According to the National AIDS Control Organisation (NACO) guidelines, what is the recommended antiretroviral therapy regimen, opportunistic infection prophylaxis, vaccination schedule, baseline investigations, and special management considerations for an adult diagnosed with HIV?

National AIDS Control Organisation (NACO) Guidelines for HIV Management in Adults

Immediate ART Initiation

Start antiretroviral therapy on the day of HIV diagnosis or within 7 days for all adults, regardless of CD4 count, viral load, age, or clinical status. This approach reduces all-cause mortality by 44–57% and markedly decreases AIDS progression, tuberculosis, and other opportunistic infections. 1, 2

• Do not postpone ART while awaiting routine laboratory results; only HLA-B*5701 testing must be completed before prescribing abacavir-containing regimens. 1
• Eliminate structural barriers such as staffing shortages, insurance delays, and drug stock-outs that prevent same-day ART initiation. 1

Baseline Investigations (Draw Before ART, But Do Not Delay Treatment)

• HIV-1 RNA viral load – to establish baseline viremia 1
• CD4 cell count – to assess immunologic status and determine prophylaxis needs 1
• Genotypic resistance testing – for reverse transcriptase, protease, and integrase genes 1
• HLA-B*5701 allele testing – mandatory before any abacavir use; if pending, start a tenofovir-based regimen 1, 3
• Hepatitis B surface antigen and hepatitis C antibody – to identify co-infections requiring specific management 1
• Complete blood count and comprehensive metabolic panel – including serum creatinine/eGFR for renal function 1
• Fasting lipid profile and glucose – to establish metabolic baseline 1
• Urinalysis for protein and glucose – to screen for renal disease 1
• Pregnancy test – for individuals of childbearing potential 3

Preferred First-Line ART Regimens

Most Adults (Rank Order)

1. Bictegravir/tenofovir alafenamide (TAF)/emtricitabine (single tablet, once daily) – This is the preferred regimen because it provides the highest efficacy, best tolerability, strongest resistance barrier, minimal drug-drug interactions, and does not require HLA-B*5701 testing, enabling same-day start. 1, 3

2. Dolutegravir + TAF/emtricitabine (once daily) – Offers comparable efficacy with extensive long-term safety data and superior renal and bone safety versus tenofovir disoproxil fumarate (TDF). 1, 3

3. Dolutegravir/abacavir/lamivudine (single tablet, once daily) – May be used only after confirming a negative HLA-B*5701 result; avoid in patients with significant cardiovascular risk factors, for whom a tenofovir-based regimen is preferred. 1, 3

Alternative Regimens When InSTIs Are Unavailable

• Darunavir/ritonavir (or cobicistat) + TAF/emtricitabine – Preferred protease-inhibitor option when integrase-inhibitor resistance is suspected or confirmed. 1, 3
• Raltegravir + TAF/emtricitabine – First-generation integrase inhibitor requiring twice-daily dosing with a lower resistance barrier than dolutegravir or bictegravir. 1, 3

Regimens to Avoid

• Rilpivirine-based regimens – Contraindicated when baseline HIV-1 RNA >100,000 copies/mL or CD4 <200 cells/µL due to markedly increased virologic failure risk. 1, 3
• Efavirenz + TDF/emtricitabine – Reserve for patients with active tuberculosis co-infection; associated with neuropsychiatric adverse effects and elevated suicidality risk. 1, 3
• NNRTI-based or abacavir-containing regimens for same-day start – Avoid because they require baseline resistance testing and HLA-B*5701 results, which delay therapy. 1, 3

Special Population Management

Pregnancy

• Preferred regimen: Dolutegravir + TAF/emtricitabine 1, 3
• If protease inhibitor required: Darunavir 600 mg + ritonavir 100 mg twice daily (once-daily dosing is insufficient in pregnancy) 1
• Acceptable alternatives: Atazanavir/ritonavir, raltegravir, or efavirenz combined with tenofovir-based dual-NRTI backbones 1

