Efficacy of daclatasvir plus peginterferon alfa and ribavirin for patients with chronic hepatitis C genotype 4 infection
DOI:
https://doi.org/10.3329/bjp.v12i1.29940Keywords:
Daclatasvir, Hepatitis C, Interferon, Ribavirin, Meta-analysisAbstract
Clinical trials evaluating the safety and efficacy of daclatasvir for chronic hepatitis C virus (HCV) genotype 4 infection are scarce and yet with small sample sizes. Therefore, we conducted this systematic review to investigate the efficacy of daclatasvir in HCV genotype 4 treatment. A computer literature search of PubMed, Scopus, Embase, Ovid, Web of knowledge, and Cochrane central was conducted. We selected studies comparing daclatasvir plus peginterferon-alfa/ribavirin versus placebo plus peginterferon-alfa/ribavirin in patients with HCV genotype 4 infection. Pooling data from two randomized controlled trials (n = 154 patients) showed that daclatasvir/peg-interferon/ribavirin treatment achieved a moderate sustained virologic response rate of 76% after 12 weeks and of 79% after 24 weeks. The daclatasvir containing regimen was superior to the placebo containing regimen in terms of virologic response rates after 12 weeks (RR=1.9% CI 1.3 to 2.6) and 24 weeks (RR=1.8% CI 1.3 to 2.5). More effective regimens are needed for HCV genotype 4.
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Al Ashgar HIA, Khan MQ, Al-Ahdal M, Thawadi SA, Helmy AS, Qahtani AA, Sanai FM. Hepatitis C genotype 4: Geno-typic diversity, epidemiological profile, and clinical relevance of subtypes in Saudi Arabia. Saudi J Gastroenterol. 2013; 19: 28.
Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006; 144: 705-14.
Chan P, Tafoya E, Bifano M, Bertz R, Yin P, Hughes E, Ahmad A. Exposure-response analysis of daclatasvir in patients with genotype 1 chronic HCV infection: Dose selection for phase 3 clinical trials. Rev Antivir Ther Infect Dis. 2012; 6: 14.
Cornberg M, Razavi HA, Alberti A, Bernasconi E, Buti M, Cooper C, Forns X. A systematic review of hepatitis C virus epidemiology in Europe, Canada and Israel. Liver Int. 2011; 31: 30-60.
Dore GJ, Lawitz E, Hézode C, Shafran SD, Ramji A, Tatum HA, Zaltron S. Daclatasvir plus peginterferon and ribavirin is non-inferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology 2015; 148: 355-66.
Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997; 315: 629-34.
Everson GT, Sims KD, Rodriguez-Torres M, Hézode C, Lawitz E, Bourlière M, Tatum H. Efficacy of an interferon-and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology 2014; 146: 420-29.
Fridell RA, Qiu D, Valera L, Wang C, Rose RE, Gao M. Distinct functions of NS5A in hepatitis C virus RNA replication uncovered by studies with the NS5A inhibitor BMS-790052. J Virol. 2011; 85: 7312-20.
Fridell RA, Wang C, Sun J, OBoyle DR, Nower P, Valera L, Kienzle B. Genotypic and phenotypic analysis of variants resistant to hepatitis C virus nonstructural protein 5A replication complex inhibitor BMS?790052 in Humans: In vitro and In vivo correlations. Hepatology 2011; 54: 1924-35.
Gao M, Nettles RE, Belema M, Snyder LB, Nguyen VN, Fridell RA, Serrano MH, Wu, Langley DR, Jin, Sun H, OBoyleli DR, Lemm JA, Wang C, Knipe JO, Chien C, Colonno RJ, Grasela DM, Meanwell NA, Hamann LG. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature 2010; 465: 96-100.
Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: An update. Hepatology 2009; 49: 1335-74.
Hanafiah KM, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: New estimates of age-specific antibody to HCV seroprevalence. Hepatology 2013; 57: 1333-42.
Hassanein T, Sims KD, Bennett M, Gitlin N, Lawitz E. A randomized trial of daclatasvir in combination with asuna-previr and beclabuvir in patients with chronic hepatitis C virus genotype 4 infection. J Hepatol. 2015; 62: 1204-06.
Hézode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Treitel M. Randomized controlled trial of the NS5A inhibitor daclatasvir plus peginterferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015; 4.
Hézode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Esmat G, et al. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: A randomised study. Gut 2014; 64: 948-56.
Jafferbhoy H, Gashau W, Dillon JF. Cost effectiveness and quality of life considerations in the treatment of hepatitis C infection. Clin Economics Outcomes Res. 2010; 2: 87.
