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Twelve-week ribavirin-free direct-acting antivirals for treatment-experienced Chinese with HCV genotype 1b infection including cirrhotic patients

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Abstract

Background

Treatment-experienced chronic hepatitis C (CHC) genotype (GT) 1b represents a major medical burden in China. We evaluate the efficacy, safety and cost-effectiveness of ribavirin (RBV)-free pan-oral direct-acting antivirals (DAAs) in treatment-experienced Chinese with GT1b CHC, including patients with cirrhosis.

Methods

One hundred forty treatment-experienced GT1b CHC Chinese with and without cirrhosis were included in this study. Ninety-four patients were treated with either daclatasvir (DCV, 60 mg)-sofosbuvir (SOF, 400 mg) (group 1, n = 46) or ledipasvir (LDV, 90 mg)-SOF (400 mg) (group 2, n = 48) for 12 weeks. Forty-six patients treated with pegylated interferon and RBV therapy for 72 weeks were enrolled as the control group (group 3). Patients were followed at 4-weekly intervals till 24 weeks after the end of treatment.

Results

All patients in group 1 (46/46, 100 %) and 2 (48/48, 100 %) had achieved sustained virologic response at 24 weeks after the end of treatment (SVR 24), which was significantly higher than that of group 3 (13/46, 28.3 %) (p < 0.001). The SVR 24 rates of cirrhotic patients in group 1 (27/27, 100 %) and 2 (27/27, 100 %) were also significantly higher than that of group 3 (3/25, 12 %) (p < 0.001). Twelve weeks of RBV-free LDV-SOF and DCV-SOF was either cost-saving or cost-effective. Adverse events were significantly lower in group 1 and 2 compared with group 3 (p < 0.001).

Conclusion

Compared with standard therapies, 12 weeks of RBV-free DAA therapies is highly effective, well tolerated and cost-effective in treatment-experienced Chinese with GT1b CHC including patients with cirrhosis.

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Abbreviations

AE:

Adverse event

AFP:

Alpha-fetoprotein

ALT:

Alanine aminotransferase

CI:

Confidence interval

CTP:

Child-Turcotte-Pugh

DAA:

Direct-acting antiviral

DCV:

Daclatasvir

GT:

Genotype

HCV:

Hepatitis C virus

HIV:

Human immunodeficiency virus

ICER:

Incremental cost-effectiveness ratio

kPa:

Kilopascal

LDV:

Ledipasvir

LLOQ:

Lower limit of quantification

LSM:

Liver stiffness measurement

NS:

Nonstructural

Peg-IFN:

Pegylated interferon

PR48 :

Pegylated interferon with ribavirin for 48 weeks

PR72:

Pegylated interferon with ribavirin for 72 weeks

QALY:

Quality-adjusted life years

RBV:

Ribavirin

SD:

Standard deviation

SNP:

Single nucleotide polymorphism

SOF:

Sofosbuvir

SVR:

Sustained virologic response

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Acknowledgements

We thank Shiying Ding, Ya Li, Qiaomin Wang and Huidan Cui for their excellent technical assistance.

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Authors and Affiliations

  1. Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing 302 Hospital, Beijing, China

    Dong Ji, Guo-Feng Chen, Qing Shao, Bing Li, Jia-Liang Liu, Xiao-Xia Niu & George Lau

  2. Liver Failure Treatment and Research Center, Beijing 302 Hospital, Beijing, China

    Dong Ji, Jun Zhao, Shao-Li You & Jin-Hua Hu

  3. Division of Gastroenterology and Hepatology, Humanity and Health Medical Centre, Hong Kong S.A.R., China

    Cheng Wang, Yu-Dong Wang, Jing Chen, Lei Lu, Vanessa Wu & George Lau

  4. State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China

    Cheng Wang

  5. Institute of Translational Hepatology, Beijing 302 Hospital, Beijing, China

    George Lau

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  1. Dong Ji
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Corresponding author

Correspondence to George Lau.

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Funding

This study was funded by the Chinese Medical Association Clinical Medicine Study Special Fund (No. 13071110496); Cheng Si-Yuan (China-International) Hepatitis Research Foundation, Hong Kong SAR; Humanity and Health Medical Group, Hong Kong SAR.

Conflict of interest

All authors have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Ji, D., Chen, GF., Wang, C. et al. Twelve-week ribavirin-free direct-acting antivirals for treatment-experienced Chinese with HCV genotype 1b infection including cirrhotic patients. Hepatol Int 10, 789–798 (2016). https://doi.org/10.1007/s12072-016-9755-0

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