$597GXULQJSUHJQDQF\ $QWLUHWURYLUDO3UHJQDQF\ 5HJLVWU\ HYDOXDWHGWKHULVNRIFRQJHQLWDOPDOIRUPDWLRQVLQGXFHGE\WKH DQWLUHWURYLUDOVFRQFOXGLQJWKDWWKHSUHYDOHQFHRIFRQJHQLWDOPDOIRUPDWLRQV ZDVQRWKLJKHUWKDQWKDWRIWKHJHQHUDOSRSXODWLRQ 7KH$59PHGLFDWLRQ WKDWSRVHVPRUHFRQFHUQLV()96LJQL¿FDQWFRQJHQLWDOGHIHFWVKDYHEHHQ
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 43 UHSRUWHGLQWKHFHQWUDOQHUYRXVV\VWHPRIPRQNH\VH[SRVHGLQXWHURWR ()9 FRQFHQWUDWLRQV VLPLODU WR WKRVH UHDFKHG LQ KXPDQV DW WKH VWDQGDUG WKHUDSHXWLF GRVH$GGLWLRQDOO\ WKHUH DUH IRXU FDVHV UHSRUWHG RI FKLOGUHQ H[SRVHG WR ()9 GXULQJ WKH ¿UVW WULPHVWHU WKDW SUHVHQWHG LPSRUWDQW QHXURORJLFDO GHIHFWV 7KHUHIRUH WKLV GUXJ VKRXOG QRW EH XVHG LQ ZRPHQRIFKLOGEHDULQJDJHZKHQWKHXVHRIDQHIIHFWLYHFRQWUDFHSWLYH PHWKRGFDQQRWEHDVVXUHGWRSUHYHQWWKHULVNRIWHUDWRJHQLFLW\LQFDVHWKH\ JHWSUHJQDQW :KHQ SUHJQDQF\ LV GHWHFWHG GXULQJ WKH ¿UVW WULPHVWHU LQ D ZRPDQ RQ ()9WKLVGUXJVKRXOGEHUHSODFHGIRU1HYLUDSLQH 193 RUDSURWHDVH LQKLELWRU 3, RUIRUDQRWKHUQXFOHRWLGHVXFKDVDEDFDYLU:KHQ193LV XVHGWRUHSODFH()9WKHSDWLHQWVPXVWEHFORVHO\PRQLWRUHGWKH¿UVW ZHHNVRIWKHUDS\SDUWLFXODUO\WKRVHZRPHQZLWKDJRRGLPPXQHUHVSRQVH &'!O\PSKRF\WHVPP WRWKH()9EDVHGUHJLPHQ,QWKHVHFDVHV WKHZRPHQVKRXOGVWDUWGLUHFWO\ZLWKDGRVHRI193RIPJWZLFHD GD\EHFDXVHWKHVWHSZLVHGRVDJLQJKDVEHHQDVVRFLDWHGWRVXEWKHUDSHXWLF FRQFHQWUDWLRQVRIWKHGUXJ :KHQSUHJQDQF\LVGHWHFWHGDIWHUWKH¿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
Generations free of HIV and congenital syphilis 44 5HFRPPHQGDWLRQIRUZRPHQZLWK+,9WKDWJHWSUHJQDQWZKLOHRQ $597 $YRLGWKHXVHRI()9LQZRPHQDWFKLOGEHDULQJDJHWKDWGRQRWXVHRU WKDWGRQRWKDYHDFFHVVWRDQHIIHFWLYHFRQWUDFHSWLYHPHWKRG $,9 :RPHQWKDWDUHUHFHLYLQJ$597ZLWK()9 D ,ISUHJQDQF\LVGHWHFWHGGXULQJWKH¿UVWWULPHVWHU &KDQJH()9IRU193DQGPRQLWRUFORVHO\DOOWKHZRPHQZLWK &'FRXQWV!FHOO PP EHFDXVHRIWKHWR[LFLW\ULVN $,9 RU 5HSODFH()9IRUD3, /39U649U $,9 RU 5HSODFH()9IRUDQRWKHU157, HJ $%& %,9 7KHJXLGHOLQHVZLWK157,VDUHOHVVSRZHUIXOWKDQWKRVH EDVHGRQ3,VRU1157, E ,ISUHJQDQF\LVGHWHFWHGGXULQJWKHVHFRQGRUWKLUGWULPHVWHUDQGWKH WKHUDS\KDVEHHQHIIHFWLYHWKH\VKRXOGFRQWLQXHZLWK()9 $,9 :RPHQ UHFHLYLQJ 7') LQ D VHFRQG OLQH WKHUDS\ WKH EHQH¿WV RI PDLQWDLQLQJ LW SUREDEO\ PDNH XS IRU WKH ULVN RI WR[LFLW\ LQ WKH FKLOG UHSODFHPHQWRIWKLVGUXJLVQRWUHFRPPHQGHG $,9 ,QHYHU\FDVH D ,QFOXGH$=7LQWKHPRWKHU¶VWKHUDS\VFKHPH $,9 E ,QGLFDWHWKHLQWUDDQGSRVWSDUWXPFRPSRQHQWVRI07&73 $,9
5.2.3. Antiretroviral MTCTP prophylaxis ,IWKHZRPDQLVQRWXQGHU$597DQGGRHVQRWPHHWWKHFOLQLFDODQGRU LPPXQRORJLFDOFULWHULDWRVWDUW$597VKHVKRXOGUHFHLYHWKHPRVWHIIHFWLYH SURSK\OD[LVSRVVLEOH6LQFHWKH\HDU ZKHQWKH3$&7*VWXG\ ZDVSXEOLVKHGPXOWLSOHVWXGLHVKDYHVKRZQWKHEHQH¿WRIDQWLUHWURYLUDO LQWHUYHQWLRQVLQWKHSUHYHQWLRQRIPRWKHUWRFKLOGWUDQVPLVVLRQRI+,9 7KHHYLGHQFHDYDLODEOHVKRZVWKHJUHDWHUHI¿FDF\RIWKH UHJLPHQVXVLQJWULSOHWKHUDS\YHUVXVWKHRWKHURSWLRQV DQGPDQ\ FRXQWULHVLQWKHUHJLRQKDYHDGRSWHGWKLVVFKHPHDVWKHVWDQGDUG307&7 LQWHUYHQWLRQV %\ LPSOHPHQWLQJ WKHVH JXLGHOLQHV LQ DGGLWLRQ WR WKH UHSODFHPHQW RI PDWHUQDOEUHDVWIHHGLQJDQGFHVDUHDQVHFWLRQVLQWKHFDVHVWKDWUHTXLUHLW
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 45 WKHWUDQVPLVVLRQUDWHKDVEHHQUHGXFHGWRXQGHU &OLQLFDOVFHQDULRV UHFRPPHQGDWLRQV D :RPHQZLWK+,9DQGZLWKQR$597DQGZLWKQRLQGLFDWLRQWRUHFHLYHLW DQGVHHNLQJFDUHHDUO\LQSUHJQDQF\ 7KHSURSK\ODFWLFUHJLPHQFKRVHQIRUZRPHQZLWK+,9LQIHFWLRQLV$597 VWDUWLQJ RQ WKH VHFRQG WULPHVWHU DQG GLVFRQWLQXLQJ DIWHU GHOLYHU\ 7KLV DSSURDFKUHGXFHVWKHHIIHFWLYHULVNRI07&7ZLWKDORZULVNRIRFFXUUHQFH RIUHVLVWDQFHDQGSUHVHUYLQJWKHRSWLRQVRIFDUH
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
Generations free of HIV and congenital syphilis 46 VKRXOGEHGLVFRQWLQXHGMRLQWO\DIWHUGHOLYHU\ )RUWKHFKLOG DGPLQLVWHU$=7LQV\UXSIURPWRKRXUVDIWHUFKLOGELUWK DWGRVDJHVRIPJNJHYHU\KRXUVIRUDWOHDVWZHHNV E :RPHQZLWK+,9DQGQDwYHRIWKHUDS\WKDWSUHVHQWDWWKH¿QDOVWDJHV RISUHJQDQF\DQGODERU 7KH HI¿FDF\ RI WKH LQWHUYHQWLRQV LV UHGXFHG ZKHQ WKH ZRPDQ GRHV QRW KDYHDQDGHTXDWHDQWHQDWDOFDUH:RPHQWKDWSUHVHQWDWWKH¿QDOVWDJHV RI SUHJQDQF\ PXVW EH LPPHGLDWHO\ VWDUWHG RQ D FRPELQHG SURSK\ODFWLF UHJLPHQDQGWKHFHVDUHDQVHFWLRQVKRXOGEHVFKHGXOHG ,I WKH ZRPDQ SUHVHQWV DW FKLOGELUWK LQWUDSDUWXP DQG SRVWSDUWXP FRPSRQHQWVPXVWEHDGPLQLVWHUHGHYHQLIWKHRSSRUWXQLW\WRLQGLFDWHWKH SUHSDUWXPFRPSRQHQWKDVEHHQPLVVHG,QWKHFDVHRISUHJQDQWZRPHQWKDW GRQRWVHHNDQWHQDWDOFDUHWKHUDSLGWHVWVDQGWKH307&7LQWUDSDUWXPDQG SRVWSDUWXPFRPSRQHQWVKHOSSUHYHQWQHZLQIHFWLRQVDQGUHGXFHWKHWRWDO KHDOWKFRVWFRPSDUHGWRQRWXQGHUWDNLQJWKHVHWZRLQWHUYHQWLRQV
7KHUHJLPHQRIFKRLFHLQFOXGHV ,QWUDSDUWXP&RPSRQHQW 7KHZRPDQVKRXOGLPPHGLDWHO\VWDUWDQLQWUDYHQRXVORDGLQJGRVHRI$=7 DWPJNJLQKRXUDQGRQHPJ193&RQWLQXHZLWKDFRQWLQXRXV LQWUDYHQRXVLQIXVLRQRI$=7DWPJNJKRXUXQWLOWKHWLPHRIFKLOGELUWK ,IODERUKDVQRWVWDUWHG\HWRULIWKHPRWKHUKDVQRWUXSWXUHGPHPEUDQHV FKLOGELUWKVKRXOGSUHIHUDEO\EHWKURXJKVFKHGXOHGFHVDULDQVHFWLRQ 3RVWSDUWXP&RPSRQHQW )RUWKHPRWKHU ,I193ZDVDGPLQLVWHUHGFRQWLQXHZLWK$=77& PJ HYHU\ KRXUV IRU GD\V IRU D ZHHN WR UHGXFH WKH ULVN RI 1157,UHVLVWDQFH )RUWKHFKLOG $=7193ZLWKWKHJXLGHOLQHEHORZ $=7V\UXSKRXUVDIWHUFKLOGELUWKDWDGRVHRIPJNJHYHU\KRXUV IRUZHHNV 193 LIWKHPRWKHUKDVQRWUHFHLYHGWKLVGUXJGXULQJGHOLYHU\DGPLQLVWHU RQH¿UVWPJNJGRVH VROXWLRQPJLQPO ZLWKLQWKH¿UVWKRXUV RIOLIHDQGRQHVHFRQGGRVHDWKRXUVRIOLIH,IWKHPRWKHUUHFHLYHG
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 47 1HYLUDSLQHGXULQJGHOLYHU\WKHQHZERUQZLOOKDYH1HYLUDSLQHOHYHOV GXULQJWKH¿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¿UVWPJNJGRVH VROXWLRQPJLQPO ZLWKLQ WKH¿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¿UVWVSHFLPHQLPPHGLDWHO\DWELUWK EHIRUHVWDUWLQJSURSK\OD[LVDQGWKHQH[WRQHDWZHHNV WRUDSLGO\GHWHUPLQH WKHFKLOG¶VVWDWXVDQGWRDVVHVVWKHQHHGIRUWUHDWPHQW$59SURSK\OD[LVLQ WKHFKLOGPXVWEHVWDUWHGDVVRRQDVWKHQHZERUQFDQWROHUDWHRUDOIHHGLQJ DQG LI SRVVLEOH ZLWKLQ WKH ¿UVW KRXUV RI ELUWK7KH UHFRPPHQGDWLRQ IRU
Generations free of HIV and congenital syphilis 48 WKHVHFDVHVLVWRVWDUWWKHFKLOGRQFRPELQHGWKHUDS\ZLWK$=77&193 IROORZLQJWKHJXLGHOLQHEHORZ )LUVWZHHN $GPLQLVWHU193DWPJNJGD\GHOLYHULQJWKH¿UVWGRVHDV VRRQDVSRVVLEOHKRSHIXOO\ZLWKLQWKHFKLOG¶V¿UVWKRXUV$IWHUGD\ DGPLQLVWHUPJNJGD\ 6HFRQG ZHHN FRQWLQXH ZLWK D GRVH RI PJNJGD\ IURP GD\ WR GD\ LQWHUUXSWLQJWKHUDS\LIWKHYLURORJLFDO+,9WHVWLQJ YLUDOORDG51$RU '1$3&5 LVUHSRUWHGDVQHJDWLYH $IWHULQWHUUXSWLQJ193WKHUDS\NHHS$=7DQG7&IRUGD\VWRUHGXFH WKHSRVVLELOLW\RIGHYHORSLQJ193UHVLVWDQFH 7KH WRWDO GXUDWLRQ RI SURSK\OD[LV LV ZHHNV WKH ¿UVW WZR ZHHNV ZLWK $=77&193DQGWKHODVWWZRZLWK$=77&,IDYDLODEOHLWZRXOGEH LPSRUWDQWWRGHWHUPLQHWKH+,9JHQRPH '1$RU51$ ZLWKLQWKHFKLOG¶V ¿UVWKRXUVRIOLIHUHSHDWLQJWKLVVDPHWHVWDWZHHNVDQGKDYLQJWKHUHVXOW LQKRXUVWRGHWHUPLQHWKHQHHGIRUPDLQWDLQLQJWKHUDS\,IWKHUHVXOWV RIWKH¿UVWDQGVHFRQGFRQWURODUHQHJDWLYH1HYLUDSLQHFDQEHGLVFRQWLQXHG 7KLVLVWKHRUHWLFDOO\WKHPRVWHIIHFWLYHJXLGHOLQHDOWKRXJKWKHUHDUHQRVWXGLHV WRVXSSRUWWKLVLQWHUYHQWLRQ 2QHVHFRQGFKRLFHLVWRXVH$=7193IROORZLQJWKHJXLGHOLQHEHORZ $=7 V\UXSKRXUVDIWHUFKLOGELUWKDWGRVHVRIPJNJHYHU\KRXUV IRUZHHNV 193 DGPLQLVWHURQH¿UVWPJNJGRVH VROXWLRQPJLQPO ZLWKLQWKH ¿UVWKRXUVRIOLIHDQGRQHVHFRQGGRVHDWKRXUVRIOLIH7KHPLQLPXP FKRLFHZRXOGEH$=7IRUZHHNVVWDUWLQJKRXUVDIWHUFKLOGELUWKDV VWDWHGLQSODQ$&7*7KLVRSWLRQLVOHVVHIIHFWLYH
5.2.4. Type of delivery and indication of caesarean section 8QLYHUVDO SUHFDXWLRQV RU PHDVXUHV VKRXOG EH LPSOHPHQWHG GXULQJ DOO WKH SURFHGXUHRIGHOLYHU\LQFOXGLQJWKHXVHRIDSURQJORYHVERRWVFDSDQGH\H SURWHFWLRQ )XUWKHUPRUHWKHUHFRPPHQGDWLRQVEHORZVHHNWRUHGXFHWKHULVNRIPRWKHU WRIHWXVWUDQVPLVVLRQDQGWKHDFFLGHQWDOWUDQVPLVVLRQWRDOOWKHKHDOWKVWDII D $YRLG 8QQHFHVVDU\LQYDVLYHSURFHGXUHV
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 49 7KHHSLVLRWRP\XQOHVVLWLVFOLQLFDOO\LQGLFDWHG $UWL¿FLDOUXSWXUHRIPHPEUDQHV 3URORQJHGUXSWXUHRIPHPEUDQHV 8VHRIVWUDLJKWVXWXUHQHHGOHV 8VHRIVFDOSHOWRVHYHUWKHXPELOLFDOFRUG $PQLRFHQWHVLV $PQLRVFRS\ ,QYDVLYHPRQLWRULQJ E &ODPSLQJDQGLPPHGLDWHFXWWLQJRIWKHXPELOLFDOFRUG F 8VLQJJORYHVWRPDQLSXODWHWKHQHZERUQ G %DWKLQJWKHFKLOGLPPHGLDWHO\ZLWKVRDSDQGZDWHU
,QGLFDWLRQIRUSODQQHGFHVDUHDQVHFWLRQ 7KHSODQQHGFHVDUHDQVHFWLRQLVWKHSURFHGXUHSHUIRUPHGEHIRUHVWDUWLQJODERU DQGEHIRUHWKHUXSWXUHRIPHPEUDQHV,WLVDVVRFLDWHGZLWKUHGXFWLRQVRI WKH07&7DQGXSWR LIWKHZRPDQUHFHLYH$59IRU307&7 ZKLFK KDVUHVXOWHGLQDVLJQL¿FDQWLQFUHDVHRILWVSUHVFULSWLRQLQZRPHQZLWK+,9 :KHQWKHSURFHGXUHLVSURJUDPPHGLWKDVVKRZQWREHHIIHFWLYHVDIHDQG FRVWHIIHFWLYH KRZHYHULWLVWRQRWHWKDWLWLVQRWIUHHIURPULVNVDQGWKDWLWKDV DFRPSOLFDWLRQUDWHVOLJKWO\KLJKHUWKDQQRQHOHFWLYHFHVDUHDQVHFWLRQLQWKH VKRUWWHUP 2WKHUFRQVWUDLQWVRIWKHSURFHGXUHLQFOXGHWKHODFNRILQIRUPDWLRQ DERXWWKHEHQH¿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
Generations free of HIV and congenital syphilis 50 5HFRPPHQGDWLRQVRQFKLOGELUWKW\SHLQSUHJQDQWZRPHQZLWK+,9
3URJUDPPHGFHVDUHDQVHFWLRQDW:HHNWRWKHZRPHQ :KRVHYLUDOORDGKDVQRWEHHQDVVHVVHGDWWKHWKLUGWULPHVWHURI SUHJQDQF\ $, ZLWKDYLUDOORDG!FRSLHVPO $,
3URYLGHYDJLQDOGHOLYHU\WRWKRVHZRPHQZLWKQRREVWHWULFLQGLFDWLRQ RIFHVDUHDQVHFWLRQRQVWDEOH$597JRRGFRPSOLDQFHDQGYLUDOORDG SHUIRUPHGRQWKHODVWWULPHVWHURISUHJQDQF\ FRSLHVPO $,9
