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ObjectiveTo describe the anti-hepatitis B virus (HBV) efficacy, HBeAg serologic changes, HBV perinatal transmission, and safety in pregnant women who are living with human immunodeficiency virus (HIV) and HBV co-infection who were randomized to various antiretroviral therapy (ART) regimens.MethodsThe PROMISE (Promoting Maternal and Infant Survival Everywhere) trial was a multicenter randomized trial for ART-naive pregnant women with HIV infection. Women with HIV and HBV co-infection at 14 or more weeks of gestation were randomized to one of three ART arms: one without HBV treatment (group 1) and two HBV treatment arms with single (group 2) or dual anti-HBV activity (group 3). The primary HBV outcome was HBV viral load antepartum change from baseline (enrollment) to 8 weeks; safety assessments included alanine aminotransferase (ALT) level, aspartate aminotransferase (AST) level, and anemia (hemoglobin less than 10 g/dL). Primary comparison was for the HBV-active treatment arms. Pairwise comparisons applied t test and the Fisher exact tests.ResultsOf 3,543 women, 3.9% were HBsAg-positive; 42 were randomized to group 1, 48 to group 2, and 48 to group 3. Median gestational age at enrollment was 27 weeks. Among HBV-viremic women, mean antepartum HBV viral load change at week 8 was -0.26 log 10 international units/mL in group 1, -1.86 in group 2, and -1.89 in group 3. In those who were HBeAg-positive, HBeAg loss occurred in 44.4% at delivery. Two perinatal HBV transmissions occurred in group 2. During the antepartum period, one woman (2.4%) in group 1 had grade 3 or 4 ALT or AST elevations, two women (4.2%) in group 2, and three women (6.3%) in group 3.ConclusionOver a short period of time, HBV DNA suppression was not different with one or two HBV-active agents. HbeAg loss occurred in a substantial proportion of participants. Perinatal transmission of HBV infection was low. Hepatitis B virus-active ART was well-tolerated in pregnancy, with few grade 3 or 4 ALT or AST elevations.Clinical trial registrationClinicalTrials.gov , NCT01061151.

BackgroundThere are limited data on the impact of antenatal antiretroviral regimens (ARV) on pregnancy and infant outcomes in HIV/HBV coinfection. We compared outcomes among 3 antenatal antiretroviral regimens for pregnant women with HIV/HBV.MethodsThe PROMISE study enrolled ARV-naive pregnant women with HIV. Women with HBV were randomized to (no anti-HBV)-zidovudine (ZDV) + intrapartum nevirapine and 1 week of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC); (3TC)-3TC + ZDV + LPV/r; or (FTC-TDF)-FTC + TDF + LPV/r. Pairwise group comparisons were performed with Fisher exact, t , or log rank tests. Adverse pregnancy outcome (APO) was a composite of low birth weight, preterm delivery, spontaneous abortion, stillbirth, or congenital anomaly.ResultsOf 138 women with HIV/HBV, 42, 48, and 48 were analyzed in the no anti-HBV, 3TC, and FTC-TDF arms. Median age was 27 years. APOs trended lower in the no anti-HBV (26%) vs 3TC (38%), and FTC-TDF arms (35%), P ≥ 0.25). More infant deaths occurred among the FTC-TDF [6 (13%)] vs no anti-HBV [2 (5%)] and 3TC [3 (7%)] arms. There were no differences in time-to-death, HIV-free survival, birth or one-year WHO Z-score length-for-age, and head circumference. Hepatitis B e antigen (HBeAg) was associated with an increased risk of APO, 48% vs 27% (odds ratio 2.79, 95% confidence interval: 1.19 to 6.67, post hoc ).ConclusionWith HBV/HIV coinfection, the risk of an APO was increased with maternal ARV compared with ZDV alone, although the differences were not statistically significant. Maternal HBeAg was associated with a significantly increased risk of APO. Infant mortality was highest with FTC + TDF + LPV/r. Early assessment of HBeAg could assist in identifying high-risk pregnancies for close monitoring.

