Daclatasvir + asunaprevir + beclabuvir ± ribavirin for chronic HCV genotype 1-infected treatment-naive patients
Background and Aims This phase‐2b study examined the safety and efficacy of an all‐oral, interferon‐free combination of the NS5A replication complex inhibitor daclatasvir (DCV), the NS3 protease inhibitor asunaprevir (ASV), and the nonnucleoside NS5B polymerase inhibitor beclabuvir (BCV) with or wit...
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| Published in | Liver international Vol. 36; no. 2; pp. 189 - 197 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Blackwell Publishing Ltd
01.02.2016
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1478-3223 1478-3231 1478-3231 |
| DOI | 10.1111/liv.12964 |
Cover
| Abstract | Background and Aims
This phase‐2b study examined the safety and efficacy of an all‐oral, interferon‐free combination of the NS5A replication complex inhibitor daclatasvir (DCV), the NS3 protease inhibitor asunaprevir (ASV), and the nonnucleoside NS5B polymerase inhibitor beclabuvir (BCV) with or without ribavirin in patients with HCV genotype (GT) 1 infection.
Methods
A total of 187 patients received 12 weeks of DCV 30 mg BID plus ASV 200 mg BID and BCV 150 mg BID (n = 86) or 75 mg BID with (n = 21) or without (n = 80) weight‐based ribavirin BID. The primary endpoint was HCV RNA <25 IU/ml at post‐treatment week 12 (SVR12).
Results
Overall, 90% of patients (169/187) in the combined treatment groups achieved SVR on or after post‐treatment week 12. SVR rates were similar across subgroups (by mITT analysis), i.e. patients with cirrhosis (88%, 14/16), HCV GT‐1a (90%, 137/155), and IL28B non‐CC genotype (90%, 115/128). There were no drug‐related serious AEs or grade 4 AEs. The most frequently reported AEs were headache, diarrhoea, fatigue and nausea. Addition of ribavirin to DCV+ASV+BCV was associated with decreased haemoglobin, compared with DCV+ASV+BCV alone. There were six grade 3/4 laboratory abnormalities noted, all unrelated to the study drugs. Viral breakthrough occurred in 2.5–4.8% of patients across groups and appeared unrelated to BCV dose or ribavirin inclusion.
Conclusions
Results support phase 3 evaluation of a twice‐daily, fixed‐dose formulation of this DCV+ASV+BCV regimen with or without ribavirin in HCV GT‐1‐infected patients.
See Editorial on Page 181 |
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| AbstractList | See Editorial on Page
181 This phase-2b study examined the safety and efficacy of an all-oral, interferon-free combination of the NS5A replication complex inhibitor daclatasvir (DCV), the NS3 protease inhibitor asunaprevir (ASV), and the nonnucleoside NS5B polymerase inhibitor beclabuvir (BCV) with or without ribavirin in patients with HCV genotype (GT) 1 infection.BACKGROUND AND AIMSThis phase-2b study examined the safety and efficacy of an all-oral, interferon-free combination of the NS5A replication complex inhibitor daclatasvir (DCV), the NS3 protease inhibitor asunaprevir (ASV), and the nonnucleoside NS5B polymerase inhibitor beclabuvir (BCV) with or without ribavirin in patients with HCV genotype (GT) 1 infection.A total of 187 patients received 12 weeks of DCV 30 mg BID plus ASV 200 mg BID and BCV 150 mg BID (n = 86) or 75 mg BID with (n = 21) or without (n = 80) weight-based ribavirin BID. The primary endpoint was HCV RNA <25 IU/ml at post-treatment week 12 (SVR12).METHODSA total of 187 patients received 12 weeks of DCV 30 mg BID plus ASV 200 mg BID and BCV 150 mg BID (n = 86) or 75 mg BID with (n = 21) or without (n = 80) weight-based ribavirin BID. The primary endpoint was HCV RNA <25 IU/ml at post-treatment week 12 (SVR12).Overall, 90% of patients (169/187) in the combined treatment groups achieved SVR on or after post-treatment week 12. SVR rates were similar across subgroups (by mITT analysis), i.e. patients with cirrhosis (88%, 14/16), HCV GT-1a (90%, 137/155), and IL28B non-CC genotype (90%, 115/128). There were no drug-related serious AEs or