Current First-Line Antiretroviral Therapy Regimen in India
The current first-line antiretroviral therapy (ART) regimen in India for HIV/AIDS treatment is dolutegravir (DTG) 50 mg with tenofovir disoproxil fumarate (TDF) 300 mg and lamivudine (3TC) 300 mg as a fixed-dose combination. 1
Evolution of ART Regimens in India
- Previously, the standard first-line regimen in India was tenofovir disoproxil fumarate (TDF) with either emtricitabine (FTC) or lamivudine (3TC) combined with efavirenz (EFV) 2
- India has transitioned from older regimens containing nevirapine (NVP) and stavudine (d4T) to more effective and less toxic combinations 2, 3
- The shift to DTG-based regimens follows global recommendations due to superior efficacy and tolerability compared to efavirenz-based regimens 1
Current First-Line Regimen Components and Rationale
DTG-Based Regimen Benefits:
- Higher rates of virological suppression compared to other regimens 4
- Lower risk of treatment discontinuation due to adverse effects 1
- High genetic barrier to resistance development 2
- Demonstrated safety and efficacy specifically in the Indian population with 86.8% of patients achieving viral suppression (<50 copies/mL) at 24 weeks 1
TDF/3TC as Backbone:
- TDF demonstrates significantly lower rates of virological failure compared to older NRTIs like stavudine or zidovudine (6.7 vs. 11.9 failures per 100 person-years) 5
- TDF has fewer long-term toxicities compared to older thymidine analogue NRTIs 3
- 3TC is well-tolerated and has comparable efficacy to emtricitabine when used in combination regimens 2
Special Considerations for the Indian Context
- The DTG/TDF/3TC regimen is suitable for the public health approach in India with its large treatment program (1.2+ million people on first-line ART) 6
- Single tablet regimens improve adherence, which is critical for treatment success 6
- For patients who cannot tolerate DTG, an alternative regimen of TDF/3TC/EFV400 (reduced dose efavirenz at 400mg) may be used as it showed excellent efficacy and safety as a switch strategy in Indian patients 6
Monitoring Recommendations
- HIV RNA level testing within the first 6 weeks of starting ART, then every 3 months until <50 copies/mL for 1 year, then every 6 months 2
- CD4 cell count monitoring every 6 months until >250/μL for 1 year, then can be stopped as long as virus is suppressed 2
- Baseline resistance testing (HIV RT-pro genotype) before initiating therapy, though treatment may begin before results are available 2, 4
- Regular assessment for drug toxicities, particularly during the first few months of therapy 4
Common Pitfalls to Avoid
- Not monitoring for DTG-specific adverse effects like headache, which was reported in 18% of Indian patients on this regimen 1
- Overlooking potential drug interactions, particularly with medications that may affect DTG metabolism 4
- Delaying ART initiation, as early treatment is associated with better outcomes in terms of morbidity and mortality 2, 4
- Failing to provide adequate adherence counseling, as mean adherence <95% is independently associated with virological failure 5
Special Populations
- For patients with tuberculosis co-infection, efavirenz-based regimens may still be considered due to fewer drug interactions with TB medications 2
- For pregnant women or those planning pregnancy, careful consideration is needed due to historical concerns about neural tube defects with DTG, though recent data shows reduced risk over time 2