September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT ALL HIV INFECTED PATIENTS MUST BE MANAGED BY A CCHCS HIV SPECIALIST GOALS • Offer HIV screening to all • Ensure a sexual history and appropriate risk reduction counseling is performed • Refer all patients with HIV to HIV specialists as by a primary care team member for every patient with HIV at least annually. soon as possible • Initiate antiretroviral therapy (ART) for all patients with HIV as soon as possible • Identify newly diagnosed cases of HIV/Acquired • Screen and evaluate the patients with substance use disorder as a Immunodeficiency Syndrome (AIDS) transmission risk factor (see CCHCS Substance Use Disorder Care Guide) • Identify acute HIV seroconversion
ALERTS Inappropriate or suboptimal treatment regimens Red Flags • Patients receiving only one HIV medication rather than a multi-drug ANY CD4 CD4 <200 CD4 <100 combination (note that some co-formulations exist) • New onset fevers • Dyspnea • Headache • Patients on treatment for months with a persistently detectable viral • Weight loss >10% • Cough • Blurry or lost load • Fatigue • Fevers vision • Patients with CD4 <200 cells/mm3 who are not on Pneumocystis • Skin lesions • Diarrhea jiroveci (PCP) prophylaxis (see page 6) • Night sweats
DIAGNOSTIC CRITERIA/EVALUATION (SEE PAGE 2 FOR HIV TESTING ALGORITHM) D Consider HIV in the following circumstances: • Patients with known high risk behaviors prior to or during incarceration (tattoos, injection drug use, sexual exposure) • Patients with symptoms suggesting immunocompromised state (e.g., unexplained weight loss (>10%), recurring fevers, rashes, diarrhea, enlarged lymph nodes, recurrent infections, thrush) I E • Date of diagnosis • Current opportunistic infection (OI) • Vaccination history • Transmission risk factors prophylaxis (if applicable) • Smoking/substance use history • History of AIDS related conditions • HIV medication history • Thorough review of systems • Lowest (nadir) CD4 count • HIV resistance history • Transmission and risk reduction • History of opportunistic infections • History of Tuberculosis/Sexually Transmitted strategies Diseases/Rapid Plasma Reagin • Baseline Labs (See page 4) TREATMENT OPTIONS - INITIATING TREATMENT: GUIDELINES FOR WHEN TO START AND WHAT TO USE Do not initiate, change, or discontinue HIV medications without first consulting an HIV specialist WHEN TO START HIV TREATMENT: • ART is recommended for all HIV infected individuals as soon as possible, regardless of CD4 counts. ART should be initiated ONLY in consultation with an HIV specialist. The patients starting ART must be willing to commit to treatment and understand the risks and benefits of treatment and the importance of adherence. The patients and/or providers may elect to defer therapy based on clinical or psychosocial factors. WHAT TO USE: • Monotherapy is NEVER acceptable for HIV treatment. In general, three agents are used in combination. See page 5 for recommended initial HIV combination treatment regimens. See pages 8-11 for treatment precautions and side effects: noting specific contraindications and interactions between HIV medications and the patient’s existing medications. • Ensure a sexual history is performed annually and provide risk reduction counseling and education. Order ART and confirm eligibility in CCHCS’ 340b program as documented in the Electronic Health Record System (EHRS). Education for health care staff on conducting a sexual history can be found on the Center for Disease Control’s website: https://www.cdc.gov/hiv/pdf/clinicians/screening/cdc-hiv-php- discussing-sexual-health.pdf
MONITORING (See page 4 for monitoring details) Clinic visits are recommended as clinically indicated during TABLE OF CONTENTS treatment: HIV TESTING ALGORITHM ...... PAGE 2 • Components of the clinical evaluation include: NONOCCUPATIONAL POST‐EXPOSURE PROPHYLAXIS (nPEP) ...... PAGE 3 Review of systems (fever, weight loss, cough, diarrhea, etc.), MONITORING HIV PATIENTS ...... PAGE 4 Physical examination (vitals, oropharynx, lymph nodes, skin, etc.), ANTIRETROVIRAL TX REGIMENS ...... PAGE 5 Assessment: date of diagnosis, note CD4, viral load, h/o OI, HIV OPPORTUNISTIC INFECTION PROPHYLAXIS...... PAGE 6 medication regimen, previous medications, RECOMMENDED IMMUNIZATIONS ...... PAGE 7 Education: discuss risk reduction, adherence. MEDICATIONS ...... PAGE 8‐12 PATIENT EDUCATION ...... PE‐1 & 2
Contact the HIV Program mailbox with questions: [email protected] InformaƟon contained in the Care Guide is not a subsƟtute for a health care professional's clinical judgment. EvaluaƟon and treatment should be tailored to the individual paƟent and the clinical circumstances. Furthermore, using this informaƟon will not guarantee a specific outcome for each paƟent. Refer to “Disclaimer Regarding Care Guides” for further clarificaƟon. h p://www.cchcs.ca.gov/clinical‐resources/
