Risk of hepatitis B virus reactivation in hepatitis B virus + hepatitis C virus‐co‐infected patients with compensated liver cirrhosis treated with ombitasvir, paritaprevir/r + dasabuvir + ribavirin

• Published in: Journal of viral hepatitis Vol. 25; no. 7; pp. 834 - 841
• Main Authors: Preda, C. M., Popescu, C. P., Baicus, C., Constantinescu, I., Oproiu, A., Voiosu, T., Diculescu, M., Negreanu, L., Gheorghe, L., Sporea, I., Trifan, A., Ceausu, E., Proca, D., Manuc, M.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-07-2018
• Subjects: Adult; Aged; Aged, 80 and over; Alanine Transaminase - blood; Antigens; Antiretroviral drugs; Antiviral agents; Antiviral Agents - therapeutic use; Antiviral drugs; Cirrhosis; Deoxyribonucleic acid; direct‐acting antiviral agents; DNA; Drug Therapy, Combination - methods; Female; Follow-Up Studies; Genotype; Genotypes; HBV reactivation; Hepatitis; Hepatitis B; Hepatitis B Surface Antigens - blood; hepatitis B virus; Hepatitis B virus - classification; Hepatitis B virus - genetics; Hepatitis B virus - isolation & purification; Hepatitis B, Chronic - complications; Hepatitis B, Chronic - virology; Hepatitis C; hepatitis C virus; Hepatitis C, Chronic - complications; Hepatitis C, Chronic - drug therapy; Humans; Incidence; Interferon; Liver; Liver cirrhosis; Liver Cirrhosis - virology; Male; Middle Aged; Nucleotide analogs; paritaprevir/ombitasvir/ritonavir/dasabuvir + ribavirin; Prospective Studies; Ribavirin; Risk Assessment; Ritonavir; Romania - epidemiology; Serology; Viral Load; Virus Activation; paritaprevir/ombitasvir/ritonavir/dasabuvir + ribavirin; hepatitis C virus; direct-acting antiviral agents; HBV reactivation; hepatitis B virus; liver cirrhosis
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1111/jvh.12872

Summary
Hepatitis B virus may reactivate in patients with chronic hepatitis C treated with direct‐acting antivirals. The aim of this study was to investigate the risk of hepatitis B virus (HBV) reactivation in HBV + hepatitis C virus (HCV)‐co‐infected patients with compensated liver cirrhosis treated with paritaprevir/ombitasvir/ritonavir, dasabuvir with ribavirin. We reviewed prospectively gathered data from a national cohort of 2070 hepatitis C virus patients with compensated liver cirrhosis who received reimbursed paritaprevir/ombitasvir/r, dasabuvir with ribavirin for 12 weeks from the Romanian National Health Agency during 2015‐2016. Twenty‐five patients in this cohort were HBs antigen positive (1.2%); 15 untreated with nucleotide analogues agreed to enter the study. These patients were followed up: ALT monthly, serology for HBV and DNA viral load at baseline, EOT and SVR at 12 weeks. Hepatitis B virus (HBV)‐co‐infected patients were all genotype 1b and 52% females, with a median age of 60 years (51 ÷ 74); 76% were pretreated with peginterferon + ribavirin; 72% were with severe necroinflammatory activity on FibroMax assessment; 40% presented comorbidities; and all were HBe antigen negative. Hepatitis C virus (HCV) SVR response rate was 100%. Hepatitis B virus (HBV)‐DNA viral load was undetectable in 7/15 (47%) before therapy, and for the other 8 patients, it varied between below 20 and 867 IU/mL. Five patients (33%) presented virological reactivation (>2 log increase in HBV‐DNA levels) during therapy. One patient presented with hepatitis associated with HBV reactivation, and two started anti‐HBV therapy with entecavir. Hepatitis B virus (HBV) virological reactivation was present in 33% in our patients. Generally, HBV‐DNA elevations were mild (<20 000 IU/mL); however, we report one case of hepatitis associated with HBV reactivation.