Objectives-Antibodies against Clq (CIqAb)

Background/Aims: Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited. Methods:We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR 12 ) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. The safety profiles were reported.Results: The SVR 12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval (CI): 82.5%-94.2%), 94.1% (95% CI: 87.8%-97.3%), and 100% (96 of 96 patients; 95% CI: 96.2%-100%). No patients who failed to achieve SVR 12 were attributed to virologic failures. The SVR 12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs).Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR 12 , 84.4% and 64.6% had improved Child-Pugh and Model for End-Stage Liver Disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥ 15 was associated with an improved MELD score of ≥ 3 (odds ratio (OR): 4.13, 95% CI: 1.16-14.71; p = 0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate (eGFR) declines than patients with CKD stage 2 (-0.42 mL/min/1.73m 2 /month; p = 0.01) or stage 3 (-0.56 mL/min/1.73m 2 /month; p < 0.001). 8Conclusions: SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.

BackgroundReal-world data are scarce about the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for retreating East Asian patients with hepatitis C virus (HCV) infection who previously received NS5A direct-acting antivirals (DAAs). We conducted a multicenter study to assess the performance of SOF/VEL/VOX in patients who were not responsive to prior NS5A inhibitors in Taiwan. MethodsBetween September 2021 and May 2022, 107 patients who failed NS5A inhibitor-containing DAAs with SOF/VEL/VOX salvage therapy for 12 weeks were included at 16 academic centers. The sustained virologic response at off-treatment week 12 (SVR 12 ) was assessed in the evaluable (EP) and per-protocol (PP) populations. The safety pro les were also reported. ResultsAll patients completed 12 weeks of treatment and achieved an end-of-treatment virologic response. The SVR 12 rates were 97.2% (95% con dence interval (CI): 92.1%-99.0%) and 100% (95% CI: 96.4%-100%) in EP and PP populations. Three (2.8%) patients were lost to off-treatment follow-up and did not meet SVR 12 in the EP population. No baseline factors predicted SVR 12 . Two (1.9%) not-fatal serious adverse events (AE) occurred, but unrelated to SOF/VEL/VOX. Sixteen (15.0%) had grade 2 total bilirubin elevation, and three (2.8%) had grade 2 alanine transaminase (ALT) elevation. Thirteen (81.3%) of the 16 patients with grade 2 total bilirubin elevation had unconjugated hyperbilirubinemia. The estimated glomerular ltration rates (eGFR) were comparable between baseline and SVR 12 , regardless of baseline renal reserve. ConclusionsSOF/VEL/VOX is highly e cacious and well-tolerated for East Asian HCV patients previously treated with NS5A inhibitor-containing DAAs.

Background Real-world data are scarce about the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for retreating East Asian patients with hepatitis C virus (HCV) infection who previously received NS5A direct-acting antivirals (DAAs). We conducted a multicenter study to assess the performance of SOF/VEL/VOX in patients who were not responsive to prior NS5A inhibitors in Taiwan. Methods Between September 2021 and May 2022, 107 patients who failed NS5A inhibitor-containing DAAs with SOF/VEL/VOX salvage therapy for 12 weeks were included at 16 academic centers. The sustained virologic response at off-treatment week 12 (SVR12) was assessed in the evaluable (EP) and per-protocol (PP) populations. The safety profiles were also reported. Results All patients completed 12 weeks of treatment and achieved an end-of-treatment virologic response. The SVR12 rates were 97.2% (95% confidence interval (CI): 92.1%-99.0%) and 100% (95% CI: 96.4%-100%) in EP and PP populations. Three (2.8%) patients were lost to off-treatment follow-up and did not meet SVR12 in the EP population. No baseline factors predicted SVR12. Two (1.9%) not-fatal serious adverse events (AE) occurred, but unrelated to SOF/VEL/VOX. Sixteen (15.0%) had grade 2 total bilirubin elevation, and three (2.8%) had grade 2 alanine transaminase (ALT) elevation. Thirteen (81.3%) of the 16 patients with grade 2 total bilirubin elevation had unconjugated hyperbilirubinemia. The estimated glomerular filtration rates (eGFR) were comparable between baseline and SVR12, regardless of baseline renal reserve. Conclusions SOF/VEL/VOX is highly efficacious and well-tolerated for East Asian HCV patients previously treated with NS5A inhibitor-containing DAAs.