Simple Regimens Are Highly Effective in Developing World 

By Brian Boyle, MD

HIV prevalence is highest in some of the poorest parts of the world. Efforts to get ARV treatment to HIV-infected individuals in developing countries have been ongoing for many years. Unfortunately, even modest treatment goals, such as the UN 3 x 5 initiatives, which sought to get 3million individuals in developing countries on ARVs by 2005, have not been met.

The sense of dismay caused by the tragic failure to get ARV therapy to individuals in developing countries who need it is heightened by studies such as ANRS 1207/IMEA 025. This study, like others before it, indicates that if ARV therapy is provided it can achieve success rates that are similar to those achieved in developed countries.

This study is a prospective, open-label, single-arm study that enrolled 40 treatment-naive HIV-1-infected patients in Senegal. These individuals were treated with an ARV regimen of tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV). The enrolled patients were more advanced than those seen in trials done in developed countries with 7.5%, 70%, and 22.5% with CDC stage A, B, or C, respectively, and a median HIV RNA of 5.3 log₁₀ copies/mL and CD4 count of 122 cells/mm³ at baseline.

Using an intent to treat analysis, at months  1, 3, 6, and 9, 55%, 85%, 87.5%, 87.5%, respectively, had an HIV RNA <400 copies/ml and 22.5%, 50% , 80% ,77.5%, respectively, had an HIV RNA <50 copies/ml. The median CD4 count at months 3, 6, and 9 were 248, 232 and 242 cells/mm³, respectively. The regimen was relatively well tolerated with 50% of patients experiencing EFV-related dizziness during the first 2 weeks of therapy, but only 1 patient switching treatment for dizziness, and 16% and 12% experiencing mild nausea or diarrhea, respectively.

The authors conclude, “In this first evaluation in a developing country, this easy-to-take once-daily regimen of TDF, FTC, and EFV was well accepted and tolerated and exhibited potent antiretroviral and immunological effect in patients with advanced HIV infection. A fixed dose of this combination is expected and could be a major advance.”

02/28/06

Reference
R Landman and others. Short-term Evaluation of TDF/FTC/EFV Once Daily, First-line Regimen in West Africa: ANRS 1207/IMEA 025 Trial.13^th Conference on Retroviruses and Opportunistic Infections, Denver, CO, February 5-8, 2006. Abstract 543.