Population: Children and adults with HIV infection.
Organizations
IDSA 2018, USPSTF 2019, HHS 2022
Recommendations
Evaluation
–Obtain a comprehensive present and past medical history, physical examination, medication/social/family history, and review of systems, including HIV-related information upon initiation of care.
–Assess for the presence of depression, substance abuse, or domestic violence.
–Baseline labs upon initiation of care: HIV serostatus; CD4 count; quantitative HIV RNA by PCR (viral load); HIV genotyping and genotypic resistance testing; CBCD, chemistry panel, G6PD testing; fasting lipid profile; random or fasting glucose; hepatitis A/B/C serology; HLA B5701 test (if abacavir will be used); tropism testing (if the use of a CCR5 antagonist is being considered); urinalysis; pregnancy test; Pap smear in women.1
–Screening labs: M. tuberculosis testing (PPD or interferon-γ release assay); toxoplasma antibodies; hepatitis B panel, HCV antibodies; VDRL; urine NAAT for gonorrhea; and urine NAAT for chlamydia (except in men age <25 y); anti-CMV IgG in lower risk groups (populations other than men who have sex with men or injection drug users), trichomoniasis in all women, Chlamydia trachomatis in all women ≤25 y of age.
–Monitoring labs:
• HIV viral load 4–8 wk after initiation or modification or ART and q 4–6 wk until undetectable then every 3–6 mo.
• CD4 every 3 mo if <300, CD4 every 6 mo if ≥300 for first 2 y, after 2 y with consistently suppressed viral load, every 12 mo for 300–500 and optional if >500. Monitor CBCD yearly when no longer monitoring CD4.
• Chemistries every 6 mo.
• STI screening and TB screening tests should be repeated periodically depending on symptoms and signs, behavioral risk, and possible exposures.
• Lipid panel 1–3 mo after initiation or modification.
–Ask all women of childbearing age living with HIV about their plans and desires regarding pregnancy upon initiation of care and routinely thereafter.
–Pap smear with HPV or reflex to HPV based on age in women every 6 mo and annually thereafter if results are normal. For ASC-US Pap result, if reflex HPV testing is negative, a repeat Pap test in 6–12 mo or repeat co-testing in 12 mo is recommended. For any result ≥ASC-US on repeat cytology, referral to colposcopy is recommended.
–Perform individualized assessment of risk for breast cancer and inform them of the potential benefits and risks of screening mammography for women ages 40–49 y. Perform mammogram annually for age >50 y.
Management
–Educate patient on high-risk behaviors to minimize risk of HIV transmission.
–Start antiretroviral therapy (ART) as soon as feasibly possible.
–Start ART within first 2 wk after initiation of treatment for most opportunistic infections:
• Within 4–6 wk after starting antifungals for cryptococcal meningitis.
• Within 2–8 wk after starting TB treatment in patients with CD4 >50.
• Start immediately in patients with HIV and cancer with special attention to drug interactions.
–Use one of these antiretroviral regimens for most patients with HIV:
• Bictegravir/tenofovir alafenamide (TAF)/emtricitabine.
• Dolutegravir + emtricitabine or lamivudine + TAF or tenofovir disoproxil fumarate (TDF).
• Dolutegravir/lamivudine (except if HIV RNA >500,000 copies/mL, CD4 <200, on active treatment for opportunistic infection, HBV coinfection and not without HIV genotyping so not to be started on the day of diagnosis).
• Raltegravir + emtricitabine or lamivudine + TAF or TDF.
–For patients with history of CAB-LA (long-acting injectable cabotegravir) use for PrEP, recommend INSTI genotypic resistance testing before initiation and treating with darunavir/cobicistat or darunavir/ritonavir + TAF or TDF + emtricitabine or lamivudine pending results.
• For pregnant women/women of childbearing age recommend: dolutegravir, raltegravir, atazanavir/ritonavir, darunavir/ritonavir (dosed twice daily), or efavirenz, PLUS either TDF/emtricitabine or TDF/lamivudine.
• Pregnant women taking ART should be switched to a recommended regimen after review of genotype testing and ART therapy. Selection of a regimen should be individualized.
• Efavirenz is teratogenic.
• Tenofovir should be used cautiously with renal insufficiency.
• Ritonavir-boosted atazanavir and rilpivirine should not be used with high-dose proton pump inhibitors.
• Regimens that include InSTIs have higher rates of weight gain, greater in dolutegravir, bictegravir.
• Patients on rifamycin-based TB treatment should be on ART with 2 nRTIs plus efavirenz (600 mg/d), raltegravir (800 mg BID), or dolutegravir (50 mg BID).
• Cabotegravir (CAB) + Rilpivirine RPV not recommended as initial ART, patients desiring long-acting injectable regimen should first attain viral suppression on one of the above regimens then transition to a month of oral CAB/RPV with proof of maintenance of suppression before transitioning to injectable.
–How and when to switch between ART therapies:
• To simplify regimen in patients with viral suppression, switch from 3-drug to 2-drug regimens to reduce AEs and adherence. Recommended regimens include dolutegravir/rilpivirine, boosted PPT/lamivudine, dolutegravir/lamivudine, and long-acting injectable cabotegravir/rilpivirine q 4 wk.
• Virologic failure (HIV RNA >200 copies/mL on 2 consecutive measurements): NNRTI failure → dolutegravir + 2 nRTIs, InSTI failure → boosted PI + 2 nRTIs, raltegravir or elvitegravir failure → dolutegravir BID + 1 fully active other agent, multiclass (>3) resistance → construct new regimen from new classes of drugs.
• Development of concomitant disease including kidney, liver, cardiovascular, or bone disease, weight gain, cancer, autoimmune disease, or solid organ transplant may require switching regimens.
–Screen for HLA-B*5701 before starting abacavir.
–Interruption of ART is recommended for drug toxicity, intercurrent illness, or operations that preclude oral intake.
–Management of a patient with prior antiretroviral exposure is complex and should be managed by an HIV specialist if changing regimens.
–Vaccinate for pneumococcal infection, influenza, varicella, hepatitis A, HPV, and HBV according to standard immunization charts.
Surveillance
–Laboratory testing:
• Screen non-HIV-infected high-risk patients every 3 mo as long as risk persists and offer PrEP (TDF/emtricitabine daily, double dose on first day for MSM).
• While on PrEP, screen quarterly with combined HIV Ab/Ag, genital and nongenital GC/Ch, syphilis, pregnancy, and screen annually for estimated CrCl and hepatitis C Ab.
• If high-risk exposure within 72 h screen with rapid HIV antibody test, if negative offer PEP (3-drug ART regimen within first 24–72 h and continued × 28 d) and obtain testing for Cr, hepatitis B sAg, STIs, and HIV Ab/Ag or HIV RNA.
• If positive for HIV, obtain HIV RNA, CD4, reverse transcriptase-prodrug resistance genotype testing, kidney and liver function, lipid levels, CBC, glucose, pregnancy, viral hepatitis A/B/C, TB and STI testing, but do not delay initiation of ART while awaiting results (add serum cryptococcal Ag if CD4 <100).
• Within 6 wk of starting ART, repeat HIV RNA; if levels have not declined considerably in adherent patient, then perform genotypic resistance testing.
• If viral suppression is considered stable, monitor HIV RNA levels every 3 mo until 1 y of suppression, then monitor every 6 mo.
• If previously achieved suppression and HIV RNA >50, quickly repeat HIV RNA and assess adherence and tolerability.
• Measure CD4 counts every 6 mo until >250 × 1 y then only repeat if ART failure or immunosuppressive condition.
–Recommend coreceptor tropism assay whenever a CCR5 coreceptor antagonist is considered.
Practice Pearls
• This guideline focuses on antiretroviral management in HIV-1-infected individuals.
• Alternative regimens for specific clinical scenarios or patient characteristics are beyond the scope of this book.
• Baseline evaluation should include:
- Patient’s readiness for ART.
- Psychosocial assessment.
- Substance abuse screening.
- Mental illness screening.
- HIV risk behavior screening.
- Health insurance and coverage status.
- Discussion of risk reduction and disclosure to sexual and/or needle-sharing partners.
