Adverse effects after HAART Initiation in resource-limited settings: a prospective study from Mysore, India.

INTRODUCTION There are few studies from India documenting the adverse effects of generic HAART (Highly Active Anti-retroviral Therapy). METHODOLOGY A prospective study was conducted at Mysore, India, to study the adverse effects after HAART initiation in a cohort of 100 antiretroviral therapy (ART)-naive patients, who were evaluated prospectively every three months by clinical and laboratory monitoring for adverse effects after HAART initiation for one year. RESULTS The most common first-line regimens were zidovudine (AZT) plus lamivudine (3TC) plus nevirapine (NVP) (42%); followed by Stavudine (d4T) plus 3TC plus NVP  (33%); AZT plus 3TC plus efavirenz (EFV) (13%); and d4T plus 3TC plus EFV (12%). The first-line regimen was modified in14% of patients. The most common reasons for modifying therapy were development of an adverse effect (eight cases; 57.14%) and completion of antituberculous therapy (six cases; 42.86%). The commonest cause for modifying therapy was skin rashes due to NVP (four cases) followed by anaemia two cases) and peripheral neuropathy (two cases). Grade 1 or 2 severity adverse effects by laboratory monitoring were seen in 54 patients after ART initiation and grade 3 or 4 severity adverse effects were seen in eight patients. CONCLUSIONS A significant proportion of patients had adverse effects of a lower grade severity after HAART. A significant proportion of those started on ART substitute therapy due to adverse effects and those on NVP-based regimens are more likely to do so when compared with those on non-NVP- based regimens.