grade 4 AEs. The most frequently reported AEs were headache, diarrhoea, fatigue and nausea. Addition of ribavirin to DCV+ASV+BCV was associated with decreased haemoglobin, compared with DCV+ASV+BCV alone. There were six grade 3/4 laboratory abnormalities noted, all unrelated to the study drugs. Viral breakthrough occurred in 2.5-4.8% of patients across groups and appeared unrelated to BCV dose or ribavirin inclusion.RESULTSOverall, 90% of patients (169/187) in the combined treatment groups achieved SVR on or after post-treatment week 12. SVR rates were similar across subgroups (by mITT analysis), i.e. patients with cirrhosis (88%, 14/16), HCV GT-1a (90%, 137/155), and IL28B non-CC genotype (90%, 115/128). There were no drug-related serious AEs or grade 4 AEs. The most frequently reported AEs were headache, diarrhoea, fatigue and nausea. Addition of ribavirin to DCV+ASV+BCV was associated with decreased haemoglobin, compared with DCV+ASV+BCV alone. There were six grade 3/4 laboratory abnormalities noted, all unrelated to the study drugs. Viral breakthrough occurred in 2.5-4.8% of patients across groups and appeared unrelated to BCV dose or ribavirin inclusion.Results support phase 3 evaluation of a twice-daily, fixed-dose formulation of this DCV+ASV+BCV regimen with or without ribavirin in HCV GT-1-infected patients.CONCLUSIONSResults support phase 3 evaluation of a twice-daily, fixed-dose formulation of this DCV+ASV+BCV regimen with or without ribavirin in HCV GT-1-infected patients. Background and Aims This phase‐2b study examined the safety and efficacy of an all‐oral, interferon‐free combination of the NS5A replication complex inhibitor daclatasvir (DCV), the NS3 protease inhibitor asunaprevir (ASV), and the nonnucleoside NS5B polymerase inhibitor beclabuvir (BCV) with or without ribavirin in patients with HCV genotype (GT) 1 infection. Methods A total of 187 patients received 12 weeks of DCV 30 mg BID plus ASV 200 mg BID and BCV 150 mg BID (n = 86) or 75 mg BID with (n = 21) or without (n = 80) weight‐based ribavirin BID. The primary endpoint was HCV RNA <25 IU/ml at post‐treatment week 12 (SVR12). Results Overall, 90% of patients (169/187) in the combined treatment groups achieved SVR on or after post‐treatment week 12. SVR rates were similar across subgroups (by mITT analysis), i.e. patients with cirrhosis (88%, 14/16), HCV GT‐1a (90%, 137/155), and IL28B non‐CC genotype (90%, 115/128). There were no drug‐related serious AEs or grade 4 AEs. The most frequently reported AEs were headache, diarrhoea, fatigue and nausea. Addition of ribavirin to DCV+ASV+BCV was associated with decreased haemoglobin, compared with DCV+ASV+BCV alone. There were six grade 3/4 laboratory abnormalities noted, all unrelated to the study drugs. Viral breakthrough occurred in 2.5–4.8% of patients across groups and appeared unrelated to BCV dose or ribavirin inclusion. Conclusions Results support phase 3 evaluation of a twice‐daily, fixed‐dose formulation of this DCV+ASV+BCV regimen with or without ribavirin in HCV GT‐1‐infected patients. See Editorial on Page 181 This phase-2b study examined the safety and efficacy of an all-oral, interferon-free combination of the NS5A replication complex inhibitor daclatasvir (DCV), the NS3 protease inhibitor asunaprevir (ASV), and the nonnucleoside NS5B polymerase inhibitor beclabuvir (BCV) with or without ribavirin in patients with HCV genotype (GT) 1 infection. A total of 187 patients received 12 weeks of DCV 30 mg BID plus ASV 200 mg BID and BCV 150 mg BID (n = 86) or 75 mg BID with (n = 21) or without (n = 80) weight-based ribavirin BID. The primary endpoint was HCV RNA <25 IU/ml at post-treatment week 12 (SVR12). Overall, 90% of patients (169/187) in the combined treatment groups achieved SVR on or after post-treatment week 12. SVR rates were similar across subgroups (by mITT analysis), i.e. patients with cirrhosis (88%, 14/16), HCV GT-1a (90%, 137/155), and IL28B non-CC genotype (90%, 115/128). There were