1 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)
SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT HIV TESTING
Clinical Routine HIV testing is offered to new arrivals. See Opt Out* HIV screening policy, Patient reports a presentation Health Care Department Operations Manual (HCDOM) Section 3.1.8, Reception Cen- history of HIV suspicious ter. HIV testing is also available on patient request and should be considered routine- disease, but no for acute ly in patients at high risk for acquiring HIV (persons who inject drugs and their sex documentation of versus chronic partners, persons who exchange sex for money or drugs, sex partners of person with a positive HIV HIV: offer HIV HIV infection, persons or their partners who have had more than one sex partner antibody in the testing since their most recent HIV test, and transgender women). health record
Patient agrees to HIV test Patient agrees to HIV test No Yes Document reasons Is Acute HIV suspected? (any of the following for ≥ 6 weeks): for refusal of test • Fevers/Myalgia • Pharyngitis • Diarrhea • Lymphadenopathy • Rash • Headache
Yes No
Order HIV-1/2 antigen/antibody 4th generation Order HIV-1/2 antigen/antibody 4th generation screening test screening test AND quantitative HIV viral load positive negative Screening test and Screening test and/or viral load negative viral load positive Patient Tests HIV Positive: Patient is HIV Negative: Confirmatory HIV-1 and Consider retesting HIV-2 antibodies performed annually and as automatically clinically indicated Patient is HIV Patient is HIV Positive: Negative: Consider retesting 1. Order baseline labs (Page 4) HIV-1 positive or Both HIV-1 annually and as 2. Perform clinical evaluation (Page 1) HIV-2 positive And HIV-2 clinically indicated 3. Refer to a CCHCS HIV specialist Or both positive negative onsite or via telemedicine. 4. Ensure the patient is transferred out of a restricted-cocci area 1 or 2 in- stitution. Qualitative HIV viral load 3 5. If CD4 <200 cells/mm , start PCP positive (automatically performed) negative prophylaxis (Pages 6, 12) 6. If CD4 <50 cells/mm3, start Mycobacterium avium complex Note: Western Blot is NO longer recommended as (MAC) prophylaxis (Pages 6, 12) a confirmatory HIV screening test 7. Do not attempt to initiate HIV *Patient has the option to decline HIV test. Signed consent/refusal not required. Patient declination HIV Screening Test Result Interpretation recorded in progress notes. HIV-1/2 antigen/ Reflex Qualitative Reflex HIV-1 and HIV-2 antibodies Diagnosis: antibody 4th generation HIV viral load
Positive HIV-1 positive and/or HIV-2 positive Not performed HIV Positive
Positive HIV-1 and HIV-2 negative Positive HIV Positive; Acute HIV False Positive HIV test. No further Positive HIV-1 and HIV-2 negative Negative workup recommended. HIV Negative; no further testing Negative Not performed Not performed recommended
• Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines
2 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)
SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT PATIENT NONOCCUPATIONAL POST-EXPOSURE PROPHYLAXIS (nPEP) For employee occupational exposures, contact employee’s supervisor (do not use this Care Guide) NOTE: Protocols for the patient occupational and non-occupational exposures are the same. D C /E R L HIGHER LOWER NEGLIGIBLE RISK
• Percutaneous injury • Receptive or insertive • Kissing from non-bloody vaginal or anal intercourse • Receptive and insertive • Mouth to mouth Exposure sharps • Bites with blood exposure oral-vaginal, oral-anal, or resuscitation • Mutual masturbation • Needle sharing oral-penile contact • Non bloody human bites without blood or skin • Hollow-bore needle sticks • Solid bore needle sticks breakdown
Source HIV Evaluate case-by case: Positive or unknown Any negative, positive or unknown status Yes if: • HIV positive and HIV viral load is elevated* • Mucosa is not intact (gingival disease, oral lesions) nPEP YES • Blood exposure noted NO warranted? • Genital ulcer disease
Otherwise: No T O *S PEP 72 28 P R P E P (PEP) ( ) Medication (2 pill regimen) Sig Prescribe This Quantity Notes Tenofovir disoproxil fumarate/ 1 PO daily Prescribe 28 Include: Do not exceed 28 days or emtricitabine (Truvada®) for post-exposure. *See pages 8-11 for side effects and dosing. with Raltegravir (Isentress®) 400mg 1 PO BID Prescribe 56 Include: Do not exceed 28 days or *See pages 8-11 for side effects and dosing. for post-exposure. or Dolutegravir (Tivicay®) 50mg 1 PO daily Prescribe 28 Include: Do not exceed 28 days or *See pages 8-11 for side effects and dosing. for post-exposure.
