[Clinical safety of a generic fixed-dose combination of stavudine/lamivudine/névirapine (Triomune). Study of 297 cases in Togo].

The aim of this study was to determine the incidence of the side-effects of the fixed dose combination of stavudine/lamivudine/nevirapine (Triomune) during treatment of the HIV infected patients in Togo. It was a multicentric retrospective study carried out from September 2003 to October 2005. We collected data from the medical files of the HIV infected patients using antiretroviral therapy Patients were included in the study if using Triomune and were followed up regularly in an accredited centre of management of HIV infected patients for at least one month. Biological examinations carried out were blood cells count, transaminases, uremia, creatininemia, glycemia and lymphocyte T CD4 cells count. During the period of our study on one sample out of 1000 files of HIV infected patients followed in the medical centres using antiretroviral therapy 297 patients took Triomune. The average age was 36.8 years (range: 5-68 years), 64% were female. The average duration of the antiretroviral therapy of the patients using Triomune was 6 months. Side-effects were noted in 78 cases (26,3%). The main side-effects were: digestive disorders (30 cases; 10%), skin rashes (27 cases; 9%), headaches (19 cases; 6.4%), paresthesias (7 cases; 2.4%). We found neither hepatotoxicity nor lipodystrophy. The majority of skin rashes (63%) had occurred during the first month of treatment, and was severe (stade 3 and 4 of WHO) in 6 cases (22.2%) and consequently justified the stop of nevirapine. The paresthesias had occurred after about 3 months of treatment, they were severe in 2 cases (stade 3 of WHO) justifying consequently the stop of stavudine. The results of this study confirm the low severe side-effects of Triomune during the first six months of treatment.