- Initial labs:
• CD4 T-cell count.
• HIV-1 antibody testing.
• HIV RNA viral load.
• Genotypic drug-resistance testing.
• CBCD, chemistry panel, LFTs, urinalysis.
• Serologies for hepatitis B and C.
• Fasting glucose or A1c and lipid panel.
• Pregnancy test.
• STI screening.
• Specific ART recommendations are updated regularly at the CDC’s website: https://clinicalinfo.hiv.gov/en/guidelines.
• Screen for anogenital human papilloma virus (HPV) with anal Pap testing for men who have sex with men, women with abnormal cervical Pap smear results, and persons with a history of genital warts.
• Test for serum testosterone level in men complaining of fatigue, ED, or decreased libido.
• Chest x-ray should be obtained in persons with pulmonary symptoms or who have a positive PPD test result.
• Screen for STI via mode of intercourse, ie, anal, vaginal, or oral swab for gonorrhea and chlamydia.
• Patient should be informed that maintaining HIV RNA <200 with ART prevents sexual transmission to partners.
• Patients starting ART should use another form of protection (condoms, PrEP, abstinence) for the first 6 mo of treatment and until viral load <200.
• Do not have to wait for results of all tests to be back to initiate ART (except those to confirm HIV diagnosis), but should obtain all labs above before starting ART and follow up to adjust therapy as appropriate.
Sources
–http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/0
–JAMA. 2020;324(16):1651-1669. doi:10.1001/jama.2020.17025
–Clin Infect Dis. 2014;58(1):e1-e34, http://academic.oup.com/cid/article/58/1/e1/374007#74163693
–https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea.htm
Population: Children with HIV infection.
Organizations
HHS 2018, IDSA 2019, HHS 2022
Recommendations
Evaluation
–Obtain a comprehensive present and past medical history, physical examination, medication/social/family history, and review of systems, including HIV-related information upon initiation of care.
–Assess for the presence of depression, substance abuse, or domestic violence.
–Baseline labs upon initiation of care: HIV serostatus; CD4 count; quantitative HIV RNA by PCR (viral load); HIV genotyping and genotypic resistance testing; CBCD, chemistry panel, G6PD testing; fasting lipid profile; random or fasting glucose; hepatitis A/B/C serology; HLA B5701 test (if abacavir will be used); tropism testing (if the use of a CCR5 antagonist is being considered); urinalysis; pregnancy test.1
–Screening labs: M. tuberculosis testing (PPD or interferon-γ release assay); toxoplasma antibodies; hepatitis B panel, HCV antibodies; VDRL.
Management
–Specific ART recommendations are updated regularly at the CDC’s website: https://clinicalinfo.hiv.gov/en/guidelines.
Surveillance
–Monitoring labs:
• HIV viral load 4–8 wk after initiation or modification or ART and q 4–6 wk until undetectable then every 3–6 mo.
• CD4 every 3 mo if <300, CD4 every 6 mo if ≥300 for first 2 y, after 2 y with consistently suppressed viral load, every 12 mo for 300–500 and optional if >500 monitor CBCD yearly when no longer monitoring CD4.
• Chemistries every 6 mo.
• STI screening and TB screening tests should be repeated periodically depending on symptoms and signs, behavioral risk, and possible exposures.
• Lipid panel 1–3 mo after initiation or modification.
–ART is recommended for all children, regardless of symptoms or CD4 count.
–HIV genotypic resistance testing is recommended:
• At the time of diagnosis.
• Prior to initiation of therapy.
• For all treatment-naïve children.
–Evaluate for possible side effects and evaluate response to therapy in all children 1–2 wk after initiation of ART or changing ART regimen.
–Recommend laboratory testing for toxicity and viral load response at 2–4 wk after treatment initiation.
–Check absolute CD4 T lymphocyte (CD4) cell count and plasma HIV RNA (viral load) and evaluate therapy adherence, effectiveness, and toxicities every 3–4 mo. CD4 count can be monitored every 6–12 mo in children who are adherent to therapy and have had CD4 counts well above threshold for opportunistic infections, sustained viral suppression, and stable clinical status for 2–3 y.
Sources
–Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
–http://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf