J Korean Med Sci.  2021 May;36(21):e142. 10.3346/jkms.2021.36.e142.

Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study

• Kang YW
• Baek YH
• Lee SW
• Park SJ
• Yoon JS
• Yoon KT
• Hong Y
• Heo NY
• Seo KI
• Lee SS
• Cho HC
• Shin JW

• KMID: 2516253
• DOI: http://doi.org/10.3346/jkms.2021.36.e142

Abstract

Background
The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimens for the treatment of patients with chronic HCV genotype 2.
Methods
We retrospectively analyzed the clinical data of patients treated with sofosbuvir plus ribavirin (SOF + RBV) or glecaprevir/pibrentasvir (G/P) for chronic HCV genotype 2 infection at seven university hospitals in the Korean southeast region.
Results
SOF + RBV therapy produced an 89% and 98.3% sustained virologic response 12 week (SVR12) after treatment completion in the full analysis set and per-protocol set, respectively, and the corresponding values for G/P therapy were 89.5% and 99.2%, respectively. The difference between the treatments was probably because 6.2% (59/953) of patients in the SOF + RBV group did not complete the treatment and 9.8% (14/143) in the G/P group did not test HCV RNA after treatment completion. Adverse events (A/Es) were reported in 59.7% (569/953) and 25.9% (37/143) of the SOF + RBV and G/P groups, respectively. In the SOF + RBV group, 12 (1.26%) patients discontinued treatment owing to A/Es, whereas no patients discontinued treatment because of A/Es in the G/P group.
Conclusion
In both treatment groups, SVR was high when treatment was completed. However, there was a high dropout rate in the SOF + RBV group, and the dropout analysis showed that these were patients with liver cirrhosis (LC; 43/285, 15.1%), especially those with decompensated LC (12/32, 37.5%). Therefore, an early initiation of antiviral therapy is recommended for a successful outcome before liver function declines. Furthermore, patients with decompensated LC who are considered candidates for SOF + RBV treatment should be carefully monitored to ensure that their treatment is completed, especially those with low hemoglobin and high alanine transaminase.

Keyword

Chronic Hepatitis C; Direct-acting Antiviral; Effectiveness; Safety

Figure

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  Fig. 1 Flow chart of patient enrollment.HCV = hepatitis C virus, SOF = sofosbuvir, RBV = ribavirin, G/P = glecaprevir/pibrentasvir, SVR = sustained virologic response.

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  Fig. 2 (A) SVR in patients with or without LC including decompensated LC. (B) SVR in patients with LC according to the CTP stage.SVR = sustained virologic response, LC = liver cirrhosis, CTP = Child-Turcotte-Pugh, FAS = full analysis set, PPS = per-protocol set, SOF = sofosbuvir, RBV = ribavirin.

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