Hepatitis B virus clinical and virologic characteristics in an HIV perinatal transmission study in sub-saharan Africa, HPTN 046- a post-hoc analysis.

OBJECTIVES: To describe the clinical and virologic characteristics of HIV-HBV coinfection, including the predictors of high maternal HBV viral load in pregnant women with HIV in sub-Saharan Africa (SSA).

METHODS: HPTN 046 was a HIV perinatal transmission clinical trial evaluating infant nevirapine vs placebo. Women-infant pairs (n = 2016) were enrolled in SSA from 2007-2010; 1579 (78%) received antiretrovirals (ARV). Maternal delivery samples were retrospectively tested for hepatitis B surface antigen (HBsAg), and if positive, were tested for hepatitis B e antigen (HBeAg) and HBV viral load (VL). High HBV VL was defined as ≥106 IU/ml.

RESULTS: Overall, 4.4% (88/2016) had HBV co-infection, with geographic variability ranging from 2.4-8.7% (p < 0.0001); 25% (22/88) were HBeAg positive with prevalence in countries ranging from 10.5-39%. Fifty-two percent (40/77) of those with HBV received ARV, the majority (97%) received 3TC as the only HBV active agent.. HBeAg positivity was associated with high maternal HBV VL, OR 37.0, 95% CI 5.4-252.4. Of those with high HBV VL, 40% (4/10) were receiving HBV active drugs (HBV-ARV).. HBV drug resistance occurred in 7.5% (3/40) receiving HBV- ARV.

CONCLUSIONS: In SSA, HBV co-infection is common in pregnant women with HIV. HBsAg and HBeAg prevalence vary widely by country in this clinical trial cohort. HBeAg is a surrogate for high HBV viral load. HBV drug resistance occurred in 7.5% receiving HBV-ARV with lamivudine as the only HBV active agent.. These findings reinforce the importance of HBsAg screening and early treatment with with two active agents for HBV.