Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial

Hepatology

Volumn 67, Issue 2, 2018, Pages 514-523

  Wyles, David ^a   Poordad, Fred ^b   Wang, Stanley ^c   Alric, Laurent ^d   Felizarta, Franco ^e   Kwo, Paul Y ^f   Maliakkal, Benedict ^g   Agarwal, Kosh ^h   Hassanein, Tarek ⁱ   Weilert, Frank ^j   Lee, Samuel S ^k   Kort, Jens ^c   Lovell, Sandra S ^c   Liu, Ran ^c   Lin, Chih Wei ^c   Pilot Matias, Tami ^c   Krishnan, Preethi ^c   Mensa, Federico J ^c  

^a DENVER HEALTH MEDICAL CENTER   (United States)

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

^c ABBVIE INC   (United States)

^d UMR 152 IRD Universite Paul Sabatier   (France)

^e Private Practice   (United States)

^f STANFORD UNIVERSITY   (United States)

^g UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^h KING S COLLEGE HOSPITAL   (United Kingdom)

ⁱ Southern California Liver Centers and Southern California Research Center   (United States)

^j Tawa Street Specialist Clinic   (New Zealand)

^k UNIVERSITY OF CALGARY   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; GLECAPREVIR PLUS PIBRENTASVIR; ABT-493; ANTIVIRUS AGENT; BENZIMIDAZOLE DERIVATIVE; PIBRENTASVIR; QUINOXALINE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIVIRAL THERAPY; ARTICLE; ASPARTATE AMINOTRANSFERASE LEVEL; BILIRUBIN BLOOD LEVEL; COMPENSATED LIVER CIRRHOSIS; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 3; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUSTAINED VIROLOGIC RESPONSE; BLOOD; CHRONIC HEPATITIS C; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPLICATION; GENOTYPE; LIVER CIRRHOSIS; MIDDLE AGED; VIROLOGY;

ADULT; AGED; ALANINE TRANSAMINASE; ANTIVIRAL AGENTS; BENZIMIDAZOLES; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPATITIS C, CHRONIC; HUMANS; LIVER CIRRHOSIS; MALE; MIDDLE AGED; QUINOXALINES; SULFONAMIDES; SUSTAINED VIROLOGIC RESPONSE;

EID: 85040766496     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.29541     Document Type: Article

References (28)

