• Effectiveness of a PMTCT programme in rural Western Kenya.

      Azcoaga-Lorenzo, A; Ferreyra, C; Alvarez, A; Palma, P P; Velilla, E; del Amo, J; Medecins Sans Frontieres-Spain/Operational Centre Barcelona-Athens, Barcelona, Spain. azcoaga@yahoo.es (Taylor and Francis, 2011-03)
      We assess the coverage of a Prevention of Mother-to-child Transmission (PMTCT) programme in Busia (Kenya) from 1 January 2006 to 31 December 2008 and estimate the risk of transmission of HIV. We also estimate the odds of HIV transmission according to pharmacological intervention received. Programme coverage was estimated as the proportion of mother-baby pairs receiving any antiretroviral (ARV) regimen among all HIV-positive women attending services. We estimated the mother-to-child transmission (MTCT) rate and their 95% confidence interval (95%CI) using the direct method of calculation (intermediate estimate). A case-control study was established among all children born to HIV-positive mothers with information on outcome (HIV status of the babies) and exposure (data on pharmacological intervention). Cases were all HIV-positive children and controls were the HIV-negative ones. Exposure was defined as: (1) complete protocol: ARV prescribed according World Health Organisation recommendations; (2) partial protocol: does not meet criteria for complete protocol; and (3) no intervention: ARVs were not prescribed to both mother and child. Babies were tested using DNA Polymerase Chain Reaction at six weeks of life and six weeks after breastfeeding ceased. In the study period, 22,566 women accepted testing, 1668 were HIV positive (7.4%; 95%CI 7.05-7.73); 1036 (62%) registered in the programme and 632 were lost. Programme coverage was 40.4% (95%CI 37.9-42.7). Out of the 767 newborns, 28 (3.6%) died, 148 (19.3%) defaulted, 282 (36.7%) were administratively censored and 309 (40.2%) babies completed the follow-up as per protocol; 49 were HIV positive and MTCT risk was 15.86% (95%CI 11.6-20.1). The odds of having an HIV-positive baby was 4.6 times higher among pairs receiving a partial protocol compared to those receiving a complete protocol and 43 times higher among those receiving no intervention. Our data show a good level of enrolment but low global coverage rate. It demonstrates that ARV regimens can be implemented in low resource rural settings with marked decreases of MTCT. Increasing the coverage of PMTCT programmes remains the main challenge.
    • Generic Fixed-Dose Combination Antiretroviral Treatment in Resource-Poor Settings: Multicentric Observational Cohort

      Calmy, A; Pinoges, L; Szumilin, E; Zachariah, R; Ford, N; Ferradini, L; MSF, Campaign for Access to Essential Medicines, 78 rue de Lausanne, 1205 Geneva, Switzerland. acalmy@stvincents.com.au (2006-05-12)
      BACKGROUND: The use fixed-dose combination (FDC) is a critical tool in improving HAART. Studies on the effectiveness of combined lamivudine, stavudine and nevirapine (3TC/d4T/NVP) are scarce. OBJECTIVE: To analyse 6861 patients in a large observational cohort from 21 Médecins Sans Frontieres (MSF) HIV/AIDS programmes taking 3TC/d4T/NVP, with subcohort analyses of patients at 12 and 18 months of treatment. METHODS: Survival was analysed using Kaplan-Meier method and factors associated with progression to death with Cox proportional hazard ratio. RESULTS: Median baseline CD4 cell count at initiating of FDC was 89 cells/microl [interquartile range (IQR), 33-158]. The median follow-up time was 4.1 months (IQR, 1.9-7.3). The incidence rate of death during follow-up was 14.2/100 person-years [95% confidence interval (CI), 13.8-14.5]. Estimates of survival (excluding those lost to follow-up) were 0.93 (95% CI, 92-94) at 6 months (n = 2,231) and 0.90 (95% CI, 89-91) at 12 months (n = 472). Using a Cox model, the following factors were associated with death: male gender, symptomatic infection, body mass index < 18 kg/m and CD4 cell count 15-50 cells/microl or < 15 cells/microl. Subcohort analysis of 655 patients after 1 year of follow-up (M12 FDC cohort) revealed that 77% remained on HAART, 91% of these still on the FDC regimen; 5% discontinued the FDC because of drug intolerance. At 18 months, 77% of the patients remained on HAART. CONCLUSIONS: Positive outcomes for d4T/3TC/NVP are reported for up to 18 months in terms of efficacy and safety.
    • Response to highly active antiretroviral therapy among severely immuno-compromised HIV-infected patients in Cambodia.