M Recommended Laboratory evaluation for the patients who receive nPEP for HIV exposure Test Baseline Week 2 Week 4 Week 12 Week 24 HIV 4th gen Antigen/Antibody test E, S* E E E¥ Serum liver enzymes E E Blood Urea Nitrogen (BUN)/creatinine E E STD screen (gonorrhea, chlamydia, syphilis) E,S E E€ Hepatitis B Virus (HBV) serology (HBVsAb, E¶,S E***¶ E∞ HBVsAg, HBVcAb) Hepatitis C Virus (HCV) serology E,S Eα Pregnancy test (for women of reproductive age) E E*** HIV viral load S E** E** HIV resistance testing S E** E** E=Exposed S=Source *HIV testing of source is indicated for sources of unknown serostatus **If determined to be HIV positive on follow up testing ***Additional testing for pregnancy, STDs and HBV should be performed as clinically indicated ¶Start HBV vaccination if evidence of non-immunity. ¥Only if HCV infection is acquired during the original exposure. €Syphills only unless clinically indicated. αIf exposed person is susceptible to Hep C at baseline. ∞If exposed person is susceptible to Hep B at baseline. Centers for Disease Control and Prevention. Updated Guidelines for Antiretroviral Post-exposure Prophylaxis After Sexual, Injection Drug Use, or Other Non-occupational Exposure to HIV United States, 2016: https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf 3 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT
MONITORING HIV PATIENTS Pre Treatment On Treatment Treatment Failure At time Q 3–6 Starting 2-8wks Q4-8 Q3-4 Q 6 If clinically of Test Baseline Q yr after 1 Q yr treat- mos treatment start wks mos mos indicated ment failure HIV antibody test 9 (HIV 1/2 Antigen/Antibody 4th generation) 3 CD4 count (lymphocyte subset panel 5) 2 2 2 HIV viral load (HIV-1 RNA Quantitative PCR) HIV genotype 1 1 4 HIV Tropism Test (HIV-1 Coreceptor Tropism) CBC with differential and PLT 5 5 5 5 Comprehensive Metabolic Panel Pregnancy Test14 11,14 11,14 Random or Fasting Glucose 7 7 7 Random or Fasting Lipid Panel 6 6 6 Urinalysis 8, 13 8 13 Rapid Plasma Reagin (RPR) Serum Phosphorus 14 14 14 14 14 14
Gonorrhea/chlamydia (NAAT) 16,17 16, 17 Trichomoniasis screen (NAAT) 17 Hepatitis A Antibody total 11 19 Hepatitis B Core Antibody Total (Not IGM) Hepatitis B Surface Antibody Immunity Quantitative 10,19 Hepatitis B Surface Antigen19 19 Hepatitis B Viral Load 12,19 Hepatitis C Antibody with Reflex to Viral Load Varicella-Zoster Antibody, IgG 10 Toxoplasma Antibody, IgG 15 Glucose-6-phosphate dehydrogenase (G6PD) HLA-B5701 TB Screening PA and lateral CXR if not in health record Cryptococcal Serum Antigen 15 15 Measles Titer 18 Anal Cancer Screening: The Department of Health and Human Services HIV Guidelines for Adult and Adolescent Opportunistic Infections do not provide recommendations for routine screening for anal cancer, but do acknowledge that some specialists and organizations recommend annual anal pap smears in patients living with HIV. They only recommend screening for anal cancer if referral for high resolution anoscopy (HRA) is available (CCHCS has HRA available in select regions). CCHCS’ prevalence of anal dysplasia and/or anal cancer in patients living with HIV since 2016 is less than 1% and providers can consider annual screening with anal pap smears for their patients living with HIV. At the present time there is no national guidance on the management based on HRA results and the follow-up plans will be determined by the HRA provider.