1. Adinolfi LE, Gambardella M, Andreana A, Tripodi MF, Utili R, Ruggiero G. Steatosis accelerates the progression of liver damage of chronic hepatitis C patients and correlates with specific HCV genotype and visceral obesity. Hepatology 2001;33:1358-1364.
2. Fartoux L, Poujol-Robert A, Guechot J, Wendum D, Poupon R, Serfaty L. Insulin resistance is a cause of steatosis and fibrosis progression in chronic hepatitis C. Gut 2005;54:1003-1008.
3. Leandro G, Mangia A, Hui J, Fabris P, Rubbia-Brandt L, Colloredo G, et al. Relationship between steatosis, inflammation, and fibrosis in chronic hepatitis C: a meta-analysis of individual patient data. Gastroenterology 2006;130:1636-1642.
4. Asselah T, Rubbia-Brandt L, Marcellin P, Negro F. Steatosis in chronic hepatitis C: why does it really matter? Gut 2006;55:123-130.
5. Kumar D, Farrell GC, Fung C, George J. Hepatitis C virus genotype 3 is cytopathic to hepatocytes: reversal of hepatic steatosis after sustained therapeutic response. Hepatology 2002;36:1266-1272.
6. Rubbia-Brandt L, Quadri R, Abid K, Giostra E, Male PJ, Mentha G, et al. Hepatocyte steatosis is a cytopathic effect of hepatitis C virus genotype 3. J Hepatol 2000;33:106-115.
7. Bochud PY, Cai T, Overbeck K, Bochud M, Dufour JF, Mullhaupt B, et al. Genotype 3 is associated with accelerated fibrosis progression in chronic hepatitis C. J Hepatol 2009;51:655-666.
8. De Nicola S, Aghemo A, Rumi MG, Colombo M. HCV genotype 3: an independent predictor of fibrosis progression in chronic hepatitis C. J Hepatol 2009;51:964-966.
9. Nkontchou G, Ziol M, Aout M, Lhabadie M, Baazia Y, Mahmoudi A, et al. HCV genotype 3 is associated with a higher hepatocellular carcinoma incidence in patients with ongoing viral C cirrhosis. J Viral Hepat 2011;18:e516-e522.
10. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, 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;61:1127-1135.
11. Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: a randomized phase III study (ALLY-3+). Hepatology 2016;63:1430-1441.
12. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. HCV guidance: recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org/sites/default/files/full-guidance-pdf/HCVGuidance_September_21_2017_e.pdf. Published September 2017.
13. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2016. J Hepatol 2017;66:153-194.
14. Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med 2015;373:2608-2617.
15. Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, et al. Sofosbuvir plus velpatasvir combination therapy for treatment-experienced patients with genotype 1 or 3 hepatitis C virus infection: a randomized trial. Ann Intern Med 2015;163:809-817.
16. Ng T, Reisch T, Middleton T, McDaniel K, Kempf D, Lu L, et al. ABT-493, a potent HCV NS3/4A protease inhibitor with broad genotypic coverage [Abstract]. In: 21st Annual Conference on Retroviruses and Opportunistic Infections; March 3-6, 2014; Boston, MA. Abstract 636.
17. Ng T, Pilot-Matias T, Tripathi R, Schnell G, Reisch T, Beyer J, et al. Analysis of HCV genotype 2 and 3 variants in patients treated with combination therapy of next generation HCV direct-acting antiviral agents ABT-493 and ABT-530 [Abstract]. In: The International Liver Conference; April 13-17, 2016; Barcelona, Spain; 2016. Abstract 430.
18. Ng TI, Krishnan P, Pilot-Matias T, Kati W, Schnell G, Beyer J, et al. In vitro. antiviral activity and resistance profile of the next generation hepatitis C virus NS5A inhibitor pibrentasvir. Antimicrob Agents Chemother 2017;61:e02558-16.
19. Kosloski MP, Dutta S, Zhao W, Pugatch D, Mensa F, Kort J, et al. Pharmacokinetics, safety, and tolerability of next generation direct-acting antivirals ABT-493 and ABT-530 in subjects with renal impairment [Abstract]. In: The International Liver Conference; April 13-17, 2016; Barcelona, Spain. Abstract THU-230.
20. Mavyret (glecaprevir and pibrentasvir tablets) [US package insert]. North Chicago, IL: AbbVie; 2017.
21. Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol 2017;67:263-271.
22. Epclusa (sofosbuvir and velpatasvir) [package insert]. Foster City, CA: Gilead Sciences; 2016.
23. Daklinza (daclatasvir) [package insert]. Princeton, NJ: Bristol-Meyers Squibb; 2016.
24. Hernandez D, Zhou N, Ueland J, Monikowski A, McPhee F. Natural prevalence of NS5A polymorphisms in subjects infected with hepatitis C virus genotype 3 and their effects on the antiviral activity of NS5A inhibitors. J Clin Virol 2013;57:13-18.
25. Walker A, Siemann H, Groten S, Ross RS, Scherbaum N, Timm J. Natural prevalence of resistance-associated variants in hepatitis C virus NS5A in genotype 3a–infected people who inject drugs in Germany. J Clin Virol 2015;70:43-45.
26. Banerjee D, Reddy KR. Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy. Aliment Pharmacol Ther 2016;43:674-696.
27. Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med 2015;373:2599-2607.
28. Kowdley KV, Colombo M, Zadeikis N, Mantry P, Calinas F, Aguilar H, et al. ENDURANCE-2: safety and efficacy of glecaprevir/pibrentasvir in hepatitis C virus genotype 2-infected patients without cirrhosis: a randomized, double-blind, placebo-controlled study [Abstract]. In: The Liver Meeting; November 11-15, 2016; Boston, MA; 2016. Abstract 73.