Tuberculosis Co-infection

CD4 Count	TB Type	ART Timing	Regimen Options
<50 cells/µL	Non-meningeal TB	Within 2 weeks of TB therapy start	Dolutegravir 50 mg twice daily, efavirenz 600 mg daily, or raltegravir 800 mg twice daily + 2 NRTIs [1]
≥50 cells/µL	Non-meningeal TB	Within 2–8 weeks of TB therapy start	Same as above [1]
Any	TB meningitis	Within 2 weeks (expert consensus)	Same as above with close IRIS monitoring [1]

• Bictegravir must not be co-administered with rifampin due to clinically significant drug-drug interactions. 1
• Efavirenz + TDF/emtricitabine is recommended for TB co-infection due to extensive experience with concurrent rifampin therapy. 3, 4

Renal Impairment or Osteoporosis

• Avoid TDF in patients with creatinine clearance <60 mL/min or with osteopenia/osteoporosis; use TAF instead to reduce nephrotoxicity and bone loss. 1, 3
• TAF is not recommended when creatinine clearance <30 mL/min. 1
• Monitor eGFR, urinalysis, glycosuria, and proteinuria at ART initiation, after regimen changes, and every 6 months once HIV-RNA is stable. 1

Hepatitis B Co-infection

• Start an ART regimen that includes TDF or TAF together with lamivudine or emtricitabine to provide dual activity against HBV. 1
• Entecavir may be added for HBV treatment but should be avoided if HIV-RNA is not suppressed, as it can select for HIV drug resistance. 1
• Avoid dolutegravir/lamivudine two-drug regimen in HBV co-infection. 3

Hepatitis C Co-infection

• Choose ART drugs with no significant pharmacokinetic interactions with direct-acting HCV agents. 1

Opportunistic Infection Prophylaxis

Pneumocystis Pneumonia (PCP)

• Initiate trimethoprim-sulfamethoxazole prophylaxis for all patients with CD4 <200 cells/µL and continue until CD4 rises above 200 cells/µL for at least 3 consecutive months. 1, 3

Mycobacterium Avium Complex (MAC)

• Primary MAC prophylaxis is not required when effective ART is started promptly, as early treatment markedly lowers MAC incidence. 1

Cryptococcal Disease

• Prophylaxis is not recommended in high-resource settings with low disease prevalence. 1

ART Timing with Opportunistic Infections

• Cryptococcal meningitis: Delay ART for 4–6 weeks after initiating antifungal therapy to minimize severe IRIS risk. 1
• Most other opportunistic infections: Start ART within 2 weeks of beginning infection-specific therapy. 1
• Newly diagnosed malignancy: Initiate ART immediately while carefully managing drug-drug interactions. 1

Monitoring After ART Initiation

Viral Load Monitoring

• Measure HIV-1 RNA at 4–6 weeks after ART start to assess initial response. 3, 4
• Continue testing every 4–6 weeks until viral load is <50 copies/mL (target by 24 weeks). 3
• Once suppressed, monitor every 3 months during the first year, then every 6 months after 1–2 years of sustained suppression. 3

CD4 Monitoring

• Measure CD4 count every 3–6 months during the first year. 3
• After the first year, test every 6 months until CD4 rises above 250 cells/µL for at least one year with viral suppression. 3
• CD4 monitoring may be discontinued after CD4 >500 cells/µL for 2 years with viral suppression. 1

Vaccination Schedule

• Administer all routine vaccinations according to standard adult immunization schedules, with special attention to pneumococcal, influenza, hepatitis A and B, and HPV vaccines. 1
• Live vaccines should be deferred until CD4 count is >200 cells/µL. 1

Common Pitfalls to Avoid

• Never prescribe abacavir without confirming a negative HLA-B*5701 result to prevent potentially fatal hypersensitivity reactions. 1, 3
• Do not delay ART while awaiting complete laboratory results (except HLA-B*5701 for abacavir); postponement eliminates the survival benefit of early treatment. 1
• Do not prescribe TDF to patients with low creatinine clearance or osteoporosis; substitute TAF to avoid avoidable nephrotoxicity and bone loss. 1
• Do not use rilpivirine in patients with high viral load or low CD4 counts, as this results in markedly higher virologic failure rates. 3
• In cryptococcal meningitis, do not start ART early unless strict clinical criteria are met, as early initiation raises severe IRIS risk. 1
• In patients with CD4 <50 cells/µL and TB, do not delay ART beyond 2 weeks, as this markedly increases mortality. 1