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Antiretroviral Therapy and Medical Management of Pediatric HIV Infection ABBREVIATIONS. NPHRC, National Pediatric and Family HIV South Carolina, Charleston, SC), Rosemary Johnson (Family Rep- Resource Center; ZDV, zidovudine; PI, protease inhibitor; resentative), Michael Kaiser (HRSA, Rockville, MD), Aaron PACTG, Pediatric AIDS Clinical Trials Group; NIH, National In- Kaplan (Tulane Medical School, New Orleans, LA), Mark Kline (Baylor College of Medicine, Houston, TX), Andrea Kovacs stitutes of Health; DHHS, Department of Health and Human 1 Services; HRSA, Health and Human Resources Administration; (LAC USC Medical Center, Los Angeles, CA), Keith Krasinski USPHS, US Public Health Service; IDSA, Infectious Diseases So- (New York University Medical Center, New York, NY), Kathleen ciety of America; FDA, Food and Drug Administration; OI, op- McGann (Washington University Medical Center, St Louis, MO), portunistic infection; PCP, Pneumocystis carinii pneumonia; PCR, Kenneth McIntosh (Children’s Hospital, Boston, MA), Ross McK- polymerase chain reaction; CI, confidence interval; NRTI, nucleo- inney (Duke University Medical Center, Durham, NC), George side analogue reverse transcriptase inhibitor; NNRTI, nonnucleo- McSherry (UMDNJ-New Jersey Medical School, Newark, NJ), side analogue reverse transcriptase inhibitor; 3TC, lamivudine; Mark Mintz (Children’s Hospital of Philadelphia, Philadelphia, ddI, didanosine; d4T, stavudine; ddC, zalcitabine; IDV, indinavir; PA), Charles Mitchell (University of Miami, Miami, FL), Lynne M SQV, saquinavir; RTV, ritonavir; NFV, nelfinavir; CNS, central Mofenson (NIH, Rockville, MD), John Moye, Jr (NIH, Rockville, nervous system; CSF, cerebrospinal fluid; NVP, nevirapine; DLV, MD), Brigitta Mueller (Children’s Hospital, Boston, MA), Sharon delavirdine; MAC, Mycobacterium avium complex; VZV, varicella- Murphy (Children’s Memorial Hospital, Chicago, IL), Sharon zoster virus; CMV, cytomegalovirus; EBV, Epstein–Barr virus; Nachman (State University of New York Health Science Center at BAL, bronchoalveolar lavage; G-CSF, granulocyte colony stimu- Stony Brook, Stony Brook, NY), Mary Jo O’Hara (NPHRC, New- lating factor; IVIG, intravenous immunoglobulin; LIP, lymphoid ark, NJ), James Oleske (UMDNJ-New Jersey Medical School, New- interstitial pneumonia; TMP/SMX, trimethoprim/sulfamethox- ark, NJ), Savita Pahwa (North Shore University Hospital, Manhas- azole; TB, tuberculosis; MMR, measles-mumps-rubella; STD, sex- set, NY), Paul Palumbo (UMDNJ-New Jersey Medical School, ually transmitted disease; HPV, human papilloma virus; RDA, Newark, NJ), Ligia Peralta (University of Maryland, Baltimore, Recommended Daily Allowance; DEXA, dual x-ray absorptiom- MD), Jane Pitt (Columbia University Medical Center, New York City, NY), Philip Pizzo (Harvard Medical School/Children’s Hos- etry; TPN, total parenteral nutrition; PE, progressive encephalop- pital, Boston, MA), Tamara Rakusan (Children’s Hospital, Wash- athy; ADC, AIDS dementia complex; SE, static encephalopathy; ington, DC), Merlin Robb (Walter Reed Army Institute of Re- CT, computed tomography; MRI, magnetic resonance imaging; search, Rockville, MD), John Rodman (St Jude Children’s Research EPS, extrapyramidal syndrome; ADHD, attention deficit/hyper- Hospital, Memphis, TN), Arye Rubinstein (Albert Einstein College activity disorder; PNS, peripheral nervous system; NMDA, N- of Medicine, Bronx, NY), Mary Sawyer (Emory University, At- methyl-d-aspartate; EMLA, eutectic mixture of local anesthetics. lanta, GA), Gwendolyn B. Scott (University of Miami, Miami, FL), John Sever (Children’s National Medical Center, Washington, These guidelines were developed by the Working Group on DC), Minora Sharpe (Family Representative), William Shearer Antiretroviral Therapy and Medical Management of Infants, Chil- (Baylor College of Medicine, Houston, TX), R. J. Simonds (Centers dren and Adolescents with HIV Infection convened by the Na- for Disease Control and Prevention, Atlanta, GA), Peter Smith tional Pediatric and Family HIV Resource Center (NPHRC), the (Hasbro Children’s Hospital, Providence, RI), Stephen Spector Health Resources and Services Administration (HRSA), and the (University of California at San Diego, La Jolla, CA), Deborah National Institutes of Health (NIH). The Co-Chairs of the Working Storm (UMDNJ-New Jersey Medical School, Newark, NJ), Russell Group were James Oleske, MD, MPH, University of Medicine and Van Dyke (Tulane University School of Medicine, New Orleans, Dentistry of New Jersey (UMDNJ)-New Jersey Medical School, LA), Diane Wara (University of California at San Francisco School Newark, NJ and Gwendolyn B. Scott, MD, University of Miami of Medicine, San Francisco, CA), Catherine Wilfert (Duke Univer- School of Medicine, Miami, FL. sity Medical Center, Durham, NC; The Pediatric AIDS Founda- Members of the Working Group who participated in the devel- tion, Santa Monica, CA), Harland Winter (Boston Medical Center, opment of this document include: Elaine Abrams (Harlem Hospi- Boston, MA), Andrew Wiznia (Bronx Lebanon Hospital Center, tal Center, New York City, NY), Arthur Ammann (AmFAR, New Bronx, NY), Ram Yogev (Children’s Memorial Hospital, Chicago, York City, NY), Martin Anderson (University of California at Los IL). Angeles, Los Angeles, CA), Carol Baker (Baylor College of Med- icine, Houston, TX), Lawrence Bernstein (Albert Einstein College INTRODUCTION of Medicine, Bronx, NY), Michael Brady (Columbus Children’s n 1993, the Working Group on Antiretroviral Hospital, Columbus, OH), Kathleen Brooke (Family Representa- Therapy and Medical Management of HIV-in- tive), Sandra Burchett (Children’s Hospital, Boston, MA), Carolyn fected Children, composed of specialists in the Burr (NPHRC, Newark, NJ), Joseph Cervia (Cornell Medical Cen- I ter, New York City, NY), Diana Clarke (Boston Medical Center, care of infants, children, and adolescents with HIV Boston, MA), Daniel Collado (Family Representative), Ellen Coo- infection, was convened by the National Pediatric per (Boston University School of Medicine, Boston, MA), Marilyn and Family HIV Resource Center (NPHRC). On the Crain (University of Alabama at Birmingham, Birmingham, AL), basis of available data and a consensus reflecting Barry Dashefsky (NPHRC and UMDNJ-New Jersey Medical School, Newark, NJ), Carol DiPaolo (Family Representative), Di- clinical experience, the Working Group concluded ane Donovan (Family Representative), Janet A. Englund (Baylor that antiretroviral therapy was indicated for any College of Medicine, Houston, TX), Mary Glenn Fowler (NIH, child with a definitive diagnosis of HIV infection Rockville, MD), Lisa M Frenkel (University of Washington, Seat- who had evidence of substantial immunodeficiency tle, WA), Donna Futterman (Montefiore Medical Center, New York City, NY), Anne Gershon (Columbia University, New York City, NY), Samuel Grubman (St Vincent’s Hospital and Medical Received for publication Mar 24, 1998; accepted Apr 24, 1998. Center of New York, New York City, NY), Peter Havens (Chil- Address correspondence to Dr James Oleske, Division of Allergy, Immu- dren’s Hospital of Wisconsin, Milwaukee, WI), Karen Hench nology, and Infectious Diseases, New Jersey Medical School, 185 S Orange (HRSA, Rockville, MD), Neal Hoffman (Montefiore Medical Cen- Ave, MSB F570A, Newark, NJ 07103-2714. ter, Bronx, NY), Walter Hughes (St Jude Children’s Research Hos- PEDIATRICS (ISSN 0031 4005). Copyright © 1998 by the American Acad- pital, Memphis, TN), George Johnson (Medical University of emy of Pediatrics. Downloaded from www.aappublications.org/news byPEDIATRICS guest on October Vol. 2, 2021 102 No. 4 October 1998 1005 (based on age-related CD41 T-lymphocyte count TABLE 1. Principles of Therapy of HIV Infection thresholds) and/or who had HIV-associated symp- 1. Ongoing HIV replication leads to immune system damage toms. Zidovudine (ZDV) monotherapy was recom- and progression to AIDS. HIV infection is always harmful, mended as the standard of care for initiation of ther- and true long-term survival free of clinically significant apy. Routine antiretroviral therapy for infected immune dysfunction is unusual. 2. Plasma HIV RNA levels indicate the magnitude of HIV children who were asymptomatic or had only mini- replication and its associated rate of CD41 T-cell destruction, mal symptoms (eg, isolated lymphadenopathy or whereas CD41 T-cell counts indicate the extent of HIV- hepatomegaly) and normal immune status was not induced immune damage already suffered. Regular, periodic 1 recommended.1 measurement of plasma HIV RNA levels and CD4 T-cell counts is necessary to determine the risk of disease Since the Working Group developed these recom- progression in an HIV-infected individual and to determine mendations, dramatic advances have been made in when to initiate or modify antiretroviral treatment regimens. laboratory and clinical research. The rapidity and 3. As rates of disease progression differ among individuals, treatment decisions should be individualized by level of risk magnitude of HIV replication during all stages of 1 infection are greater than believed previously and indicated by plasma HIV RNA levels and CD4 T-cell counts. account for the emergence of drug-resistant viral 4. The use of potent combination antiretroviral therapy to variants when antiretroviral treatment does not max- suppress HIV replication to below the levels of detection of imally suppress replication.2,3 New assays that quan- sensitive plasma HIV RNA assays limits the potential for titate plasma HIV RNA copy number
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  • SYMTUZA™ (Darunavir, Cobicistat, Emtricitabine, Tenofovir Alafenamide) Oral

    SYMTUZA™ (Darunavir, Cobicistat, Emtricitabine, Tenofovir Alafenamide) Oral

    PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 9/20/2018 SECTION: DRUGS LAST REVIEW DATE: 8/19/2021 LAST CRITERIA REVISION DATE: 8/19/2021 ARCHIVE DATE: SYMTUZA™ (darunavir, cobicistat, emtricitabine, tenofovir alafenamide) oral Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Pharmacy Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as “Description” defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as “Criteria” defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Pharmacy Coverage Guidelines are subject to change as new information becomes available. For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable.