CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

734

Circulating HBV RNA Helps Characterize HBV Disease in Senegal Lorin Begré 1 , Hubert Akotia 2 , Bruce Wembulua Shinga 3 , Melissa S. Pandi 2 , Ousseynou Ndiaye 2 , Judicaël Tine 3 , Pascal Bittel 4 , Christoph Niederhauser 4 , Martin Stolz 5 , Andri Rauch 1 , Ndeye Fatou Ngom 3 , Adrià Ramírez Mena 1 , Moussa Seydi 3 , Gilles Wandeler 1 , for SEN-B 1 University Hospital of Bern, Bern, Switzerland, 2 Cheikh Anta Diop University, Dakar, Senegal, 3 Centre Hospitalier Universitaire de Fann, Dakar, Senegal, 4 University of Bern, Bern, Switzerland, 5 Interregional Blood Transfusion SRC, Bern, Switzerland Background: Hepatitis B virus (HBV) infection affects >10% of the population in West Africa and is the most common cause of liver cirrhosis and hepatocellular carcinoma. Circulating HBV RNA may help improve the characterization of HBV disease and prognosis. We aimed to evaluate the associations between HBV RNA and conventional biomarkers of HBV replication in the Senegalese Hepatitis B Cohort study (SEN-B). Methods: We included all treatment-naïve participants without HIV infection from SEN-B. We measured HBV RNA levels using the cobas HBV RNA investigational assay (Roche Molecular Diagnostics, Pleasanton, CA) with a lower limit of quantification of 10 copies/ml. Participants were classified into three phases of HBV infection: Hepatitis e antigen (HBeAg)-positive (EP), HBeAg-negative chronic infection (ENCI) and HBeAg-negative chronic hepatitis (ENCH). ENCH was defined by HBV DNA ≥2000 IU/ml in combination with elevated alanine aminotransferase (ALT ≥30 IU/ml for men, ≥19 IU/ml for women) and/or significant liver fibrosis (liver stiffness measurement >7.0 kPa). We compared participants with and without detectable HBV RNA using descriptive statistics and evaluated associations between HBV RNA, HBV DNA, and quantitative hepatitis B surface antigen (qHBsAg) using Spearman's rank correlation coefficient among participants with detectable HBV RNA levels. Results: Among 713 participants, 17 (2.4%) were in the EP phase, 615 (86.3%) in the ENCI phase and 81 (11.4%) in the ENCH phase. Median age was 31 years (interquartile range 25-38) and 335 (47.0%) were female. HBV RNA was undetectable in 3/17 (17.6%) of EP individuals, 338/615 (55.0%) of ENCI individuals and 19/81 (23.5%) of ENCH individuals. The 353/713 (49.5%) participants with detectable HBV RNA were more likely to have HBV DNA >20 IU/ml (95.8% vs. 80.0%) and to have significant fibrosis (13.9% vs. 7.5%) than participants with undetectable HBV RNA levels. We did not observe significant differences in age, sex, ALT levels and qHBsAg levels between the two groups. As depicted in the Figure, HBV RNA showed strong correlation with HBV DNA in EP, moderate correlation in ENCH and poor correlation in ENCI participants. HBV RNA and qHBsAg correlated moderately in EP, but not in ENCI and ENCH participants. Conclusion: In our cohort of treatment-naïve persons with HBV in Senegal, approximately 50% had detectable HBV RNA levels. HBV RNA correlated well with HBV DNA in the EP and ENCI groups, whereas qHBsAg levels correlated with HBV RNA only in EP individuals.

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Efficacy and Safety of BLV 2 or 10 mg for 96 Weeks in CHD Including in 2 Patients With HIV/HBV/HDV Heiner Wedemeyer 1 , Soo Aleman 2 , Maurizia Brunetto 3 , David L Wyles 4 , Viacheslav Morozov 5 , Vladimir Chulanov 6 , Ben Da 4 , Renee-Claude Mercier 4 , Grace M. Chee 4 , Mingyang Li 4 , Pietro Lampertico 7 1 Medizinische Hochschule Hannover, Hannover, Germany, 2 Karolinska Institute, Stockholm, Sweden, 3 University Hospital of Pisa, Pisa, Italy, 4 Gilead Sciences, Inc, Foster City, CA, USA, 5 Medical Company Hepatology, Samara, Russian Federation, 6 Federal Budget Institute of Science, Moscow, Russian Federation, 7 Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy Background: Bulevirtide (BLV) is a first-in-class, entry inhibitor, approved in the EU for the treatment of chronic hepatitis D. Limited data exists on the safety and efficacy of BLV in HIV/HBV/HDV coinfection. The aim of this Week (W) 96 analysis from the Phase 3 MYR301 (NCT03852719) study is to describe the safety and efficacy of BLV over 96 weeks including in patients with HIV/HBV/HDV. Methods: 150 patients with CHD were randomized (1:1:1) into three arms: Arm A: no active anti-HDV treatment for 48 weeks, followed by BLV 10mg/d for 96 weeks (n=51), and Arms B or C: immediate treatment with BLV at 2 mg/d (n=49) or 10 mg/d (n=50), respectively, each for 144 weeks, with follow-up of 96 weeks after end of treatment. Efficacy was measured by combined (undetectable HDV RNA or ≥2 log 10 IU/mL decline from BL and ALT normalization), virologic and biochemical response rates. Controlled HIV infection (defined as CD4 count >500/mL, HIV RNA

Poster Abstracts

736

Transaminase Elevations Among Patients With Occult HBV Infection on 2-Drug Antiretroviral Regimens Luca Mezzadri , Bianca Monti, Alice Ranzani, Anna Cappelletti, Silvia Limonta, Alessandro Soria, Elisa Colella, Ilaria C. Caramma, Nicola Squillace, Paolo Bonfanti, Giuseppe Lapadula Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy Background: Concerns have been raised about the possibility of hepatitis reactivation among individuals with occult HBV infection (OHBVI) who discontinue antiretroviral agents with anti-HBV activity. Whether OHBVI is associated with increased risk of transaminase elevation among those switching to two-drugs regimens (2DR), discontinuing lamivudine (3TC) and/or tenofovir (TFV), merits to be investigated.

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