Two direct-acting antiviral (DAA) regimens — sofosbuvir/velpatasvir (SOF/VEL) and gelcaprevir/pibrentasvir (GLE/PIB) — had favorable outcomes and were safe for the treatment of hepatitis C virus genotype 6 (HCV-6) infection. These findings were published in the Journal of the Formosan Medical Association.
Between 2019 and 2020, researchers in Taiwan conducted a study among patients (N=286) with HCV-6 to assess the safety and effectiveness of DAA treatment with either SOF/VEL or GLE/PIB. Included patients received either a 12-week course of SOF/VEL (n=161) or an 8-week course of GLE/PIB (n=125). The primary endpoint was the number of patients who achieved a sustained virologic response (SVR) after a follow-up period of 12 weeks.
Among patients in the SOF/VEL and GLE/PIB cohorts, the median age was 57.85 (range, 18-91) and 56.99 (range, 25-86) years, 95 and 80 patients were men, HCV RNA viral loads were 6.13 (range, 2.85-7.91) and 5.95 (range, 2.04-8.08) log10 IU/mL, and 98.1% and 97.6% were treatment naive, respectively. The most common comorbidities were diabetes in 23.1% of patients, hypertension in 29.4%, and coronary artery disease in 5.9%. At baseline, kidney function was worse among patients in the GLE/PIB cohort, with stage III to V chronic kidney disease (CKD) observed in 25.6% compared with 7.45% among those in the SOF/VEL cohort.
Results of the intention-to-treat analysis showed that SVRs were achieved by all but 1 patient in the SOF/VEL and 100% of those in the GLE/PIB cohort. Of note, the patient in the SOF/VEL cohort who did not achieve SVR had died during treatment.
Between baseline and the end of treatment, significant decreases in g-glutamyltransferase (P <.01), fibrosis-4 (FIB-4) scores (P <.01), and concentrations of high-density lipoprotein cholesterol (HDL-C; P <.01) and albumin (P <.05) were observed among the patient cohorts. Further analysis of this period showed that platelet count (P <.01), cholesterol (P <.01), low-density lipoprotein cholesterol (P <.01), and triglycerides (P <.05) had significantly increased.
Laboratory results obtained at SVR achievement showed significant decreases in g-glutamyltransferase (P <.01), FIB-4 scores (P <.01), total bilirubin (P <.05), a-fetoprotein (P <.05), and glycated hemoglobin (P <.05) among all patients. The researchers also observed increases in albumin (P <.01), platelet count (P <.01), cholesterol (P <.01), and HDL-C (P <.05) at SVR achievement compared with baseline.
After stratification of patients in the SOF/VEL cohort by baseline CKD stage,, patients with stage I CKD had significantly decreased estimated glomerular filtration rates (eGFRs) at the end of the 12week follow-up period (P <.0001). No other significant changes in eGFR were observed.
A total of 46 patients experienced an adverse event (AE). The most common AEs were pruritis (6.64%), followed by poor sleep quality (1.75%), malaise (1.75%), epigastralgia (1.40%), and diarrhea (1.40%). Adverse increases in bilirubin and alanine aminotransferase concentrations (£7.45%) also were observed, but all were of grades 1 or 2 severity.
This study may have been limited by its small sample size and cohort imbalances.
“The high [rate] of SVR and excellent safety of SOF/VEL and GLE/PIB in [a] real-world settings reveals that [these] 2 DAA regimens are favorable options for the treatment of [HCV-6],” the researchers concluded.
Ghen J-J, Chiu Y-C, Lee P-L, et al. Real-world effectiveness and safety of sofosbuvir/velpatasvir and glecaprevir/pibrentasvir for genotype 6 chronic hepatitis C. J Formos Med Assoc. 2022;S0929-6646(22)00185-1. doi:10.1016/j.jfma.2022.04.020