Nevirapine versus efavirenz based antiretroviral treatment in naive Indian patients: comparison of effectiveness in clinical cohort.

OBJECTIVE: Our objective was to compare immunologic effectiveness of nevirapine and efavirenz based antiretroviral therapy in antiretroviral naïve HIV-1 infected Indian patients. DESIGN AND METHODS: Study was an observational, non-randomized, longitudinal cohort. Antiretroviral naive HIV-1 infected patients receiving efavirenz + 2NRTI (n=254) and nevirapine + 2 NRTI (n=857) from April 2000 were followed up at two tertiary care HIV clinics at Ahmedabad and Pune. Patients were followed up clinically monthly and CD4 was carried out every 3 monthly. All patients were examined for various side effects as well as development of various OIs. Data were analyzed using standard statistical methods. RESULTS: Baseline characteristics for both the groups (NVP and EFV) were comparable. In the random effects model, there was an increase of 40.97 (p < 0.05) units of CD4 cell counts with an unit increase in time in the NVP arm as against a 44.75 (p < 0.05) units of increase in CD4 cell counts in the EFV group with a unit increase in time, which is significant for both groups. However, at any given point of time there was no difference in the rate of increase of CD4 count between the two treatment arms (p = 0.58). Hypersensitivity reaction (6.6% in NVP vs. 2.32% in EFV, p = 0.0146) and hepatitis (3.2% in NVP vs. 0% in EFV, p = 0.0085) were more common with nevirapine, while neurologic disturbances (0.93% in NVP vs. 20.15% in EFV, p = 0.0001) were more common with efavirenz. Incidence of distal sensory neuropathy and lipid abnormalities was similar in both the groups. CONCLUSION: Use of NVP and EFV based HAART in antiretroviral naive Indian patients led to significant and durable rise in CD4 cell count. Although observational and non-randomized, our study showed equivalent immunological response amongst NVP and EFV based HAART which is in line with the results of the 2NN study.