To evaluate treatment outcome in the first 12 months among HIV-positive patients managed with a combination of nevirapine + stavudine + lamivudine under the current national antiretroviral (ARV) program in Nigeria.
This was a prospective observational, cohort study on 50 ARV-naive patients who met the inclusion criteria for the program and had given informed consent. All patients were in stage 2 or stage 3 periods of infection based on World Health Organization clinical classification. The patients were treated with the generic brands of ARVs and treatment consisted of oral nevirapine (Nevimal, Cipla, Mumbai, India), 200 mg daily, lamivudine (Lamivir, Cipla), 150 mg twice daily, and stavudine (Stavir, Cipla), 40 mg twice daily. Prior to initiation of treatment, the clinical history and baseline data for each patient were documented. The levels of plasma HIV-1 RNA, CD4+ cell counts, frequency of opportunistic infections, and estimated body mass index were recorded at baseline and subsequently at intervals during treatment. Data obtained at the various sampling times for each parameter were compared against their baseline values.
Data on the plasma HIV-1 RNA levels indicated that between baseline and week 24, the median viral load of the patients decreased by 1.79 log10 copies/mL. Equally between baseline and week 48 the median CD4+ cell counts increased by 186 × 106 cells/L, the frequency of opportunistic infections decreased by 82%, the median body mass index increased by 4.8 kg/m2, and 36% experienced side effects, which were minor and transient. The most prevalent side effect recorded was skin rash associated with nevirapine. Good adherence to this triple regimen was recorded in >85% of the patients.
The overall results within the 12-month treatment period indicated an effective suppression of viral replication, the reconstitution of the immune system, and improvement of the physical well-being of the study population. Though there may be differences in global distribution of the infecting HIV-1 subtypes, the clinical and biologic results of this study compared favorably to those documented in cohorts treated with branded and generic ARV drugs in some developed and developing countries. The cumulative data in this study further confirmed that the correct use of generic brands of ARVs is a feasible option in HIV care and support programs in resource-poor countries.
From the *Clinical Research Centre, Nigerian Institute of Medical Research, Federal Ministry of Health, Lagos, Nigeria; and †Harvard School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts.
Received for publication December 22, 2003; accepted February 3, 2005.
Grant support from the Federal Government of Nigeria, the Ford Foundation, and the AIDS Prevention Initiative in Nigeria.
Reprints: Emmanuel O. Idigbe, Nigerian Institute of Medical Research, Federal Ministry of Health, 6 Edmond Crescent, PMB 2013, Yaba, Lagos, Nigeria (e-mail: email@example.com).