1. Obtain an HIV genotype if no previous genotype is or other cardiovascular risk factors are present, repeat tenofovir containing regimens. noted in the health record. annually; otherwise repeat every 5 years. 14. In women of childbearing potential and planning to 2. Obtain HIV viral load every 4-8 weeks after starting 7. Repeat fasting if abnormal, non-fasting, and no history initiate dolutegravir. treatment until it is undetectable, then obtain every 3-4 of diabetes. Repeat annually to screen for diabetes. 15. Consider in patients newly diagnosed with HIV without months if consistently undetectable x2 years, may 8. UA pre-treatment and every 6 months while on signs of meningitis if the CD4 <100 increase interval to every 6 months. treatment if regimen contains tenofovir (Atripla, 16. Offer annual 3-site testing (urogenital/pharyngeal/ 3. Obtain CD4 every 3-6 months during 1st 2 years of Complera, Genvoya, Stribild, Truvada, Viread); monitor rectal) for gonorrhea/chlamydia if clinically indicated. HIV treatment. After 1st 2 years, if CD4 300-500, may glucose and protein. 17. Offer all patients with vaginal sex in the past 12 months increase interval to every 12 months, if CD4 >500, CD4 9. Repeat serology if previously negative and clinical and then annually if ongoing. re-check is optional. If CD4 <300, continue checking suspicion of disease or prophylaxis is indicated. 18. Not needed if born in US prior to 1957 or every 3-6months. 10. Repeat serology post vaccination if applicable. documentation of previous vaccination. 4. Only obtain tropism testing if considering maraviroc in 11. In women of childbearing potential. 19. Offer to all patients sexually active with high risk next HIV regimen 12. If HBV Core Antibody is Positive and HBV Surface partners, men who have sex with men, intravenous 5. Obtain CBC after ~4 weeks on treatment if on AZT; Antibody is negative or if HBV Surface Antigen drug abuse, sex in exchange for money, and/or check CBC if CD4 ordered. Positive. multiple partners 6. Repeat fasting if abnormal and non-fasting. If abnormal 13. In patients with chronic kidney disease who are on
• Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines • Sexually Transmitted Diseases Treatment Guidelines, 2021. Centers for Disease Control and Prevention. https://www.cdc.gov/std/treatment-guidelines/STI-Guidelines-2021.pdf • Thompson, M & Horberg, et al. Primary Care Guidance for Persons with Human Immunodeficiency Virus: 2020 Update by the HIV Medicine Assoc. of the IDSA. Clin Infect Dis 2020. 4 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)
SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT
ANTIRETROVIRAL (ARV) REGIMENS RECOMMENDED FOR TREATMENT - NAÏVE PATIENTS
DO NOT initiate, change, or discontinue HIV medications without first consulting an HIV specialist [email protected]
R R - Those with optimal and durable C efficacy, favorable tolerability and toxicity profile, and ease of use I S T I R Abacavir and Abacavir/lamivudine and Dolutegravir/ Abacavir/lamivudine:
® • Should not be used in the patients who test positive for • Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ) HLA-B5701. Atazanavir: • Dolutegravir (Tivicay®) and tenofovir alafenamide/ • Should not be used in the patients who require >20mg emtricitabine (Descovy®) or tenofovir disoproxil fumarate/ omeprazole equivalent per day. emtricitabine (Truvada®) Cobicistat: • Should not be started in the patients with a pretreatment estimated CrCl <70ml/min. ® • Dolutegravir/lamivudine (Dovato ) • Cobicistat is a potent CYP3A inhibitor. It can increase the concentration of other drugs metabolized by this pathway. Multiple drug-drug interactions exist. • Dolutegravir/abacavir/lamivudine (Triumeq®) Darunavir: • Treatment experienced patients with a history of • Raltegravir (Isentress®) and tenofovir alafenamide/ resistance to HIV medications require twice daily emtricitabine (Descovy®) or tenofovir disoproxil fumarate/ darunavir boosted with ritonavir. emtricitabine (Truvada®) • Consult an HIV specialist for dosing requirements. Dolutegravir: • Recommended as a preferred regimen in pregnant P R P women regardless of trimester (updated data show a C O C O reduced risk of neural tube defects over time and the difference is no longer significant compared with other ART regimens). Dolutegravir/lamivudine: • Abacavir/lamivudine • Atazanavir ® ® • Except in the patients with