Community‐based real‐world treatment outcomes of sofosbuvir/ledipasvir in Asians with chronic hepatitis C virus genotype 6 in the United States

Journal of Viral Hepatitis - Tập 24 Số 1 - Trang 17-21 - 2017
R. J. Wong1, M. T. Nguyen1, H. N. Trinh1, A. Huynh1, M. T. Ly1, H. A. Nguyen1, K. K. Nguyen1, J. Yang1, R. T. Garcia1, B. Levitt1, E. Silveira1, R. G. Gish1
1National Viral Hepatitis Roundtable San FranciscoCAUSA

Tóm tắt

Summary Sofosbuvir/ledipasvir (SOF/LDV) is the first all‐oral ribavirin‐free treatment approved for chronic hepatitis C virus (HCV) genotype 6, offering a safe and highly efficacious treatment option. Large studies evaluating real‐world outcomes of this regimen are lacking. We aim to evaluate real‐world treatment outcomes for HCV genotype 6. A retrospective cohort study evaluated 65 adults (age ≥18) with chronic HCV genotype 6 treated with SOF/LDV without ribavirin at a community gastroenterology clinic in the United States from November 2014 to May 2016. Rates of undetectable virus at week 4 on treatment, at end of treatment (EOT) and SVR12 were stratified by the presence of cirrhosis and prior treatment (treatment naïve vs treatment experienced). Among 65 patients with chronic HCV genotype 6 treated with SOF/LDV (52.3% male, mean age 66.3 years [SD 9.7], 41.5% cirrhosis and 15.4% treatment experienced), 97.3% had undetectable virus at week 4 on treatment, 96.9% had undetectable virus at EOT and 95.3% achieved SVR12. SVR12 was 100% in females vs 91.2% in males, P=.096, and 92.3% in patients with cirrhosis vs 97.4% in those without cirrhosis, P=.347. Resistance testing of treatment failures was attempted but unsuccessful due to lack of conforming primers to define the possible resistance mutations. Among the largest U.S. community‐based real‐world cohort of Asian chronic HCV genotype 6 patients treated with all‐oral SOF/LDV without ribavirin, SVR12 was similar to SVR12 reported in clinical trials, confirming the safety and effectiveness of this regimen and validating current HCV genotype 6 treatment guideline recommendations.

Từ khóa

#direct‐acting antivirals #hepatitis C virus #sustained virologic response

Tài liệu tham khảo

Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61:77–87. Gower E, Estes C, Blach S, Razavi‐Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014;61(1 Suppl):S45–S57. Razavi H, Elkhoury AC, Elbasha E, et al. Chronic hepatitis C virus (HCV) disease burden and cost in the United States. Hepatology. 2013;57:2164–2170. Wong RJ, Aguilar M, Cheung R, et al. Nonalcoholic steatohepatitis is the second leading etiology of liver disease among adults awaiting liver transplantation in the United States. Gastroenterology. 2015;148:547–555. Wong RJ, Cheung R, Ahmed A. Nonalcoholic steatohepatitis is the most rapidly growing indication for liver transplantation in patients with hepatocellular carcinoma in the U.S. Hepatology. 2014;59:2188–2195. Kohli A, Shaffer A, Sherman A, Kottilil S. Treatment of hepatitis C: a systematic review. JAMA. 2014;312:631–640. Chahal HS, Marseille EA, Tice JA, et al. cost‐effectiveness of early treatment of hepatitis C virus genotype 1 by stage of liver fibrosis in a US treatment‐naive population. JAMA Intern Med. 2016;176:65–73. Leidner AJ, Chesson HW, Xu F, Ward JW, Spradling PR, Holmberg SD. Cost‐effectiveness of hepatitis C treatment for patients in early stages of liver disease. Hepatology. 2015;61:1860–1869. Lam KD, Trinh HN, Do ST, et al. Randomized controlled trial of pegylated interferon‐alfa 2a and ribavirin in treatment‐naive chronic hepatitis C genotype 6. Hepatology. 2010;52:1573–1580. Thu Thuy PT, Bunchorntavakul C, Tan Dat H, Rajender Reddy K. A randomized trial of 48 versus 24 weeks of combination pegylated interferon and ribavirin therapy in genotype 6 chronic hepatitis C. J Hepatol. 2012;56:1012–1018. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878–1887. AASLD‐IDSA. Recommendations for testing m, and treating hepatitis C. 2016. www.hcvguidelines.org. Accessed June 10, 2016. Gane EJ, Hyland RH, An D, et al. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015;149:1454–1461. e1. Zeuzem S, Ghalib R, Reddy KR, et al. Grazoprevir‐elbasvir combination therapy for treatment‐naive cirrhotic and noncirrhotic patients with chronic hepatitis C Virus genotype 1, 4, or 6 infection: a randomized trial. Ann Intern Med. 2015;163:1–13.