What is the typical treatment regimen for HIV/AIDS in India?

HIV/AIDS Treatment Regimen in India

The current recommended first-line antiretroviral therapy (ART) regimen in India is dolutegravir (DTG) 50mg combined with tenofovir disoproxil fumarate (TDF) 300mg and lamivudine (3TC) 300mg. 1

Evolution of ART Regimens in India

• India's first-line ART regimen has evolved from earlier regimens that primarily consisted of tenofovir disoproxil fumarate (TDF) with either emtricitabine (FTC) or lamivudine (3TC) combined with efavirenz (EFV) 1
• The shift to DTG-based regimens aligns with global guidelines that recognize the superior efficacy and higher genetic barrier to resistance of integrase strand transfer inhibitors (InSTIs) 2, 1
• This evolution mirrors the global convergence of HIV treatment guidelines between high-income and low/middle-income countries 2

Current First-Line Regimen Components

Backbone: TDF/3TC

• TDF/3TC serves as the nucleoside reverse transcriptase inhibitor (NRTI) backbone in the recommended regimen 1
• TDF-based regimens have demonstrated significantly lower rates of virological failure compared to older NRTIs like stavudine (d4T) or zidovudine (AZT) in Indian populations (6.7 vs. 11.9 failures per 100 person-years) 3
• Lamivudine (3TC) has comparable efficacy to emtricitabine when used in combination regimens 1

Third Agent: Dolutegravir (DTG)

• DTG is preferred due to its high barrier to resistance development and superior virological suppression rates 1
• A Phase IV study in treatment-naïve Indian patients showed that 86.8% achieved viral suppression (<50 copies/mL) after 24 weeks on DTG+TDF+3TC, with an average increase in CD4 count of 143.2 cells 4
• DTG-based regimens are now recommended as initial therapy over non-nucleoside reverse transcriptase inhibitor (NNRTI) regimens due to efficacy, tolerability, and resistance profile 2

Special Considerations in the Indian Context

• For tuberculosis co-infection (common in India), efavirenz-based regimens may still be considered due to fewer drug interactions with TB medications 1
• For pregnant women, DTG requires careful consideration due to historical concerns about neural tube defects, though recent data shows reduced risk 1
• In patients with renal impairment, TDF should be avoided or dose-adjusted if creatinine clearance is below 60 mL/min 2

Alternative Regimens

• For patients who cannot tolerate DTG, alternative third agents include:
  • Efavirenz (EFV) 400mg (lower dose than traditional 600mg) - shown to be effective as a switch strategy in virologically suppressed Indian patients 5
  • Boosted protease inhibitors like darunavir/ritonavir, though these have more side effects and drug interactions 2

Monitoring Recommendations

• HIV RNA level testing is recommended:
  • Within 6 weeks of starting ART
  • Every 3 months until viral load is <50 copies/mL for 1 year
  • Every 6 months thereafter if virologically suppressed 2, 1
• Baseline resistance testing (HIV RT-pro genotype) is recommended before initiating therapy 1
• Regular monitoring for drug toxicities is essential, particularly:
  • Renal function for patients on TDF
  • Neuropsychiatric symptoms for patients on EFV 2

Common Pitfalls and Challenges

• High rates of regimen changes due to drug toxicity have been reported in Indian cohorts (39.6% in one study), primarily due to NRTI-related adverse effects 6
• Adherence <95% is independently associated with virological failure in Indian patients 3
• Negative attitudes toward HIV testing and stigma remain barriers to effective treatment 7
• Regular adherence counseling is crucial for treatment success, as some patients (19% in one study) can achieve viral resuppression after confirmed virological failure with enhanced adherence support 3

Treatment Failure Management

• For failure of NNRTI-based regimens, DTG plus active NRTIs is superior to protease inhibitor-based regimens 2
• For failure of InSTI-based regimens, boosted PI with active NRTIs is recommended 2
• Virological failure should be confirmed with repeat testing, and adherence counseling should be reinforced before switching regimens 2