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¿UVWVL[PRQWKVWKHQH[FOXVLYH PDWHUQDO EUHDVWIHHGLQJ VKRXOG EH FRQVLGHUHG XQWLO WKH ³$)$66´ FRQGLWLRQV DUH PHW 3URORQJLQJ WKH H[FOXVLYH PDWHUQDO EUHDVWIHHGLQJ SHULRG EH\RQG VL[ PRQWKVLQFUHDVHVWKHULVNRIPDOQXWULWLRQ0RWKHUVVKRXOGUHFHLYHFRXQVHOLQJ DQGVXSSRUWDWOHDVWXQWLOWKHFKLOGWXUQVWZR\HDUVRIDJHWRHQVXUHDQDGHTXDWH QXWULWLRQ&RXQVHOLQJLVWRLQFOXGHWKHULVNVDQGEHQH¿WVRIWKHVHDOWHUQDWLYH ZD\VRIIHHGLQJDFKLOGWKHWHFKQLTXHUHTXLUHGWRLPSOHPHQWWKHPDQGWKH WKHUDSHXWLF PHWKRGV WR VXSSUHVV WKH PRWKHU¶V SURGXFWLRQ RI PLON ZKHQHYHU QHFHVVDU\
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 51 7KHUHDUHUHFHQWVWXGLHVVXJJHVWLQJWKDWPDLQWDLQLQJWKHPRWKHURQWULSOHWKHUDS\ GXULQJWKHEUHDVWIHHGLQJSHULRGVLJQL¿FDQWO\UHGXFHVWKHULVNRI+,907&7 ([FOXVLYHPDWHUQDOEUHDVWIHHGLQJZLWK$597FDQEHFRQWHPSODWHG H[FHSWLRQDOO\LQWKRVHFDVHVZKHUHLWLVLPSRVVLEOHWRDVVXUHIRUPXODIHHGLQJ LQOLQHZLWKWKH$)$66FRQGLWLRQVHYHQLIWKHUHFRPPHQGDWLRQIRUDQRSWLPDO SURSK\OD[LVLVVXSSUHVVLQJPDWHUQDOEUHDVWIHHGLQJDQGUHSODFLQJLWZLWKPLON IRUPXOD 0L[HGEUHDVWIHHGLQJ PRWKHU¶VPLONDQGPLONIRUPXOD SRVHVDJUHDWHUULVNRI WUDQVPLVVLRQWKDQWKHH[FOXVLYHPDWHUQDOEUHDVWIHHGLQJRUIHHGLQJH[FOXVLYHO\ ZLWKPLONIRUPXODDQGVKRXOGDOZD\VEHDYRLGHG ,QRUGHUWRHQVXUHWKDW FKLOGUHQ ZLOO QRW UHFHLYH PL[HG IHHGLQJ DQG IRU WKH PRWKHUV¶ FRQYHQLHQFH WKH SURJUDPV PXVW HQVXUH WKHLU DFFHVV WR FRXQVHOLQJ VXSSRUW DQG VSHFL¿F PHGLFDWLRQWRVXSSUHVVODFWDWLRQZKHQDSSURSULDWH
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¿UVW PRQWKVDQGH[WHQGLQJWKHPRWKHU¶V$597DVORQJDVVKHEUHDVWIHHGV KHUFKLOGHYHQLIKHURZQKHDOWKGRHVQRWZDUUDQWVXFKWKHUDS\ $,
Generations free of HIV and congenital syphilis 52 5.2.6. Safety of ARVT in pregnant women and children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
5.2.6.1 Antiretroviral safety in the treatment of the pregnant woman 7KHWR[LFLW\RI$59VGXULQJSUHJQDQF\LVQRWJUHDWHUWKDQLQQRQSUHJQDQW ZRPHQ 7KH$597JXLGHOLQHIRUDGXOWVGHYHORSHGE\3$+2:+2FRQWDLQV DPRUHLQGHSWKGHVFULSWLRQRIWKHWR[LFLW\RIDQWLUHWURYLUDOV,QWKLVFKDSWHUZH ZLOOVSHFL¿FDOO\DGGUHVVWKHVDIHW\LVVXHVUHODWHGWRSUHJQDQF\
D 1XFOHRVLGH5HYHUVH7UDQVFULSWDVH,QKLELWRUV 7KH 157,V WKDW KDYH EHHQ XVHG PRUH H[WHQVLYHO\ IRU SUHJQDQW ZRPHQ DUH$=7DQG7& KHQFHWKRVHWZRGUXJVDUHFRQVLGHUHGWKH157,VRI FKRLFH7KHRSWLRQDO¿UVWOLQH157,VLQWKH$597JXLGHOLQHVLQFOXGH$%& G7DQGGGO7KHSKDUPDFRNLQHWLFVWXGLHVFRQGXFWHGLQSUHJQDQWZRPHQ LQGLFDWHWKDWQRGRVHDGMXVWPHQWVDUHUHTXLUHGIRU$=77&$%&GGORU G7 )7&KDVDVLPLODUVWUXFWXUHWR7&DOWKRXJKWKHUHLVOLPLWHG HYLGHQFHRILWVVDIHW\LQSUHJQDQF\7')LVDQXFOHRWLGHDQDORJWKDWKDV EHHQLQFOXGHGDVDQRSWLRQLQWKH$597JXLGHOLQHVDV¿UVWOLQHWKHUDS\RI DGXOWV7KHH[SHULHQFHZLWK7')LQSUHJQDQF\LVOLPLWHG7KHVWXGLHVLQ PRQNH\VH[SRVHGWRWKHGUXJLQXWHUXVVKRZUHGXFWLRQRIIHWDOJURZWKDQG ERQHSRURVLW\ %RQHGHPLQHUDOL]DWLRQKDVDOVREHHQUHSRUWHGLQKXPDQV LQVRPHLQIHFWHGFKLOGUHQWKDWUHFHLYHGFKURQLFWKHUDS\ZLWK7') 7KHSULPDU\WR[LFLW\REVHUYHGZLWK$=7LVKHPDWRORJLFDO DQDHPLDDQG QHXWURSDHQLD SUHJQDQWZRPHQZLWKDVHYHUHDQDHPLD KHPRJORELQ JGO WKHXVHRI$=7VKRXOGEHDYRLGHGUHSODFLQJLWE\RWKHU157,VVXFK
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 53 DV$%&RUG77KHFRPELQDWLRQRIGGODQGG7KDVEHHQLPSOLFDWHGLQ VHYHUDO UHSRUWV RI FDVHV RI ODFWLF DFLGRVLV LQ SUHJQDQW ZRPHQ VRPH RI ZKLFK KDG D IDWDO RXWFRPH HLWKHU IRU WKH PRWKHU RU WKH IHWXV$OO WKHVH ZRPHQWKDWKDGUHFHLYHGWKLV UHJLPHQVLQFHEHIRUHFRQFHSWLRQDQG KDG FRQWLQXHGLWGXULQJSUHJQDQF\SUHVHQWHGV\PSWRPVRIODFWLFDFLGRVLVDWWKH HQGRISUHJQDQF\ 7KHUHDUHQRUHSRUWVRILQFUHDVHGULVNRIFRQJHQLWDODEQRUPDOLWLHVDPRQJ FKLOGUHQH[SRVHGWR$=77&RU$%&GXULQJWKH¿UVWWULPHVWHUHYDOXDWHG SURVSHFWLYHO\FRQVLGHULQJWKDWWKHQXPEHURIFDVHVHYDOXDWHGZRXOGSHUPLW WRGHWHFWDIROGLQFUHDVHDQGIRUWKHFDVHRI$%&WKHULVNLVWZLFHDV KLJK :LWKUHJDUGGG,PDOIRUPDWLRQVZHUHREVHUYHGLQFDVHVRIWKH OLYHERUQH[SRVHGWRWKHGUXJGXULQJWKH¿UVWWULPHVWHUYHUVXV FDVHVRI QHZERUQVH[SRVHGWRGGODIWHUWKH¿UVWWULPHVWHU
E 1RQ1XFOHRWLGH5HYHUVH7UDQVFULSWDVH,QKLELWRUV 193LVWKH1157,RIFKRLFHIRUWKH$597GXULQJSUHJQDQF\DVDUHVXOWRI WKHDFFXPXODWHGFOLQLFDOH[SHULHQFHDQGLWVHI¿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
Generations free of HIV and congenital syphilis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¿UVWWULPHVWHU :LWK UHVSHFW ()9 WKH DOWHUQDWLYH 1157, IRU WKH ¿UVWOLQH WKHUDS\ WKHUH LV HYLGHQFH VXJJHVWLQJ LW PLJKW EH LPSOLFDWHG LQ D KLJKHU ULVN RI FRQJHQLWDOPDOIRUPDWLRQV6LJQL¿FDQWPDOIRUPDWLRQVKDYHEHHQREVHUYHG LQ\RXQJPRQNH\VH[SRVHGLQXWHUXVWRDFRQFHQWUDWLRQRI()9VLPLODU WR WKH WKHUDSHXWLF FRQFHQWUDWLRQV XVHG LQ KXPDQV VXFK DV DQHQFHSKDO\ DQRSKWKDOPLD DQG FOHIW SDODWH ³ 6L[ FDVHV RI FHQWUDO QHUYRXV V\VWHP GHIHFWV KDYH EHHQ UHSRUWHG LQ FKLOGUHQ H[SRVHG WR ()9 GXULQJ WKH ¿UVW WULPHVWHU WKUHHRIWKHPZLWKP\HORPHQLQJRFHOHDQGRQHZLWKD:DONHU 3HWLPHWUHPDOIRUPDWLRQ ,QDSURVSHFWLYHUHJLVWU\RISUHJQDQF\FDVHVZKLFKLQFOXGHGZRPHQWKDW GLGQRWNQRZWKHLUSUHJQDQF\VWDWXVRUWHVWVVXFKDVDQWHQDWDOXOWUDVRXQG FRQJHQLWDOPDOIRUPDWLRQVZHUHREVHUYHGLQRI &, OLYHERUQLQIDQWVH[SRVHGWR()9GXULQJWKH¿UVWWULPHVWHU 1RQH RIWKHDEQRUPDOLWLHVUHSRUWHGLQWKLVVWXG\ZHUHVLPLODUWRWKRVHREVHUYHG LQWKHDQLPDOVWXGLHVRULQWKHFDVHUHSRUWV'HVSLWHWKHODUJHQXPEHURI OLYHERUQLQIDQWH[SRVHGWR()9WKDWKDYHEHHQPRQLWRUHGLWKDVQRWEHHQ SRVVLEOHWRFRQFOXVLYHO\GHWHFWDVLJQL¿FDQWLQFUHDVHLQWKHULVNRIFRQJHQLWDO PDOIRUPDWLRQV+RZHYHUPRUHH[KDXVWLYHVWXGLHVDUHUHTXLUHGWRHYDOXDWH WKHULVNRIVSHFL¿FFRQJHQLWDOPDOIRUPDWLRQVVXFKDVWKHGHIHFWVRIWKH QHXUDOWXEHEHFDXVHWKHFXUUHQWSURVSHFWLYHVWXGLHVODFNWKHSRZHUWRGUDZ FRQFOXVLRQVDERXWWKHVHULVNV 7KH86)RRGDQG'UXJ$GPLQLVWUDWLRQ )'$ UDQNV()9DVDFDWHJRU\ 'GUXJLH³3RVLWLYHHYLGHQFHRIXQGHVLUDEOHHIIHFWVRQWKHKXPDQIHWXV EDVHGRQH[SHULPHQWDORUSRVWPDUNHWLQJGDWDHYHQWKRXJKWKHSRWHQWLDO
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 55 EHQH¿WVPLJKWEHDFFHSWDEOHGHVSLWHWKHLUSRVVLEOHULVNV´ 7KHXVHRI ()9FRXOGEHFRQVLGHUHGLQSUHJQDQWZRPHQJRLQJWKURXJKWKHLUVHFRQG RUWKLUGWULPHVWHUDQGZKRFDQQRWUHFHLYH193 HJDSUHJQDQWZRPDQ ZLWKVHYHUH193LQGXFHGWR[LFLW\RUZLWKWXEHUFXORVLV :KHQDZRPDQDWFKLOGEHDULQJDJHLVSUHVFULEHGDQ()9EDVHGJXLGHOLQH WKHWUHDWLQJSURIHVVLRQDOPXVWHQVXUHWKDWVKHLVQRWSUHJQDQWDQGWKDWVKH KDVDFFHVVWRFRXQVHOLQJDQGHIIHFWLYHFRQWUDFHSWLYHPHWKRGV,QDUHFHQW VWXG\LQ&{WHG¶,YRLUHZRPHQWKDWUHFHLYHG()9ZLWKIDPLO\SODQQLQJ FRXQVHOLQJDQGKRUPRQHFRQWUDFHSWLRQPHWKRGVWKHDQQXDOLQFLGHQFHRI SUHJQDQF\ZDV F 3URWHDVH,QKLELWRUV 7KH UHFRPPHQGDWLRQV FRQFHUQLQJ WKH VHFRQG OLQH WKHUDS\ LQ SUHJQDQW ZRPHQ DUH OLPLWHG DV D UHVXOW RI WKH VFDQWLHU H[SHULHQFH ZLWK WKH SURWHDVHLQKLELWRUV 3,V LQSUHJQDQF\7KHPRVWFRPPRQO\XVHGSURWHDVH LQKLELWRUVDQGIRUZKLFKWKHUHLVPRUHVDIHW\GDWDIRUSUHJQDQF\DYDLODEOH DUHVDTXLQDYLUHQKDQFHGZLWKORZGRVHULWRQDYLU 649U DQGQHO¿QDYLU 1)9 'XULQJSUHJQDQF\WKHGUXJGLVWULEXWLRQPD\FKDQJHVLJQL¿FDQWO\ KRZHYHUWKHUHVHHPVWREHQRQHHGWRDGMXVWWKH649UGRVH ,QWKHFDVHRIQHO¿QDYLUWKHUHVXOWVKDYHEHHQFRQWUDGLFWRU\VLQFHVHYHUDO VWXGLHVKDYHVKRZQWKDWWKHFRQFHQWUDWLRQRIWKLVGUXJLVH[WUHPHO\YDULDEOH LQSUHJQDQWZRPHQ 7KHFDSVXOHIRUPXODWLRQRIORSLQDYLUHQKDQFHG ZLWKULWRQDYLU /39U KDYHDOVRVKRZQWRDVVRFLDWHWRORZHUFRQFHQWUDWLRQV GXULQJWKHWKLUGWULPHVWHU +RZHYHUDQRWKHUVWXG\REVHUYHGVXI¿FLHQWO\ KLJKSODVPDFRQFHQWUDWLRQVLQPRVWZRPHQ 7KHUHDUHQRGDWDRQWKH FKDQJHV RI WKH SKDUPDFHXWLFDO IRUP RI /39 U LQ KHDWVWDEOH WDEOHWV LQ SUHJQDQF\ KHQFHDQGXQWLOIXUWKHUGDWDLVDYDLODEOHWKHXVXDOGRVHLQWDUJHWV VKRXOGEHXVHG7KHFRQFHQWUDWLRQVRILQGLQDYLU ,'9 ZLWKQRERRVWLQJ DUHORZHUGXULQJSUHJQDQF\WKDQLQWKHSRVWSDUWXPSHULRG 7KHUH LVQRLQIRUPDWLRQDYDLODEOHRQWKHFRQFHQWUDWLRQVRIDWD]DQDYLU $79 RU IRVDPSUHQDYLU I$39 LQSUHJQDQWZRPHQHLWKHUDORQHRIDXJPHQWHGZLWK ORZGRVHULWRQDYLU DVDUHVXOWWKHVHGUXJVVKRXOGEHDYRLGHGXQWLOPRUH GDWDEHFRPHDYDLODEOHXQOHVVWKH\DUHWKHRQO\RSWLRQDYDLODEOH 7KHUHDUHFRQWUDGLFWRU\GDWDZLWKUHVSHFWWKHSRWHQWLDODGYHUVHHIIHFWVRI $597ZLWK3,VLQSUHJQDQF\HVSHFLDOO\ZLWKUHJDUGWKHULVNRISUHPDWXUH FKLOGELUWK 2EVHUYDWLRQDOVWXGLHVFRQGXFWHGLQHQYLURQPHQWV
Generations free of HIV and congenital syphilis 56 ZLWK OLPLWHG UHVRXUFHV VXFK DV &{WH G¶,YRLUH DQG 7KDLODQG GHVFULEHG VLPLODUUDWHVRISUHPDWXUHFKLOGELUWKVLQWKHZRPHQWKDWKDGUHFHLYHG$597 DQGWKRVHWKDWUHFHLYHG07&7SURSK\OD[LVZLWKRQHRUWZRGUXJV 6RPHVWXGLHVVXJJHVWWKDWWKHXVHRI3,VLQSUHJQDQF\FRXOGEHDVVRFLDWHG ZLWK D KLJKHU ULVN RI JHVWDWLRQDO K\SHUJO\FDHPLD RU GLDEHWHV DOWKRXJK WKLVKDVQRWEHHQVKRZQLQPRUHUHFHQWVWXGLHV7KHUROHRIWKH3,VLQWKH GHYHORSPHQWRISUHHFODPSVLDLVDOVRXQGHUGHEDWH ,QWKHFDVHRIWKH ZRPHQWKDWUHTXLUHDVHFRQGOLQHWKHUDS\DQGJHWSUHJQDQWZKLOHWKH\ZHUH UHFHLYLQJ3,VRUWKH\QHHGWRVZLWFKGUXJVGXULQJSUHJQDQF\WKHEHQH¿WV RI WUHDWPHQW WR PRWKHUV RYHUZHLJK WKH WKHRUHWLFDO ULVNV RI DQ DGYHUVH RXWFRPHRISUHJQDQF\DQGWKHWUHDWPHQWPXVWEHVWDUWHGRUFRQWLQXHGDV DSSURSULDWH7KHUHDUHHQRXJKREVHUYDWLRQVRIH[SRVXUHWRQHO¿QDYLUDQG ULWRQDYLULQWKH¿UVWWULPHVWHUWRGHWHFWDWZRIROGLQFUHDVHRIWKHULVNRI JHQHUDOFRQJHQLWDOPDOIRUPDWLRQV QRWKDYLQJGHWHFWHGWKLVLQFUHDVHWRGDWH 7KHGDWDDYDLODEOHDERXWWKHXVHRIRWKHU3,VLQSUHJQDQF\GRHVQRW SHUPLWWRGUDZFRQFOXVLRQV
