625B
Clinical and Virological Outcomes of Patients on HAART in a Large-scale Simplified Treatment Program in a Rural District of Malawi
A Jeannin1, L Pinoges2, A Calmy3, J Izopet4, D Odhiambo1, L Mankhambo5, G Karungi6, E Szumilin7, J M Tassié2, C Brasher7, S Balandine2, G Fedida7, N Ford8, and Laurent Ferradini*2
1Médecins Sans Frontières, Chiradzulu, Malawi; 2Epicentre, Paris, France; 3Access Campaign, Geneva, Switzerland; 4Purpan Hospital, Toulouse, France; 5Ministry of Health, Chiradzulu, Malawi; 6Epicentre, Kampala, Uganda; 7Médecins Sans Frontières, Paris, France; and 8Médecins Sans Frontières, London, United Kingdom
Background:
Results of large-scale simplified
HAART programs in sub-Saharan Africa are still
scarce. We report here outcomes and virological
assessment of patients treated in such a program in the Chiradzulu
district, Malawi.
Methods:
Adults
who started HAART ³ 6 months before the analysis (April 15, 2004) were included. Data
were collected using FUCHIAâ
monitoring software. Incidence rate ratios of death plus lost to
follow-up events (failures) 6 months after starting HAART were analyzed using
Poisson regression for potential risk factors. For the virological
evaluation, 398 adults still on HAART were randomly selected and reverse
transcriptase genotyping was performed for viral load > 1000 copies/mL.
Results: Of the 1266 patients included,
64.5% were female, and median age was 34.8 years. At baseline, 96.8% were ART-naïve. Most were at an advanced stage: 55.4% were at WHO stage III and 26.5% at WHO stage IV, 32.3% had a body
mass index < 18.5 kg/m2 and 20.8% had CD4 count < 50 cells/mL. Stavudine/lamivudine/nevirapine
(d4T/3TC/NVP) in fixed dose-combination (CIPLA, India) was the dominant regimen
(79.1%). At follow-up (median duration = 8.3 months, IQR 5.6 to 13.4), 967
(76.4%) were still on HAART, 213 (16.8%) had died (median time to death = 3.0
months, IQR 1.3 to 5.8), 73 (5.8%) were lost to follow-up, and 13 (1.0%)
stopped treatment. The estimates of survival (i.e., alive and still in
follow-up) were 77.9% at 12 months (95% CI 75.3% to 80.3%) and 68.7% at 24
months (95% CI 64.3% to 72.7%). Independent risk factors for failure at 6
months were male sex (IRR 1.47, 95% CI 1.03 to 2.11), WHO stage IV (IRR 2.24,
95% CI 1.2 to 4.19) and body mass index < 18.5 kg/m² (IRR 2.12, 95% CI 1.49
to 3.02). Of patients tested, 84.1% had a viral load below 400 copies/mL and only 13.1% had > 1000 copies/mL.
Viral genotyping (n = 50) revealed NRTI mutations for 42 patients (38 with
M184V, 6 with T215Y/F) and NNRTI mutations for 47 (mostly K103N and Y181C/I).
The K65R mutation, which confers cross-resistance to TDF, was observed for 5
patients. Thus, 42 patients had HIV resistance to both 3TC and NVP/EFV and 5 to
NVP/EFV only.
Conclusions: Because > 2 of 3 of the
patients were still alive 2 years after starting HAART, our data strongly
support the implementation of large-scale simplified programs in rural African
settings. Although failure rates were high, largely due to the advanced illness
of patients at HAART initiation, the virological
outcomes are comparable to data from industrialized countries for those who
survive the first 6 months of therapy.
Keywords: Antiretroviral therapy; Simplification; Virology
