High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection

Liver International

Volumn 36, Issue 8, 2016, Pages 1125-1132

  Poordad, Fred ^a   Landis, Charles S ^b   Asatryan, Armen ^c   Jackson, Daniel F ^d   Ng, Teresa I ^c   Fu, Bo ^c   Lin, Chih Wei ^c   Yao, Betty ^c   Kort, Jens ^c  

^a UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c ABBVIE INC   (United States)

^d Digestive Health Specialists of the Southeast   (United States)

Author keywords

direct acting antiviral; next generation; pharmacokinetics; resistant variant; sustained virological response

Indexed keywords

ALANINE; BILIRUBIN; HEMOGLOBIN; LYSINE; METHIONINE; NONSTRUCTURAL PROTEIN 3; PARITAPREVIR; PHENYLALANINE; PIBRENTASVIR; RIBAVIRIN; RITONAVIR; SERINE;

ADULT; AGED; AMINO ACID SUBSTITUTION; ANTIVIRAL ACTIVITY; ANTIVIRAL THERAPY; ARTICLE; BILIRUBIN BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL ASSESSMENT; COHORT ANALYSIS; CONTROLLED STUDY; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ERUPTION; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DYSPNEA; EC50; FATIGUE; FEMALE; GENETIC VARIABILITY; HEMOGLOBIN BLOOD LEVEL; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 3; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MALE; MIDDLE AGED; MONOTHERAPY; MULTICENTER STUDY; MYALGIA; NAUSEA; OPEN STUDY; PHARMACOGENETICS; PHASE 2 CLINICAL TRIAL; REPLICON; SEQUENCE ANALYSIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT RESPONSE; VIROLOGY; VIRUS RESISTANCE; VIRUS STRAIN; WILD TYPE;

EID: 84978858063     PISSN: 14783223     EISSN: 14783231     Source Type: Journal    
DOI: 10.1111/liv.13067     Document Type: Article

References (38)

