Taiwan HCV registry: Pangenotypic DAAs effective, well tolerated

Pangenotypic direct-acting antiviral (DAA) regimens, including sofosbuvir/velpatasvir (SOF/VEL), are generally effective and well tolerated in patients with hepatitis C virus (HCV) infection who fulfil guideline-recommended criteria for simplified treatment, according to data from Taiwan’s nationwide HCV registry presented at the Asian Pacific Association for the Study of the Liver (APASL) 2023 Annual Meeting.

In the real-world retrospective-prospective study, researchers screened 10,641 HCV-infected patients registered in Taiwan’s HCV registry between August 2019 and August 2021. A total of 7,677 patients who had received ≥1 dose of SOF/VEL or glecaprevir/pibrentasvir (GLE/PIB) and fulfilled the European Association for the Study of the Liver (EASL) or American Association for the Study of Liver Diseases (AASLD)–Infectious Diseases Society of America (IDSA) criteria for simplified HCV treatment were identified for analysis of treatment efficacy and incidence of laboratory abnormalities in alanine transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin (BIL[T]) during and at 3 months after treatment. Risk factors associated with liver function abnormalities in these patients were also analyzed. [Yu ML, et al, APASL 2023, abstract PPD-085]

“Overall, 92.8 percent [n=7,128] of patients had sustained virological response [SVR],” the researchers reported.

Rates of laboratory abnormalities in ALT/AST/BIL(T) were low. AST/ALT elevation of grade 2 occurred in 0.2 percent of patients on SOF/VEL and 0.2 percent of those on GLE/PIB (p=nonsignificant), while grade 3–4 events occurred in 0.1 percent and 0.2 percent of patients, respectively (p=nonsignificant). Grade 2 BIL(T) elevation was reported in 0.8 percent of patients on SOF/VEL and 3.1 percent of those on GLE/PIB (p<0.001), while grade 3–4 BIL(T) elevation was reported in 0 percent and 0.2 percent of patients (p=0.001), respectively. Two patients (SOF/VEL, n=1; GLE/PIB, n=1) who experienced grade 3–4 ALT/AST/BIL(T) abnormalities discontinued treatment.

On multivariate analysis, risk factors significantly associated with increased risks of ALT/AST/BIL(T) abnormalities were BIL(T) >1.2 mg/dL (vs ≤1.2 mg/dL; odds ratio [OR], 4.8; 95 percent confidence interval [CI], 3.3–7.0; p<0.01), GLE/PIB use (vs SOF/VEL use; OR, 4.8; 95 percent CI, 3.3–6.8; p<0.01), hepatocellular carcinoma (HCC) (vs no HCC; OR, 2.6; 95 percent CI, 1.5–4.5; p<0.01), Fibrosis-4 score >3.25 (vs ≤3.25; OR, 1.8; 95 percent CI, 1.3–2.7; p<0.01), age >70 years (vs ≤70 years; OR, 1.6; 95 percent CI, 1.1–2.4; p=0.01), and estimated glomerular filtration rate (by Modification of Diet in Renal Disease equation) <60 mL/min/1.73 m² (vs ≥60 mL/min/1.73 m²; OR, 1.6; 95 percent CI, 1.0–2.4; p=0.03) .

“Real-world data confirmed that pangenotypic SOF/VEL and GLE/PIB are generally effective and well tolerated in HCV patients who fulfil the EASL or AASLD-ISDA criteria for simplified treatment. However, special attention may be needed for some patients who are at higher risks of developing liver function abnormalities,” the researchers concluded.