Effectiveness of generic fixed-dose combinations of highly active antiretroviral therapy for treatment of HIV infection in India.
OBJECTIVE
To assess clinical and immunologic effectiveness and acute toxicity to nevirapine (NVP)-based fixed-dose combinations (FDCs) in antiretroviral-naive HIV-1-infected patients in India.


METHODS
Observational study of patients initiated on NVP-based combination therapy delivered as FDCs.


METHODS
Antiretroviral-naive HIV-1-infected patients initiated on FDCs (zidovudine/lamivudine [3TC]/NVP or stavudine/3TC/NVP) were assessed clinically and with CD4 counts periodically. Adverse events to NVP were assessed clinically and by laboratory markers. Frequency and risk factors for development of adverse events and clinical outcomes were determined.


RESULTS
Of the 1291 patients started on therapy, 1253 completed a minimum of 3 months of follow-up. Rash and hepatitis were documented in 6.6% (95% confidence interval [CI]: 5.5-8.3) and 3.2% (95% CI: 2.3-4.8) of patients initiating therapy, respectively. There was significant improvement in CD4 counts over 2 years. Fourty-eight patients died, and 186 clinical events were documented in these patients. Tuberculosis was the most common cause of morbidity and mortality. Self-reported adherence was high.


CONCLUSIONS
Fixed-dose formulations of NVP-based combination therapy are safe and produced durable clinical and immunologic benefit.
Pujari
Sanjay N
SN
Department of HIV Medicine, Ruby Hall Clinic, Pune, India. san1@medscape.com
Patel
Atul K
AK
Naik
Eknath
E
Patel
Ketan K
KK
Dravid
Ameet
A
Patel
Jagdish K
JK
Mane
Abhay A
AA
Bhagat
Shobha
S
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D007194:India; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D019380:Anti-HIV Agents; D016568:Drugs, Generic; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine