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Observational Study
. 2018 Sep 12;8(1):13699.
doi: 10.1038/s41598-018-32060-7.

Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study

Chen-Hua Liu  1   2   3 , Yi-Jie Huang  4 , Sien-Sing Yang  5   6 , Chung-Hsin Chang  4 , Sheng-Shun Yang  4   7   8 , Hsin-Yun Sun  1 , Chun-Jen Liu  1   2   9 , Wen-Chun Liu  1 , Tung-Hung Su  1   2 , Hung-Chih Yang  1   2   10 , Chun-Ming Hong  11 , Tai-Chung Tseng  1   2 , Pei-Jer Chen  1   2   9 , Ding-Shinn Chen  1   2   12 , Chien-Ching Hung  1   13   14 , Jia-Horng Kao  15   16   17
Affiliations
Observational Study

Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study

Chen-Hua Liu et al. Sci Rep. .

Abstract

Real-world data regarding the effectiveness and safety of generic sofosbuvir (SOF)-based interferon-free direct acting antiviral agents (DAAs) for patients with chronic hepatitis C virus (HCV) infection remain limited. A total of 517 chronic HCV-infected patients receiving 12 or 24 weeks of SOF-based therapies were retrospectively enrolled in 4 academic centers in Taiwan. The rate of sustained virologic response at week 12 off-therapy (SVR12) and that of treatment completion were assessed. The baseline characteristics and on-treatment HCV viral kinetics to predict SVR12 were analyzed. By evaluable population (EP) analysis, the SVR12 rate was 95.4% (95% confidence interval [CI]: 93.2-96.9%). The SVR12 was achieved in 29 of 34 patients (85.3%, 95% CI: 69.6-93.6%), 130 of 139 patients (93.5%, 95% CI: 88.2-96.6%), 119 of 124 patients (96.0%, 95% CI: 90.9-98.3%) and 215 of 220 patients (97.7%, 95% CI: 94.8-99.0%) who received SOF in combination with ribavirin (RBV), ledipasvir (LDV), daclatasvir (DCV) and velpatasvir (VEL), respectively. Of 517 patients, 514 (99.4%) completed the scheduled treatment. All 15 patients with true virologic failures were relapsers. Two decompensated cirrhotic patients had on-treatment deaths which were not related to DAAs. All 7 patients who were lost to follow-up had undetectable HCV RNA level at the last visit. The SVR12 rates were comparable in terms of baseline patient characteristics and viral decline at week 4 of treatment. In conclusion, generic SOF-based regimens are well tolerated and provide high SVR12 rates in patients with chronic HCV infection.

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Conflict of interest statement

Chen-Hua Liu: advisory board for Abbvie, Gilead Science, Merck Sharp & Dohme; speaker’s bureau for Abbott, Abbvie, Gilead Science, Merck Sharp & Dohme; research grant from Abbvie, Gilead Science, Merck Sharp & Dohme. Jia- Horng Kao: advisory board for Abbott, Abbvie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; speaker’s bureau for Abbott, Abbvie, Bayer, Bristol-Myers Squibb, Gilead Science, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; Ding-Shinn Chen: advisory board for Abbvie, Gilead Science, GlaxoSmithKline, Merck Sharp & Dohme, Novartis; Pei-Jer Chen: advisory board for Abbvie, Novartis, Roche; Chien-Ching Hung: advisory boards for Abbvie, Gilead Sciences, Janssen, ViiV;. Speaker’s bureau for Abbvie, Bristol-Myers Squibb, Gilead Sciences, ViiV; research grant from Gilead Sciences, Janssen, Merck, ViiV. All other authors declare no competing interests.

Figures

Figure 1
Figure 1
Study flow.
Figure 2
Figure 2
(A) Child-Pugh class shift in cirrhotic patients with baseline Child-Pugh B and C, (B) Changes of MELD scores from baseline. *Two patients who died during treatment were excluded from the analysis. MELD: model for end-stage liver disease.
See this image and copyright information in PMC

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