G /RQJWHUPHIIHFWVRIWKHFKLOG¶VLQWUDXWHULQHH[SRVXUHWR$59V 7KHGDWDRQWKHORQJWHUPHIIHFWVRIWKHFKLOG¶VLQWUDXWHULQHH[SRVXUHWR DQWLUUHWURYLUDOGUXJVUHSRUWHGE\WKHLQGXVWULDOL]HGFRXQWULHVDUHFRQWUDGLFWRU\ 5HSRUWVRQDODUJH)UHQFKFRKRUWVKRZHGHYLGHQFHRIFOLQLFDOV\PSWRPVRI PLWRFKRQGULDOG\VIXQFWLRQLQRIWKHQRQLQIHFWHGH[SRVHGFKLOGUHQ WKDWKDGUHFHLYHGDQWLUHWURYLUDOVGXULQJSUHJQDQF\DVVRFLDWHGWRD PRUWDOLW\UDWH 7KHFKLOGUHQSUHVHQWHGPDLQO\QHXURORJLFDOV\PSWRPV VRPHWLPHVDVVRFLDWHGZLWKDVLJQL¿FDQWK\SHUODFWDWHPLDDQGDQLPSDLUPHQW RIWKHIXQFWLRQRIWKHPLWRFKRQGULDOUHVSLUDWRU\FKDLQHQ]\PHV+RZHYHU WKHVH¿QGLQJVKDYHQRWEHHQFRQ¿UPHGLQRWKHUFRKRUWVLQ(XURSHDQGWKH 8QLWHG6WDWHV 7KHUH DUH UHSRUWV GHVFULELQJ DV\PSWRPDWLF EXW SHUVLVWHQW KHPDWRORJLFDO DEQRUPDOLWLHVLQWKHQRQLQIHFWHGFKLOGUHQZLWKLQWUDXWHULQHH[SRVXUHWR DQWLUHWURYLUDOV 7KHUHLVFXUUHQWO\DORQJWHUPIROORZXSVWXG\XQGHUZD\ RQ WKH H[SRVHG QRQ LQIHFWHG FKLOGUHQ WKDW UHFHLYHG DQWLUHWURYLUDOV WR HYDOXDWHWKHFKLOG¶VULVNDVDUHVXOWRIWKDWH[SRVXUH
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 57 5.2.6.2 Safety of the antiretrovirals used as prophylaxis for the prevention of HIV infection in newborns 6KRUWWHUPWR[LFLW\LVLQIUHTXHQWDVUHYHDOHGE\WKHFOLQLFDOVWXGLHVRQ307&7 DQGZLWKWKHJXLGHOLQHVWKDWDUHXVHGIRUWKHDQWLUHWURYLUDOSURSK\OD[LVLQPRVW VHWWLQJVZLWKOLPLWHGUHVRXUFHV 6HYHUDOFRQWUROOHGWULDOVZLWKDSURORQJHG IROORZXS XVDJH RI $=7 IRU 07&73 ZDV QRW DVVRFLDWHG ZLWK VLJQL¿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¿FDQWO\GLIIHUHQW IURP WKH EUDQFK FRPSDUHG SODFHER$=7 DORQH RU$=7 DQG 7& /LNHZLVH LQ WKH PRVW UHFHQW VWXGLHV DGGUHVVLQJ WKH DVVRFLDWLRQ RI GX193 DQGWKH$=7RU$=7DQG7&JXLGHOLQHVWKHUHLVQRHYLGHQFHRIDVLJQL¿FDQW PDWHUQDORUFKLOGWR[LFLW\ $ VWXG\ RQ WKH SURSK\OD[LV RI FKLOGUHQ ZLWK RQH 193 DORQH RU DVVRFLDWHG ZLWK$=7VKRZHGHYLGHQFHRIWUDQVLHQWDQGPLOGDEQRUPDOLWLHV ¿UVWGHJUHH LQEORRGDQGLQWKHOLYHUHQ]\PHVDWVL[ZHHNVRIDJHLQWKHQHZERUQVWKDW KDGUHFHLYHGRQHGRVHRI193DQGVHYHQGD\VRISURSK\OD[LVZLWK$=7DV FRPSDUHGZLWKWKRVHWKDWRQO\UHFHLYHGGX193
5.2.7. Drug resistance following HIV PMTCT
%DFNJURXQG 7KH JXLGHOLQHV WKDW IDLO WR DFKLHYH D FRPSOHWH YLUDO VXSSUHVVLRQ IDYRU WKH RFFXUUHQFHDQGWKHLQFUHDVHRIWKHUHVLVWLQJYLUXVRYHUWKHQRQPXWDWHGYLUXV GXHWRWKHVHOHFWLRQSUHVVXUH,QWKHFRQWH[WRIVXERSWLPDOWKHUDSLHVUHVLVWDQFH GHYHORSVPRUHHDVLO\IRU193DQG7&EHFDXVHWKHRFFXUUHQFHRIRQHVLQJOH PXWDWLRQ FDXVHV KLJK JUDGH UHVLVWDQFH ,Q WKH FDVH RI$=7 KRZHYHU VHYHUDOPXWDWLRQVDUHUHTXLUHGWRSURYLGHKLJKJUDGHUHVLVWDQFHVRUHVLVWDQFH
Generations free of HIV and congenital syphilis 58 LVXVXDOO\HYLGHQFHGDIWHUVHYHUDOPRQWKVRIVXERSWLPDOWKHUDS\DQGLQWKH SHRSOHZLWKDGYDQFHGGLVHDVH 193KDVDSURORQJHGPHDQOLIHZLWKFRQFHQWUDWLRQVWKDWFDQEHGHWHFWHGXSWR GD\VDIWHUUHFHLYLQJ193 193 UHVLVWDQFH WR ()9 LV GHWHFWHG ZLWK WKH XVXDO WHVW IRU DQWLUHWURYLUDO UHVLVWDQFHLQWRRIWKHZRPHQWKDWUHFHLYHRQHVLQJOHGRVHDOWKRXJK WKLV¿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¿FXOWWR H[WUDSRODWH WKHVH UHVXOWV EHFDXVH RI WKHVH SDWLHQWV KDG UHFHLYHG$59 HDUOLHU ,Q%UD]LODVWXG\DGGUHVVHGWKHGHYHORSPHQWRI1)9UHVLVWDQFHLQZRPHQ H[SRVHGWRWKLVGUXJIRUWKH07&73FRQGXFWLQJDUHVLVWDQFHWHVWDWEDVHOLQH DQGDWPRQWKVIURPGHOLYHU\7KLUW\SDWLHQWVWKDWUHFHLYHG$=77&1)9 ZHUH VWXGLHG$W EDVHOLQH $59QDwYHSDWLHQWV SUHVHQWHG PXWDWLRQV RI $59V$WPRQWKV RIWKHZRPHQH[SRVHGWR1)9GHYHORSHG VRPHPXWDWLRQDVVRFLDWHGZLWKGUXJUHVLVWDQFHWRWKLVGUXJ LQWZRFDVHVWKHUH ZHUHPDMRUPXWDWLRQVDQGLQWZRFDVHVWKH\ZHUHPLQRUPXWDWLRQV DQGRWKHU SDWLHQWVGHYHORSHGPXWDWLRQVWR157,
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 59 3UHYHQWLRQRI193UHVLVWDQFH 7KHULVNRIHPHUJHQFHRIUHVLVWDQFHWR$59GUXJVLVHVSHFLDOO\DVVRFLDWHG ZLWKWKHSODVPDYLUDOORDGDQGZLWKWKHPRWKHU¶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wYHSUHJQDQWZRPHQ6HYHUDOVWXGLHVLQWUHDWPHQW QDwYHSDWLHQWVKDYHVKRZQWKDWWKHSUHYDOHQFHRIUHVLVWDQFHLQWKHUHJLRQ LVPDLQWDLQHGDWDPRGHUDWHO\ORZOHYHO DOWKRXJKLWFRXOGUHDFK ZKLOHLQWKH8QLWHG6WDWHVXSWRRIWKHSUHJQDQWZRPHQSUHVHQW UHVLVWDQFHWRVRPHRIWKHGUXJVW\SLFDOO\XVHGLQ307&7
Generations free of HIV and congenital syphilis 60 E ,PSOLFDWLRQVRIUHVLVWDQFH 7KHDFWXDOLPSDFWRIWKHRFFXUUHQFHRIUHVLVWDQFHRQWKHPRQLWRULQJRIWKH H[SRVHGPRWKHUVKDVQRWEHHQHVWDEOLVKHG\HW,QUHFHQWVWXGLHVLQ$IULFDWKH DXWKRUVREVHUYHGWKDWSUHYLRXVH[SRVXUHWRDGX193ZRXOGQRWUHGXFHWKH HI¿FDF\RIWKLVVLQJOHGRVHLQVXEVHTXHQWSUHJQDQFLHV +RZHYHUWKH YLURORJLFDOUHVSRQVHWR193WKHUDS\LQWKHPRWKHUPD\EHORZHULIVKHZDV SUHYLRXVO\H[SRVHGWRDVLQJOHGRVHRI193
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 61 6. CHILD MONITORING
7KHPDLQHOHPHQWVWREHFRQVLGHUHGLQWKHIROORZXSRIWKHFKLOGERUQWRDPRWKHU ZLWK+,9RUV\SKLOLVDUHUHODWHGZLWKWKHHDUO\GLDJQRVLVRIERWKLQIHFWLRQVIHHGLQJ JURZWKDQGGHYHORSPHQWDQGWKHHDUO\LGHQWL¿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
Generations free of HIV and congenital syphilis 62 &KDUW 3DFNDJHRILQWHUYHQWLRQVWKDWVKRXOGEHLQFOXGHGLQWKHFKLOG¶VIROORZXS
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¿UVW PRQWKV RI OLIH +RZHYHU WKH VSRQWDQHRXVUHYHUVLRQVXJJHVWVWKDWWKLVPLWRFKRQGULDOGDPDJHKDVQRV\PSWRPDWLF FOLQLFDOH[SUHVVLRQLQWKHYDVWPDMRULW\RIFKLOGUHQ ,WLVLPSRUWDQWWRNQRZ WKDWWKHULVNRIV\PSWRPDWLFPLWRFKRQGULDOGLVHDVHLVVFDUFHEXWVRPHKRZODUJHU WKDQWKDWLQWKHJHQHUDOSRSXODWLRQDQGWKDWDKLJKGHJUHHRIVXVSLFLRQLVUHTXLUHGWR GLDJQRVHLWEHFDXVHRIWKHODFNRIVSHFL¿FLW\RIWKHFOLQLFDOV\PSWRPV
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 63 $QRWKHUFRPPRQRFFXUUHQFHLQFKLOGUHQH[SRVHGWR157,LVDQDHPLDSDUWLFXODUO\ IUHTXHQWZLWK$=7DQGZKLFKFRXOGLQFUHDVHZLWKWKHDVVRFLDWLRQRI7&,WWHQGVWR EHPLOGDQGVHOIOLPLWHGDQGLWXVXDOO\GRHVQRWUHTXLUHWUHDWPHQW,QWKH¿UVWPRQWKV RIWKHFKLOG¶VOLIHWKHFRQWUROVSHUIRUPHGIRUWKHFRQ¿UPDWLRQGLDJQRVLVRUH[FOXVLRQ RI+,9LQIHFWLRQXVXDOO\LQFOXGHKHPRJORELQDVVD\V+RZHYHUWKH\PLJKWQRWEH QHFHVVDU\GXHWRWKHPLOGDQGVHOIOLPLWHGFRXUVHRIWKHDQDHPLD 7KHFKLOG¶VPRQLWRULQJPXVWEHFRQGXFWHGLQWKHFRQWH[WRIDQLQWHJUDWHGFDUHWR WKH IDPLO\ DQG QHZERUQ WKDW FRQWHPSODWHV WKH SRRO RI LQWHUYHQWLRQV LQGLFDWHG LQ &KDUW7KHGLIIHUHQWLQWHUYHQWLRQVVXFKDVFRXQVHOLQJLPPXQL]DWLRQVFOLQLFDO HYDOXDWLRQVODERUDWRU\VDPSOLQJHWFVKRXOGEHDVFRQFHQWUDWHGDVSRVVLEOHERWKLQ WLPHDQGVLWHRIFDUHRSWLPL]LQJWKHQXPEHURIYLVLWVDQGWKXVLPSURYLQJFDUHDQG UHGXFLQJWKHORVVHVWRIROORZXS 7KHVHFWLRQEHORZVKRZVDVFKHGXOHIRUFDUH,GHDOO\DVLWKDVEHHQUHFRPPHQGHG WKURXJKRXW WKLV GRFXPHQW WKH V\SKLOLV DQG +,9 VHURORJLFDO VWDWXV RI WKH PRWKHU VKRXOGEHNQRZQEHIRUHGHOLYHU\WRHQDEOHWKHSODQQLQJRISUHDQGLQWUDSDUWXPFDUH DQGFRXQVHOLQJRQWKHGHFLVLRQVWKDWQHHGWREHWDNHQDIWHUGHOLYHU\,WLVHVSHFLDOO\ LPSRUWDQWWRWDONZLWKWKHPRWKHUDERXWWKHGHFLVLRQVFRQFHUQLQJWKHIHHGLQJRIWKH QHZERUQLQFDVHWKHFKLOGLV+,9SRVLWLYH
6.1 Systematic immunizations of the HIV-exposed child within the first months of life
7KHLPPXQRJHQLFUHVSRQVHWRYDFFLQHVLVJRRGGXULQJWKH¿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¿UVWPRQWKV RIOLIHGRHVQRWGLIIHUIURPWKHVFKHGXOHRIWKHQRQH[SRVHGFKLOGH[FHSWIRU VRPHFRQVLGHUDWLRQVRQWKHSROLRYDFFLQDWLRQDQGLQDJUHDWHUH[WHQWWRWKH DSSOLFDWLRQRI%&*
Generations free of HIV and congenital syphilis 64 ,QWKHRU\WKHDWWHQXDWHGSROLRYDFFLQDWLRQVKRXOGQRWEHDGPLQLVWHUHGRUDOO\ IRUWKHWKHRUHWLFDOSRVVLELOLW\RIWUDQVPLVVLRQWRSHRSOHLQIHFWHGZLWK+,9DQG OLYLQJLQWKHVDPHKRXVHKROGEXWWKHUHDUHPDQ\VWXGLHVWKDWKDYHVKRZQIRU \HDUVWKDWWKLVULVNLVH[FHSWLRQDO
6.1.2 BCG immunization (187) 8OWLPDWHO\WKHGHFLVLRQRQ%&*LPPXQL]DWLRQDWDQDWLRQDOOHYHOLVEDVHGRQD QXPEHURIIDFWRUVGHWHUPLQHGORFDOO\ 3UHYDOHQFHRIWXEHUFXORVLVLQWKHJHQHUDOSRSXODWLRQ 3RWHQWLDOH[SRVXUHWRWXEHUFXORVLV 3UHYDOHQFHRI+,9LQIHFWLRQ &RYHUDJHDQGHI¿FDF\RIWKHLQWHUYHQWLRQVWRSUHYHQWWKHPRWKHUWRFKLOG WUDQVPLVVLRQRI+,9 ([FOXVLYHDQGPL[HGPDWHUQDOEUHDVWIHHGLQJ &DSDFLW\WRLPSOHPHQWWKHPRQLWRULQJRIWKHYDFFLQDWHGFKLOGUHQ &DSDFLW\WRFRQGXFWYLURORJLFDOWHVWLQJWKH¿UVWPRQWKVRIOLIH
7KHULVNRIYDFFLQDWLQJDQ+,9LQIHFWHGFKLOGZLWKWKH%&*LVWRFDXVHDVHYHUH DQG SRWHQWLDOO\ IDWDO GLVHDVH DV D UHVXOW RI WKH VSUHDGLQJ RI WKH &DOPHWWH *XpULQEDFLOOXVLQIHFWLRQ *XLGDQFHWRIDFLOLWDWHGHFLVLRQPDNLQJDWDORFDODQGQDWLRQDOOHYHORQWKHXVH RIWKH%&*LPPXQL]DWLRQRIWKHFKLOGUHQDWULVNRISUHVHQWLQJ+,9LQIHFWLRQ D ,QJHQHUDOWKHSRSXODWLRQVZLWKDKLJKSUHYDOHQFHRI+,9LQIHFWLRQDOVR KDYH WKH KLJKHVW LQIHFWLRQ UDWH RI WXEHUFXORVLV VR WKDW WKH FKLOGUHQ QRW LQIHFWHGZLWK+,9LQWKLVSRSXODWLRQPD\HVSHFLDOO\EHQH¿WRIWKHXVHRI %&*LPPXQL]DWLRQ E ,IWKHORFDOSUHYDOHQFHRI7%LVKLJKHVSHFLDOO\LQWKHFDVHRIPXOWLUHVLVWDQW 7%WKHEHQH¿WVRIDGPLQLVWHULQJ%&*LPPXQL]DWLRQWRFKLOGUHQERUQWR +,9PRWKHUVEXWZKRVH WKHFKLOG¶V +,9LQIHFWLRQVWDWXVLVXQNQRZQ DQGZLWKQRREYLRXVVLJQVRUV\PSWRPVVXJJHVWLQJ+,9LQIHFWLRQZRXOG H[FHHGWKHULVNV F +RZHYHU WKH ULVNV RI YDFFLQDWLQJ ZLWK %&* WKH FKLOGUHQ NQRZQ WR EH LQIHFWHG ZLWK +,9 ZLWK RU ZLWKRXW VLJQV RU V\PSWRPV RI +,9 H[FHHGWKHEHQH¿WVRIWKDWLPPXQL]DWLRQ7KHVHFKLOGUHQPXVWQRWEH LPPXQL]HG
