Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment
Journal
Clinical Infectious Diseases
Journal Volume
75
Journal Issue
3
Pages
453
Date Issued
2022-08-01
Author(s)
Sheen, I. Shyan
Chen, Chi Yi
Chuang, Wan Long
Wang, Horng Yuan
Tseng, Kuo Chih
Chang, Ting Tsung
Yang, Jenny
Massetto, Benedetta
Suri, Vithika
Camus, Gregory
Jiang, Deyuan
Zhang, Fangqiu
Gaggar, Anuj
Hu, Tsung Hui
Hsu, Yu Chun
Lo, Gin Ho
Chu, Chi Jen
Chen, Jyh Jou
Peng, Cheng Yuan
Chien, Rong Nan
Abstract
Background: For patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV), HCV treatment with direct-acting antivirals can lead to HBV reactivation. We evaluated HBV reactivation during ledipasvir/sofosbuvir treatment and 108-week follow-up. Methods: In Taiwan, 111 patients with HCV genotype 1 or 2 and HBV received ledipasvir/sofosbuvir (90mg/400mg) once daily for 12 weeks. HBV virologic reactivation was defined as postbaseline increase in HBV DNA from either less than the lower limit of quantification (LLOQ, 20 IU/mL) to equal to or more than LLOQ or equal to or more than LLOQ to >1 log10 IU/mL. HBV clinical reactivation was HBV virologic reactivation with alanine aminotransferase (ALT) >2× upper limit of normal. Factors associated with development of HBV virologic or clinical reactivation were evaluated with logistic regression analysis. Results: All patients (100%, 111/111) maintained HCV suppression through 108 weeks after treatment. HBV virologic reactivation occurred in 73% of patients (81/111). Clinical reactivation occurred in 9% (10/111). The majority of HBV virologic reactivations (86%, 70/81) occurred by follow-up week 12, whereas clinical reactivation was generally more delayed. Eight (7%, 8/111) initiated HBV therapy. In regression analyses, baseline HBV DNA and hepatitis B surface antigen (HBsAg) levels were associated with HBV virologic reactivation and baseline ALT and HBV DNA, and HBsAg levels were associated with HBV clinical reactivation. Conclusion: Among HCV/HBV coinfected patients treated with direct-acting antivirals for HCV, HBV virologic reactivation occurred in a majority of patients during treatment and follow-up. In most patients, HBV virologic reactivation was asymptomatic; only a small proportion initiated HBV treatment. Notably, clinical reactivation may still occur >3 months after end of therapy. Clinical Trials Registration: NCT02613871.
Subjects
alanine aminotransferase | coinfection | hepatitis B surface antigen | reactivation
Publisher
OXFORD UNIV PRESS INC
Type
journal article