no drug-related serious AEs or grade 4 AEs. The most frequently reported AEs were headache, diarrhoea, fatigue and nausea. Addition of ribavirin to DCV+ASV+BCV was associated with decreased haemoglobin, compared with DCV+ASV+BCV alone. There were six grade 3/4 laboratory abnormalities noted, all unrelated to the study drugs. Viral breakthrough occurred in 2.5-4.8% of patients across groups and appeared unrelated to BCV dose or ribavirin inclusion. Results support phase 3 evaluation of a twice-daily, fixed-dose formulation of this DCV+ASV+BCV regimen with or without ribavirin in HCV GT-1-infected patients. |
| Author | Webster, Lynn Grasela, Dennis M. Sims, Karen D. McPhee, Fiona Hinestrosa, Federico Desta, Tadesse Hawkins, Trevor Hassanein, Tarek Schwartz, Howard Younossi, Zobair Gitlin, Norman Eley, Timothy Huang, Shu-Pang Thuluvath, Paul J. Rodriguez-Torres, Maribel Everson, Gregory T. Lawitz, Eric Levin, James M. Rustgi, Vinod Gardiner, David F. |
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| References_xml | – reference: McPhee F, Friborg J, Levine S, et al. Resistance analysis of the hepatitis C virus NS3 protease inhibitor asunaprevir. Antimicrob Agents Chemother 2012; 56: 3670-81. – reference: McPhee F, Sheaffer AK, Friborg J, et al. Preclinical profile and characterization of the hepatitis C virus NS3 protease inhibitor asunaprevir (BMS-650032). Antimicrob Agents Chemother 2012; 56: 5387-96. – reference: Lok AS, Gardiner DF, Hezode C, et al. Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders. J Hepatol 2014; 60: 490-9. – reference: Poordad F, Sievert W, Mollison L, et al. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA 2015; 313: 1728-35. – reference: Chayama K, Takahashi S, Toyota J, et al. Dual therapy with the nonstructural protein 5A inhibitor, daclatasvir, and the nonstructural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b-infected null responders. Hepatology 2012; 55: 742-8. – reference: Muir A, Poordad F, Lalezari JP, et al. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C genotype 1 infection with compensated cirrhosis. JAMA 2015; 313: 1736-44. – reference: Coilly A, Roche B, Samuel D. Current management and perspectives for HCV recurrence after liver transplantation. Liver Int 2013; 33(Suppl. 1): 56-62. – reference: Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1195-206. – reference: McPhee F, Falk P, Lemm J, et al. Characterization of viral escape in HCV genotype 1-infected patients treated with BMS-791325 and pegylated interferon-alfa and ribavirin. J Hepatol 2012; 56(Suppl. 2): S473. – reference: Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-87. – reference: Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011; 364: 2405-16. – reference: Averhoff FM, Glass N, Holtzman D. Global burden of hepatitis C: considerations for healthcare providers in the United States. Clin Infect Dis 2012; 55(Suppl. 1): S10-5. – reference: Fridell RA, Wang C, Sun JH, et al. Genotypic and phenotypic analysis of variants resistant to HCV NS5A replication complex inhibitor BMS-790052: in vitro and in vivo correlations. Hepatology 2011; 54: 1924-35. – reference: Ferenci P, Bernstein D, Lalezari J, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014; 370: 1983-92. – reference: Gao M, Nettles RE, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature 2010; 465: 96-100. – reference: Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014; 370: 211-21. – reference: Guedj J, Rong L, Dahari H, Perelson AS. A perspective on modelling hepatitis C virus infection. J Viral Hepat 2010; 17: 825-33. – reference: Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014; 370: 1889-98. – reference: Suzuki Y, Ikeda K, Suzuki F, et al. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol 2013; 58: 655-62. – reference: Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012; 366: 216-24. – reference: European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol 2015; 63: 199-236. – reference: Jacobson IM, Dore GJ, Foster GR, et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2014; 384: 403-13. – reference: Everson GT, Sims KD, Rodriguez-Torres M, et al. 