Jensen D, Sherman KE, Hézode C, Pol S, Ledinghen V, De Tran A, Hughes E. Daclatasvir and asunaprevir plus peginterfe-ron alfa and ribavirin in HCV. J Hepatol. 2015; 2: 18.
Kamal SM. Hepatitis C virus genotype 4 therapy: Progress and challenges. Liver Int. 2011; 31: 45-52.
Karoney MJ, Siika AM. Hepatitis C virus (HCV) infection in Africa: A review. Pan Afr Med J. 2013; 14.
Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, Takaguchi K. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 2014; 59: 2083-91.
Larrey D, Ripault MP, Pageaux GP. Patient adherence issues in the treatment of hepatitis C. Patient Prefer Adher. 2014; 8: 763.
Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Reddy KR. Sofosbuvir for previously untrea-ted chronic hepatitis C infection. N Engl J Med. 2013; 368: 1878-87.
Lee C, Ma H, Hang JQ, Leveque V, Sklan EH, Elazar M, Glenn JS. The hepatitis C virus NS5A inhibitor (BMS-790052) alters the subcellular localization of the NS5A non-structural viral protein. Virology 2011; 414: 10-18.
Lindsay KL. Therapy of hepatitis C: Overview. Hepatology 1997; 26.
Moher D. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009; 151: 264. e1000097.
Moreno C, Hezode C, Marcellin P, Bourgeois S, Francque S, Samuel D, Ouwerkerk-Mahadevan S. P1319 once-daily simeprevir (tmc435) with peginterferon/ribavirin in treatment-naive or treatment-experienced chronic HCV genotype 4-infected patients: Final results of a phase III trial. J Hepatol. 2014; 60: S535.
Negro F, Alberti A. The global health burden of hepatitis C virus infection. Liver Int. 2011; 31: 1-3.
Pawlotsky JM, Aghemo A, Back D. EASL recommendations on treatment of hepatitis C 2015. J Hepatol. 2015; 63, 199-236.
Qiu D, Lemm JA, Oboyle DR, Sun JH, Nower PT, Nguyen V, Ruediger E Hamann LG, Snyder LB, Deon DH, Ruediger E, Meanwell NA, Belema M, Gao M, Fridell RA. The effects of NS5A inhibitors on NS5A phosphorylation, polyprotein processing and localization. J Gen Virol. 2011; 92: 2502-11.
Smith DB, Bukh J, Kuiken C, Muerhoff AS, Rice CM, Stapleton JT, Simmonds P. Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: Updated criteria and genotype assignment web resource. Hepatology 2014; 59: 318-27.
Smith-Palmer J, Cerri K, Valentine W. Achieving sustained virologic response in hepatitis C: A systematic review of the clinical, economic and quality of life benefits. BMC Infect Dis. 2015; 15: 1.
Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Grasela DM. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014; 370: 211-21.
Suzuki Y, Ikeda K, Suzuki F, Toyota J, Karino Y, Chayama K, Hu W. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol. 2013; 58: 655-62.
Swallow E, Song J, Yuan Y, Kalsekar A, Kelley C, Mu F, Signorovitch J. Daclatasvir + sofosbuvir versus standard of care for hepatitis C genotype 3: A matching-adjusted indirect comparison. J Comp Eff Res. 2015.
Terrin N, Schmid CH, Lau J, Olkin I. Adjusting for publication bias in the presence of heterogeneity. Stats Med. 2003; 22: 2113-26.
Thompson AJ, Muir AJ, Sulkowski MS, Ge D, Fellay J, Shianna KV, Esteban R. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology 2010; 139: 120-29.
Wang C, Jia L, Huang H, Qiu D, Valera L, Huang X, Gao M. In vitro activity of BMS-790052 on hepatitis C virus genotype 4 NS5A. Antimicrob Agents Chemother. 2012; 56: 1588-90.
Wang C, Jia L, OBoyle DR, Sun JH, Rigat K, Valera L, Roberts S. Comparison of daclatasvir resistance barriers on NS5A from hepatitis C virus genotypes 1 to 6: Implications for cross-genotype activity. Antimicrob Agents Chemother. 2014; 58: 5155-63.
Yu J, Wang G, Sun L, Li X, Li S. Predictive value of rapid virological response and early virological response on sustained virological response in HCV patients treated with pegylated interferon ??2a and ribavirin. J Gastroenterol Hepatol. 2007; 22: 832-36.
Zhou N, Hernandez D, Ueland J, Yang X, Yu F, Sims K, McPhee F. NS5A sequence heterogeneity and mechanisms of daclatasvir resistance in hepatitis C virus genotype 4 infection. J Infect Dis. 2016; 213: 206-15.
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