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.

Prevalence of adverse drug reactions in adult patients on anti-retrovirals at Kenyatta National Hospital, Comprehensive Care Centre

“…The difference may also be attributed to the low use of laboratory diagnosis of hepatoxicity and other ADRs in resource-limited settings. However, our results compare well with those of a retrospective study involving 3154 patients at a tertiary HIV care referral centre in South India which reported hepatitis in 3.5% of patients (24).…”

Risk factors, management and outcomes of adverse drug reactions in adult patients on antiretrovirals at Kenyatta National Hospital, Nairobi

“…Stavudine containing regimens were also associated with more cases of lipid abnormalities. Stavudine-associated peripheral neuropathy has been found in other resource-limited settings which use stavudine based combinations as the first line HAART regimen (15,16,(21)(22)(23) and there have been calls for replacement of stavudine with tenofovir or zidovudine as a first line drug (24).…”

Adverse Effect of Highly Active Anti-Retroviral Therapy (HAART) In HIV/AIDS Patients

“…54 Another study from South India reported a 5.4% incidence of anemia. 50 In SM Curkendall et al, it was reported that 13.0% of patients initiating a ZDVcontaining regimen and 8.7% of those initiating another NRTI containing regimen had anemia's. The non-nucleoside reverse transcriptase inhibitors (NNRTI) are potent antiretroviral agents recommended for use in the treatment of HIV infection.…”

“…[47][48][49] After the therapy initiation, Zidovudine-related anemia usually occurs within 3 months. 50 Risk factors include high zidovudine dosage, increased treatment duration, low CD4 cell count, and preexisting anemia. 51 Studies from 8 Nigeria, Co te d'Ivoire, Haiti, and India have found rates of zidovudine-related anemia of 3%-12%.…”

“…51 Studies from 8 Nigeria, Co te d'Ivoire, Haiti, and India have found rates of zidovudine-related anemia of 3%-12%. [50][51][52][53] A study by Sharma et al from Gujarat has reported 20% of anemia by observing 71% incidence of side effects in their patients who were on HAART. 54 Another study from South India reported a 5.4% incidence of anemia.…”