1. Mohd Hanafiah K, 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.
2. Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 2015; 61: 77–87.
3. Ampuero J, Romero-Gomez M, Reddy KR. Review article: HCV genotype 3 – the new treatment challenge. Aliment Pharmacol Ther 2014; 39: 686–98.
4. Kohli A, Shaffer A, Sherman A, Kottilil S. Treatment of hepatitis C: a systematic review. JAMA 2014; 312: 631–40.
5. Pybus OG, Cochrane A, Holmes EC, Simmonds P. The hepatitis C virus epidemic among injecting drug users. Infect, Genet Evol 2005; 5: 131–9.
6. Jhaveri R, McHutchison J, Patel K, Qiang G, Diehl AM. Specific polymorphisms in hepatitis C virus genotype 3 core protein associated with intracellular lipid accumulation. J Infect Dis 2008; 197: 283–91.
7. Goossens N, Negro F. Is genotype 3 of the hepatitis C virus the new villain? Hepatology 2014; 59: 2403–12.
8. Nkontchou G, Ziol M, Aout M, et al. HCV genotype 3 is associated with a higher hepatocellular carcinoma incidence in patients with ongoing viral C cirrhosis. J Viral Hepatitis 2011; 18: e516–22.
9. Wartelle-Bladou C, Le Folgoc G, Bourliere M, Lecomte L. Hepatitis C therapy in non-genotype 1 patients: the near future. J Viral Hepatitis 2012; 19: 525–36.
10. Tapper EB, Afdhal NH. Is 3 the new 1: perspectives on virology, natural history and treatment for hepatitis C genotype 3. J Viral Hepatitis 2013; 20: 669–77.
11. SOVALDI (sofosbuvir). Prescribing Information. Gilead Sciences. Foster City, CA, 2014.
12. DAKLINZA (daclatasvir). Summary of Product Characteristics. Bristol-Myers Squibb. Uxbridge, UK, 2014.
13. DAKLINZA (daclatasvir). Prescribing Information. Bristol-Myers Squibb, New York City, NY, 2015.
14. HARVONI (ledipasvir and sofosbuvir). Summary of Product Characteristics. Gilead Sciences, Cambridge, UK, 2015.
15. Foster GR, McLauchlan J, Irving W, et al. Treatment of decompensated HCV cirrhosis in patients with diverse genotypes: 12 weeks of sofosbuvir and NS5A inhibitors with/without ribavirin is effective in genotypes 1 and 3. J Hepatol 2015; 62: S187–212.
16. Andriulli A, Mangia A, Iacobellis A, et al. Meta-analysis: the outcome of anti-viral therapy in HCV genotype 2 and genotype 3 infected patients with chronic hepatitis. Aliment Pharmacol Ther 2008; 28: 397–404.
17. Nelson DR, Cooper JN, Lalezari JP, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015; 61: 1127–35.
18. 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.
19. Keating GM. Ledipasvir/Sofosbuvir: a review of its use in chronic hepatitis C. Drugs 2015; 75: 675–85.
20. Menon RM, Klein CE, Lawal AA, et al. Pharmacokinetics and Tolerability of the HCV Protease Inhibitor ABT-450 Following Single Ascending Doses in Healthy Adult Volunteers With and Without Ritonavir. HepDART, Kohala Coast, HI, 2009.
21. VIEKIRA PAK (ombitasvir, paritaprevir/ritonavir, dasabuvir). Prescribing Information. AbbVie Inc., North Chicago, IL, 2015.
22. Lawitz E, Sullivan G, Rodriguez-Torres M, et al. Exploratory trial of ombitasvir and ABT-450/r with or without ribavirin for HCV genotype 1, 2, and 3 infection. J Infect 2015; 70: 197–205.
23. Pilot-Matias T, Tripathi R, Cohen D, et al. In vitro and in vivo antiviral activity and resistance profile of the hepatitis C virus NS3/4A protease inhibitor ABT-450. Antimicrob Agents Chemother 2015; 59: 988–97.
24. Krishnan P, Beyer J, Mistry N, et al. In vitro and in vivo antiviral activity and resistance profile of ombitasvir, an Inhibitor of HCV NS5A. Antimicrob Agents Chemother 2014; 59: 979–87.
25. Ng T, Krishnan P, Kati W, et al. ABT-530, an HCV NS5A inhibitor with potent pangenotypic activity and high genetic barrier to resistance. Abstract 639. 21st Annual Conference on Retroviruses and Opportunistic Infections. Boston, 2014.
26. Gane E, Nahass R, Luketic V, et al. P0776: Efficacy of 12 or 18 weeks of grazoprevir plus elbasvir with ribavirin in treatment-naive, noncirrhotic HCV genotype 3-infected patients. J Hepatol 2015; 62: S621.
27. Schnell G, Tripathi R, Beyer J, et al. Hepatitis C virus genotype 4 resistance and subtype demographic characterization of patients treated with ombitasvir plus paritaprevir/ritonavir. Antimicrob Agents Chemother 2015; 59: 6807–15.
28. Lawitz EJ, O'Riordan WD, Asatryan A, et al. Potent antiviral activity of direct-acting antivirals, ABT-493 and ABT-530, with 3-day monotherapy for hepatitis C genotype 1 infection. Antimicrob Agents Chemother 2015; 60: 1546–55.
29. A 4-drug combination (Viekira Pak) for hepatitis C. Med Lett Drugs Ther 2015;57:15–7.
30. Colucci G, Ferguson J, Harkleroad C, et al. Improved COBAS TaqMan hepatitis C virus test (Version 2.0) for use with the high pure system: enhanced genotype inclusivity and performance characteristics in a multisite study. J Clin Microbiol 2007; 45: 3595–600.
31. Ng T, Reisch T, Middleton T, et al. ABT-493, a potent HCV NS3/4A protease inhibitor with broad genotypic coverage. Abstract 636. 21st Annual Conference on Retroviruses and Opportunistic Infections. Boston, 2014.
32. Halfon P, Locarnini S. Hepatitis C virus resistance to protease inhibitors. J Hepatol 2011; 55: 192–206.
33. Ng T, Pilot-Matias T, Liangjun L, et al. A next generation HCV DAA combination: potent, pangenotypic inhibitors ABT-493 and ABT-530 with high barriers to resistance. Hepatology 2014; 60: 1142A.
34. Nakamoto S, Kanda T, Wu S, Shirasawa H, Yokosuka O. Hepatitis C virus NS5A inhibitors and drug resistance mutations. World J Gastroenterol 2014; 20: 2902–12.
35. National Institutes of Health, National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. 2009. Available at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed 18 December 2014.
36. Lawitz EJ, O'Riordan WD, Freilich BF, et al. Potent antiviral activity of ABT-493 and ABT-530 with 3-day monotherapy in patients with and without compensated cirrhosis with hepatitis C virus (HCV) genotype 1 infection. Hepatology 2014; 60: 1128A–61A.
37. Gane E, Hyland RH, An D, et al. Once daily sofosbuvir with GS-5816 for 8 weeks with or without ribavirin in patients with HCV genotype 3 without cirrhosis result in high rates of SVR12: the ELECTRON2 study. Abstract #79. Hepatology 2014; 60: 236A.
38. Poordad F, Lawitz EJ, Gutierrez JA, et al. C-SWIFT: Grazoprevir/elbasvir + sofosbuvir in cirrhotic and noncirrhoitic, treatment-naive patients with hepatitis C virus genotype 1 infection, for durations of 4, 6, or 8 weeks and genotype 3 infection for durations of 8 or 12 weeks. J Hepatol 2015; 62: S187–212.