Adverse Drug Event Profile of Haart Regimen (NACO-FDC) Consisting of Stavudine, Lamivudine and Nevirapine in HIV/AIDS Patients

Adverse drug events caused by Highly Active Anti-Retroviral Therapy (HAART) varies from patient to patient and from country to country. This prospective cohort study was carried out to document the adverse drug events caused by fixed dose combination (FDC) of stavudine/lamivudine/nevirapine regimen (NACO) in HIV patients. A total of 181 adult HIV/AIDS patients received above FDC regimen during the period from October 2009 to September 2010 in ART centre of PBM and AG Hospital, Bikaner, India. Out of these '36' patients (19.9%) had shown one or more adverse drug reactions (ADRs). The mean (± SD) of age was 35.3±8.13 years and of weight was 47.6±10.8 kg. About 64% patients were found to have advanced stages of HIV infection. The patients who had shown ADRs were divided into two subgroups on the basis of CD4 cell counts (group A<200 cell/mm³ and group B≥200 cell/mm³). The 14 patients of group A having mean (± SD) CD4 cell count 120.86±50 cells/mm³ and 22 patients of group B having mean (± SD) CD4 cell count 409.73±176.64 cells/mm³. The most frequently observed adverse event was skin reactions in 9.95% and peripheral neuropathy in 7.2% (out of 181) patients. Most of patients of peripheral neuropathy were from group B, i.e. 10 out of 13. However, there was no significant difference in ADR profile of group A and group B (p>0.05). Severe adverse events (S.J. Syndrome and hepatitis) were seen in 1.66% of total 181 patients and all were females. Lipodystrophy was observed late (after 3 yrs) in only 1.10% of patients. Nausea/vomiting and skin reactions were reported in early part of treatment. In conclusion, stavudine/ lamivudine/nevirapine regimen was safe and well tolerated by HIV-infected patients with baseline CD4 cell count<200 and ≥200 cells/mm³ in resource-poor countries like India.