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 65 G 7KH ULVNV HQWDLOHG E\ %&* LPPXQL]DWLRQ DUH JHQHUDOO\ KLJKHU WKDQ WKH EHQH¿WVLQQHRQDWHVERUQWR+,9PRWKHUVDQGZKRVH+,9LQIHFWLRQVWDWXV LVXQNQRZQEXWZKRKDYHSUHVHQWHGVLJQVRUV\PSWRPVVXJJHVWLYHRI+,9 LQIHFWLRQ7KHVHFKLOGUHQPXVWQRWEHLPPXQL]HG $OOWKHDERYHKDVOHGWRWKHIROORZLQJUHFRPPHQGDWLRQV D 'HOD\WKH%&*YDFFLQDWLRQRIWKHFKLOGERUQWRDPRWKHUZLWK+,9XQWLOWKH FKLOG¶VQHJDWLYHVWDWXVFDQEHFRQ¿UPHG E 'HOD\WKH%&*YDFFLQDWLRQRIWKHFKLOGERUQWRDPRWKHUZLWKQR+,9 WHVWLQJXQWLOWKHPRWKHUKDVXQGHUJRQHVFUHHQLQJ F &KLOGUHQFRQ¿UPHGDV+,9SRVLWLYHPXVWQRWUHFHLYH%&*LPPXQL]DWLRQ G &KLOGUHQ ZLWK D VXVSHFWHG V\PSWRPDWLF +,9 LQIHFWLRQ HYHQ LI QRW FRQ¿UPHG PXVWQRWUHFHLYH%&*LPPXQL]DWLRQ H ,QDUHDVZLWKDKLJKSUHYDOHQFHRIPXOWLUHVLVWDQWWXEHUFXORVLVDQGZKHQ LWLVSRVVLEOHWRGLDJQRVHWKH%&*GLVHDVHLQWKHFKLOGDQGWKHUHLVWKH FDSDFLW\WRWUHDWWKH%&*GLVVHPLQDWHGGLVHDVHWKHFKLOGERUQWRDPRWKHU ZLWK+,9PXVWUHFHLYH%&*LPPXQL]DWLRQ1RWZLWKVWDQGLQJHYHQLQWKLV FRQWH[WLIWKHFKLOGLVFRQ¿UPHGDV+,9RULIWKHFKLOGLVVXVSHFWHGWR KDYHDQ+,9V\PSWRPDWLFLQIHFWLRQWKHFKLOGPXVWQRWEHLPPXQL]HG I &KLOGUHQ FRQ¿UPHG DV QRW LQIHFWHG ZLWK +,9 PD\ UHFHLYH %&* LPPXQL]DWLRQ
6.2 Follow-Up Schedule
D %LUWK &OLQLFDO H[DPLQDWLRQ DQG JHQHUDO FDUH RI WKH QHZERUQ KHSDWLWLV% LPPXQL]DWLRQLQDFFRUGDQFHZLWKQDWLRQDOJXLGHOLQHV &RQ¿UPDWLRQRIWKHPRWKHU¶V+,9DQGV\SKLOLVVHURORJLFDOVWDWXV ,IWKHPRWKHUKDVDQ+,9 VHURORJ\ R &RXQVHOLQJ RQ IHHGLQJ ,I WKH $)$66 FRQGLWLRQV DUH PHW WKH UHFRPPHQGDWLRQLVWRUHSODFHPDWHUQDOEUHDVWIHHGLQJIRUPLONIRUPXOD :KHQWKRVHFRQGLWLRQVDUHQRWPHWWKHQH[FOXVLYHPDWHUQDOEUHDVWIHHGLQJ LVUHFRPPHQGHG R 6WDUWSURSK\OD[LVZLWK$59EHIRUHWKH¿UVWWRKRXUVRIOLIHDVVRRQ DVWKHQHZERUQFDQWROHUDWHIHHGLQJDQGRUDOPHGLFDWLRQ
Generations free of HIV and congenital syphilis 66 R 'RFRXQVHOLQJWRUHLQIRUFHDGKHUHQFHWRWKHUDS\ 1RUPDOFOLQLFDOH[DPLQDWLRQ WKHUHLVQRFOLQLFDOHYLGHQFHRILQIHFWLRQ R 3RVWSRQH%&*LPPXQL]DWLRQWRFRQ¿UPWKHDEVHQFHRI+,9LQWKH¿UVW YLURORJLFDOGLDJQRVLV R $FRPSOHWHEORRGFRXQWVKRXOGEHREWDLQHGWRGHWHUPLQHWKHEDVHOLQH KHPRJORELQOHYHO R 0RQLWRULQGD\V $EQRUPDOLWLHVLQWKHFOLQLFDOH[DPLQDWLRQ FOLQLFDOVXVSLFLRQRIV\PSWRPDWLF +,9LQIHFWLRQ YHU\UDUHWKLVZRXOGLQGLFDWHLQWUDXWHULQHLQIHFWLRQ R 5XOHRXWFRQ¿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¿UVWOLQHFKRLFHIRUWKHFKLOG¶VQXWULWLRQDQG GHYHORSPHQW R $OOWKHFKLOGUHQERUQWRPRWKHUVZLWKV\SKLOLVPXVWXQGHUJRVFUHHQLQJ WHVWV LQ SDUDOHO ZLWK WKHLU PRWKHUV XVLQJ D QRQ WUHSRQHPLF WHVW IRU VXEVHTXHQWWUDFNLQJ
E GD\VRIDJH *HQHUDOFKLOGFDUHFKHFNZHLJKWDQGQXWULWLRQDOVWDWXV &RXQVHOLQJ RQ IHHGLQJ LI WKH FKLOG LV IHG ZLWK D PLON IRUPXOD HQVXUH WKDWWKHIRUPXODLVDSSURSULDWHZLWKUHJDUGFRQFHQWUDWLRQFOHDQOLQHVVDQG WHFKQLTXHLQWKHFDVHRIFKLOGUHQERUQWRDPRWKHUZLWK+,9DVH[FOXVLYH IHHGLQJ ,IWKHFKLOGLVRQ$59SURSK\OD[LVIRU307&7 R &RQ¿UPDQGVWUHVVDGKHUHQFHWRWUHDWPHQW
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 67 R (YDOXDWHWKHSUHVHQFHRIVLGHHIIHFWVHVSHFLDOO\VLJQVDQGV\PSWRPV UHODWHGZLWKDQDHPLDDQGPLWRFKRQGULDOWR[LFLW\ R $GMXVWGRVDJHWRZHLJKW ,IDQ+,9VHURORJLFDOWHVWZDVFRQGXFWHGDWELUWKUHSRUWWKHUHVXOWV LILWLV SRVLWLYH R &RQ¿UPZLWKDVHFRQGYLURORJLFDOWHVW R 2EWDLQDVSHFLPHQIRUYLUDOORDGJHQRW\SLQJIRUWKHVWXG\RI$59 UHVLVWDQFHV LIWKHWHFKQLTXHLVDYDLODEOHDQGLQDFFRUGDQFHZLWK QDWLRQDOJXLGHOLQHV DQG&'FRXQW R 3ODQ$597
F ZHHNVROG *HQHUDOFKLOGFDUHFKHFNZHLJKWDQGQXWULWLRQDOVWDWXV &RXQVHOLQJRQIHHGLQJ LIWKHFKLOGLVIHGZLWKDPLONIRUPXODHQVXUHWKDW WKHIRUPXODLVDGHTXDWHDQGLQWKHFDVHRIFKLOGUHQERUQWRDPRWKHUZLWK +,9FKHFNWKDWLVWKHFKLOG¶VH[FOXVLYHIHHGLQJ ,IWKHVXEMHFWLVRQ$59307&7SURSK\OD[LV R &KHFNWKHDEVHQFHRIVLGHHIIHFWVHVSHFLDOO\WKHVLJQVDQGV\PSWRPV UHODWHGZLWKDQDHPLDDQGPLWRFKRQGULDOWR[LFLW\ R 7HUPLQDWHSURSK\OD[LV 6WDUWSURSK\OD[LVRISQHXPRQLDE\3QHXPRF\VWLVMLURYHFLZLWKWULPHWKRSULP VXOIDPHWR[D]ROH ,PPXQL]HDJDLQVWKHSDWLWLV%IROORZLQJWKHQDWLRQDOJXLGHOLQHV ,IQRYLURORJLFDOWHVWLQJKDVEHHQFRQGXFWHGIRU+,9FRQGXFWWKHWHVW ,IDQ+,9VHURORJLFDOWHVWZDVFRQGXFWHGDWELUWKUHSRUWWKHUHVXOWV LILWLV SRVLWLYH R &RQGXFWDVHFRQGVHURORJLFDOYLURORJLFDOWHVWIRUFRQ¿UPDWLRQ R 2EWDLQDVSHFLPHQIRUYLUDOORDGJHQRW\SLQJIRUWKHVWXG\RI$59 UHVLVWDQFHV LIWKHWHFKQLTXHLVDYDLODEOHDQGLQDFFRUGDQFHZLWK QDWLRQDOJXLGHOLQHV DQG&'FRXQW R 3ODQ$597 ,IWKHUHLVDVHFRQGSRVLWLYHYLURORJLFDOWHVWIRU+,9 R &RXQVHOLQJ WR UHSRUW WKH UHVXOWV ZLWK D PXOWLGLVFLSOLQDU\ DSSURDFK ZHLJKWKHQHHGWRDVVHVVWKHSV\FKRORJLFDOVXSSRUW
Generations free of HIV and congenital syphilis 68 R &RXQVHOLQJRQWKHVWDUWRI$5976SHFLDOHPSKDVLVRQFRPSOLDQFHWR WKHUDS\ R 6WDUW$597
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¿UPDWLRQ R 2EWDLQDVSHFLPHQIRUYLUDOORDGJHQRW\SLQJIRUWKHVWXG\RI$59 UHVLVWDQFHV LIWKHWHFKQLTXHLVDYDLODEOH DQG&'FRXQW R 3ODQ$597 ,IDSRVLWLYHYLURORJLFDOWHVWFRQ¿UPVGLDJQRVLV R &RXQVHOLQJ WR UHSRUW WKH UHVXOWV ZLWK D PXOWLGLVFLSOLQDU\ DSSURDFK ZHLJKWKHQHHGIRUSV\FKORJLFDOVXSSRUW R &RXQVHOLQJWRVWDUW$5976SHFLDOHPSKDVLVRQDGKHUHQFHWRWKHUDS\ R 6WDUW$597 ,IWKHPRWKHU¶VV\SKLOLVVHURORJ\ZDVSRVLWLYHDQGWKHQRQWUHSRQHPLFWHVW ZDVGRQHWRWKHPRWKHUDWWKHWLPHRIELUWKWKHVDPHWHVWFDQEHGRQHWRWKH FKLOGQRZWRDVVHVVWKHFRXUVHRIWLWHUV
H PRQWKVRIDJHDQGROGHU 'XULQJWKH¿UVW\HDUWKHUHFRPPHQGDWLRQLVDPRQWKO\IROORZXSFKHFNLQJ WKH FKLOG¶V JHQHUDO FDUH ZHLJKW JDLQ JURZWK DQG QXWULWLRQDO VWDWXV &RXQVHOLQJRQIHHGLQJPXVWEHSURYLGHG LIWKHFKLOGLVIHGZLWKDPLON IRUPXODHQVXUHWKDWWKHIRUPXODLVDGHTXDWHDQGLQWKHFDVHRIFKLOGUHQ ERUQWRPRWKHUVZLWK+,9PDNHVXUHLWLVEHLQJXVHGDVH[FOXVLYHIHHGLQJ ZLWKQREUHDVWIHHGLQJ ³PL[HG´IHHGLQJ
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 69 ,I WKH VXEMHFW LV RQ$597 PDNH VXUH WKH IROORZLQJ DUH FKHFNHG LQ HYHU\ YLVLW R $EVHQFHRIVLGHHIIHFWVZLWKVSHFLDOFDUHWRVLJQVDQGV\PSWRPVUHODWHG WRPLWRFKRQGULDOWR[LFLW\ R &KHFNWKDWWKHPHGLFDWLRQLVEHLQJWDNHQDGHTXDWHO\ R $GMXVWWKHGRVHWRWKHFKLOG¶VFKDQJLQJZHLJKW R 6WUHVVWKHDGKHUHQFHWRWKHUDS\ )RU WKH DVSHFWV VSHFL¿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
Generations free of HIV and congenital syphilis 70 7. SPECIAL CONSIDERATIONS
7.1. Pregnant women with HIV and active tuberculosis
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¿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¿UVWOLQH WKHUDS\ HWF WKLV VFKHPH PD\ EH UHTXLUHG :KHQ DSSOLHGLWVKRXOGEHGRQHXQGHUFORVHPRQLWRULQJ2WKHURSWLRQVLQFOXGHXVLQJ /39ZLWKKLJKGRVHVRIULWRQDYLU PJPJWZLFHDGD\ RU649U PJPJWZLFHDGD\ RQO\LIDSRVVLEOHWRNHHSDFORVHFOLQLFDODQGODERUDWRU\ PRQLWRULQJ
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 71 7.2. Pregnant women with HIV and hepatitis
&RLQIHFWLRQZLWK+&9 7KHFRH[LVWHQFHRI+,9DQG+&9LQDSUHJQDQWZRPDQIXUWKHUFRPSOLFDWHVWKH PDQDJHPHQWRIWKHUDS\6WXGLHVRQWKHHIIHFWRI+&9RQWKHFOLQLFDOSURJUHVVLRQ RI+,9KDYH\LHOGHGFRQWURYHUVLDOUHVXOWVEXWVRPHUHVHDUFKVXJJHVWVWKDWSHRSOH ZLWK+,9+&9FRLQIHFWLRQH[SHULHQFHDVORZHULPPXQHUHFRYHU\ZLWK$597 UHFRYHU\RIWKH&'O\PSKRF\WHV +&9FRLQIHFWLRQLVDVVRFLDWHGZLWKD JUHDWHUULVNRI$597LQGXFHGKHSDWRWR[LFLW\ /LNHZLVH SDWLHQWV ZLWK WKDW FRLQIHFWLRQ KDYH D KLJKHU +&9 YLUDO ORDG DQG H[SHULHQFH D IDVWHU SURJUHVVLRQ WR OLYHU ¿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¿UVWKRXUVRIELUWK7KHVH FKLOGUHQPD\WKHQUHFHLYHWKHUHJXODULPPXQL]DWLRQSODQDJDLQVW+9% DQG PRQWKV 1HZERUQVZHLJKLQJOHVVWKDQJUVKRXOGUHFHLYHIRXUGRVHVRIWKH +9%YDFFLQH DWELUWKDQGPRQWKV +%V$JWHVWLQJVKRXOGEHGRQHDW DQGPRQWKVRIDJHWRDOOFKLOGUHQERUQWR+%V$JSRVLWLYHPRWKHUV
Generations free of HIV and congenital syphilis 72 7.3. Pregnant women with HIV and anaemia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¿FLHQF\7KHDGPLQLVWUDWLRQRI LURQVXSSOHPHQWVLVDOVRUHFRPPHQGHGGXULQJSRVWSDUWXP0RUHRYHUSUHYHQWLRQ DQGWUHDWPHQWDUHLPSRUWDQWLQFDVHVRIPDODULDWRUHGXFHWKHDQDHPLDRIWKH SUHJQDQWZRPHQOLYLQJLQUHJLRQVZKHUHPDODULDLVHQGHPLF :RPHQZLWKDQLQGLFDWLRQRIDUDSLGVWDUWRI$597DQGDVHYHUHDQDHPLD +E JGO VKRXOGEHVWDUWHGRQDQ$=7IUHHUHJLPHQDQGWUHDWPHQWRIWKHLUDQDHPLD 7KHWUHDWPHQWVRIFKRLFHDUHG7DQG$%& ,Q WKH FDVH RI ZRPHQ ZLWK +,9 LQIHFWLRQ EXW ZLWK QR LQGLFDWLRQV WR UHFHLYH DQWLUHWURYLUDOVWKHSULRULW\LVWRWUHDWWKHVHYHUHDQDHPLD7KH$=7FRQWDLQLQJ SURSK\ODFWLFUHJLPHQVVKRXOGRQO\EHVWDUWHGDIWHUWKHVHYHUHDQDHPLDKDVEHHQ FRUUHFWHG +E!JGO
7.4. Intravenous Drug Use in pregnant women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¶VDFFHVVWRKHDOWKFDUHLVXVXDOO\KLQGHUHGE\YDULRXVLVVXHV7KH VWLJPDWL]LQJ DWWLWXGH RI KHDOWK FDUH SURIHVVLRQDOV DQG WKH ODFN RI FRRUGLQDWLRQ
Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 73 EHWZHHQREVWHWULFLDQVDQGH[SHUWVLQGUXJGHSHQGHQFLHVDQGWKHGDPDJHUHGXFWLRQ SURJUDPVDUHVRPHRIWKHIDFWRUVLQYROYHG 7KHQDWLRQDOSURJUDPVVKRXOGDLPDWHQVXULQJDQHQYLURQPHQWWKDWPD\EHIULHQGO\ WRIHPDOH+,9LQWUDYHQRXVGUXJXVHUVDWWKHFHQWHUVWKDWSURYLGHDQWHQDWDOODERU DQGSRVWSDUWXPFDUH 7KHVHZRPHQUHTXLUHFRXQVHOLQJRQWKHHIIHFWVRIDOFRKRODQGWKHRWKHUGUXJVLQ WKHIHWDOJURZWKDQGGHYHORSPHQWDQGRQWKHEHQH¿WVRIWKHGDPDJHUHGXFWLRQ VHUYLFHV$Q RQJRLQJ LQWHJUDWHG FDUH LV UHTXLUHG WKURXJKRXW SUHJQDQF\ DQG LQ WKHSRVWSDUWXPSHULRGWRDGGUHVVWKHLVVXHVSRVHGE\WKHWUHDWPHQWRIWKH+,9 LQIHFWLRQ WKH J\QDHFRORJLFDO DQG REVWHWULF QHHGV DQG WKRVH GHULYLQJ IURP WKH XVHRI,9GUXJVWRLQFOXGHVSHFL¿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¿QLWLRQFRQVLVWVRIPDQLIHVWDWLRQVRIZLWKGUDZDO RI FRFDLQH DQSKHWDPLQHV DQG DOFRKRO 7KH QHRQDWDO ZLWKGUDZDO V\QGURPH RFFXUVLQFORVHWRRIDOOWKHIHWXVHVH[SRVHGWRWKHVHGUXJVXVXDOO\ZLWKLQ WKH ¿UVW KRXUV RI OLIH 7KH FOLQLFDO PDQLIHVWDWLRQV RI QHRQDWDO ZLWKGUDZDO YDU\GHSHQGLQJRQWKHVXEVWDQFHLPSOLHGWKHPHWDEROLVPDQGH[FUHWLRQRIWKH GUXJ DQG LWV PHWDEROLWHV 6\PSWRPV LQFOXGH JDVWURLQWHVWLQDO GLVRUGHUV VXFK DV LQFUHDVHGRULQHIIHFWLYHVXFNOLQJYRPLWVH[FHVVLYHUHJXUJLWDWLRQDQGGLDUUKHD FDUGLRUHVSLUDWRU\V\QGURPHVOLNHWDFK\FDUGLDWDFK\SQHDF\DQRVLV QHXURORJLFDO OLNH VKDNLQJ K\SRWRQLD K\SHUWRQLD K\SHUUHÀH[LD LUULWDELOLW\ DJLWDWLRQ RU VHL]XUHV DQG JHQHUDO V\PSWRPV OLNH IHYHU GLDSKRUHVLV KLJKSLWFKHG FU\LQJ VOHHSGLVWXUEDQFHVDQGIDLOXUHWRWKULYH7KHGLDJQRVLVUHTXLUHVDKLJKGHJUHHRI VXVSLFLRQDQGWKHPDQDJHPHQWXVXDOO\LQFOXGHVÀXLGDQGHOHFWURO\WHEDODQFHDQG QXWULWLRQDOVXSSRUW ,QJHQHUDOWKHVDPHSULQFLSOHVIRUWKHFOLQLFDODQGLPPXQRORJLFDOHYDOXDWLRQRI WKH+,9SRVLWLYHSUHJQDQWZRPHQDSSO\IRUSUHJQDQW,'8V'UXJLQWHUDFWLRQV PD\EHDQLVVXHLQWKHFDVHRISUHJQDQWZRPHQWKDWZHUHDOUHDG\UHFHLYLQJ$597
