In this real‑world multicenter study (Wenzhou, China), 113 chronic hepatitis C patients received colbopasvir (60 mg) + sofosbuvir (400 mg) daily for 12 weeks. Overall SVR12 was 99.1% (112/113). SVR12 was 100% for genotypes 3a, 3b, 6a, and compensated cirrhosis, 93.3% for genotype 1b, and 90% for HBV co‑infection. Liver function (ALBI) and fibrosis scores (FIB‑4, APRI) significantly improved. No serious adverse events occurred. The colbopasvir + sofosbuvir regimen showed excellent effectiveness and safety across diverse genotypes (including difficult‑to‑treat genotype 3b) and comorbidities.
Introduction
Chronic HCV is a major cause of cirrhosis and HCC in China. Genotype 3b is less responsive to some DAAs. Colbopasvir is a pan‑genotypic NS5A inhibitor approved with sofosbuvir in China. Real‑world data from Eastern China are needed.
Methods
Retrospective study at three centers (June 2023 – October 2024). Patients received colbopasvir (60 mg) + sofosbuvir (400 mg) for 12 weeks; ribavirin was added for genotype 3 or cirrhosis. Primary endpoint: SVR12 (HCV RNA <15 IU/mL).
Results
Patients (N=113): median age 46 years, 84% male. Genotypes: 3 (58%; 3a 31%, 3b 27%), 6 (20%), 1b (13%). Cirrhosis 15%, HBV co‑infection 9%, HIV 1%.
SVR12 rates: Overall 99.1% (112/113). 100% for genotypes 3a (35/35), 3b (30/30), 6a (23/23), compensated cirrhosis (17/17), HCC (1/1), hypertension (10/10), diabetes (19/19). 93.3% for genotype 1b (14/15). 90% for HBV co‑infection (9/10).
Improvements: ALBI, FIB‑4, and APRI significantly decreased from baseline to EOT and SVR12 (all p<0.05).
Safety: No serious AEs; no discontinuations due to AEs. Common AEs: headache, nausea, fatigue.
One failure: Genotype 1b + HBV co‑infection did not achieve SVR12.
Discussion
This real‑world study confirms high efficacy (99.1% SVR12) of colbopasvir + sofosbuvir, including 100% in 30 genotype 3b patients – higher than reported for sofosbuvir/velpatasvir (76%). The regimen also improved liver function and fibrosis markers. Limitations: retrospective design, small HBV/HIV subgroups, no decompensated cirrhosis, limited long‑term follow‑up.
Conclusions
Colbopasvir plus sofosbuvir is highly effective and safe for chronic HCV in Eastern China, including genotype 3b and patients with compensated cirrhosis or HBV co‑infection. It is a valuable option for HCV elimination.
Full text
https://www.xiahepublishing.com/2310-8819/JCTH-2025-00673
The study was recently published in the Journal of Clinical and Translational Hepatology .
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