title: Spectrum of adverse events after generic HAART in southern Indian HIV-infected patients.
abstract: To determine the incidence of clinically significant adverse events after long-term, fixed-dose, generic highly active antiretroviral therapy (HAART) use among HIV-infected individuals in South India, we examined the experiences of 3154 HIV-infected individuals who received a minimum of 3 months of generic HAART between February 1996 and December 2006 at a tertiary HIV care referral center in South India. The most common regimens were 3TC + d4T + nevirapine (NVP) (54.8%), zidovudine (AZT) + 3TC + NVP (14.5%), 3TC + d4T + efavirenz (EFV) (20.1%), and AZT + 3TC + EFV (5.4%). The most common adverse events and median CD4 at time of event were rash (15.2%; CD4, 285 cells/microL) and peripheral neuropathy (9.0% and 348 cells/microL). Clinically significant anemia (hemoglobin <7 g/dL) was observed in 5.4% of patients (CD4, 165 cells/microL) and hepatitis (clinical jaundice with alanine aminotransferase > 5 times upper limits of normal) in 3.5% of patients (CD4, 260 cells/microL). Women were significantly more likely to experience lactic acidosis, while men were significantly more likely to experience immune reconstitution syndrome (p < 0.05). Among the patients with 1 year of follow-up, NVP therapy was significantly associated with developing rash and d4T therapy with developing peripheral neuropathy (p < 0.05). Anemia and hepatitis often occur within 12 weeks of initiating generic HAART. Frequent and early monitoring for these toxicities is warranted in developing countries where generic HAART is increasingly available.
authors.affiliation: YRG Centre for AIDS Research and Education, VHS, Chennai, India. kumarasamy@yrgcare.org
authors.forename: N
authors.initials: N
authors.lastname: Kumarasamy
authors.forename: Kartik K
authors.initials: KK
authors.lastname: Venkatesh
authors.forename: Anitha J
authors.initials: AJ
authors.lastname: Cecelia
authors.forename: Bella
authors.initials: B
authors.lastname: Devaleenal
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Lai
authors.forename: Suneeta
authors.initials: S
authors.lastname: Saghayam
authors.forename: P
authors.initials: P
authors.lastname: Balakrishnan
authors.forename: Toku
authors.initials: T
authors.lastname: Yepthomi
authors.forename: S
authors.initials: S
authors.lastname: Poongulali
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Flanigan
authors.forename: Suniti
authors.initials: S
authors.lastname: Solomon
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
mesh_terms: D000328:Adult; D000740:Anemia / Q000139:chemically induced / Q000453:epidemiology; D019380:Anti-HIV Agents / Q000009:adverse effects; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D018791:CD4 Lymphocyte Count; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology; D004359:Drug Therapy, Combination; D016568:Drugs, Generic / Q000009:adverse effects*; D005076:Exanthema / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D008297:Male; D019829:Nevirapine / Q000009:adverse effects; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000453:epidemiology; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects; D018119:Stavudine / Q000009:adverse effects
chemical_list: D019380:Anti-HIV Agents; D016568:Drugs, Generic; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; D018119:Stavudine