Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis
1
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
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 (SVR12) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. The safety profiles were reported. Results: The SVR12 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% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR12 were attributed to virologic failures. The SVR12 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 SVR12, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 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 declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m2/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m2/month; P<0.001). Conclusions: SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.
Abstract
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 (SVR12) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. The safety profiles were reported. Results: The SVR12 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% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR12 were attributed to virologic failures. The SVR12 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 SVR12, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 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 declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m2/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m2/month; P<0.001). Conclusions: SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.
참고문헌 (42)
- Lauer GM, "Hepatitis C virus infection", N Engl J Med, 345, pp.41~52 (2001)
- Planas R, "Natural history of decompensated hepatitis C virus-related cirrhosis. A study of 200 patients", J Hepatol, 40, pp.823~830 (2004)
- Zarrinpar A, "Liver transplantation : past, present and future", Nat Rev Gastroenterol Hepatol, 10, pp.434~440 (2013)
- Garcia-Retortillo M, "Hepatitis C virus kinetics during and immediately after liver transplantation", Hepatology, 35, pp.680~687 (2002)
- Forman LM, "The association between hepatitis C infection and survival after orthotopic liver transplantation", Gastroenterology, 122, pp.889~896 (2002)
- Gambato M, "Treatment options in patients with decompensated cirrhosis, pre- and post-transplantation", J Hepatol, 61(1 Suppl), pp.S120~S131 (2014)
- Foster GR, "Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis", J Hepatol, 64, pp.1224~1231 (2016)
- Cheung MCM, "Outcomes after successful direct-acting antiviral therapy for patients with chronic hepatitis C and decompensated cirrhosis", J Hepatol, 65, pp.741~747 (2016)
- Verna EC, "DAA therapy and long-term hepatic function in advanced", decompensated cirrhosis : real-world experience from HCV-TARGET cohort, 2020, pp.73, 540~548
- Mandorfer M, "Sustained virologic response to interferon-free therapies ameliorates HCV-induced portal hypertension", J Hepatol, 65, pp.692~699 (2016)
- AASLD-IDSA HCV Guidance Panel, "Hepatitis C guidance 2018 update : AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection", Clin Infect Dis, 67, pp.1477~1492 (2018)
- European Association for the Study of the Liver, "EASL recommendations on treatment of hepatitis C : final update of the series", J Hepatol, 73, pp.1170~1218 (2020)
- Kanda T, "Interferon-free treatment for HCV-infected patients with decompensated cirrhosis", Hepatol Int, 11, pp.38~44 (2017)
- Curry MP, "Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis", N Engl J Med, 373, pp.2618~2628 (2015)
- Flamm S, "High efficacy and improvement in CPT class with sofosbuvir", velpatasvir plus ribavirin for 12 weeks in patients with CPT C decompensated cirrhosis, 2019, pp.70, E221~E222
- Li JP, "Effectiveness and safety of sofosbuvir", velpatasvir combination ± ribavirin in the treatment of Chinese adults with chronic hepatitis C virus infection, 2020, pp.28, 831~837
- Child CG, "Surgery and portal hypertension", Major Probl Clin Surg, 1, pp.1~85 (1964)
- Levey AS, "A new equation to estimate glomerular filtration rate", Ann Intern Med, 150, pp.604~612 (2009)
- Prati D, "Updated definitions of healthy ranges for serum alanine aminotransferase levels", Ann Intern Med, 137, pp.1~10 (2002)
- Liu CH, "Comparison of Abbott RealTime HCV genotype II with Versant Line Probe Assay 2. 0 for hepatitis C virus genotyping", J Clin Microbiol, 53, pp.1754~1757 (2015)
- Kamath PS, "A model to predict survival in patients with endstage liver disease", Hepatology, 33, pp.464~470 (2001)
- "Copegus (ribavirin) tablet"[URL]
- "Common Terminology Criteria for Adverse Events (CTCAE)"[URL]
- Zeger SL, "Longitudinal data analysis for discrete and continuous outcomes", Biometrics, 42, pp.121~130 (1986)
- Liu CH, "Comorbidities, concomitant medications and potential drug-drug interactions with interferon-free direct-acting antiviral agents in hepatitis C patients in Taiwan", Aliment Pharmacol Ther, 48, pp.1290~1300 (2018)
- Takehara T, "Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis : an open-label phase 3 trial", J Gastroenterol, 54, pp.87~95 (2019)
- Ohya K, "Real-world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus-related decompensated cirrhosis", Hepatol Res, 50, pp.1234~1243 (2020)
- Atsukawa M, "Real-world clinical application of 12-week sofosbuvir", velpatasvir treatment for decompensated cirrhotic patients with genotype 1 and 2 : a prospective, multicenter study, 2020, pp.9, 851~866
- Tahata Y, "Sofosbuvir plus velpatasvir treatment for hepatitis C virus in patients with decompensated cirrhosis : a Japanese real-world multicenter study", J Gastroenterol, 56, pp.67~77 (2021)
- Takaoka Y, "Real-world efficacy and safety of 12-week sofosbuvir", velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection, 2021, pp.51, 51~61
- Fernández Carrillo C, "Treatment of hepatitis C virus infection in patients with cirrhosis and predictive value of model for end-stage liver disease : analysis of data from the Hepa-C registry", Hepatology, 65, pp.1810~1822 (2017)
- Agarwal K, "Sofosbuvir", velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients, 2018, pp.69, 603~607
- Maesaka K, "Clinical course of hepatitis C virus-positive patients with decompensated liver cirrhosis in the era of direct-acting antiviral treatment", Hepatol Res, 51, pp.517~527 (2021)
- Waziry R, "Hepatocellular carcinoma risk following direct-acting antiviral HCV therapy : a systematic review, meta-analyses, and meta-regression", J Hepatol, 67, pp.1204~1212 (2017)
- Garcia-Tsao G, "Management of varices and variceal hemorrhage in cirrhosis", N Engl J Med, 362, pp.823~832 (2010)
- Okubo T, "Efficacy and safety of ledipasvir", sofosbuvir for genotype 1b chronic hepatitis C patients with moderate renal impairment, 2018, pp.12, 133~142
- Liu CH, "Evolution of eGFR in chronic HCV patients receiving sofosbuvir-based or sofosbuvir-free direct-acting antivirals", J Hepatol, 72, pp.839~846 (2020)
- Liu CH, "Sofosbuvir", velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease : real-world data in Taiwan, 2021, pp.15, 338~349
- Flemming JA, "Reduction in liver transplant wait-listing in the era of direct-acting antiviral therapy", Hepatology, 65, pp.804~812 (2017)
- Chan J, "Costeffectiveness analysis of sofosbuvir and velpatasvir in chronic hepatitis C patients with decompensated cirrhosis", J Viral Hepat, 28, pp.260~267 (2021)
- Younossi ZM, "Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis : an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial", Lancet Gastroenterol Hepatol, 1, pp.122~132 (2016)
- Liu CH, "Sofosbuvir", velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment, 2021, ~