Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open‐label, phase 3 trial

Abstract

SUMMARY. Genotype 2 hepatitis C virus (HCV) accounts for up to 30% of chronic HCV infections in Japan. The standard of care for patients with genotype 2 HCV -peginterferon and ribavirin for 24 weeks -is poorly tolerated, especially among older patients and those with advanced liver disease. We conducted a phase 3, open-label study to assess the efficacy and safety of an all-oral combination of the NS5B polymerase inhibitor sofosbuvir and ribavirin in patients with chronic genotype 2 HCV infection in Japan. We enrolled 90 treatment-na€ ıve and 63 previously treated patients at 20 sites in Japan. All patients received sofosbuvir 400 mg plus ribavirin (weight-based dosing) for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after therapy (SVR12). Of the 153 patients enrolled and treated, 60% had HCV genotype 2a, 11% had cirrhosis, and 22% were over the aged 65 or older. Overall, 148 patients (97%) achieved SVR12. Of the 90 treatment-na€ ıve patients, 88 (98%) achieved SVR12, and of the 63 previously treated patients, 60 (95%) achieved SVR12. The rate of SVR12 was 94% in patients with cirrhosis and in those aged 65 and older. No patients discontinued study treatment due to adverse events. The most common adverse events were nasopharyngitis, anaemia and headache. Twelve weeks of sofosbuvir and ribavirin resulted in high rates of SVR12 in treatment-na€ ıve and previously treated patients with chronic genotype 2 HCV infection. The treatment was safe and well tolerated by patients, including the elderly and those with cirrhosis.

Nutritional status and liver steatosis after direct-acting antiviral treatment for chronic hepatitis C virus infection

“…The frequency of anemia was 27% in the patients over 65 years old, and the decrease in hemoglobin (Hb) level was -1.7 g/dL. When Hb level decreases, appropriate adjustment of RBV dosage is necessary [21]. The -1.7 g/dL reduction in Hb level at EOT in this study was similar to a previous report [21].…”

“…When Hb level decreases, appropriate adjustment of RBV dosage is necessary [21]. The -1.7 g/dL reduction in Hb level at EOT in this study was similar to a previous report [21]. There were no serious side effects, and no patient dropouts throughout the duration of DAA treatment.…”

Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C

“…Several phase 3 studies have revealed that these DAA-based therapies have led to significant improvements in the SVR rates and safety [12][13][14]. However, there is no established DAA therapy for dialysis patients with an HCV infection.…”

Sequencing Analysis of NS3/4A, NS5A, and NS5B Genes from Patients Infected with Hepatitis C Virus Genotypes 5 and 6

“…With the recent approval of HCV direct-acting antivirals (DAAs) active against multiple genotypes, such as Sovaldi (sofosbuvir), Harvoni (ledipasvir and sofosbuvir), and Daklinza (daclatasvir), there is an increased need to monitor the efficacy of pan-genotypic regimens and resistance-associated variants (RAVs) that may be present at baseline and posttreatment (14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). However, compared to HCV genotype 1, genotypes 5 and 6 are not well-studied.…”