      Madec, Y; Laureillard, D; Pinoges, L; Fernandez, M; Prak, N; Ngeth, C; Moeung, S; Song, S; Balkan, S; Ferradini, L; et al. (2007-01-30)
      BACKGROUND: HAART efficacy was evaluated in a real-life setting in Phnom Penh (Médecins Sans Frontières programme) among severely immuno-compromised patients. METHODS: Factors associated with mortality and immune reconstitution were identified using Cox proportional hazards and logistic regression models, respectively. RESULTS: From July 2001 to April 2005, 1735 patients initiated HAART, with median CD4 cell count of 20 (inter-quartile range, 6-78) cells/microl. Mortality at 2 years increased as the CD4 cell count at HAART initiation decreased, (4.4, 4.5, 7.5 and 24.7% in patients with CD4 cell count > 100, 51-100, 21-50 and < or = 20 cells/microl, respectively; P < 10). Cotrimoxazole and fluconazole prophylaxis were protective against mortality as long as CD4 cell counts remained < or = 200 and < or = 100 cells/microl, respectively. The proportion of patients with successful immune reconstitution (CD4 cell gain > 100 cells/microl at 6 months) was 46.3%; it was lower in patients with previous ART exposure [odds ratio (OR), 0.16; 95% confidence interval (CI), 0.05-0.45] and patients developing a new opportunistic infection/immune reconstitution infection syndromes (OR, 0.71; 95% CI, 0.52-0.98). Similar efficacy was found between the stavudine-lamivudine-nevirapine fixed dose combination and the combination stavudine-lamivudine-efavirenz in terms of mortality and successful immune reconstitution. No surrogate markers for CD4 cell change could be identified among total lymphocyte count, haemoglobin, weight and body mass index. CONCLUSION: Although CD4 cell count-stratified mortality rates were similar to those observed in industrialized countries for patients with CD4 cell count > 50 cells/microl, patients with CD4 cell count < or = 20 cells/microl posed a real challenge to clinicians. Widespread voluntary HIV testing and counselling should be encouraged to allow HAART initiation before the development of severe immuno-suppression.
    • Very early mortality in patients starting antiretroviral treatment at primary health centres in rural Malawi.

      Zachariah, Rony; Harries, Katie; Moses, Massaquoi; Manzi, Marcel; Line, Arnould; Mwagomba, Beatrice; Harries, Anthony D; Medecins Sans Frontieres, Medical Department, Brussels, Belgium. zachariah@internet.lu (2009-07-15)
      OBJECTIVES: To report on the cumulative proportion of deaths occurring within 3 months of starting antiretroviral treatment (ART) and to identify factors associated with such deaths, among adults at primary health centres in a rural district of Malawi. METHODS: Retrospective cohort study: from June 2006 to April 2008, deaths occurring over a 3-month period were determined and risk factors examined. RESULTS: A total of 2316 adults (706 men and 1610 women; median age 35 years) were included in the analysis and followed up for a total of 1588 person-years (PY); 277 (12%) people died, of whom 206 (74%) people died within 3 months of initiating ART (cumulative incidence: 13.0; 95% confidence interval: 11.3-14.8 per 100 PY of follow-up). Significant risk factors associated with early deaths included male sex, WHO stage 4 disease, oesophageal or persistent oral candidiasis and unexplained presumed or measured weight loss >10%. One in every 3 patients who either died or was lost to follow up had unexplained weight loss >10%, and survival in this group was significantly different from patients without this condition. CONCLUSIONS: Seven in 10 individuals initiating ART at primary health centres die early. Specific groups of patients are at higher risk of such mortality and should receive priority attention, care and support.