Background: The World Health Organization (WHO) recommends the use of pre-exposure prophylaxis (PrEP) in key populations at elevated risk for exposure to HIV. If used effectively, PrEP can reduce annual HIV incidence to below 0.05%. However, PrEP is not acceptable among all communities that might benefit from it. There is, therefore, a need to understand perceptions of PrEP and factors associated with willingness to use PrEP among key populations at risk of HIV, such as members of communities with exceptionally high HIV prevalence.Objective: To examine the perceptions and factors associated with willingness to use oral PrEP among members of fishing communities in Uganda, a key population at risk of HIV.Methods: We conducted an explanatory sequential mixed-methods study at Ggaba fishing community from February to June 2019. Survey data were collected from a systematic random sample of 283 community members in which PrEP had not been rolled out yet by the time of we conducted the study. We carried out bivariate tests of association of willingness to use PrEP with demographic characteristics, HIV risk perception, HIV testing history. We estimated prevalence ratios for willingness to use PrEP. We used backward elimination to build a multivariable modified Poisson regression model to describe factors associated with willingness to use PrEP. We purposively selected 16 participants for focus group discussions to contextualize survey findings, analysing data inductively and identifying emergent themes related to perceptions of PrEP.Key Results: We enrolled 283 participants with a mean age of 31 ± 8 years. Most (80.9%) were male. The majority of participants had tested for HIV in their lifetime, but 64% had not tested in the past 6 months. Self-reported HIV prevalence was 6.4%. Most (80.6, 95%CI 75.5-85.0) were willing in principle to use PrEP. Willingness to use PrEP was associated with perceiving oneself to be at high risk of HIV (aPR 1.99, 95%CI 1.31-3.02, P = 0.001), having tested for HIV in the past 6-months (aPR 1.13, 95%CI 1.03-1.24, P = 0.007), and completion of tertiary education (aPR 1.97, 95%CI 1.39-2.81, P < 0.001). In focus group discussions, participants described pill burden, side-effects and drug safety as potential barriers to PrEP use.Conclusions and Recommendations: Oral PrEP was widely acceptable among members of fishing communities in peri-urban Kampala. Programs for scaling-up PrEP for fisherfolk should merge HIV testing services with sensitization about PrEP and also increase means of awareness of PrEP as an HIV preventive strategy . [ABSTRACT FROM AUTHOR]

Background: Acceptability of Pre-exposure Prophylaxis (PrEP) could be hampered by low self-perceived risk for HIV acquisition. Moreover, discordance between risk perception and actual risk of HIV acquisition is likely to occur. We assessed congruence between the level of self- perceived and that of objectively scored risk of HIV acquisition among HIV-negative individuals in discordant relationships.Methods: This was a cross-sectional study among a representative sample of HIV-negative adult males and females whose partners were receiving antiretroviral therapy for at least 3 months from the Infectious Diseases Institute Clinic in Kampala, Uganda. Perceived risk was measured based on self-report using a numerical rating scale whereas objective risk was measured using a validated risk score tool. Congruence between perceived risk and objectively scored risk was evaluated using descriptive statistics and validity measures. Incongruence between the two phenomena was further evaluated using univariate and multivariate regression analyses.Results: HIV-negative partners evaluated in this study were mostly male (64%) with a median age of 41 years (IQR 35 to 50). Majority (76.3%) of the partners perceived themselves as low risk for HIV acquisition. Similarly, most (93.8%) were objectively scored as low risk. However, nearly three quarters (72.7%) of partners who were objectively scored as high risk perceived themselves as being at low risk and all were men. The sensitivity and specificity of perceived risk for detecting the objectively measured risk was 27.3 and 76.5% respectively; area under ROC curve = 0.52; 95%CI (0.38, 0.66). The proportion of participants at high risk of HIV acquisition who perceived their risk as low was greater among those whose partners had detectable viral load compared to participants whose partners had undetectable viral load (PR = 0.51; 95%CI 0.29 to 0.90).Conclusion: Incongruence between perceived and objectively measured risk of HIV acquisition does occur especially among individuals whose partners had a detectable viral load. PrEP counselling for serodiscordant couples should focus on explaining the consequence of detectable viral load in the HIV-positive partner on HIV transmission risk. [ABSTRACT FROM AUTHOR]