Generations free of HIV and congenital syphilis 74 )RUSUHJQDQW,'8VZLWK+,9QRWHOHJLEOHIRU$597WKHUHJLPHQRIFKRLFHLVWKH VDPHDVWKHSURSK\OD[LVWKHUDS\XVHGIRU07&73LQQRQ,'8ZRPHQ 7KH XVHRIGUXJVLVRQHRIWKHPDLQIDFWRUVWKDWKLQGHU$597VRGUXJXVHUVUHTXLUH SV\FKRVRFLDOVXSSRUWDQGFORVHPRQLWRULQJRIWKHLUFRPSOLDQFH 0RVWGUXJXVHUVIDLOWRVHHNDQWHQDWDOFDUHDQGWKH\RQO\JRWRWKHKHDOWKVHUYLFHV IRUODERU,QWKHVHFDVHVWKHKHDOWKVWDIIPXVWEHUHDG\WRHYDOXDWHWKHXVHRIGUXJV RIIHUFRXQVHOLQJDQG+,9WHVWLQJWRSURYLGHWKHUDS\LQFDVHRIZLWKGUDZDODQG FRXQVHOLQJRQWKHHIIHFWRIWKHGUXJVRQWKHQHZERUQ
7.5. Women with primary HIV-infection during pregnancy 0DQ\ZRPHQPD\SUHVHQWDQHJDWLYHVHURORJ\WHVWWKH¿UVWWULPHVWHUEXWWKH\ PD\FRQWLQXHWREHDWULVNRIDFTXLULQJWKHLQIHFWLRQHLWKHUEHFDXVHWKHLUXVXDO SDUWQHUKDV+,9RUEHFDXVHVKHLVH[SHULHQFLQJDQDFXWHLQIHFWLRQ'XULQJWKH DFXWH LQIHFWLRQ WKH WUDQVPLVVLRQ UDWHV DUH KLJKHU WKDQ GXULQJ WKH HVWDEOLVKHG LQIHFWLRQEHFDXVHRIWKHKLJKHUFRQFHQWUDWLRQVRIWKHYLUXVWKDWFLUFXODWHDWWKLV VWDJH7KLVDOVRDSSOLHVLQWKHVHWWLQJRI07&7 ,Q1HZ Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 75 8. ANNEXES $11(; $/*25,7+0672%($33/,(',17+(9$5,286 6(77,1*6 $11(; 0(',&$7,21'26$*(6 $11(; '58*,17(5$&7,216 $11(; 9(57,&$/027+(572&+,/'75$160,66,21 2),1)(&7,2166&5((1,1*$1'6<67(0$7,& ,17(59(17,216 $11(; */2%$/0($685(67235(9(17,1)(&7,216 '85,1*35(*1$1&< Generations free of HIV and congenital syphilis 76 $QQH[$/*25,7+06)257+(',))(5(176&(1$5,26 $QQH[ 2SWLRQVIRUWKHDQWLUHWURYLUDOWKHUDS\RISUHJQDQWZRPHQZLWKD&'FRXQW RYHUFHOOVPPDQG$597SUHVFULSWLRQ 2SWLRQ $GYDQWDJHV 'LVDGYDQWDJHV 8VHD3,EDVHGJXLGHOLQH /RZHUULVNRI /LPLWVWKHFKRLFHVRI KHSDWRWR[LFLW\ VHFRQGOLQHWKHUDS\ .HHSV3LVIRUWKHVHFRQG 6WDUWDQ193EDVHGWKHUDS\ OLQHJXLGHOLQH 3RWHQWLDOULVNRIVHULRXV XQGHUFORVHVXUYHLOODQFHWKH KHSDWRWR[LFLW\ ¿UVWZHHNV &RPSDWLEOHZLWKWKH FXUUHQWUHFRPPHQGDWLRQV /HVVSRZHUIXOWDQ JXLGHOLQHVZLWK1157,RU 7KH3,LVNHSWIRUWKH 3, 6WDUWDJXLGHOLQHZLWK VHFRQGOLQHJXLGHOLQH 7KHXVHRI7')LVQRW 157,V /RZHUULVNRI UHFRPPHQGHGEHFDXVH KHSDWRWR[LFLW\ RISRWHQWLDOWR[LFLW\VWLOO XQGH¿QHG Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 77 Annex 1.2 Guidelines for the prophylaxis of ARVT-naïve women with HIV with no indication for ARVT, and seeking care at early stages of pregnancy 5HFRPPHQGDWLRQ 3UHJQDQF\ /DERU 3RVWSDUWXP $GYDQWDJHV 'LVDGYDQWDJHV OHYHO 0RWKHU 'LVFRQWLQXH193 5LVNRIWR[LFLW\LQ 5HFRPPHQGHG $=77&193 DQGFRQWLQXHGD\V 9HU\HIIHFWLYH ZRPHQZLWK&' $=77& $, DIWHUZHHN $=7(9 JXLGHOLQH FRXQWV FHOO &KLOG $=7ZHHNV PP +LJKHUFRVW7KHXVH $=7&73, 5HFRPPHQGHG 0RWKHU 'LVFRQWLQXH 9HU\HIIHFWLYH RI3,PD\MHRSDUGL]H /39U649U JXLGHOLQH LWVIXWXUHXVHDVQG $, DIWHUZHHN $=7(9 &KLOG $=7ZHHNV OLQHWKHUDS\ /RZHUYLURORJLFDO (DV\ HI¿FDF\ GRVDJLQJLQ $=77&$%& 0RWKHU 'LVFRQWLQXH 5LVNRI157, 2SWLRQDO&,,, FRPELQDWLRQ DIWHUZHHN UHVLVWDQFH $=7(9 &KLOG $=7ZHHNV ZLWKD¿[HG GRVH 5LVNRI$%& K\SHUVHQVLWLYLW\ 'LVFRQWLQXHLIWKHPRWKHUGRHVQRWKDYHDQLQGLFDWLRQIRUVWDUWLQJ$597 Generations free of HIV and congenital syphilis 78 Annex 1.3 Guidelines for the prophylaxis of therapy-naïve women with HIV that seek care at labor 5HFRPPHQGDWLRQ /DERU 3RVWSDUWXP $GYDQWDJHV 'LVDGYDQWDJHV OHYHO 0RWKHU $=77&î GD\V $=77&PXVW 5HFRPPHQGHG &KLOG $=7ZHHNV 3HUPLWVWRUHGXFHWKH GX193$=7 EHDGPLQLVWHUHG 193 RUGRVHV 07&7UDWHVFORVHUWR %,, WRSUHYHQWWKH LYXSWR VHHWH[W FRPELQHGWKHUDS\ RFFXUUHQFHRI1157, FKLOGELUWK $VVHVVWULSOHWKHUDS\ (DVLO\LPSOHPHQWHG UHVLVWHQFH GHSHQGLQJRQULVN IDFWRUV VHHWH[W +LJKHUFRVW7KHXVH 5HFRPPHQGHG 0RWKHU 'LVFRQWLQXH 9HU\HIIHFWLYH RID3,PD\KLQGHULWV $=7(9 $, &KLOG $=7ZHHNV JXLGHOLQH IXWXUHXVHDVVHFRQG OLQHWKHUDS\ 1RWH VHHGRVDJHVLQ$QQH[ 7KHUHDUHOLPLWHGGDWDDYDLODEOHRQWKHHI¿FDF\RIDZHHN$=7IRUWKHFKLOG Annex 1.4 Guidelines for antiretroviral prophylaxis of children born to mothers with HIV that received no prophylaxis 3RVWSDUWXP $GYDQWDJHV 'LVDGYDQWDJHV 7KHUHDUHQRVWXGLHVVXSSRUWLQJ &KLOG WULSOHWKHUDS\ 5HFRPPHQGHG *UHDWHUWKHRUHWLFDO WKLVHYLGHQFH $=77&193IRU %,, HI¿FDF\ 9LURORJLFDOWHVWLQJVKRXOGEH ZHHNV FRQGXFWHGEHIRUHVWDUWLQJWKHUDS\ &KLOG 193 GRVH 193$=7LVPRUH 7R[LFLW\ULVN 2SWLRQ 7KH¿UVWLPPHGLDWHO\ HIIHFWLYHWKDQGX193 5LVNRI193UHVLVWDQFHLIWKHFKLOG %,, DIWHUFKLOGELUWK DORQHRU$=7DORQH ZDVLQIHFWHGGXULQJGHOLYHU\ $=7îZHHNV 1RWH VHHGRVDJHVLQ$QQH[ Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 79 Annex 2. MEDICATION DOSAGES Annex 2.1 Medication for mothers 0HGLFDWLRQ 'RVDJH 6WUHQJWKV 7DEOHW[PJ =LGRYXGLQH PJKRXUV 7DEOHW[PJ /DPLYXGLQH PJKRXUV 7DEOHW[PJ =LGRYXGLQH/DPLYXGLQH PJPJKRXUV 7DEOHW[PJ$=7PJ7& 1HYLUDSLQH PJKRXUV 7DEOHW[PJ /RSLQDYLU5LWRQDYLU PJPJKRXUV 7DEOHW[PJPJ 6WDYXGLQH PJKRXUV 7DEOHWPJ %HQ]DWKLQH3HQLFLOOLQ ,8 $PSRXOH8, Annex 2.2 Medication for children 0HGLFDWLRQ 'RVDJH 6WUHQJWKV =LGRYXGLQH PJ.JFDGDKRXUV %RWWOHPJPO[PO /DPLYXGLQH PJ.JKRXUV %RWWOHPJPO[PO 1HYLUDSLQH PJ.JGD\ %RWWOHPJPO[PO %HQ]DWKLQHSHQLFLOOLQ 8,.J $PSRXOH,8 3URFDLQHSHQLFLOOLQ 8,.JGD\ ,0 $PSRXOH $TXRXVFU\VWDOOLQHSHQLFLOOLQ ±,8NJ $PSRXOH * KRXUV LY 7ULPHWRSULPVXOIDPHWR[D]ROH POGD\ %RWWOHPJPJPO Generations free of HIV and congenital syphilis 80 Annex 3. DRUG INTERACTIONS Nucleoside Reverse Transcriptase Inhibitors (NRTIs) or Nucleoside Analogs (NA) &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV &RPPHQWV 7')$=7$%&GGOG7,3 DOO 0DUDYLURF193()95DOWHJUDYLU )7& 7& &LGRIRYLU Ļ7&DQG)7&FOHDUDQFH (OLWHUJUDYLU(QIXYLUWLGH(WUDYLULQH 70& )DPLF\FORYLU 7ULPHWURSULP VXOIDPHWR[D]RO DGRVLVHOHYDGDV DXPHQWDHOULHVJRGH $=7G7GGO,3 DOO0DUDYLURF193 7& RWRWR[LFLGDG &LGRIRYLU Ļ7&DQG)7&FOHDUDQFH ()9(QIXYLUWLGH(WUDYLULQH5DQLWLGLQ )RVFDUQHW )7& *DQFLFORYLU *DQF\FORYLU KHPDWRORJLYDOWR[LFLW\ &DXWLRQZLWKRWKHUVKHPDWRWR[LF 7&$%&$F\FORYLU$WRYDTXRQH GUXJVVXFKDV70360; $]\WKURP\FLQGGO()9(OY,WHJUDYLU GDSVRQH3LULPHWDPLQULEDYLULQHRU (QIXYLUWLGH(WUDYLULQH)RVFDUQHW)7& DPSKRWHULFLQH $=7 G7 ,QWHUIHURQ PD\Ĺ$=7OHYHOV ,3 DOO 739 PLJKWĻOHYHOV$=7 0DUDYLURF0HJHVWURO 9DOSURDWH Ĺ $=7 1933DUDFHWDPRO5DQLWLGLQH )OXFRQD]ROH Ĺ$=7 5LIDPSLQ5LIDEXWLQ 3UREHQHFLGH Ĺ$=7 &LGRIRYLU UHFRPPHQGĻ$=7E\KDOI $79Ļ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Ļ$%&OHYHOV 3,V DOO :KHQVWDUWLQJ 0DUDYLURF(OYLWHJUDYLU(QIXYLUWLGH 157,V1157, (WUDYLULQH EHFDXVHWKH K\SHUVHQVLWLYLW\ DOOHUJLFUHDFWLRQ FDQEHFRQIXVHG 0RQLWRUF\FORVSRULQOHYHOVZLWK()9DQG193 7KH\LQFUHDVHWKHWR[LFLW\RIFRFDLQH 193LQFUHDVHVWKHOHYHORIHWK\QLOHVWUDGLRODQG()9UHGXFHVWKHP Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 81 Non Nucleoside Reverse Transcriptase Inhibitors (NNRTIs &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV &RPPHQWV $PRGLDTXLQH 5LIDPSLFLQDQGULIDEXWLQPD\ $FHW\OVDOLF\OLFDFLG &OLQLFDO 2UDO ORZHUOHYHOV $PLWULSW\OLQH$PSKRWHULFLQ% PRQLWRULQJRI FRQWUDFHSWLYHV &ODULWKURP\FLQWKLVDQWLELRWLF $QWDFLGV &16V\PSWRPV FRQFHQWUDWLRQPD\EHĻE\ $QWLYLUDOV 0RVW$WRYDTXRQH ZKHQFRPELQLQJ $VWHPL]ROH Ļ&DUEDPD]HSLQHRIERWK $]LWKURP\FLQ ZLWKLQWHUIHURQ %HSULGLO ĻOHYHOVRIOLSLGORZHULQJ %EORFNHUV 0RVW %XSURSLRQ 3RVVLEOHĻWDFUROLPXVDQG &HWLUL]LQHFLSURÀR[DFLQ &DXWLRQZKHQ &LVDSULGH F\FORVSRULQH &OLQGDP\FLQFKORURTXLQH VWDUWLQJZLWK (UJRWDPLQH Ļ$8&RI,'9 &KORUSURPD]LQH $%&6HYHUH GHULYDWLYHV Ļ$8&RI$39)39 8VH 'DSVRQH'RPSHULGRQH $%&UHODWHG (WUDYLULQH )39U 'R[RUXELFLQ(QIXYLUWLGH K\SHUVHQVLWLYLW\ )OXYDVWDWLQ ĻOHYHOVRI/39 (U\WKURP\FLQ FRXOGEH 0LGD]RODP ĻOHYHOVRI$798VH$79U )OXFRQD]ROH)OXF\WRVLQH(WKDPEXWRO FRQIXVHGZLWK ()9 3LPR]LGH 1RWUHFRPPHQGHG649$39 )OXR[HWLQH*DEDSHQWLQ ()9UHODWHGUDVK 649 'RQRWFRPELQHZLWK193 ,EXSURIHQ+DORSHULGRO 7HUIHQDGLQH 0RQLWRUFRQFHQWUDWLRQRIRUDO ,VRQLD]LG/DPRWULJLQH 2WKHUDFFHSWHG 7ULD]RODP DQWLFRDJXODQWV /DQVRSUD]ROH/RUD]HSDP0HÀRTXLQH &OR¿EUDWH 9RULFRQD]ROH 0RQLWRUWR[LFLW\DQGHI¿FDF\RI 0RUSKLQH0HWURQLGD]ROH1$ *HP¿EUR]LO DQWLDUUK\WKPLFV 2PHSUD]ROH %XGHVRQLGH (UHFWLOHG\VIXQFWLRQGUXJVVKRXOGEH 2QGDQVHWURQ2[D]HSDP )OXWLFDVRQH XVHGZLWKFDXWLRQRUDWORZGRVHV $FHWDPLQRSKHQ3DUR[HWLQH 0HJHVWURO 3HQWDPLGLQH3\UD]LQDPLGH 3\ULPHWKDPLQH3LUR[LFDP3URJXDQLO 5DQLWLGLQH6WUHSWRP\FLQ 6XPDWULSWDQVXOIDGR[LQH7KHRSK\OOLQH 7HUELQD¿QH7HWUDF\FOLQHV 70360;5RVXYDVWDWLQ 9DOSURDWH9LJDEDWUL 2UDO &ODULWKURP\FLQWKLVDQWLELRWLF 6LPLODUWR()9ZLWKWKHIROORZLQJ 1RWH[SHFWHG FRQWUDFHSWLYHV FRQFHQWUDWLRQPD\EHĻE\ GLIIHUHQFHV LPSRUWDQW &DUEDPD]HSLQH 5LIDPSLFLQFRXOGĻFRQFHQWUDWLRQ LQWHUDFWLRQ (WUDYLULQH ,PSURYHGOLSLGORZHULQJ 