Background: Our objective was to determine safety, tolerability, and efficacy of nevirapine (NVP)-based HAART amongst antiretroviral naïve HIV-1-infected patients in tertiary care HIV clinics in Pune and Ahmedabad, India.

Methods: 347 antiretroviral-naïve subjects initiated on 2NRTIs+NVP were followed-up clinically monthly, and with CD4/CD8 counts quarterly.  CD4 estimations were done by flow cytometry.  2 NRTIs offered to patients were either d4T/3TC (174) or AZT/3TC (173). Nevirapine was administered as a lead-in dose. Adverse events (AE) was defined as any event judged by the investigator to be definitely, probably or possibly related to nevirapine. Risk factors for development of AE’s were assessed by Mantel-Haenszel method. Paired t test was used to assess improvement in CD4 counts. Difference in efficacy between the 2 backbone nucleosides was assessed by Cox proportional hazard model with AZT/3TC as the reference category and more than 20% increase in CD4 count defined as responder.

Results: 347 patients (296 males and 51 females) with minimum 6 months of follow up were evaluable. Mean baseline CD4 was 144.2 (124.2-164.8). Rash was documented in 10.5% patients (4 with SJS), self-limiting GI disturbances in 21% patients, and sub-clinical hepatitis in 4.7% patients. Skin rashes developed within 1 month of initiation. Female gender was significantly associated with development of rash (RR- 1.27, 1.09-1.49) while age, baseline CD4, and concomitant TMP-SMX was not associated with the same. Mean CD4 counts at 3, 6, 9, and 12 months was 275.5 (259.3-291.6), 296.7 (278.4-315.1), 303.2 (285.5-320.9), and 315.1 (294.7-335.3) respectively. There was no difference between the 2 backbone nucleoside regimes in improving CD4 counts at any point of time (12 months RH-1.25, 0.96-1.63). Overall 64.6% had more than 20% increase in CD4 counts at 12 months.  23 patients developed opportunistic infections of which 6 died.

Conclusion: This is the largest observational study till date, documenting the efficacy, safety and tolerability of nevirapine based HAART amongst Indian patients in clinical practice. Within a clinical setting, nevirapine in combination with NRTIs is safe and well tolerated amongst HIV-1 infected Indian patients. Being the cheapest third drug in India, NVP can be positioned as a first line HAART option for antiretroviral naïve patients.