Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment

Chun Jen Liu; I. Shyan Sheen; Chi Yi Chen; Wan Long Chuang; Horng Yuan Wang; Kuo Chih Tseng; Ting Tsung Chang; Jenny Yang; Benedetta Massetto; Vithika Suri; Gregory Camus; Deyuan Jiang; Fangqiu Zhang; Anuj Gaggar; Tsung Hui Hu; Yu Chun Hsu; Gin Ho Lo; Chi Jen Chu; Jyh Jou Chen; Cheng Yuan Peng; Rong Nan Chien; Pei Jer Chen

doi:10.1093/cid/ciab971

Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment

Chun Jen Liu, I. Shyan Sheen, Chi Yi Chen, Wan Long Chuang, Horng Yuan Wang, Kuo Chih Tseng, Ting Tsung Chang, Jenny Yang, Benedetta Massetto, Vithika Suri, Gregory Camus, Deyuan Jiang, Fangqiu Zhang, Anuj Gaggar, Tsung Hui Hu, Yu Chun Hsu, Gin Ho Lo, Chi Jen Chu, Jyh Jou Chen, Cheng Yuan PengRong Nan Chien, Pei Jer Chen

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

7 Citations (Scopus)

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.

Original language	English
Pages (from-to)	453-459
Number of pages	7
Journal	Clinical Infectious Diseases
Volume	75
Issue number	3
DOIs	https://doi.org/10.1093/cid/ciab971
Publication status	Published - 2022 Aug 1

All Science Journal Classification (ASJC) codes

Microbiology (medical)
Infectious Diseases

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10.1093/cid/ciab971

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Liu, C. J., Sheen, I. S., Chen, C. Y., Chuang, W. L., Wang, H. Y., Tseng, K. C., Chang, T. T., Yang, J., Massetto, B., Suri, V., Camus, G., Jiang, D., Zhang, F., Gaggar, A., Hu, T. H., Hsu, Y. C., Lo, G. H., Chu, C. J., Chen, J. J., ... Chen, P. J. (2022). Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment. Clinical Infectious Diseases, 75(3), 453-459. https://doi.org/10.1093/cid/ciab971

@article{d07a4d1b5fc04fad89bb55b8f4bceed6,

title = "Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment",

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.",

author = "Liu, {Chun Jen} and Sheen, {I. Shyan} and Chen, {Chi Yi} and Chuang, {Wan Long} and Wang, {Horng Yuan} and Tseng, {Kuo Chih} and Chang, {Ting Tsung} and Jenny Yang and Benedetta Massetto and Vithika Suri and Gregory Camus and Deyuan Jiang and Fangqiu Zhang and Anuj Gaggar and Hu, {Tsung Hui} and Hsu, {Yu Chun} and Lo, {Gin Ho} and Chu, {Chi Jen} and Chen, {Jyh Jou} and Peng, {Cheng Yuan} and Chien, {Rong Nan} and Chen, {Pei Jer}",

note = "Publisher Copyright: {\textcopyright} 2021 The Author(s). Published by Oxford University Press for the Infectious Diseases Society of America.",

year = "2022",

month = aug,

day = "1",

doi = "10.1093/cid/ciab971",

language = "English",

volume = "75",

pages = "453--459",

journal = "Clinical Infectious Diseases",

issn = "1058-4838",

publisher = "Oxford University Press",

number = "3",

}

Liu, CJ, Sheen, IS, Chen, CY, Chuang, WL, Wang, HY, Tseng, KC, Chang, TT, Yang, J, Massetto, B, Suri, V, Camus, G, Jiang, D, Zhang, F, Gaggar, A, Hu, TH, Hsu, YC, Lo, GH, Chu, CJ, Chen, JJ, Peng, CY, Chien, RN & Chen, PJ 2022, 'Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment', Clinical Infectious Diseases, vol. 75, no. 3, pp. 453-459. https://doi.org/10.1093/cid/ciab971

TY - JOUR

T1 - Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan

T2 - Follow-up at 108 Weeks Posttreatment

AU - Liu, Chun Jen

AU - Sheen, I. Shyan

AU - Chen, Chi Yi

AU - Chuang, Wan Long

AU - Wang, Horng Yuan

AU - Tseng, Kuo Chih

AU - Chang, Ting Tsung

AU - Yang, Jenny

AU - Massetto, Benedetta

AU - Suri, Vithika

AU - Camus, Gregory

AU - Jiang, Deyuan

AU - Zhang, Fangqiu

AU - Gaggar, Anuj

AU - Hu, Tsung Hui

AU - Hsu, Yu Chun

AU - Lo, Gin Ho

AU - Chu, Chi Jen

AU - Chen, Jyh Jou

AU - Peng, Cheng Yuan

AU - Chien, Rong Nan

AU - Chen, Pei Jer

PY - 2022/8/1

Y1 - 2022/8/1

N2 - 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.

AB - 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.

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U2 - 10.1093/cid/ciab971

DO - 10.1093/cid/ciab971

M3 - Article

C2 - 34864948

AN - SCOPUS:85123375366

SN - 1058-4838

VL - 75

SP - 453

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JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

IS - 3

ER -

Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment

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