Efforts should be directed at developing fixed-dose combinations (FDCs) of antiretroviral drugs for treatment of HIV infection. FDCs improve adherence to therapy because of their convenience. Generic companies in the developing world have developed certain FDC formulations for drugs used as highly active antiretroviral therapy (HAART), some of which are not available through international companies. Bioequivalence studies have shown equivalence between some of these formulations and the patented products. It is essential to document the long-term effectiveness of these generic formulations in clinical settings.

We report here the safety and long-term clinical and immunological effectiveness of generic FDC formulations (AZT/3TC/NVP and d4T/3TC/NVP) amongst antiretroviral naïve HIV-1 infected patients in India. Carried out at two private tertiary referral centres, this observational study recruited 1253 patients with minimum three months of follow up, thus making it the largest study from India. Safety was assessed clinically and by laboratory markers and immunologic effectiveness was assessed by serial CD4 counts. Clinical events were documented during follow up.

There was a significant improvement in the mean CD4 counts over time. Most improvement occurred within 3-6 months of initiation of HAART and was sustained for up to 2 years. Rash and hepatitis were documented in 6.9% (95% CI 5.5-8.3) and 3.2% (CI 2.3-4.8) respectively of patients initiating therapy. Only female gender was associated with higher risk of development of any adverse event. All adverse events occurred within 1-12 weeks of initiating therapy.

The incidence of mortality and morbidity on HAART was 5.2 and 28.1 per 100 person years of follow up respectively. Tuberculosis was the commonest cause of death and overall clinical events in the cohort. Only baseline CD4 counts were significantly associated with increased risk of development of clinical events.

Thus HAART delivered as FDCs has shown potent and durable effect amongst HIV-infected patients in this clinical study. Programmes intending to scale up antiretroviral therapy in the developing world should consider FDCs containing nevirapine-based HAART as a first line regimen.