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Reply to Ozaras et al

Year: 2017
Type: letter
Abstract: To the Editor—We appreciate the concern raised by Ozaras et al regarding the hepatitis B surface antibody (anti-HBs) status of the 103 hepatitis C virus (HCV)–infected patients who were hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) positive and had no evidence of hepatitis B virus (HBV) reactivation during or following treatment with ledipasvir/sofosbuvir [1, 2]. To address this concern, we retrospectively determined the anti-HBs status of the 103 patients who were positive for anti-HBc, by analyzing archived samples using the ADVIA Centaur Anti-HBs Reagent Kit (Seimens Healthcare Diagnostics, Tarrytown, New York). Of 103 patient samples analyzed, 37 (36%) were anti-HBs negative, 63 (61%) were anti-HBs positive, and 3 (3%) could not be evaluated because the remaining samples were inadequate. Of the 2 patients identified in our initial analysis as being HBsAg negative and anti-HBc positive with detectable HBV DNA below the lower limit of quantification, both were found to be negative for anti-HBs. Importantly, none of the 37 anti-HBc–positive/HBs-negative patients experienced HBV reactivation in our study, including the 2 patients with detectable HBV DNA. Published case reports suggest that clinical HBV reactivation is a rare occurrence. The majority of described cases occurred in persons who were HBsAg positive, indicative of active HBV infection. Some of these patients may have met criteria for HBV treatment prior to the initiation of HCV therapy. In the case series reported by Bersoff-Matcha and colleagues from the US Food and Drug Administration, the status of HBV infection was incomplete for many patients, which limits the interpretation of the risk of HBV flare, particularly among those reported to be HBsAg negative [3]. Liu and colleagues presented data in 2016 on HBV reactivation in 134 patients receiving DAA treatment for HCV [4]. Of the 134 patients, 81 patients were HBsAg negative and anti-HBc positive. No evidence of HBV reactivation was observed in these 81 patients, which is consistent with our findings. The precise risk of HBV reactivation is difficult to estimate, but the relatively high global prevalence of HBV infection in persons with chronic HCV infection and the small number of cases of HBV reactivation or alanine aminotransferase flare reported among the >1 million persons treated with direct-acting antivirals (DAAs) for HCV suggest that the risk is low [5]. We believe that HCV-infected patients should be screened for HBV infection prior to initiation of DAAs and, for those found to have active HBV infection, HBV treatment guidelines should be followed. Given the benefits of successful HCV treatment, the risk of HBV reactivation should not be overstated. Financial support. This work was supported by Gilead Sciences. Potential conflicts of interest. M. S. S. has received research grants from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck, and personal fees from AbbVie, Gilead, Janssen, Cocrystal, Merck, and Trek. D. M. B. and J. C. Y. are employees of and hold stock interest in Gilead. E. J. G. has received research grants from Gilead Sciences; has served on advisory boards for AbbVie, Boehringer Ingelheim, Gilead Sciences, Janssen, Novartis, Roche, and Tibotec; and has served on the speaker’s bureaus for Gilead Sciences, Novartis, Roche, and Tibotec. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
DOI: 10.1093/cid/cix213
Language: French
Subfield: Hepatology
Field: Medicine
Open Access status: green
OpenAlex ID: W2607656085
Cites: 2
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Related to: 10