Hepatitis C: SOF/VEL effective, well tolerated in Chinese PWID and CKD populations

Sofosbuvir/velpatasvir (SOF/VEL) treatment is effective and well tolerated in chronic hepatitis C (CHC) patients who inject drugs or have chronic kidney disease (CKD), according to two studies in China presented at the Asian Pacific Association for the Study of the Liver (APASL) 2023 Annual Meeting.

Study in PWID
The efficacy and safety of SOF/VEL with or without ribavirin was evaluated in hepatitis C virus (HCV)–positive people who inject drugs (PWID) taking opioid agonist therapy. The patients (n=260), enrolled between December 2021 and September 2022 in a methadone clinic in Southwest China, completed 12 weeks of HCV treatment. The most common HCV genotype was 3b (n=137; 41 percent), followed by 3a (n=87; 26 percent) and 6a (n=80; 24 percent). One patient (0.3 percent) was coinfected with hepatitis B virus (HBV), while two (0.6 percent) were coinfected with HIV. At baseline, 24 patients (7.2 percent) had fibrosis, 18 (5.4 percent) had cirrhosis, and one (0.3 percent) had liver cancer. [He Y, et al, APASL 2023, abstract EPD-098]

The primary endpoint of sustained virologic response at 12 weeks post-treatment (SVR12) was achieved in 145 patients (55.8 percent). However, HCV treatment was still ongoing in 22 patients.

Notably, SVR12 was achieved in 16 patients who missed HCV treatment for up to 15 days.

In the study, SOF/VEL was well tolerated, with no treatment discontinuation due to severe adverse events (AEs).

“PWID with HCV infection achieved high SVR12 with SOF/VEL with or without ribavirin, regardless of cirrhosis and HBV or HIV coinfection,” the investigators concluded. “SOF/VEL with or without ribavirin was effective and well tolerated in PWID on opioid agonist therapy. SVR12 was still achieved despite a short period of nonadherence during treatment.”

Study in CKD patients
The study in patients with comorbid CKD included 75 patients (mean age, 52 years; male, n=58 [77.3 percent]) treated between June 2018 and May 2022. The most common HCV genotype was 3b (n=37; 49.3 percent), followed by 3a (n=26; 34.7 percent). At baseline, most patients were in CKD stage 2 (n=52; 69.3 percent) or stage 3 (n=12; 16 percent). About half (n=36; 48 percent) of the patients had decompensated cirrhosis, while 20 percent (n=15) had compensated cirrhosis. [Yang Y, et al, APASL 2023, abstract EPD-094]

The patients were treated with SOF/VEL with or without ribavirin (dosage of ribavirin depended on body weight and renal function) for 12 weeks. The primary endpoint was change in renal function during treatment. SVR12 and AEs were also evaluated.

“Results showed that SOF/VEL with or without ribavirin was well tolerated and effective in CHC patients with CKD, regardless of CKD stage and cirrhosis status. Both renal function and liver function improved after treatment,” the researchers reported.

Mean estimated glomerular filtration rate (eGFR) numerically improved from 63.19 ± 3.01 mL/min/1.73 m² at baseline to 72.71 ± 4.73 mL/min/1.73 m² after treatment (p=0.078). Renal function improved in 32 patients (42.7 percent) and remained stable in 39 patients (52 percent).

At baseline, none of the patients were in CKD stage 1. After treatment, CKD improved to stage 1 in 16 patients (21.3 percent).

Alanine transaminase (ALT) levels decreased significantly from 51.36 ± 35.08 U/L at baseline to 25.30 ± 35.64 U/L after treatment (p<0.05), while aspartate aminotransferase (AST) levels decreased significantly from 58.10 ± 35.69 U/L to 42.70 ± 75.76 U/L (p<0.05).

Overall SVR12 rate was high, at 98.7 percent. SVR12 rate was 100 percent in patients with HCV genotype 3a, 97.3 percent in patients with HCV genotype 3b, and 100 percent in patients with other genotypes. All patients (n=15/15) with compensated cirrhosis and 97.2 percent (n=35/36) of those with decompensated cirrhosis achieved SVR12.

AEs were reported by 22 patients (29.3 percent) during treatment, but no serious AEs were reported.