A non-randomized vaccine effectiveness trial of accelerated infant hepatitis B immunization schedules with a first dose at birth or age 6 weeks in Côte d'Ivoire.

Most African countries do not initiate hepatitis B vaccination at birth. We conducted a non-randomized controlled trial comparing hepatitis B vaccination given at age 0, 6, and 14 weeks versus the current Côte d'Ivoire schedule of 6, 10, and 14 weeks. Pregnant women were enrolled at four health centers in Abidjan. At age 9 months, 0.5% of infants in both the birth and 6-week cohorts were positive for HBsAg and all were born to HBeAg-positive women. Among infants of HBeAg-positive mothers, 9 of 24 (37.5%) in the birth cohort and 10 of 17 (58.8%) in the 6-week cohort were HBsAg positive (adjusted OR, 2.7; 95% CI: 0.7-11.0). While both vaccine schedules prevented most cases of infant HBV transmission, both also had high failure rates among infants of HBeAg-positive mothers. African infants may benefit from a birth dose but additional studies are needed to verify this hypothesis.

Change over time of mortality predictors after HAART initiation in a Senegalese cohort.

BACKGROUND: In 1998, Senegal was among the first sub-Saharan African countries to launch a Highly active anti-retroviral therapy (HAART) access program. Initial studies have demonstrated the feasibility and efficacy of this initiative. Analyses showed a peak of mortality short after starting HAART warranting an investigation of early and late mortality predictors. METHODS: 404 HIV-1-infected Senegalese adult patients were enrolled and data censored as of September 2005. Predictor effects on mortality were first examined over the whole follow-up period (median 46 months) using a Cox model and Shoenfeld residuals. Then, changes of these effects were examined separately over the early and late treatment periods; i.e., less and more than 6-month follow-up. RESULTS: During the early period, baseline body mass index and baseline total lymphocyte count were significant predictors of mortality (Hazard Ratios 0.82 [0.72-0.93] and 0.80 [0.69-0.92] per 200 cell/mm3, respectively) while baseline viral load was not significantly associated with mortality. During the late period, viro-immunological markers (baseline CD4-cell count and 6-month viral load) had the highest impact. In addition, the viral load at 6-month was a significant predictor (HR = 1.42 [1.20-1.66]). CONCLUSION: In this cohort, impaired clinical status could explain the high early mortality rate while viro-immunological markers were rather predictors of late mortality.

A 84-month follow up of adherence to HAART in a cohort of adult Senegalese patients.

OBJECTIVES: To assess long-term adherence of the first HIV-1 patients receiving highly active antiretroviral therapy (HAART) in Senegal, and to identify the main determinants of adherence. METHODS: The first 180 patients enrolled in the Senegalese HAART initiative between August 1998 and April 2001 followed up for at least 30 days were eligible. Adherence was assessed monthly at each drug dispensation between November 1999 and November 2006 by a pharmacist using a pill count completed by a questionnaire. Adherence was expressed as the proportion of tablets taken to prescribed tablets. An adherence of 95% was considered to be good. A random-intercept logit model was fitted to identify the main determinants of adherence. RESULTS: Adherence data were available for 158 of 167 eligible patients. Twenty-nine patients died during the study period and 10 were lost to follow-up. Median treatment duration was 78 months, accruing to 6657 person-months of observation. Overall, mean adherence reached 91% [median: 100%, interquartile range (IQR) 96-100%] and adherence exceeded 95% in 78% [95% CI 77-79%] of observations. After 4 years of treatment mean adherence stabilized around 90% and adherence > or =95% stabilized around 70%. Treatment duration and protease inhibitor (PI)-based regimen (indinavir) had a negative effect on adherence, but adherence tended to improve with time for patients receiving a PI. Patient-level variance was highly significant and accounted for a third of total variance. CONCLUSIONS: This work demonstrates that good long-term adherence can be achieved in the sub-Saharan context given close monitoring and adherence support measures, confirms the worse adherence for indinavir and underlines the importance of patient heterogeneity.