HIV RNA >500,000 copies/mL, (Epzicom ) (Reyataz ) boosted HBV coinfection or in whom ART would be started before with ritonavir the results of a HIV Genotype or HBV testing are ® • Tenofovir disoproxil (Norvir ) available. fumarate/ PLUS Efavirenz: ® emtricitabine (Truvada ) • Darunavir • Now considered safe to use in pregnancy (Prezista®) boosted • Screen and monitor for antepartum depression in • Tenofovir disoproxil with ritonavir pregnancy. fumarate (Viread®) and Elvitegravir/cobicistat/tenofovir/emtricitabine: ® lamivudine (Epivir ) • Dolutegravir • Should not be started in the patients with a pretreatment (Tivicay®) estimated CrCl <70ml/min and should be changed to an alternative regimen if the patient’s CrCl falls below 50 ml/min. • Raltegravir ® • Cobicistat is a potent CYP3A inhibitor. It can increase the (Isentress ) concentration of other drugs metabolized by this pathway. Multiple drug-drug interactions exist. Emtricitabine (Emtriva®): • May be substituted by lamivudine (Epivir®) and vice versa. Tenofovir: • Use with caution in the patients with renal insufficiency.
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. February 10, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new-guidelines Saag, M., et al. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults, 2020 Recommendations of the International Antiviral Society-USA Panel. JAMA. 2020;324(16):1651-1669.
Dental Management of HIV infected Patients
• HIV infected patients do not require special precautions or prophylaxis for dental care beyond standard precautions and the routine standard of care. • Check patient’s dental history for evidence of a routine comprehensive dental examination. Advise HIV infected patients to request a dental comprehensive exam once a year.
Bold = Formulary 5 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT PROPHYLAXIS TO PREVENT THE FIRST EPISODE OF OPPORTUNISTIC INFECTION (OI) C I P A CD4 count <200 cells/mm3 Pneumocystis Trimethoprim- jiroveci sulfamethoxazole TMP-SMX, orally one double strength CD4 % <14% or history of AIDS defining illness three times a week pneumonia (TMP-SMX), one or (PCP) CD4 count >200 but <250 cells/mm3 and monitoring CD4 double strength orally dapsone 100mg orally once daily or count at least every three months is not possible daily (first choice) 50mg orally twice daily or or Indication for Discontinuing Primary Prophylaxis: one single strength dapsone 50mg orally daily and CD4 count increased from <200 cells/mm3 to ≥200cells/ 3 orally daily pyrimethamine 50mg orally weekly mm for ≥3 months in response to ART. and leucovorin 25 mg orally weekly or Can consider when CD4 count is 100–200 cells/mm3 and Aerosolized pentamidine 300mg via HIV RNA remains below limit of detection of the assay Respirgard II® nebulizer every month used for ≥3 months to 6 months or atovaquone 1,500mg orally daily Indication for Restarting Primary Prophylaxis: or CD4 count <100 cells/mm3 regardless of HIV RNA atovaquone 1,500mg and pyrimethamine 25mg and CD4 count 100–200 cells/mm3 and HIV RNA above leucovorin 10mg orally daily detection limit of the assay used
Toxoplasma Toxoplasma IgG positive patients with CD4 count TMP-SMX, one TMP-SMX orally one double strength gondii <100 cells/mm3 double strength orally three times a week encephalitis daily or TMP-SMX orally one single strength Seronegative patients receiving PCP prophylaxis daily not active against toxoplasmosis should have or dapsone 50mg orally daily and toxoplasma serology retested if CD4 count declines pyrimethamine 50mg orally weekly to <100cells/mm3 and leucovorin 25mg orally weekly or dapsone 200mg and pyrimethamine Prophylaxis should be initiated if toxoplasmosis lgG 75mg and leucovorin 25mg orally weekly or seroconversion occurs Atovaquone 1,500mg with/without pyrimethamine 25mg and leucovorin 10 mg orally daily