3RVVLEOHLQWHUDFWLRQV 739 3KHQ\WRLQ FRQFHQWUDVWLRQ (U\WKURP\FLQ 6XOIRQDPLGHV 3KHQREDUELWDO SUDYDVWDWLQURVXYDVWDWLQ .HWRFRQD]ROH 1RLQWHUDFWLRQ &DXWLRQZKHQ 5LIDPSLFLQ 3RVVLEOHĻ&\FORVSRULQHWDFUROLPXV &LPHWLGLQH VWDUWLQJZLWK 649 VLUROLPXVDQGSUHGQLVRQH '59 $%&6HYHUH 9RULFRQD]ROH )39 $%&UHODWHG )OXFRQD]ROHPD\ĹĹFRQFHQWUDWLRQ /RUDWDGLQH K\SHUVHQVLWLYLW\ 193 DQGKHSDWRWR[LFLW\ 1)9 FRXOGEH 579 FRQIXVHGZLWK Ļ$8&,'9 3UDYDVWDWLQ 193UHODWHGUDVK Ļ$8&RI$39 5LIDEXWLQ Ļ/39OHYHOV ĻFRQFHQWUDWLRQRI$79 XVH$79U 'RQRWFRPELQHZLWK()9 0RQLWRUWR[LFLW\DQGHI¿FDF\RI DQWLDUUK\WKPLFV ĻFRQFHQWUDWLRQRIHUHFWLOH G\VIXQFWLRQGUXJV LLQGLYLGXDOL]H 0RQLWRUFRQFHQWUDWLRQRIRUDO DQWLFRDJXODQWV Generations free of HIV and congenital syphilis 82 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Fusion Inhibitors (QIXYLUWLGH 7 1RFOLQLFDOO\VLJQLÀFDQWLQWHUDFWLRQV Protease Inhibitors (PI) &RPPRQLQWHUDFWLRQVZLWK,3V &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV 5HPDUNV &RQWUDLQGLFDWHG 0D\ĹOHYHOVRI %HVWOLSLGUHGXFLQJDJHQW SUDYDVWDWLQ 6RPH,3V GUXJV &\FORVSRULQHDQGRWKHU &DXWLRQZLWKDQWLHSLOHSWLFV WKH\FRXOGĻ,3OHYHOV PLJKWSURGXFH ,6 PRQLWRU 0RVWDGHTXDWH JDEDSHQWLQDQGYLJDEDWULP DGLVXOSKDP $VWHPL]ROH HIIHFWZKHQ 6DIHGUXJVWRDOO3,V &LVDSULGH 0RQLWRUOHYHOVZLWK FRPELQHGZLWK (UJRWDPLQH VWHURLGV 7&$$6 ,EXSURIHQ SRVVLEOHZLWK579 FHUWDLQGUXJV GHULYDWLYHV $%& SRVVLEOHZLWK/39DQG739 ,QWHUIHURQ,QWHUOHXNLQ FRQWDLQLQJ +DORIDQWULQH $GHIRYLU SRVVLEOHZLWK739 ,VRQLD]LG DOFRKRO /XPHIDQWULQH 7KHUHLVDSRWHQWLDO $PSKRWHULFLQ% /RUD]HSDP0HJHVWURO 0LGD]RODP $QWLYLUDOV PDMRULW\ SRVVLEOHDGHIRYLUZLWK649 0HWRFORSUDPLGH QRGDWDZLWK649 LQWHUDFWLRQZLWKGUXJV $]LWKURP\FLQ SRVVLEOHZLWK'591)9DQG579 2ÀR[DFLQ 3LPRFLGH PHWDEROL]HGWKURXJKWKH &HWLG]LQH&LSURÀR[DFLQ 2QGDQVHWURQ SRVVLEOHZLWK739 7HUIHQDGLQH &<3$SDWKZD\ VHH &OLQGDP\FLQ SRVVLEOHZLWK579 2[D]HSDP3DUDFHWDPRO 7ULD]RODP IRRWQRWH DQGRWKHU3 &OR¿EUDWH 3HQWDPLGLQH SRVVLEOHZLWK579 HQ]\PHV&RQVLGHUWKH &KORURTXLQH SRVVLEOHZLWK579 3\ULPHWKDPLQH SRVVLEOHZLWK579 LQWHUDFWLRQVRI579LQWKH G7'RPSHULGRQH 3URJXDQLO SRVVLEOHZLWK579 5DOWHJUDYLU 'R[RUXELFLQ SRVVLEOHZLWK739 ,3FRPELQDWLRQV (QIXYLUWLGH SRVVLEOHZLWK739 5LVSHULGRQH SRVVLEOHZLWK579DQG'59 0RQLWRUDQWLFRDJXODQWV 6WUHSWRP\FLQ 6XOIDGR[LQH SRVVLEOHZLWK579DQG739 8VXDOO\DQWLDUK\WKPLFV (WDPEXWRO)OXFLWRVLQ 7HUELQD¿QH PRQLWRU )7& 7HWUDF\FOLQH )OXFRQD]ROH SRVVLEOHZLWK739 7KLRULGD]LQH SRVVLEOHZLWK'59DQG579 )OXYDVWDWLQ*DEDSHQWLQ 70360; SRVVLEOHZLWK739 *HP¿EUR]LO+\GUR[\XUHD 9LJDEDWULQ $39 &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV 5HPDUNV $PLRGDURQH 6LPYDVWDWLQ $QWDFLGV KRXUDSDUW $WRYDTXRQH 2UDOFRQWUDFHSWLYHV 9LWDPLQ( 3KHQLWRLQHFDUEDPD]HSLQHDQGSKHQREDUELWDOPD\ %EORFNHUV DWHQROROELVRSURORO %HSULGLO $VWHPL]ROH Ļ$39 SURSUDQRORO &LVDSULGH 'LD]HSDP 0RQLWRU,6 (OYLWHJUDYLU )OHFDLQLGH )OXUD]HSDP 6LOGHQD¿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Ļ,'9 %EORFNHUV 3DUR[HWLQ MXLFH 3LPRFLGH $QWLFRDJXODQWV DWHQROROELVRSURORO DQWLGHSUHVVDQW 1RWUHFRPPHQGHG $PLRGDURQH 6LOGHQD¿O PHWRSUROROSURSUDQRORO RIFKRLFH /RYDVWDWLQ $79 &LPHWLGLQH VLPYDWDVWLQ &DUEDPD]HSLQH&OR]DSLQH 649 LQYLWURDQWDJRQLVPDQGFRPSOLFDWHGGRVDJLQJ &DVSRIXQJLQH'DSVRQH 3UDYDVWDWLQ (WUDYLULQH)OHFDLQLGH 3RVVLEOHĹ&\FORVSRULQSUHGQLVRQHWDFUROLPXVDQG (ULWKURP\FLQ 5DQLWLGLQ 5LIDPSLQ VLUROLPXV 157, VHHGGO 5RVXYDVWDWLQ 5LIDSHQWLQ /DQVRSUD]ROH/RSHUDPLGH 7KHRSK\OOLQH 6LPYDVWDWLQ7HUIHQDGLQH ()9DQG193 EHWWHU,'9U 0HWURQLGD]ROH 9DOSURDWH 7UD]RGRQH %URDGYDULDELOLW\ZLWK/39U$QWLDUK\WKPLFV PRQLWRU $YRLGĹGRVHDWRUYDVWDWLQ 'H[DPHWKDVRQH Ā,'9 Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 83 Soft gel SQV – hard gel SQV &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV 5HPDUNV $PLRGDURQH 0RQLWRU,6 $QWDFLGV 157, 7DNHZLWKIDWW\PHDOV %HSULGLO 6LOGHQD¿O $79 V\QHUJLVWLFHIIHFW ,WUDFRQD]ROH &DUEDPD]HSLQH $WRYDTXRQH )DPRWLGLQH 1RGDWDDYDLODEOHZLWK ,'9 LQYLWUR .HWRFRQD]ROH RUDOFRQWUDFHSWLYHVRU '59 DQWDJRQLVP %EORFNHUV /DPRWULJLQH YRULFRQD]RO 'H[DPHWKDVRQH 5LIDEXWLQ DQGFRPSOLFDWHGGRVLQJ DWHQROROELVRSURORO /DQVRSUD]ROH ()9 5LIDPSLQ SURSUDQROROPHWRSURORO /39U V\QHUJLVWLFHIIHFW ,'9 QRWHQRXJKGDWD 3KHQLWRLQH 4XLQLGLQH *UDSHIUXLWMXLFHR 0HWURQLGD]ROH DYDLODEOH 3KHQREDUELWDO 7HUIHQDGLQH ĹOHYHOVRI649 &DVSRIXQJLQ )OHFDLQLGH 739 &ODU\WKURP\FLQ 1RWUHFRPPHQGHG 193 $VWHPL]ROH (ULWKURP\FLQ 1)9 3URSDIHQRQH &LVDSULGH )39U 5DQLWLGLQ /RYDVWDWLQ 3LPRFLGH EHWWHUZLWKPJRI579 5RVXYDVWDWLQ VLPYDVDWLQ 7HRSK\OOOLQ 9DOSURDWH LPV/r &RQWUDLQGLFDWLRQV ,QWHUDFFLyQSRWHQFLDO 1RLQWHUDFFLRQHVGHLQWHUpV 5HPDUNV $PLRGDURQH 3KHQ\WRLQFRXOGĻ/39DQGYLFHYHUVD $79 7DNHZLWKIRRG 2UDOFRQWUDFHSWLYHV $QWDFLGV ZLWKWKHQHZIRUPXODWLRQLWLV $VWHPL]ROH 3KHQREDUELWDO FRXOGĻ/39 &LPHWLGLQH LQGLIIHUHQW %XSURSLRQ 0RQLWRU,6HVSHFLDOO\ 'DSVRQH '59 (WUDYLULQH 1RGDWDZLWKYRULFRQD]ROH (QFDLQLGH &\FORVSRULQHDQGWDFUROLPXV )DPRWLGLQH )OHFDLQLGH ĹGLJR[LQ$8& )OXYDVWDWLQ )HZVWXGLHVZLWK,'9 )39 DQGĹYDULDELOLW\RIOHYHOV 4XLQLGLQH &DXWLRQZLWKYHUDSDPLODQGGR[RUXELFLQ 157, 3URSDIHQRQH 6LOGHQD¿O /DQVRSUD]ROH 1RWUHFRPPHQGHG /RYDVWDWLQ 5LIDPSLFLQ 2PHSUD]ROH VLPYDVWDWLQ 7HUIHQDGLQH ()9DQG193 Ļ/39 3DUR[HWLQH EHVWDQWLGHSUHVVDQW 9RULFRQD]ROH 3UDYDVWDWLQ (UJRWDPLQLFGHULYDWLYHV 739 FRXOGĻOHYHOVRI/39 5DQLWLGLQ 0LGD]RODP $YRLGFRPELQDWLRQZLWKRUDOVROXWLRQRI 649U V\QHUJLFHIIHFW 3LPRFLGH7ULD]RODP PHWURQLGD]ROH IDYRUDEOHFRPELQDWLRQ 739 0RQLWRUHI¿FDF\RIDWRYDTXRQH ,'9 FPV &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV 5HPDUNV 2UDOFRQWUDFHSWLYHV 739 3KHQ\WRLQFDUEDPD]HSLQHDQG $]\WKURP\FLQDVDQDOWHUQDWLYHWR $GPLQLVHUKEHIRUH $WRUYDVWDWLQ 9RULVFRQD]ROH SKHQREDUELWDOSXHGHQĻ)39 FODU\WKURP\FLQDQGHU\WKURP\FLQ SURWRQSXPSLQKLELWRUV &OR]DSLQH &LVDSULGH /39 3LPRFLGH $OWHUQDWLYH$QWLHSLOHSWLFV JDEDSHQWLQ 7KHUHDUHQR /RUDWDGLQ 0LGD]RODP 0RQLWRU,6 ODPRWULJLQHYDOSURDWH GDWD,'9U 5LIDPSLQ 7ULD]RODP 6LOGHQD¿O RUZLWK1)9 5LIDSHQWLQ 3URSDIHQRQH &HWUL]LQH 7HUIHQDGLQH )OHFDLQDPLGH ĹSDUR[HWLQOHYHOV ()9 Ļ)39 DOZD\VXVH)39U )OXFRQD]ROH EHVWDQWLIXQJDO WKHVDPHZLWK193 157, 0RQLWRUWR[LFLW\RIDQWLDUK\WKPLFVDQG 193 DQWLFRDJXODQWV 2PHSUD]ROH &RUWLFRVWHURLGVPD\Ļ$39 5DQLWLGLQ Generations free of HIV and congenital syphilis 84 NFV &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV 5HPDUNV $PLRGDURQH /XPHIDQWULQH 6RPHFDVHVRIWR[LFLW\IRU $WRYDTXRQH 157, 7DNHZLWKIDWW\ 2UDOFRQWUDFHSWLYHV 0LGD]RODP FDUEDPD]HSLQ $39 ,WUDFRQD]ROH PHDO $PLWULSW\OLQH .HWRFRQD]ROH $VWHPL]ROH 2PHSUD]ROH 0RQLWRU,6 7KHUHDUHQRGDWD /DPRWULJLQH %XSURSLRQ 3LPRFLGH 6LOGHQD¿O EEORFNHUV DWHQRORO ZLWKYRULFRQD]ROH ELVRSUROROSURSUDQRORO /DQVRSUD]ROH RU)39 &LVDSULGH 4XLQLGLQH ()9 PD\ĻOHYHOV1)9 PHWRSURORO /RSHUDPLGH (UJRWDPLQHGHULYDWLYHV 5LIDPSLQ 3KHQREDUELWDO PD\ĻOHYHOV1)9 &DVSRIXQJLQ 0HWURQLGD]ROH +DORIDQWULQH 6LPYDVWDWLQ $WRUYDVWDWLQ XVHDWORZHUGRVH &LPHWLGLQH 193 1RUWULSWLOLQH /DQVRSUD]ROH 7HUIHQDGLQH SRVVLEOH 'DSVRQH 2PHSUD]ROH 1RWUHFRPPHQGHG (ULWKURP\FLQ /RYDVWDWLQ 7ULD]RODP 3DUR[HWLQH ORYDVWLQVLPYDVWDWLQ )DPRWLGLQH 739 5DQLWLGLQ )OXR[HWLQ 649 7KHRSK\OOLQH RTV 1RUHOHYDQW &RQWUDLQGLFDWLRQV ,QWHUDFFLyQSRWHQFLDO 5HPDUNV LQWHUDFWLRQV $OSUD]RODP )OHFDLQLGH 5LIDPSLQ Ļ5790RQLWRUOLYHUWR[LFLW\ $QWDFLGV 3UDYDVWDWLQ 0RUH $VWHPL]ROH )OXUD]HSDP 5LIDEXWLQ Ĺ &LPHWLGLQH K\SROLSLGHPLF $PLRGDURQH )OXYDVWDWLQ &ODU\WKURP\FLQ ĻGRVHLIWKHUHLVUHQDORUOLYHUIDLOXUH 'DSVRQH 2UDOFRQWUDFHSWLYHV .HWRFRQD]ROH 579PD\ĻOHYHOVRISKHQ\WRLQODPRWULJLQHDQGYDORURDWH (VFLWDORSUDP EHVW 1RUPDOO\XVHGDW 6HYHUDOFDVHVRIWR[LFLW\ZLWKFDUEDPD]HSLQH DQWLGHSUHVVDQW UHGXFHGGRVHVDV $WRUYDVWDWLQ /RUDWDGLQH DQHQKDQFHURI $QWLFRDJXODQW %HSULGLO 0HSHULGLQH )DPRWLGLQH RWKHU,3V Ĺ/HYHOVRI&\FORVSRULQHDQGWDFUROLPXVDQGPD\EHVLUROLPXV VHHGRVDJLQJ %XSURSLRQ 0LGD]RODP 157, 0RQLWRU,6 193 &LVDSULGH 3LUR[LFDP ,QFUHDVHVOHYHOV 7KHUHDUHFDVHVUHSRUWHGRIDGUHQDOVXSSUHVVLRQZLWKLQKDOHG 2PHSUD]ROH &ORUD]HSDWH 3URSDIHQRQH ÀXWLFDVRQH RIDOEHQGD]ROH 3UDYDVWDWLQ PRQLWRUWR[LFLW\ &OR]DSLQH 4XLQLGLQH 6LOGHQD¿O 'LD]HSDP 7HUIHQDGLQH 6SDFHGGOKRXUV 5DQLWLGLQ (QFDLQLGH 9RULFRQD]ROH 3RVVLEO\ĹFOLQGDP\FLQ $QWLFRQYXOVDQW DOWHUQDWLYH $YRLGORYDVWDWLQVLPYDVWDWLQPHWURQLGD]ROH:LWKDF\FORYLU (VWD]RODP =ROSLGHP JDEDSHQWLQ LQFUHDVHGULVNRIFU\VWDOXULD0RQLWRUHI¿FDF\RIDWRYDTXRQH (WUDYLULQH (UJRWGHULYDWLYHV ODPRWULJLQHYDOSURDWH 3KHQREDUELWDO ATV &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV 5HPDUNV $VWHPL]ROH 2PHSUD]ROH 2PHSUD]ROH 'DSVRQH :LWKPHDOV 2UDODQWLFRQFHSWLYHV 3URSDIHQRQH 0RQLWRU,6 '59 1RGDWDZLWK %HSULGLO 3LPRFLGH 8VH$79UZLWK7') (ULWKURP\FLQ YRULFRQD]ROH 6LOGHQD¿O &LVDSULGH 4XLQLGLQH )39U 193 QRGDWD )OHFDLQLGH 5LIDPSLFLQ $GPLQLVWHUKRXUVDSDUWZLWKDQWL+DQGKZLWKDQWDFLGV &RQVLGHUDVZLWK :LWK193DQG()9 ĻOHYHOVRI$79DGPLQLVWHUDOZD\V 157, SRVVLEOH ()9 )93 649 LQWHUDFWLRQZLWK7') ZLWK579 6\QHUJLFHIIHFWV ,'9 7HUIHQDGLQH DQGGGO Ĺ OHYHOVRIFODU\WKURP\FLQ DYRLG ZLWK649U /DQVRSUD]ROH 739 /39U3UDYDVWDWLQ $YRLGFDUEDPD]HSLQHSKHQ\WRLQSKHQREDUELWDO Ļ$79 ,ILWLV 0LGD]RODP 7ULD]RODP 1RWUHFRPPHQGHG ,'9ORYDVWDWLQVLPYDVWDWLQ 649U DGPLQLVWHUHGZLWK 19) (UJRWGHULYDWLYHV ĹOHYHOVRIRUDODQWLFRQFHSWLYHV