Sustained virologic response at 12 weeks was achieved by sofosbuvir/velpatasvir dual therapy among most study patients with hepatitis C virus (HCV) infection, irrespective of cirrhosis status. These findings were published in BMC Gastroenterology.
Patients with HCV infection were recruited starting in 2017 for a nationwide program in Taiwan that aimed to eliminate HCV by 2025. This study analyzed data from patients (N=823) treated between June 2019 and September 2020 at Chang Gung Memorial Hospital. Patients were given fixed-dose combination treatment with sofosbuvir/velpatasvir for 12 weeks; a supplement of ribavirin was added for patients with a history of decompensation.
Stratified by fibrosis scores, 635 patients did not have fibrosis and 188 did: mean age was 61.87±14.33 and 70.53±12.75 years (P <.001), 48.66% and 52.66% were men, and 95.28% and 96.28% were treatment naive, respectively. Indicators of liver function were significantly worse among the subset with fibrosis, and there was no evidence of renal dysfunction or hepatitis B coinfection among the cohorts.
HCV genotypes included genotype 2 (49.09%), 1b (39.61%), mixed (4.98%), and 1a (3.28%).
In the evaluable population and per-protocol analyses, sustained virologic response at 12 weeks was observed among 93.4% and 99.2% of the nonfibrosis and 91.5% and 100% of the fibrosis cohorts, respectively.
Among the patients, 2 experienced relapse and 3 did not have a response. Among the 5 patients who did not have clinical success, no demographic or clinical trends were observed. No patient with relapse or nonresponse had evidence of fibrosis.
The fibrosis cohort had increased bilirubin (11.2% vs 0.9%; P <.001) and aspartate aminotransferase (4.3% vs 0.5%; P <.001) levels. Total adverse events did not differ significantly between cohorts (15% vs 12.1%; P =.38).
A total of 6 deaths occurred during the study period and were attributed to hepatic encephalopathy, spontaneous bacterial peritonitis, pneumonia and septic shock, acute respiratory failure and cardiac arrest, suspected acute myocardial infarction, and pneumonia or lung malignancy. No death was considered due to sofosbuvir/velpatasvir therapy.
This study may have included some referral bias because all patients were treated at a single center.
Based on these data, the investigators concluded that sofosbuvir/velpatasvir was effective and well tolerated among patients with HCV infection regardless of cirrhosis status.
Huang YT, Hsieh YY, Chen WM, et al. Sofosbuvir/velpatasvir is an effective treatment for patients with hepatitis C and advanced fibrosis or cirrhosis in a real‑world setting in Taiwan. BMC Gastroenterol. 2021;21(1):259. doi:10.1186/s12876-021-01837-y