Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection

New England Journal of Medicine

Volumn 378, Issue 4, 2018, Pages 354-369

  Zeuzem, S ^a   Foster, G R ^c   Wang, S ^d   Asatryan, A ^d   Gane, E ^f   Feld, J J ^h   Asselah, T ^k   Bourliere M ^l   Ruane, P J ⁿ   Wedemeyer, H ^b   Pol, S ^m   Flisiak, R ^q   Poordad, F ^r   Chuang, W L ^t   Stedman, C A ^g   Flamm, S ^e   Kwo, P ^o   Dore, G J ^u   Sepulveda Arzola, G ^w   Roberts, S K ^v   Soto Malave, R ^x   Kaita, K ⁱ   Puoti, M ^y   Vierling, J ^s   Tam, E ^j   Vargas, H E ^z   Bruck, R ^aa   Fuster, F ^ab   Paik, S W ^ac   Felizarta, F ^p   Kort, J ^d   Fu, B ^d   Liu, R ^d   Ng, T I ^d   Pilot Matias, T ^d   Lin, C W ^d   Trinh, R ^d   Mensa, F J ^d   more..

^a UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^b HANNOVER MEDICAL SCHOOL   (Germany)

^c QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^d ABBVIE INC   (United States)

^e NORTHWESTERN UNIVERSITY   (United States)

^f AUCKLAND CITY HOSPITAL   (New Zealand)

^g UNIVERSITY OF OTAGO   (New Zealand)

^h UNIVERSITY OF TORONTO   (Canada)

ⁱ UNIVERSITY OF MANITOBA   (Canada)

^j LAIR Centre   (Canada)

^k CENTRE DE RECHERCHE SUR L INFLAMMATION   (France)

^l HÔPITAL SAINT JOSEPH   (France)

^m Groupe Hospitalier Cochin Saint Vincent de Paul ^*  (France)

ⁿ Ruane Medical and Liver Health Institute   (United States)

^o STANFORD UNIVERSITY   (United States)

^p Klinika Chorób Zakaźnych i Hepatologii UM W Białymstoku ^*  (United States)

^q Klinika Chorob Zakaznych I N   (Poland)

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

^s BAYLOR COLLEGE OF MEDICINE   (United States)

^t KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^u UNIVERSITY OF NEW SOUTH WALES   (Australia)

^v ALFRED HOSPITAL   (Australia)

^w Instituto de Investigación Científica Del sur   (Puerto Rico)

^x UNIVERSITY OF PUERTO RICO   (Puerto Rico)

^y OSPEDALE NIGUARDA CA GRANDA   (Italy)

^z MAYO CLINIC   (United States)

^aa TEL AVIV UNIVERSITY   (Israel)

^ab Centro de Investigaciones Clinicas Viña Del Mar   (Chile)

^ac Samsung Medical Center   (South Korea)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; DACLATASVIR; GLECAPREVIR; GLECAPREVIR PLUS PIBRENTASVIR; PIBRENTASVIR; SOFOSBUVIR; ABT-493; ANTIVIRUS AGENT; BENZIMIDAZOLE DERIVATIVE; BMS-790052; IMIDAZOLE DERIVATIVE; QUINOXALINE DERIVATIVE; SULFONAMIDE; VIRUS RNA;

ABDOMINAL PAIN; ADULT; ARTICLE; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 3; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERTRANSAMINASEMIA; MAJOR CLINICAL STUDY; MALAISE; MALE; MIXED INFECTION; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUSTAINED VIROLOGIC RESPONSE; AGED; BLOOD; CHRONIC HEPATITIS C; CLINICAL TRIAL; DRUG ADMINISTRATION; DRUG COMBINATION; GENETICS; GENOTYPE; HEPACIVIRUS; MIDDLE AGED; VERY ELDERLY; VIROLOGY; VIRUS LOAD;

ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; BENZIMIDAZOLES; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; MALE; MIDDLE AGED; QUINOXALINES; RNA, VIRAL; SOFOSBUVIR; SULFONAMIDES; VIRAL LOAD;

EID: 85041385639     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1702417     Document Type: Article

References (36)