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: 420-9. – reference: Nettles RE, Gao M, Bifano M, et al. Multiple ascending dose study of BMS-790052, an NS5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology 2011; 54: 1956-65. – volume: 56 start-page: S473 issue: Suppl. 2 year: 2012 article-title: Characterization of viral escape in HCV genotype 1‐infected patients treated with BMS‐791325 and pegylated interferon‐alfa and ribavirin publication-title: J Hepatol – volume: 55 start-page: S10 issue: Suppl. 1 year: 2012 end-page: 5 article-title: Global burden of hepatitis C: considerations for healthcare providers in the United States publication-title: Clin Infect Dis – volume: 58 start-page: 655 year: 2013 end-page: 62 article-title: Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options publication-title: J Hepatol – volume: 370 start-page: 211 year: 2014 end-page: 21 article-title: Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection publication-title: N Engl J Med – volume: 313 start-page: 1728 year: 2015 end-page: 35 article-title: Fixed‐dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection publication-title: JAMA – volume: 146 start-page: 420 year: 2014 end-page: 9 article-title: Efficacy of an interferon‐ and ribavirin‐free regimen of daclatasvir, asunaprevir, and BMS‐791325 in treatment‐naive patients with HCV genotype 1 infection publication-title: Gastroenterology – volume: 33 start-page: 56 issue: Suppl. 1 year: 2013 end-page: 62 article-title: Current management and perspectives for HCV recurrence after liver transplantation publication-title: Liver Int – volume: 370 start-page: 1889 year: 2014 end-page: 98 article-title: Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection publication-title: N Engl J Med – volume: 56 start-page: 3670 year: 2012 end-page: 81 article-title: Resistance analysis of the hepatitis C virus NS3 protease inhibitor asunaprevir publication-title: Antimicrob Agents Chemother – volume: 366 start-page: 216 year: 2012 end-page: 24 article-title: Preliminary study of two antiviral agents for hepatitis C genotype 1 publication-title: N Engl J Med – volume: 55 start-page: 742 year: 2012 end-page: 8 article-title: Dual therapy with the nonstructural protein 5A inhibitor, daclatasvir, and the nonstructural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b‐infected null responders publication-title: Hepatology – volume: 465 start-page: 96 year: 2010 end-page: 100 article-title: Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect publication-title: Nature – volume: 54 start-page: 1956 year: 2011 end-page: 65 article-title: Multiple ascending dose study of BMS‐790052, an NS5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1 publication-title: Hepatology – volume: 54 start-page: 1924 year: 2011 end-page: 35 article-title: Genotypic and phenotypic analysis of variants resistant to HCV NS5A replication complex inhibitor BMS‐790052: and correlations publication-title: Hepatology – volume: 17 start-page: 825 year: 2010 end-page: 33 article-title: A perspective on modelling hepatitis C virus infection publication-title: J Viral Hepat – volume: 63 start-page: 199 year: 2015 end-page: 236 article-title: EASL Recommendations on Treatment of Hepatitis C 2015 publication-title: J Hepatol – volume: 56 start-page: 5387 year: 2012 end-page: 96 article-title: Preclinical profile and characterization of the hepatitis C virus NS3 protease inhibitor asunaprevir (BMS‐650032) publication-title: Antimicrob Agents Chemother – volume: 364 start-page: 1195 year: 2011 end-page: 206 article-title: Boceprevir for untreated chronic HCV genotype 1 infection publication-title: N Engl J Med – volume: 60 start-page: 490 year: 2014 end-page: 9 article-title: Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders publication-title: