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. 2018 Sep;24(3):311-318.
doi: 10.3350/cmh.2017.0070. Epub 2018 Jun 4.

Efficacy and safety of sofosbuvir plus ribavirin for Korean patients with hepatitis C virus genotype 2 infection: A retrospective multi-institutional study

Young Min Kim  1 , Suk Bae Kim  1 , Il Han Song  1 , Sae Hwan Lee  2 , Hong Soo Kim  2 , Tae Hee Lee  3 , Young Woo Kang  3 , Seok Hyun Kim  4 , Byung Seok Lee  4 , Hee Bok Chae  5 , Myeong Jun Song  6 , Ji Woong Jang  7 , Soon Young Ko  8 , Jae Dong Lee  8
Affiliations

Efficacy and safety of sofosbuvir plus ribavirin for Korean patients with hepatitis C virus genotype 2 infection: A retrospective multi-institutional study

Young Min Kim et al. Clin Mol Hepatol. 2018 Sep.

Abstract

Background/aims: Sofosbuvir plus ribavirin is a standard treatment for patients infected with chronic hepatitis C virus (HCV) genotype 2 in Korea. The purpose of this study was to examine the efficacy and safety of this treatment in Korean patients with chronic HCV genotype 2 infection.

Methods: We retrospectively analyzed clinical data of patients treated with sofosbuvir plus ribavirin for chronic HCV genotype 2 from May 2016 to December 2017 at eight hospitals located in the Daejeon-Chungcheong area.

Results: A total of 172 patients were treated with sofosbuvir plus ribavirin. Of them, 163 patients completed the treatment, and 162 patients were tested for sustained virologic response 12 weeks after treatment discontinuation (SVR12). Mean age was 59.6±12.3 years (27-96), and 105 (64.4%) patients were female. Of the total patients, 49 (30.1%) were diagnosed with cirrhosis, and 31 of them were treated for 16 weeks. Sofosbuvir plus ribavirin was the first-line treatment for 144 (88.3%) patients. Eleven (6.7%) patients were intolerant to previous interferon-based treatment. Eight (5.0%) patients relapsed after interferon-based treatment. HCV RNA non-detection rate at 4, 8, and 12 weeks was 97.5%, 99.1%, and 99.3%, respectively, and SVR12 was 98.8% (161/163). During treatment, 18 (11.0%) patients had to reduce their administrated dose of ribavirin because of anemia. One patient stopped the treatment because of severe anemia. Other adverse events, including dizziness, indigestion, and headache, were found in 26 (16.0%) patients.

Conclusion: A 12-16 week treatment with sofosbuvir plus ribavirin is remarkably effective and well tolerated in Korean patients with chronic HCV genotype 2 infection.

Keywords: Hepatitis C virus; Korea; Ribavirin; Sofosbuvir.

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Conflict of interest statement

Conflict of Interest

SB Kim, SH Lee, BS Lee, JW Jang receives grants from Gilead Sciences. The other authors declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
Flow chart summarizing patient selection. Finally, 163 patients were enrolled and completed the treatment. Only 1 patient stopped the treatment due to severe anemia. SOF, sofosbuvir; RBV, ribavirin; SVR12, sustained virologic response at post-treatment week 12.
Figure 2.
Figure 2.
The changes of mean ALT level. After 4 weeks treatment, the mean ALT level was returned to normal range. After the treatment was complete, the lowest levels of ALT were observed. ALT, alanine aminotransferase.
Figure 3.
Figure 3.
The ALT normalization rate. We analyzed 69 patients who showed ALT level higher than 40 IU/L to determine the ALT normalization rate. ALT, alanine aminotransferase.
Figure 4.
Figure 4.
Virologic response at 4, 8, and 12 weeks and SVR12 in 163 patients enrolled in the present study. Two patients failed to achieve the SVR12. SVR12, sustained virologic response 12 weeks after t reatment discontinuation.
Figure 5.
Figure 5.
SVR12 according to baseline age, sex, presence of cirrhosis, treatment history, pretreatment HCV RNA level, and RBV dose reduction in 163 patients. There was no significant difference between groups. SVR12, sustained virologic response 12 weeks after t reatment discontinuation; HCV, hepatitis C virus; RBV, ribavirin.
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