1. Blach S, Zeuzem S, Manns M, et al. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol2017; 2: 161-76.
2. 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: Suppl: S45-S57.
3. Asselah T, Thompson AJ, Flisiak R, et al. A predictive model for selecting patients with HCV genotype 3 chronic infection with a high probability of sustained virological response to peginterferon alfa- 2a/ribavirin. PLoS One 2016; 11(3): e0150569.
4. Harvoni (ledipasvir and sofosbuvir). Foster City, CA: Gilead Sciences, 2015 (package insert).
5. Epclusa (sofosbuvir and velpatasvir). Foster City, CA: Gilead Sciences, 2015 (package insert).
6. Viekira Pak (ombitasvir, paritaprevir, ritonavir, dasabuvir). North Chicago, IL: AbbVie, 2015 (package insert).
7. Zepatier (elbasvir, grazoprevir). Whitehouse Station, NJ: Merck Sharp & Dohme, 2016 (package insert).
8. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2016. J Hepatol 2017; 66: 153-94.
9. American Association for the Study of Liver Disease, Infectious Diseases Society of America. HCV guidance: recommendations for testing, managing, and treating hepatitis C virus. 2017 (http://www.hcvguidelines .org).
10. European Association for Study of Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol 2015; 63: 199-236.
11. 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
12. Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med 2015; 373: 2608-17.
13. Townsend K, Petersen T, Gordon LA, et al. Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir. AIDS 2016; 30: 261-6.
14. Schinazi RF, Asselah T. From HCV to HBV cure. Liver Int 2017; 37: Suppl 1: 73-80.
15. Ng TI, Krishnan P, Pilot-Matias T, et al. In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus NS5A inhibitor pibrentasvir. Antimicrob Agents Chemother 2017; 61(5): e02558-16.
16. Ng TI, Tripathi R, Reisch T, et al. In vitro antiviral activity and resistance profile of the next-generation hepatitis c virus NS3/4A protease inhibitor glecaprevir. Antimicrob Agents Chemother 2018; 62(1): e01620-17.
17. Kwo PY, Poordad F, Asatryan A, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol 2017; 67: 263-71.
18. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988; 75: 800-2.
19. Food and Drug Administration. Noninferiority clinical trials to establish effectiveness: guidance for industry. March 2010 (http://www.fda.gov/downloads/Drugs/Guidances/UCM202140 .pdf).
20. Statistical principles for clinical trials E9. ICH harmonised tripartite guideline. 1998 (http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E9/Step4/E9-Guideline.pdf).
21. The European Agency for the Evaluation of Medicinal Products. Points to consider on switching between superiority and non-inferiority. July 2000 (http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003658.pdf).
22. Banerjee D, Reddy KR. Safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy. Aliment Pharmacol Ther 2016; 43: 674-96.
23. Fried MW, Buti M, Dore GJ, et al. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment- naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology 2013; 58: 1918-29.
24. Manns M, Marcellin P, Poordad F, et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment- naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2014; 384: 414-26
25. Kowdley KV, Colombo M, Zadeikis N, 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. Hepatology 2016; 64: Suppl 1: 73.
26. Asselah T, Hezode C, Zadeikis N, et al. ENDURANCE-4: efficacy and safety of glecaprevir/pibrentasvir (formerly ABT- 493/ABT-530) treatment in patients with chronic HCV genotype 4, 5, or 6 infection. Hepatology 2016; 64: Suppl 1: 114.
27. Hassanein T, Wyles D, Wang S, et al. SURVEYOR-II: glecaprevir/pibrentasvir demonstrates high SVR rates in patients with HCV genotype 2, 4, 5, or 6 infection without cirrhosis following an 8-week treatment duration. Hepatology 2016; 64: 1128A.
28. Cavalcante LN, Lyra AC. Predictive factors associated with hepatitis C antiviral therapy response. World J Hepatol 2015; 7: 1617-31.
29. Daklinza (daclatasvir). New York: Bristol-Myers Squibb, 2015 (package insert).
30. Ng TI, Pilot-Matias T, Rakesh T, et al. Analysis of HCV genotype 2 and 3 variants in patients treated with combination therapy of next generation HCV directacting antiviral agents ABT-493 and ABT- Presented at the 2016 International Liver Congress (EASL), Barcelona, April 13-17, 2016. abstract THU-240.
31. 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 3ainfected people who inject drugs in Germany. J Clin Virol 2015; 70: 43-5.
32. 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: 13-8.
33. Gigi E, Sinakos E, Lalla T, Vrettou E, Orphanou E, Raptopoulou M. Treatmentof intravenous drug users with chronic hepatitis C: treatment response, compliance and side effects. Hippokratia 2007; 11: 196-8.
34. Harder J, Walter E, Riecken B, Ihling C, Bauer TM. Hepatitis C virus infection in intravenous drug users. Clin Microbiol Infect 2004; 10: 768-70.
35. Ampuero J, Romero-Gomez M, Reddy KR. HCV genotype 3 - the new treatment challenge. Aliment Pharmacol Ther 2014; 39: 686-98.
36. Pawlotsky JM, Tsakiris L, Roudot- Thoraval F, et al. Relationship between hepatitis C virus genotypes and sources of infection in patients with chronic hepatitis C. J Infect Dis 1995; 171: 1607-10.