AEGiS-15IAC: Very satisfactory outcomes of fixed dose combinations (FDCs) of anti-retroviral drugs among patients on HAART in Medecins Sans Frontieres programmes.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Very satisfactory outcomes of fixed dose combinations (FDCs) of anti-retroviral drugs among patients on HAART in Medecins Sans Frontieres programmes.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrB1317)

Ferradini L, Mace C, Pinoges L, Cirera A, Pascual F, Humblet P, Szumilin E, Torres V, Zachariah R, Pecoul B, Calmy A
Epicentre, Paris, France

BACKGROUND: Adherence is a constant concern in countries that are scaling-up antiretroviral treatment. The use of Fixed Drug Combinations (FDCs) reduces pill burden and is known to be associated with increased adherence. MSF is now using pre-qualified FDCs containing stavudine/lamivudine/nevirapine (d4T/3TC/NVP) as first line treatment in most of its programmes according to WHO recommendations. We assessed the efficacy and safety of FDCs in 15 MSF programmes.

METHODS: Data were routinely collected using a monitoring software (Fuchia, Epicentre, France) and treatment outcomes of patients under FDCs were analysed.

RESULTS: As of November 2003, FDCs were initiated in a total of 3780 adults. During the previous 6 months, 74.2% of new ARV patients were given FDCs in MSF programmes. Data were available for 3398 patients (64% female, 36% male) whose median age was 34 [Inter-quartile range (IQR): 29-40], 86% were ARV naïve. There were 90% at stage III/IV and 10% at WHO clinical stage I/II. At the initiation of FDCs, 806 (30%) patients had CD4 counts< 50 cells/mm³ and 2257 (85%) had CD4 counts< 200 cells/mm³. The median CD4 counts was 95 CD4 cells/mm³ (IQR: 37-166). The median follow-up period was 2.8 months (IQR 1.2-5.2), 656 (19%) patients were followed up more than 6 months. At 6 months, the median weight gain was +3 kg (IQR: 0-7). Only 10 (4%) patients remained below 50 CD4-cells/mm³ while 102 (38%) had 200 cells/mm³ or more. The median gain of CD4 counts was +100 cells/mm³ (IQR: 58-154). FDCs were stopped for intolerance in 5% of the patients, 3% during the first month of treatment. In November 2003, 2954 patients (87%) were on FDCs, 183 (5%) had stopped, 161 (5%) had died, and 100 (3%) were lost to follow-up. Conclusion Our results show satisfactory and comparable outcomes of patients under FDCs in resource-poor settings. Thus, FDCs are essential tools to standardize and simplify the administration of HAART in order to achieve the goal of scaling up.

Keywords: AEGIS, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Nevirapine, Stavudine, Lamivudine, HIV-1, CD4-Positive T-Lymphocytes, Retroviridae, Treatment Outcome, France, Adult, Female, Male, Humans

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WeOrB1317