J Hepatol – volume: 364 start-page: 2405 year: 2011 end-page: 16 article-title: Telaprevir for previously untreated chronic hepatitis C virus infection publication-title: N Engl J Med – volume: 384 start-page: 403 year: 2014 end-page: 13 article-title: Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment‐naive patients with chronic hepatitis C virus genotype 1 infection (QUEST‐1): a phase 3, randomised, double‐blind, placebo‐controlled trial publication-title: Lancet – volume: 368 start-page: 1878 year: 2013 end-page: 87 article-title: Sofosbuvir for previously untreated chronic hepatitis C infection publication-title: N Engl J Med – volume: 313 start-page: 1736 year: 2015 end-page: 44 article-title: Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C genotype 1 infection with compensated cirrhosis publication-title: JAMA – volume: 370 start-page: 1983 year: 2014 end-page: 92 article-title: ABT‐450/r‐ombitasvir and dasabuvir with or without ribavirin for HCV publication-title: N Engl J Med – ident: e_1_2_8_24_1 doi: 10.1111/j.1365-2893.2010.01348.x – ident: e_1_2_8_16_1 doi: 10.1128/AAC.00308-12 – ident: e_1_2_8_27_1 doi: 10.1056/NEJMoa1402338 – ident: e_1_2_8_14_1 doi: 10.1053/j.gastro.2013.10.057 – ident: e_1_2_8_20_1 doi: 10.1016/j.jhep.2013.10.019 – ident: e_1_2_8_6_1 doi: 10.1016/j.jhep.2015.03.025 – ident: e_1_2_8_3_1 doi: 10.1093/cid/cis361 – ident: e_1_2_8_19_1 doi: 10.1056/NEJMoa1104430 – ident: e_1_2_8_25_1 – ident: e_1_2_8_28_1 doi: 10.1001/jama.2015.3860 – ident: e_1_2_8_11_1 doi: 10.1038/nature08960 – ident: e_1_2_8_4_1 doi: 10.1111/liv.12062 – volume: 56 start-page: S473 issue: 2 year: 2012 ident: e_1_2_8_18_1 article-title: Characterization of viral escape in HCV genotype 1‐infected patients treated with BMS‐791325 and pegylated interferon‐alfa and ribavirin publication-title: J Hepatol doi: 10.1016/S0168-8278(12)61206-9 – ident: e_1_2_8_8_1 doi: 10.1056/NEJMoa1010494 – ident: e_1_2_8_13_1 – ident: e_1_2_8_26_1 doi: 10.1056/NEJMoa1402454 – ident: e_1_2_8_2_1 – ident: e_1_2_8_5_1 – ident: e_1_2_8_7_1 doi: 10.1056/NEJMoa1012912 – ident: e_1_2_8_9_1 doi: 10.1016/S0140-6736(14)60494-3 – ident: e_1_2_8_17_1 doi: 10.1002/hep.24594 – ident: e_1_2_8_22_1 doi: 10.1002/hep.24724 – ident: e_1_2_8_23_1 doi: 10.1056/NEJMoa1306218 – ident: e_1_2_8_29_1 doi: 10.1001/jama.2015.3868 – ident: e_1_2_8_15_1 doi: 10.1002/hep.24609 – ident: e_1_2_8_12_1 doi: 10.1128/AAC.01186-12 – ident: e_1_2_8_21_1 doi: 10.1016/j.jhep.2012.09.037 – ident: e_1_2_8_10_1 doi: 10.1056/NEJMoa1214853 – reference: 26781595 - Liver Int. 2016 Feb;36(2):181-4 |
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This phase‐2b study examined the safety and efficacy of an all‐oral, interferon‐free combination of the NS5A replication complex inhibitor... See Editorial on Page 181 This phase-2b study examined the safety and efficacy of an all-oral, interferon-free combination of the NS5A replication complex inhibitor daclatasvir (DCV),... |
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| SubjectTerms | Adult Aged Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Benzazepines - administration & dosage Benzazepines - adverse effects direct-acting antiviral Drug Administration Schedule drug combination Drug Monitoring Drug Therapy, Combination - methods Female Hepacivirus - drug effects Hepatitis C, Chronic - diagnosis Hepatitis C, Chronic - drug therapy Humans Imidazoles - administration & dosage Imidazoles - adverse effects Indoles - administration & dosage Indoles - adverse effects Isoquinolines - administration & dosage Isoquinolines - adverse effects liver disease Male Middle Aged Ribavirin - administration & dosage Ribavirin - adverse effects Sulfonamides - administration & dosage Sulfonamides - adverse effects therapy Treatment Outcome Viral Load - drug effects |
| Title | Daclatasvir + asunaprevir + beclabuvir ± ribavirin for chronic HCV genotype 1-infected treatment-naive patients |
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