GGOVHSDUDWHWKH GRVH Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 85 Darunavir &RQWUDLQGLFDWLRQV ,QWHUDFFLyQSRWHQFLDO 1RLQWHUDFFLRQHVGHLQWHUpV 5HPDUNV $PLRGDURQH $GMXVWGRVHVRI $QWDFLGV 1RGDWDDYDLODEOHIRU %HSULGLO&DUEDPD]HSLQ3KHQLWRLQ $WRUYDVWDWLQ $79 193 $QWLDUK\WKPLFV 3KHQREDUELWDO $QWLFRDJXODQWV )OHFDLQLGH/LGRFDOQH/39 3UDYDVWDWLQ &LPHWLGLQH 2PHSUD]ROH $QWLFRQYXOVDQWV 3URSDIHQRQH 5LIDEXWLQ (OYLWHJUDYLU 5DQLWLGLQ &DOFLXPDQWDJRQLVWV 4XLQLGLQH (WUDYLULQ 5LIDPSLQ649 (UHFWLOHG\VIXQFWLRQGUXJV )DPRWLGLQH 7HUIHQDGLQH /DQVRSUD]ROH TPV &RQWUDLQGLFDWLRQV 3RWHQWLDOLQWHUDFWLRQ 1RUHOHYDQWLQWHUDFWLRQV 5HPDUNV $OSUD]RODP /RUDWDGLQH 739UĻĻOHYHOVRIDWRUYDVWDWLQ 7& :LWKPHDOV G7 $PLRGDURQH /39 6HSDUDWHKRXUVIURPDQWDFLGV 1RGDWDDYDLODEOHZLWK ()9 PRQLWRUKHSDWRWR[LFLW\ RUDODQWLFRQFHSWLYHV 2UDOFRQWUDFHSWLYHV 3URSDIHQRQH 739FRXOGĻOHYHOVRI/39$79649DQG)39 $GPLQLVWHUZLWK739U(OYLWHJUDYLU $%& 4XLQLGLQH )7& ZLWKYRULFRQD]ROHRU $%& $YRLG739UFRXOGĻ$%&OHYHOV )OXYDVWDWLQ ZLWK,6 %HSULGLO%XSURSLRQ 5LIDPSLQ GGO$GPLQLVWHUKRXUVDSDUW /RSHUDPLGH &OR]DSLQH $79,'91)9 QRGDWD 649 ,3 DYRLGFRPELQDWLRQ H[FHSWIRU579DV 0DUDYLURF (QFDLQLGH(WUDYLULQH 193 DGPLQLVWHUZLWK739U $QWLHSLOHSWLFV 7HUIHQDGLQH HQKDQFHU E\ĻOHYHOV 3KHQREDUELWDO 2PHSUD]ROH DQWLIXQJDO $=7 )OHFDLQLGH &ODU\WKURP\FLQ OĻGRVHLQUHQDOIDLOXUH 3UDYDVWDWLQ DQWLXOFHUDJHQWV $QWLGHSUHVVDQWV PRQLWRUDGYHUVHHIIHFWV 5RVXYDVWDWLQ 7') HUHFWLOHG\VIXQFWLRQ 5LIDEXWLQ Ĺ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¿ODQGWDGDOD¿OHVSHFLDOO\LILWLV DVVRFLDWHGWR579 ,WLQGXFHVWKHUHGXFWLRQRIWKHOHYHOVRIVHYHUDO,3V3UREDEO\OHVVPDUNHGZLWK739U,WLVJHQHUDOO\QRWUHFRPPHQGHGWR DVVRFLDWHZLWKRWKHU,3VH[FHSWIRU579 %RWKSURGXFHGLQGLUHFWK\SHUELOLUXELQHPLD 5HGXFHWKHGRVHRIWUD]RGRQHRUXVHDOWHUQDWLYHGUXJV 7KLVUHIHUVWRDEXIIHUHGGGO7KHUHLVQRLQWHUDFWLRQZLWKHQWHULFFDSVXOHVRIGGO ,WPD\ĀWKHSODVPDOHYHOVRIZDUIDULQDQGDFHQRFRXPDURO PRQLWRUOHYHOV 1RWUHFRPPHQGHGZLWK,QYLUDVHDVVLQJOH,3ĀOHYHOVRI6498VH649U &RQWUDLQGLFDWHGZKHQ649LVXVHGDVDVLQJOH,3 649U *UHDWYDULDELOLW\RISODVPDOHYHOV &RXOGLQFUHDVHWKHULVNRIORQJ47 7KHLQWHUDFWLRQĀRIHWUDYLULQH LWZDVGHVFULEHGZLWK579DWIXOOGRVHVQRWDVDQHQKDQFHURIRWKHU,3V $GPLQLVWHUKRXUVDSDUWLILWLVDGPLQLVWHUHGZLWKRXW579,WQHHGVQRDGMXVWPHQWZLWK$79U VWXG\SHUIRUPHGZLWK IDPRWLGLQH $YRLGXQOHVVWKHUHLVQRRWKHUDOWHUQDWLYH739Ā$%& Generations free of HIV and congenital syphilis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¿QDVWHULGH ÀXQDUL]LQH ÀXUD]HSDP ODFLGLSLQH OLGRFDLQH ORUDWDGLQHPHSHULGLQH QLFDUGLSLQH QLIHGLSLQH QLPRGLSLQH QLWUHQGLSLQH SUHGQLVRQH TXLQLGLQH TXLQLQH VHUWUDOLQH VLOGHQD¿O YDUGHQD¿O WDGDOD¿O WDFUROLPXV YHUDSDPLO YLQFULVWLQHDQG]ROSLGHP 9. BIBLIOGRAPHY 2186,'$ 6LWXDFLyQGHODHSLGHPLDGH6LGD85/DYDLODEOHDW KWWS GDWDXQDLGVRUJSXE 5HSRUW BHSLGHPLFBXSGDWHBHVSGI &DOOHMD-0:DONHU1&XFKL3/D]]DUL6*K\V3'=DFDULDV)6WDWXVRIWKH+,9$,'6HSLGHPLFDQGPHWKRGV WRPRQLWRULWLQWKH/DWLQ$PHULFDDQG&DULEEHDQUHJLRQ$LGV 6XSSO 6 81,&()6WDWLVWLFV85/DYDLODEOHDW KWWS ZZZXQLFHIRUJLQIRE\FRXQWU\FXEDVWDWLVWLFVKWPO (0086,9(QFXHVWDGHPRUWDOLGDGPRUELOLGDG\XWLOL]DFLy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¤ 6FKPLG*36WRQHU%3+DZNHV6%URXWHW17KHQHHGDQGSODQIRUJOREDOHOLPLQDWLRQRIFRQJHQLWDOV\SKLOLV 6H[7UDQVP'LV 6XSSO 6 +LUD6.%KDW*-&KLNDPDWD'01NRZDQH%7HPER*3HULQH3/HWDO6\SKLOLVLQWHUYHQWLRQLQSUHJQDQF\ =DPELDQGHPRQVWUDWLRQSURMHFW*HQLWRXULQ0HG 6FKXO].)&DWHV:-U2¶0DUD353UHJQDQF\ORVVLQIDQWGHDWKDQGVXIIHULQJ OHJDF\RIV\SKLOLVDQG JRQRUUKRHDLQ$IULFD*HQLWRXULQ0HG :+27KH*OREDOHOLPLQDWLRQRIFRQJHQLWDOV\SKLOLV UDWLRQDOHDQGVWUDWHJ\IRUDFWLRQ*HQHYD :+2 >&RQVXOWDGRHOGH1RYLHPEUHGH@85/DYDLODEOHDWKWWS ZKTOLEGRFZKRLQW SXEOLFDWLRQV HQJSGI 7LQDMHURV)*URVVPDQ'5LFKPRQG.6WHHOH0*DUFLD6*=HJDUUD/HWDO'LDJQRVWLFDFFXUDF\RIDSRLQW RI¤FDUHV\SKLOLVWHVWZKHQXVHGDPRQJSUHJQDQWZRPHQLQ%ROLYLD6H[7UDQVPOQIHFW 6XSSO Y 3$523ODQRIDFWLRQIRUWKHHOLPLQDWLRQRIFRQJHQLWDOV\SKLOLV:DVKLQJWRQ 3$52 3$+2:+2 &( Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 87 9DOGHUUDPD-(OLPLQDFLyQGHVI¿OLVFRQJpQLWDHQ$PpULFD/DWLQD\HO&DULEH PDUFRGHUHIHUHQFLDSDUDVX LPSOHPHQWDFLyQ:DVKLQJWRQ 236 85/DYDLODEOHDW KWWS ZZZSDKRRUJ6SDQLVK$')&+$ (OLPLQD6L¿OLV/$&SGI 206 ¶$6$0%/($081',$/'(/$6$/8'$ 3XQWRGHORUGHQGHOGtDSURYLVLRQDOGH PD\RGH*LQHEUD 206 85/DYDLODEOHDW KWWS ZZZZKRLQWJEHEZKDOSGI¿OHV:+$ $ B VSSGI 206(VWUDWHJLDPXQGLDOGHSUHYHQFLyQ\FRQWUROGHODVLQIHFFLRQHVGHWUDQVPLVLyQVH[XDO*LQHEUD 206 85/DYDLODEOHDW KWWS ZZZZKRLQWUHSURGXFWLYHKHDOWKSXEOLFDWLRQVHVVWLVVWUDWHJYVWLV VWUDWHJYBHVSGI 206(OLPLQDFLyQPXQGLDOGHODVI¿OLVFRQJpQLWD IXQGDPHQWRV\HVWUDWHJLDSDUDODDFFLy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¶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pULFDV:DVKLQJWRQ 236 3XEOLFDFLyQ&LHQWt¿FD\7pFQLFD 81)3$81$,'681,&():+2(8523(6WUDWHJLF)UDPHZRUNIRUWKH3UHYHQWLRQRI+,9,QIHFWLRQLQ ,QIDQWLQ(XURSH&RSHQKDJHQ :+2 'H9LQFHQ]L,7KH(XURSHDQ6WXG\*URXSRQ+HWHURVH[XDO7UDQVPLVVLRQRI+,9$ORQJLWXGLQDOVWXG\RIKXPDQ LPPXQRGH¿FLHQF\YLUXVWUDQVPLVVLRQE\KHWHURVH[XDOSDUWQHUV1(QJO-0HG &DVWLOOD-GHO5RPHUR-+HUUDQGR90DULQFRYLFK0*DUFLD65RGULJXH]&(IIHFWLYHQHVVRIKLJKO\DFWLYH DQWLUHWURYLUDOWKHUDS\LQUHGXFLQJKHWHURVH[XDOWUDQVPLVVLRQRI+,9-$FTXLU,PPXQH'H¿F6\QGU ¤ %ULWLVK+,9$VVRFLDWLRQ&KLOGUHQ¶V,,,9$VVRFLDWLRQ*XLGHOLQHVIRUWKHPDQDJHPHQWRI+,9LQIHFWLRQLQ SUHJQDQWZRPHQ/RQGRQ %5(9$ 85/DYDLODEOHDW KWWS ZZZEKLYDRUJ¿OHV¿OHSGI 3DUDVNHYDV*3.DSDNL(.DUDUL]RX(0LWVRQLV&6IDJRV&9DVVLORSRXORV'&HUHEURVSLQDOÀXLGWDXSURWHLQ LVLQFUHDVHGLQQHXURV\SKLOLV DGLVFULPLQDWLRQIURPV\SKLOLVZLWKRXWQHUYRXVV\VWHPLQYROYHPHQW"6H[7UDQVP 'LV &HQWHUVIRU'LVHDVH&RQWURODQG3UHYHQWLRQ6H[XDOO\WUDQVPLWWHGGLVHDVHVWUHDWPHQWJXLGHOLQHV 00:5 85/DYDLODEOHDW KWWS ZZZFGFJRYVWGWUHDWPHQWUUSGI Generations free of HIV and congenital syphilis 88 /HZLV'$ Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 89 WULDO/DQFHW (O6DGU:0/XQGJUHQ-'1HDWRQ-'*RUGLQ)$EUDPV'$UGXLQR5&HWDO&'FRXQWJXLGHG LQWHUUXSWLRQRIDQWLUHWURYLUDOWUHDWPHQW1(QJO-0HG &RQQRU(06SHUOLQJ56*HOEHU5.LVHOHY36FRWW*2¶6XOOLYDQ0-HWDO5HGXFWLRQRIPDWHPDOLQIDQW WUDQVPLVVLRQRIKXPDQLPPXQRGH¿FLHQF\YLUXVW\SHZLWK]LGRYXGLQHWUHDWPHQW3HGLDWULF$,'6&OLQLFDO7ULDOV DQXS3URWRFRO6WXG\DQXS1(QJO-0HG /DOOHPDQW0-RXUGDLQ*/H&RHXU6.LP6.RHWVDZDQJ6&RPHDX$0HWDO$WULDORIVKRUWHQHG ]LGRYXGLQHUHJLPHQVWRSUHYHQWPRWKHUWRFKLOGWUDQVPLVVLRQRIKXPDQLPPXQRGH¿FLHQF\YLUXVW\SH 3HULQDWDOP\3UHYHQWLRQ7ULDO 7KDLODQG ,QYHVWLJDWRUV1(QJO-0HG &KDLVLOZDWWDQD3&KRNHSKDLEXONLW.&KDOHUPFKRFNFKDWQHQNLW$9DQSUDSDU16LULPDL.&KHDUVNXO6HWDO 6KRUWFRXUVHWKHUDS\ZLWK]LGRYXGLQHSOXVODPLYXGLQHIRUSUHYHQWLRQRIPRWKHUWRFKLOGWUDQVPLVVLRQRIKXPDQ LPPXQRGH¿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¿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¿FDF\RI]LGRYXGLQHODPLYXGLQHDQG VLQJOHGRVHQHYLUDSLQHWRSUHYHQWSHULSDUWXP+,9WUDQVPLVVLRQ$LGV 7RQZH*ROG%(NRXHYL'.9LKR,$PDQL%RVVH&7RXUH6&RI¿H3$HWDO$QWLUHWURYLUDOWUHDWPHQWDQG SUHYHQWLRQRISHULSDUWXPDQGSRVWQDWDO+,9WUDQVPLVVLRQLQ:HVW$IULFD HYDOXDWLRQRIDWZRWLHUHGDSSURDFK 3/R60HG H 0RQLV$%'REOHV$5&X8YLQ6=RUULOOD&$QGHUVRQ-+DUZHOO-,HWDO3URWHDVHLQKLELWRUXVHLQ SUHJQDQFLHV-$FTXLU,PPXQH'H¿F6\QGU 0DUD]]L0&*HUPDQR3/LRWWD**XLGRWWL*/RXUHLUR6GD&UX]*RPHV$HWDO6DIHW\RI QHYLUDSLQH¤FRQWDLQLQJDQWLUHWURYLUDOWULSOHWKHUDS\UHJLPHQVWRSUHYHQWYHUWLFDOWUDQVPLVVLRQLQDQ$IULFDQFRKRUW RI+,9LQIHFWHGSUHJQDQWZRPHQ+,90HG 5HDG-6&DKQ3/RVVR03LQWR--RDR('XDUWH*HWDO0DQDJHPHQWRIKXPDQLPPXQRGH¿FLHQF\ YLUXV¤LQIHFWHGSUHJQDQWZRPHQDW/DWLQ$PHULFDQDQG&DULEEHDQVLWHV2EVWHW*\QHFRO &KDPD&*DVKDX:2JXFKH67KHYDOXHRIKLJKO\DFWLYHDQWLUHWURYLUDOWKHUDS\LQWKHSUHYHQWLRQRIPRWKHU WR¤FKLOGWUDQVPLVVLRQRI+,9-2EVWHW*\QDHFRO &KLOH0LQLVWHULRGH6DOXG*XtDVFOtQLFDVVLQGURPHGHLQPXQRGH¿FLHQFLDDGTXLULGD 9,776LGD6DQWLDJR&KLOH 0LQLVWHULRGH6DOXG >IHFKDGHFRQVXOWDGHVHWLHPEUHGH@85/DYDLODEOHDW KWWS ZZZPLQVDOFO LFLJXLDVFOLQLFDVYLKVLGD50D\RO2SGI 8UXJXD\0LQLVWHULRGH6DOXG3~EOLFD3URJUDPD3ULRULWDULR,766LGD236&HQWUR,QWHUQDFLRQDOHQ &RRSHUDFLyQ7pFQLFDHQ9,,,6LGD,QIHFFLyQSRUHO9LUXVGHOD,QPXQRGH¿FLHQFLD+XPDQD*XtDVSDUD Generations free of HIV and congenital syphilis 90 GLDJQyVWLFRWUDWDPLHQWRDQWLUUHWURYLUDO\PRQLWRUL]DFLyQGHDGXOWRV\HPEDUD]DGDV&DStWXOR,,, 9,+6LGD\ HPEDUD]R0RQWHYLGHR 063 >IHFKDGHFRQVXOWDGHVHWLHPEUHGH@85/DYDLODEOHDW KWWS ZZZ PVSJXEX\LPJQRWLFLDVSGI &RORPELD0LQLVWHULRGH6DOXG&RQVHMR1DFLRQDOGH6HJXULGDG6RFLDOHQ6DOXG*XtDSDUDHOPDQHMRGHO 9,+VLGD%DVDGDHQODHYLGHQFLD%RJRWi 0LQLVWHULRGH6DOXG >IHFKDGHFRQVXOWDHOGHVHWLHPEUH GH@85/DYDLODEOHDW KWWS ZZZPLQSURWHFFLRQVRFLDOJRYFR9%H&RQWHQWOLEUDU\GRFXPHQWV 'RF1HZV1R'RFXPHQW1R3') 1LFDUDJXD0LQLVWHULRGH6DOXGGH1LFDUDJXD1RUPD\SURWRFRORSDUDODSUHYHQFLyQGHODWUDQVPLVLyQYHUWLFDO GHO9,+0DQDJXD 0LQLVWHULRGH6DOXG 85/DYDLODEOHDW KWWS ZZZPLQVDJREQLEQVUHJXODFLRQ 1¤3UHYHQFLRQ7UDQVPLVLRQ9HUWLFDO9,+SGI 0UXV-07VHYDW-&RVWHIIHFWLYHQHVVRILQWHUYHQWLRQVWRUHGXFHYHUWLFDO+,9WUDQVPLVVLRQIURPSUHJQDQW ZRPHQZKRKDYHQRWUHFHLYHGSUHQDWDOFDUH0HG'HFLV0DNLQJ 7KH,QWHUQDWLRQDO3HULQDWDOP\*URXS7KHPRGHRIGHOLYHU\DQGWKHULVNRIYHUWLFDOWUDQVPLVVLRQRIKXPDQ LPPXQRGH¿FLHQF\YLUXVW\SHDPHWDDQDO\VLVRISURVSHFWLYHFRKRUWVWXGLHV1(QJO-0HG 7KH(XURSHDQ0RGHRI'HOLYHU\&ROODERUDWLRQ(OHFWLYHFDHVDUHDQVHFWLRQYHUVXVYDJLQDOGHOLYHU\LQSUHYHQWLRQ RIYHUWLFDO+,9WUDQVPLVVLRQ DUDQGRPLVHGFOLQLFDOWULDO/DQFHW 5HDG-61HZHOO0.