The predictors of sustained virological response with sofosbuvir and ribavirin in patients with chronic hepatitis C genotype 2

Abstract

Background/Aims: Real-world, clinical practice data are lacking about sofosbuvir/ ribavirin (SOF/RBV) treatment of Korean patients with hepatitis C virus genotype 2 (HCV GT2) infection. This study investigated the efficacy and safety of SOF/RBV in Korean patients with HCV GT2 infection and clinical factors predicting sustained virological response 12 weeks (SVR12) after the end of SOF/RBV treatment. Methods: A total of 181 patients with HCV GT2 with/without cirrhosis were treated with SOF/RBV for 16/12 weeks. Rapid virological response (RVR) was defined as non-detectable HCV RNA at 4 weeks. Results: The RVR rate was 80.7% (146/181), the end of treatment response rate was 97.8% (177/181) and the SVR12 rate was 92.8% (168/181). Of eight patients with relapse, four did not achieve RVR. Three patients had a history of hepatocellular carcinoma (HCC). Multivariable analysis showed that RVR (p = 0.015) and no previous history of HCC (p = 0.007) were associated with SVR12. Factors significantly contributing to RVR included cirrhosis, creatinine concentration, and pre-treatment HCV RNA level. SVR12 rate was significantly higher in RVR (+) than RVR (-) patients (95.2% vs. 82.9%, p = 0.011) and also significantly higher in patients without than with a history of HCC (94.1% vs. 72.7%, p = 0.008). During treatment, 80/181 patients (44.2%) experienced mild to moderate adverse events, with 32 (17.7%) requiring RBV dose reductions due to anemia. Conclusions: SOF/RBV treatment was effective and tolerable in HCV GT2 patients. RVR and no previous history of HCC were positive predictors of SVR12.

Real-Life Effectiveness and Safety of Glecaprevir/Pibrentasvir for Korean Patients with Chronic Hepatitis C at a Single Institution

“…Therefore, high viral load at baseline and slow change of viral load during treatment seem to be associated with treatment failure. However, in contrast to our observations, a previous study 18 reported that SVR12 was independent of previous HCV treatment, HCV viral load at baseline, and on-treatment viral kinetics in groups that received treatment for different durations. These researchers attributed this result to a high genetic barrier to resistance.…”

“…The SOF plus ribavirin regimen had an SVR12 of about 90 to 95%, was associated with adverse events (AEs) and discontinuation due to ribavirin, and could not be administered to individuals who had chronic kidney disease (CKD). [16][17][18] Notably, the G/ P regimen provides a high virologic response, less than 0.1% of patients permanently discontinued treatment because of adverse reactions, and CKD patients, even those undergoing dialysis, can use the G/P regimen. 6 Although the G/P regimen had excellent efficacy and safety in trials, there are limited data regarding the efficacy of the G/P regimen in the treatment of Korean patients in non-clinical trial settings.…”

Real‐world effectiveness of direct‐acting antiviral agents for chronic hepatitis C patients with genotype‐2 infection after completed treatment

“…Nevertheless, several Asian real‐world studies have investigated CHC GT‐2 patients receiving SOF + RBV. Han et al reported that rapid virologic response and no previous history of HCC were positive predictors 35 . Akahane et al showed that advanced fibrosis and IFN‐experience were negative predictors for SVR12 rates 36 .…”

“…The reimbursement of DAA therapy for CHC by the Taiwan NHI was initially limited in 2017 to 2018 to patients with advanced fibrosis, and SOF + RBV was the first DAA therapy approved for use in CHC GT-2 patients 34. In patients treated with SOF + RBV, the SVR rate of the cir-Han et al reported that rapid virologic response and no previous history of HCC were positive predictors 35. Akahane et al showed that advanced fibrosis and IFN-experience were negative predictors for SVR12 rates 36.…”

Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose

“…In any case, severe forms of anemia with consequent treatment discontinuations were reported only in a small proportion of patients. 10,[13][14][15][16] However, taking into consideration that anemia can represent a relevant problem especially for the most frail categories of subjects and that there are patients who are not eligible for RBV mostly due to baseline anemia, an alternative strategy to reducing RBV on treatment is represented by RBV-free DAA regimens, the first of which historically available was the association of SOF plus the NS5A inhibitor daclatasvir (DCV). This regimen is obviously burdened with fewer side effects, but the optimal duration of treatment in GT2 is still object of debate.…”