Rifampin (RIF) 600mg orally daily for Mycobacterium No evidence of active TB disease and: Isoniazid (INH) 300mg (+) diagnostic test for LTBI, and no prior history orally daily and four months tuberculosis pyridoxine 50mg orally or infection of treatment for active or latent TB daily for nine months Rifabutin (RFB) (dose adjusted based (Treatment of (-) diagnostic test for LTBI, but close contact or on concomitant ART) for four months latent TB with a person with infectious pulmonary TB INH 900mg orally twice Rifapentine (RPT) (weight-based, 900 infection or a week and pyridoxine mg max) PO weekly + INH 15mg/kg LTBI) history of untreated or inadequately treated 50mg orally daily for weekly (900 mg max) + pyridoxine 50mg healed TB (i.e., old fibrotic lesions) regardless nine months weekly x12 weeks – in patients receiving of diagnostic tests for LTBI For persons exposed to an EFV- or RAL-based ART regimen drug-resistant TB, (32.1–49.9 kg 750 mg ≥ 50.0kg 900mg) selection of drugs after *Multiple drug-drug interactions exist consultation with public between RIF, RPT, and HIV medications health authorities is advised *Consultation with HIV specialist or pharmacist strongly advised Disseminated Not on ART or remain viremic on ART with no options for Azithromycin RFB 300mg orally daily (dosage Mycobacterium a suppressive ART regimen 1,200mg orally once adjustment based on drug-drug avium weekly AND: interactions with ART); rule out complex or active TB before starting RFB (MAC) CD4 count <50 cells/mm3 after ruling out active MAC Clarithromycin disease infection 500mg orally twice a day Indication for Discontinuing Primary Prophylaxis: or Azithromycin 600mg Initiation of effective ART orally twice weekly Indication for Restarting Primary Prophylaxis: CD4 count <50 cells/mm3 (only if not on fully suppressive ART) In general, primary prophylaxis against the following conditions is not recommended: • CMV • Cryptococcal disease • Histoplasmosis • Candidiasis • Coccidioidomycosis
HIV expert consultation required prior to any prophylaxis initiation, dosage change, or discontinuation
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults. 2018 Recommendations of the International Antiviral Society-USA Panel. JAMA. July, 24 2018. Available at https://jamanetwork.com/journals/jama/article-abstract/2688574 6 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) UMMARY ECISION UPPORT ATIENT DUCATION ELF ANAGEMENT S D S P E /S M Recommended Immunizations for HIV Positive Adults Please note that vaccinations can cause a transient increase in HIV viral load within a few weeks after administration. This increase should resolve over time and does not usually indicate the development of antiretroviral drug resistance.
Immunization Dosage Comments and Warnings Name Recommended for All HIV Positive Adults *There is limited data on vaccine efficacy in patients living with HIV, but due to the COVID-19 pandemic and Two injections 21-28 subsequent large outbreaks in CDCR with significant morbidity and mortality, all patients should have a COVID-19 days apart (Pfizer or discussion with their primary care provider and HIV specialist about the risks and benefits of the vaccine. (mRNA) Modena vaccine) Current data do not demonstrate an increased risk of susceptibility, severity of disease or mortality in pa- tients living wit h HIV if controlled for co-morbidities. Recommended unless: 1. Already immune (Hepatitis BsAb positive), 2. Chronic active HBV (Hepatitis BsAg Hepatitis B Virus Three injections over positive). Consider vaccination if isolated HBV cAb positive and HBV viral load negative. Check Hepatitis (HBV) a six month period BsAb 1-2 months after completion of immunization series. Additional injections (regular dose or double dose) may be necessary if antibody levels are < 10 after completion of an initial series. Should be given every year. Only injectable flu vaccine should be given to those who are HIV positive. Influenza One injection The nasal spray vaccine (FluMist/LAIV) is contraindicated. Meningococcal Two injections; two Recommended also for college students, military recruits, people who do not have a spleen, and people (MenACWY) months apart traveling to certain parts of the world. Revaccinate every 5 years. Pneumococcal Give single dose of PCV13 one or more years after PPSV23. Give PPSV23 no sooner than 8 weeks after 13-valent One injection dose of PCV13. conjugate PCV13) Should be given soon after HIV diagnosis, unless vaccinated within the previous five years. If CD4 count is Pneumococcal One or two < 200 cells/mm3 when the vaccine is given, immunization should be repeated when CD4 count is > 200 Polysaccharide injections cells/mm3. See above regarding timing of PPSV23 doses with PCV13. Repeat every 5 years if 64 years of (PPSV23) age or younger. At 65 years of age or older, only 1 dose at least 5 years after most recent dose. Tetanus and Diphtheria One injection Repeat vaccine every ten years. Toxoid (Td) Tetanus, Recommended for adults 64 years of age or younger and should be given in place of next Td booster one Diphtheria, and One injection time only. Pertussis (Tdap) Recommended for Some HIV Positive Adults Hepatitis A Virus Two injections over a Recommended for all non-immune (Hepatitis A lgG negative) HIV infected patients. (HAV) one year period Hepatitis A/ Three injections over Hepatitis B a six month period or Can be used in those who require both HAV and HBV immunization. Combined Vaccine four injections over a (Twinrix) one year period Can be used in those with functional or anatomical asplenia, sickle cell disease, undergoing elective Haemophilus splenectomy (administer 2 weeks prior to surgery). One injection* influenzae Type B *Recipients of hematopoietic stem cell transplants should receive 3 doses 4 weeks apart 6-12 months after a successful transplant regardless of Hib vaccination history. Human Three injections over Recommended for HIV infected men and women under 26 years of age. Routine vaccination is not recom- Papillomavirus 24 weeks (0, 1-2mo, mended for patients living with HIV between 26-45 years old but can be considered after shared decision (HPV) 6mo) making. The two dose regimen is not recommended in patients living with HIV. Measles, Mumps, People born before 1957 do not need to receive this vaccine. HIV positive adults with CD4 counts < 200 and Rubella One or two injections cells/mm3 or clinical symptoms of HIV should not get the MMR vaccine. Each component can be given (MMR) separately if needed to achieve adequate antibody titer levels. People born before 1980 do not need to receive this vaccine. Recommended for all others unless there is Two injections; three Varicella evidence of immunity (IgG) or CD4 count is 200 cells/mm3 or below. Not recommended to be given during months apart pregnancy. Recommended for adults > 50 regardless of previous herpes zoster or history of Zostavax (ZVL). Do not Two injections; 2-6 Zoster (Shingrix)^ give during an acute episode of herpes zoster. Consider delaying vaccination until the patient is virologically months apart suppressed on ART and CD4 count >200 cells/mm3 to maximize response to vaccine. *Recommended Adult Immunization Schedule - United States, 2021. Centers for Disease Control Website. Available at: https://www.cdc.gov/vaccines/schedules/easy-to-read/adult.html.
^Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV. Department of Health and Human Services. September 5, 2019. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection/varicella- zoster-virus-disease?view=full
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines 7 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)
SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT Medications (NOTE: Do not initiate, change or discontinue HIV medications without first consulting an HIV specialist)
• Current recommended minimum effective combination consists of three antiretroviral medications from a minimum of two classes. DO NOT PRESCRIBE MONOTHERAPY FOR HIV. If any medication is discontinued due to toxicity or other reason, discontinue combination. • Monitor for hepatotoxicity; use with caution in the patients with chronic hepatitis B or C or end stage liver disease. All Classes • The data on antiretroviral medication associated weight gain are insufficient to the recommendations. It is advised to counsel patients on the potential for weight gain. • Monitor for renal dysfunction and consult with an HIV specialist for dosing in renal dysfunction. • Multiple concerns regarding drug-drug interactions exist. (See page 12 for more information) Nucleoside/ Many NRTIs are associated with: Nucleotide • Hepatic steatosis Reverse • Lactic acidosis (rare but potentially fatal): look for nausea, vomiting, abdominal pain, fatigue, weakness, dyspnea with an Transcriptase associated metabolic acidosis. Discontinue all potential offending agents immediately Inhibitors (NRTI) • Lipodystrophy
Medication Formulation Side Effects Special Notes Tablet: • Hypersensitivity reaction; • Hypersensitivity associated with positive (Z ®, ABC) 300 mg potentially FATAL if re-challenged HLA-B5701: screen prior to initiation $$$ Solution: • Hypersensitivity reaction: look for fever, rash, GI 20mg/ml symptoms, cough, dyspnea, pharyngitis • Adjust dose for hepatic dysfunction • Avoid in treatment naïve patient if HIV viral load >100,000 copies/ml