(I¿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¿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¿UVWPRQWKVRIOLIH DQLQWHUYHQWLRQFRKRUWVWXG\/DQFHW &RXWVRXGLV$%UHDVWIHHGLQJDQGWKH+,9SRVLWLYHPRWKHU WKHGHEDWHFRQWDQWHV(DUO\+XP'HY 7LPPHUPDQV67HPSHOPDQ&*RGIULHG0+1HOOHQ-'LHOHPDQ-6SUHQJHU+HWDO1HO¿QDYLUDQGQHYLUDSLQH VLGHHIIHFWVGXULQJSUHJQDQF\$LGV %HVW%00LURFKQLFN0&DSSDUHOOL(96WHN$%XUFKHWW6.+ROODQG'7HWDO,PSDFWRISUHJQDQF\RQ DEDFDYLUSKDUPDFRNLQHWLFV$LGV 0RRGOH\-0RRGOH\'3LOOD\.&RRYDGLD+6DED-YDQ/HHXZHQ5HWDO3KDUPDFRNLQHWLFVDQG DQWLUHWURYLUDODFWLYLW\RIODPLYXGLQHDORQHRUZKHQFRDGPLQLVWHUHGZLWK]LGRYXGLQHLQKXPDQLPPXQRGH¿FLHQF\ Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 91 YLUXVW\SHLQIHFWHGSUHJQDQWZRPHQDQGWKHLURIIVSULQJ-,QIHFW'LV :DGH1$8QDGNDW-'+XDQJ66KDSLUR'(0DWKLDV$ Generations free of HIV and congenital syphilis 92 GHIHFWVDVVRFLDWHGZLWKDQWLUHWURYLUDOH[SRVXUHGXULQJSUHJQDQF\$P-2EVWHW*\QHFRO &RYLQJWRQ'/7LOVRQ+(OGHU-'RL3$VVHVVLQJWHUDWRJHQLFLW\RIDQWLUHWURYLUDOGUXJV PRQLWRULQJDQGDQDO\VLV SODQRIWKH$QWLUHWURYLUDO3UHJQDQF\5HJLVWZ3KDUPDFRHSLGHPLRO'UXJ6DI :DWWV'+7HUDWRJHQLFLW\ULVNRIDQWLUHWURYLUDOWKHUDS\LQSUHJQDQF\&XUU+,9$,'65HS 'DQHO&0RK5$Q]LDQ$$ER<&KHQDO+*XHKL&HWDO7ROHUDQFHDQGDFFHSWDELOLW\RIDQHIDYLUHQ]EDVHG UHJLPHQLQDGXOWV SUHGRPLQDQWO\ZRPHQ LQ:HVW$IULFD-$FTXLU,PPXQH'H¿F6\QGU 9LWKD\DVDL90R\OH*-6XSDMDWXUD9:DWWDQDWFKDUL\D1.DQVKDQD66LULFKWKDSRP3HWDO6DIHW\DQG HI¿FDF\RIVDTXLQDYLUVRIWJHODWLQFDSVXOHV]LGRYXGLQHRSWLRQDOODPLYXGLQHLQSUHJQDQF\DQGSUHYHQWLRQRI YHUWLFDO+,9WUDQVPLVVLRQ-$FTXLU,PPXQH'H¿F6\QGU &RYLQJWRQ'/&RQQHU6''RL3$6ZLQVRQ-'DQLHOV(05LVNRIELUWKGHIHFWVDVVRFLDWHGZLWKQHO¿QDYLU H[SRVXUHGXULQJSUHJQDQF\2EVWHW*\QHFRO $FRVWD(3%DUGHJXH]$=RUULOOD&'9DQ'\NH5+XJKHV0'+XDQJ6HWDO3KDUPDFRNLQHWLFVRIVDTXLQDYLU SOXVORZGRVHULWRQDYLULQKXPDQLPPXQRGH¿FLHQF\YLUXVLQIHFWHGSUHJQDQWZRPHQ$QWLPLFURE$JHQWV &KHPRWKHU .RVHO%:%HFNHUPDQ.3+D\DVKL6+RPPD0$ZHHND)73KDUPDFRNLQHWLFVRIQHO¿QDYLUDQGLQGLQDYLULQ +,9LQIHFWHGSUHJQDQWZRPHQ$LGV 9DQ+HHVZLMN53.KDOLT<*DOOLFDQR.'%RXUEHDX06HJXLQ,3KLOOLSV(7HWDO7KHSKDUPDFRNLQHWLFVRI QHO¿QDYLUDQG0GXULQJSUHJQDQF\DQGSRVWSDUWXP&OLQ3KDUPDFRO7KHU /\RQV)/HFKHOW0'H5XLWHU$6WHDG\VWDWHORSLQDYLUOHYHOVLQWKLUGWULPHVWHURISUHJQDQF\$LGV +D\DVKL6%HFNHQQDQ.+RPPD0.RVHO%:$ZHHND)73KDUPDFRNLQHWLFVRILQGLQDYLULQ+,9SRVLWLYH SUHJQDQWZRPHQ$LGV :DUQLQJDERXWLQGLQDYLUDQGSUHJQDQF\$,'63DWLHQW&DUH67'6 &RWWHU$0*DUFLD$*'XWKHO\0//XNH%2¶6XOOLYDQ0-,VDQWLUHWURYLUDOWKHUDS\GXULQJSUHJQDQF\ DVVRFLDWHGZLWKDQLQFUHDVHGULVNRISUHWHUPGHOLYHU\ORZELUWKZHLJKWRUVWLOOELUWK"-,QIHFW'LV 7KRPH&3DWHO'1HZHOO0/,QFUHDVHGULVNRIDGYHUVHSUHJQDQF\RXWFRPHVLQ+,9LQIHFWHGZRPHQWUHDWHG ZLWKKLJKO\DFWLYHDQWLUHWURYLUDOWKHUDS\LQ(XURSH$LGV 7XRPDOD5(:DWWV'+/L'9DMDUDQDQW03LWW-+DPPLOO,,HWDO,PSURYHGREVWHWULFRXWFRPHVDQGIHZ PDWHUQDOWR[LFLWLHVDUHDVVRFLDWHGZLWKDQWLUHWURYLUDOWKHUDS\LQFOXGLQJKLJKO\DFWLYHDQWLUHWURYLUDOWKHUDS\GXULQJ SUHJQDQF\-$FTXLU,PPXQH'H¿F6\QGU 7XRPDOD5(6KDSLUR'(0RIHQVRQ/0%U\VRQ<&XOQDQH0+XJKHV0'HWDO$QWLUHWURYLUDOWKHUDS\ GXULQJSUHJQDQF\DQGWKHULVNRIDQDGYHUVHRXWFRPH1(QJO-0HG 7XRPDOD5( Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 93 7KH3HULQDWDO6DIHW\5HYLHZ:RUNLQJ*URXS1XFOHRVLGHH[SRVXUHLQWKHFKLOGUHQRI+,9LQIHFWHGZRPHQ UHFHLYLQJDQWLUHWURYLUDOGUXJV DEVHQFHRIFOHDUHYLGHQFHIRUPLWRFKRQGULDOGLVHDVHLQFKLOGUHQZKRGLHGEHIRUH \HDUVRIDJHLQ¿YH8QLWHG6WDWHVFRKRUWV-$FTXLU,PPXQH'H¿F6\QGU (XURSHDQ&ROODERUDWLYH6WXG\([SRVXUHWRDQWLUHWURYLUDOWKHUDS\LQXWHURRUHDUO\OLIH WKHKHDOWKRIXQLQIHFWHG FKLOGUHQERUQWR+,9LQIHFWHGZRPHQ-$FTXLU,PPXQH'H¿F6\QGU /H&KHQDGHF-0D\DX[0-*XLKHQQHXF-RX\DX[&%ODQFKH63HULQDWDODQWLUHWURYLUDOWUHDWPHQWDQG KHPDWRSRLHVLVLQ+,9XQLQIHFWHGLQIDQWV$LGV 0RIHQVRQ/00XQGHUL36DIHW\RIDQWLUHWURYLUDOSURSK\OD[LVRISHULQDWDOWUDQVPLVVLRQIRU+,9LQIHFWHG SUHJQDQWZRPHQDQGWKHLULQIDQWV-$FTXLU,PPXQH'H¿F6\QGU %DUGHJXH]$'6KDSLUR'(0RIHQVRQ/0&RRPEV5)UHQNHO/0)RZOHU0*HWDO(IIHFWRIFHVVDWLRQRI ]LGRYXGLQHSURSK\OD[LVWRUHGXFHYHUWLFDOWUDQVPLVVLRQRQPDWHUQDO+,9GLVHDVHSURJUHVVLRQDQGVXUYLYDO- $FTXLU,PPXQH'H¿F6\QGU 3(75$6WXG\7HDP(I¿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¤DQDO\VLV,QW-(SLGHPLRO GRL LMHG\P85/DYDLODEOHDW KWWS LMHR[IRUGMRXUQDOVRUJ FJLUHSULQWG\PY *LXOLDQR03DOPLVDQR/*DOOX]]R&0$PLFL5*HQQLQDULR(2NRQJ3HWDO6HOHFWLRQRIUHVLVWDQFH PXWDWLRQVLQSUHJQDQWZRPHQUHFHLYLQJ]LGRYXGLQHDQGODPLYXGLQHWRSUHYHQW+,9SHULQDWDOWUDQVPLVVLRQ$LGV 2 )RZOHU0*0RIHQVRQ/0F&RQQHOO07KHLQWHUIDFHRISHULQDWDO+,9SUHYHQWLRQDQWLUHWURYLUDOGUXJ UHVLVWDQFHDQGDQWLUHWURYLUDOWUHDWPHQW ZKDWGRZHUHDOO\NQRZ"-$FTXLU,PPXQH'H¿F6\QGU 1RODQ0)RZOHU0*0RIHQVRQ/0$QWLUHWURYLUDOSURSK\OD[LVRISHULQDWDO+,9WUDQVPLVVLRQDQGWKH SRWHQWLDOLPSDFWRIDQWLUHWURYLUDOUHVLVWDQFH-$FTXLU,PPXQH'H¿F6\QGU /DUEDOHVWLHU10XOOHQ-2¶6KHD6&RWWDP)6DELQ&$&KU\VWLH,/HWDO'UXJUHVLVWDQFHLVXQFRPPRQLQ SUHJQDQWZRPHQZLWKORZYLUDOORDGVWDNLQJ]LGRYXGLQHPRQRWKHUDS\WRSUHYHQWSHULQDWDO+,9WUDQVPLVVLRQ $LGV &UHVVH\75-RXUGDLQ*/DOOHPDQW0-.XQNHDZ6-DFNVRQ-%0XVRNH3HWDO3HUVLVWHQFHRIQHYLUDSLQH H[SRVXUHGXULQJWKHSRVWSDUWXPSHULRGDOWHULQWUDSDUWXPVLQJOHGRVHQHYLUDSLQHLQDGGLWLRQWR]LGRYXGLQH SURSK\OD[LVIRUWKHSUHYHQWLRQRIPRWKHUWRFKLOGWUDQVPLVVLRQRI+,9-$FTXLU,PPXQH'H¿F6\QGU /RXEVHU6%DOIH36KHUPDQ*+DPPHU6.XKQ/0RUULV/'HFD\RI.1PXWDQWVLQFHOOXODU'1$ DQGSODVPD51$DOWHUVLQJOHGRVHQHYLUDSLQHWRUHGXFHPRWKHUWRFKLOG+,9WUDQVPLVVLRQ$LGV ¤ )O\V71LVVOH\'9&ODDVHQ&:-RQHV'6KL&*XD\/$HWDO6HQVLWLYHGUXJUHVLVWDQFHDVVD\VUHYHDO ORQJ¤WHUPSHUVLVWHQFHRI+,9YDULDQWVZLWKWKH.1QHYLUDSLQH 193 UHVLVWDQFHPXWDWLRQLQVRPHZRPHQ Generations free of HIV and congenital syphilis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¿F6\QGU ¤ &ODUNH-5%UDJDQ]D50LU]D$6WDLQVE\&$LW.KDOHG0:ULJKW$HWDO5DSLGGHYHORSPHQWRIJHQRW\SLF UHVLVWDQFHWRODPLYXGLQHZKHQFRPELQHGZLWK]LGRYXGLQHLQSUHJQDQF\-0HG9LURO 'XUDQ$6/RVVR0+6DORPRQ,,+DUULV'53DPSXUR66RWR5DPLUH]/(HWDO'UXJUHVLVWDQFHDPRQJ LQIHFWHGSUHJQDQWZRPHQUHFHLYLQJDQWLUHWURYLUDOVIRUSURSK\OD[LV$LGV .DNHKDVL)07XSLQDPEDV8&OHWR6$OHL[R$/LQ(0HOR9,,HWDO3HUVLVWHQFHRIJHQRW\SLFUHVLVWDQFH WRQHO¿QDYLUDPRQJZRPHQH[SRVHGWRSURSK\ODFWLFDQWLUHWURYLUDOWKHUDS\GXULQJSUHJQDQF\$,'65HV+XP 5HWURYLUXVHV &KDL[0/(NRXHYL'.5RXHW)7RQZH*ROG%9LKR%HTXHW/HWDO/RZULVNRIQHYLUDSLQHUHVLVWDQFH PXWDWLRQVLQWKHSUHYHQWLRQRIPRWKHUWRFKLOGWUDQVPLVVLRQRI+,9 $JHQFH1DWLRQDOHGH5HFKHUFKHVVXUOH 6,'$'LWUDPH3OXV$ELGMDQ&RWHG¶,YRLUH-,QIHFW'LV /\RQV)(&RXJKODQ6%\UQH&0+RSNLQV60+DOO:9-0XOFDK\)0(PHUJHQFHRIDQWLUHWURYLUDO UHVLVWDQFHLQ+,9SRVLWLYHZRPHQUHFHLYLQJFRPELQDWLRQDQWLUHWURYLUDOWKHUDS\LQSUHJQDQF\$LGV 0F,QW\UH-HWDO$GGLWLRQRIVKRUWFRXUVHFRPELYLU &%9 WRVLQJOHGRVHYLUDPXQH VG193 IRUWKHSUHYHQWLRQ RIPRWKHUWRFKLOGWUDQVPLVVLRQ 307&7 RI+,9FDQVLJQL¿FDQWO\GHFUHDVHWKHVXEVHTXHQWGHYHORSPHQWRI PDWHUQDODQGSDHGLDWULF1157-UHVLVWDQWYLUXV7KHUG,$6&RQIHUHQFHRQ+,93DWKRJHQHVLVDQG7UHDWPHQW 5LRGH-DQHLUR%UD]LO-XO\ $EVWUDFW7X)R (VKOHPDQ6++RRYHU'5+XGHOVRQ6(&KHQ6)LVFXV6$3LZRZDU0DQQLQJ(HWDO'HYHORSPHQW RIQHYLUDSLQHUHVLVWDQFHLQLQIDQWVLVUHGXFHGE\XVHR¿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¤ 6KHNHOOH30DJOLRQH0*HRW]0%:DJQHU*:DQJ=+LOWRQ/HWDO$QWLUHWURYLUDO $59 GUXJUHVLVWDQFHLQ WKHGHYHORSLQJZRUOG(YLG5HS7HFKQRO$VVHVV )XOO5HS 3DUHGHV5&KHQJ.XULW]NHV'57XRPDOD5(+LJKSUHYDOHQFHRISULPDU\ODPLYXGLQHDQGQHO¿QDYLU UHVLVWDQFHLQ+,9LQIHFWHGSUHJQDQWZRPHQLQWKH8QLWHG6WDWHV $LGV 0F&RQQHOO06%DNDNL3(XUH&0XELUX0%DJHQGD''RZQLQJ5HWDO(IIHFWLYHQHVVRI5HSHDW6LQJOH Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 95 'RVH1HYLUDSLQHIRU3UHYHQWLRQRI0RWKHUWR&KLOG7UDQVPLVVLRQRI+,9LQ5HSHDW3UHJQDQFLHV8JDQGD- $FTXLU,PPXQH'H¿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¿FLHQF\YLUXVLQIHFWHGFKLOGUHQUHFHLYLQJDQWLUHWURYLUDOWUHDWPHQW3HGLDWU,QIHFW'LV- 7KH,QWHUQDWLRQDO3HULQDWDO+,9*URXS7KHPRGHRIGHOLYHU\DQGWKHULVNRIYHUWLFDOWUDQVPLVVLRQRIKXPDQ LPPXQRGH¿FLHQF\YLUXVW\SH1(QJO-0HG %DUUHW%7DUGLHX05XVWLQ3/DFURL[&&KDEURO%'HVJXHUUHHWDOSHUVLVWHQWPLWRFKRQGULDOG\VIXQFWLRQLQ +,9H[SRVHGEXWXQLQIHFWHGLQIDQWV FOLQLFDOVFUHHQLQJLQDODUJHSURVSHFWLYHFRKRUW$,'6 'DELV)0VHOODWL30HGD1:HOIIHQV(NUD& Generations free of HIV and congenital syphilis 96 .HVKR%RUD6WXG\*URXS7ULSOHDQWLUHWURYLUDOSURSK\OD[LVGXULQJSUHJQDQF\DQGEUHDVWIHHGLQJFRPSDUHG WRVKRUW$59SURSK\OD[LVWRSUHYHQWPRWKHUWRFKLOGWUDQVPLVVLRQRI+,9 WKH.HVKR%RUDUDQGRPL]HG FRQWUROOHGFOLQLFDOWULDOLQ¿YHVLWHVLQ%XUNLQD)DVR.HQ\DDQG6RXWK$IULFDWK,$6&RQIHUHQFHRQ+,9 3DWKRJHQHVLV7UHDWPHQWDQG3UHYHQWLRQ&DSH7RZQ6RXWK$IULFD-XO\ :+25HYLVHG%&*YDFFLQDWLRQJXLGHOLQHVIRULQIDQWVDWULVNIRU+,9LQIHFWLRQ:HHNO\(SLGHPLRO5HFRUG 0D\ 85/DYDLODEOH KWWS ZZZZKRLQWOZHUZHUSGI )HVFLQD5+%XWUyQ%'H0XFLR%0DUWtQH]*'tD]5RVVHOOR-/&DPDFKR96LPLQL)0DLQHUR/6LVWHPD ,QIRUPiWLFR3HULQDWDO KLVWRULDFOtQLFDSHULQDWDO LQVWUXFFLRQHVGHOOHQDGR\GH¿QLFLyQGHWpUPLQRV0RQWHYLGHR &/$3605 &/$36053XEOLFDFLyQ&LHQWt¿FD 85/DYDLODEOHDW KWWS ZZZFODSRSVRPV RUJZHE%2/(7,1(6<129('$'(6(',&,21(6'(/&/$3&/$3SGI Clinical Guideline For The Elimination Of Mother-To-Child Transmission Of HIV And Congenital Syphilis In Latin America And The Caribbean 97