High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: An integrated analysis of HCV genotype 1–6 patients without cirrhosis

Journal of Hepatology

Volumn 69, Issue 2, 2018, Pages 293-300

  Puoti, Massimo ^a   Foster, Graham R ^b   Wang, Stanley ^c   Mutimer, David ^d   Gane, Edward ^e   Moreno, Christophe ^f   Chang, Ting Tsung ^g   Lee, Samuel S ^h   Marinho, Rui ⁱ   Dufour, Jean Francois ^j   Pol, Stanislas ^k   Hezode, Christophe ^l   Gordon, Stuart C ^m   Strasser, Simone I ⁿ   Thuluvath, Paul J ^o   Zhang, Zhenzhen ^c   Lovell, Sandra ^c   Pilot Matias, Tami ^c   Mensa, Federico J ^c  

^a OSPEDALE NIGUARDA CA GRANDA   (Italy)

^b QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^c ABBVIE INC   (United States)

^d University Hospital Birmingham NHS Foundation Trust   (United Kingdom)

^e UNIVERSITY OF AUCKLAND   (New Zealand)

^f ERASME HOSPITAL   (Belgium)

^g NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^h UNIVERSITY OF CALGARY   (Canada)

ⁱ UNIVERSITY OF LISBON   (Portugal)

^j UNIVERSITY OF BERN   (Switzerland)

^k UNIVERSITÉ PARIS DESCARTES   (France)

^l UNIVERSITÉ PARIS EST CRÉTEIL   (France)

^m HENRY FORD HEALTH SYSTEM   (United States)

ⁿ ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^o UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

more..

Author keywords

Direct acting antiviral; Hepatitis C; Pangenotypic; Short duration

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; GLECAPREVIR PLUS PIBRENTASVIR; PEGINTERFERON; RIBAVIRIN; SOFOSBUVIR; VIRUS RNA; ABT-493; ANTIVIRUS AGENT; BENZIMIDAZOLE DERIVATIVE; PIBRENTASVIR; QUINOXALINE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIVIRAL THERAPY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CHRONIC HEPATITIS C; COMBINATION DRUG THERAPY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEADACHE; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 2; HEPATITIS C VIRUS GENOTYPE 3; HEPATITIS C VIRUS GENOTYPE 4; HEPATITIS C VIRUS GENOTYPE 5; HEPATITIS C VIRUS GENOTYPE 6; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INTENTION TO TREAT ANALYSIS; LIVER CIRRHOSIS; LIVER FIBROSIS; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SUSTAINED VIROLOGIC RESPONSE; TREATMENT DURATION; TREATMENT RESPONSE; VIRUS LOAD; CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; GENETICS; GENOTYPE; HEPACIVIRUS; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL; TIME FACTOR; TREATMENT OUTCOME; VIROLOGY;

ADULT; AGED; ANTIVIRAL AGENTS; BENZIMIDAZOLES; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; MALE; MIDDLE AGED; QUINOXALINES; SULFONAMIDES; SUSTAINED VIROLOGIC RESPONSE; TIME FACTORS; TREATMENT OUTCOME;

EID: 85047068884     PISSN: 01688278     EISSN: 16000641     Source Type: Journal    
DOI: 10.1016/j.jhep.2018.03.007     Document Type: Article

References (32)

1. Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol 2 (2017), 161–176.
2. http://polarisobservatory.org/polaris/graphs.htm (accessed 10 July 2017).
3. AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus, 2017.
4. European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol 2018;69:461–511.
5. Hatzakis, A., Chulanov, V., Gadano, A.C., Bergin, C., Ben-Ari, Z., Mossong, J., et al. The present and future disease burden of hepatitis C virus (HCV) infections with today's treatment paradigm - volume 2. J Viral Hepat 22 (2015), 26–45.
6. Razavi, H., Waked, I., Sarrazin, C., Myers, R.P., Idilman, R., Calinas, F., et al. The present and future disease burden of hepatitis C virus (HCV) infection with today's treatment paradigm. J Viral Hepat 21 (2014), 34–59.
7. Younossi, Z.M., Kanwal, F., Saab, S., Brown, K.A., El-Serag, H.B., Kim, W.R., et al. The impact of hepatitis C burden: an evidence-based approach. Aliment Pharmacol Ther 39 (2014), 518–531.
8. Lafferty, L., Treloar, C., Guthrie, J., Chambers, G.M., Butler, T., Social capital strategies to enhance hepatitis C treatment awareness and uptake among men in prison. J Viral Hepat 24 (2017), 111–116.
9. Gilead Sciences. HARVONI (ledipasvir and sofosbuvir). Prescribing information. 2015, Gilead Sciences, Foster City.
10. AbbVie, VIEKIRAX + EXVIERA (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). Summary of product characteristics. 2016, AbbVie, Maidenhead http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003839/WC500183997.pdf (accessed 1 October 2017).
11. AbbVie, Mavyret (glecaprevir/pibrentasvir). Prescribing information. 2017, AbbVie, North Chicago.
12. AbbVie, Maviret (glecaprevir/pibrentasvir). Summary of product characteristics. 2017, AbbVie, Maidenhead http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004430/WC500233677.pdf (accessed 1 October 2017).
13. Ng, T., 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, 61, 2017 pii: e02558-16.
14. Ng, T.I., Tripathi, R., Reisch, T., Lu, L., Middleton, T., Hopkins, T.A., et al. In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus NS3/4A protease inhibitor glecaprevir. Antimicrob Agents Chemother, 62, 2018 pii: e01620-17.
15. Kosloski M, Zhao W, Asatryan A, Kort J, Geoffroy P, Liu W. No clinically relevant drug-drug interactions between methadone or buprenorphine/naloxone and anti-viral combination glecaprevir and pibrentasvir. Antimicrob Agents Chemother 2017;61 (10) pii: e00958–17.
16. Zeuzem, S., Foster, G.R., Wang, S., Asatryan, A., Gane, E., Feld, J.J., et al. Glecaprevir–pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med 378 (2018), 354–369.
17. Asselah, T., Kowdley, K.V., Zadeikis, N., Wang, S., Hassanein, T., Horsmans, Y., et al. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 weeks in Patients with Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. Clinical Gastroenterology and Hepatology 16 (2018), 417–426.
18. Kwo, P.Y., Poordad, F., Asatryan, A., Wang, S., Wyles, D.L., Hassanein, T., et al. High SVR rates upon 8- or 12-week treatment with glecaprevir and pibrentasvir in patients with chronic HCV genotype 1–6 infection without cirrhosis. J Hepatol 67 (2017), 263–271.
19. Rockstroh, J., Lacombe, K., Viani, R.M., Orkin, C., Wyles, D., Luetkemeyer, A., et al. Efficacy and safety of glecaprevir/pibrentasvir in patients co-infected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 study, Abstract #522. J Hepatol, 66, 2017, S102.
20. Gane, E., Lawitz, E., Pugatch, D., Papatheodoridis, G., Brau, N., Brown, A., et al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med 377 (2017), 1448–1455.
21. Gilead Sciences. VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) prescribing information. 2017, Gilead Sciences, Foster City.
22. VOSEVI (sofosbuvir/velpatasvir/voxilaprevir). Summary of product characteristics. 2017, Gilead Sciences International Ltd., Cambridge http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004350/WC500235373.pdf (accessed 1 October 2017).
23. Jacobson, I.M., Lawitz, E., Gane, E.J., Willems, B.E., Ruane, P.J., Nahass, R.G., et al. Efficacy of 8 weeks of sofosbuvir, velpatasvir, and voxilaprevir in patients with chronic HCV infection: 2 phase 3 randomized trials. Gastroenterology 153 (2017), 113–122.
24. Kwo, P.Y., Vinayek, R., The therapeutic approaches for hepatitis C virus: protease inhibitors and polymerase inhibitors. Gut Liver 5 (2011), 406–417.
25. Chae, H.B., Park, S.M., Youn, S.J., Direct-acting antivirals for the treatment of chronic hepatitis C: open issues and future perspectives. Sci World J, 2013, 2013, 704912.
26. Banerjee, D., Reddy, K.R., Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy. Aliment Pharmacol Ther 43 (2016), 674–696.
27. Bourlière, M., Gordon, S.C., Flamm, S.L., Cooper, C.L., Ramji, A., Tong, M., et al. Sofosbuvir, velpatasvir, and voxilaprevir for previously treated HCV infection. N Engl J Med 376 (2017), 2134–2146.
28. Gilead Sciences. EPCLUSA (sofosbuvir and velpatasvir) prescribing information. 2016, Gilead Sciences, Foster City.
29. Merck, Sharp & Dohme. Zepatier (elbasvir/grazoprevir) prescribing information. 2016, Merck, Sharp & Dohme, Whitehouse Station.
30. AbbVie, VIEKIRA PAK (ombitasvir, paritaprevir/ritonavir, dasabuvir). Prescribing information. 2015, AbbVie, North Chicago.
31. Ge, P.S., Runyon, B.A., Treatment of patients with cirrhosis. N Engl J Med 375 (2016), 767–777.
32. Negro, F., Forton, D., Craxi, A., Sulkowski, M.S., Feld, J.J., Manns, M.P., et al. Extrahepatic morbidity and mortality of chronic hepatitis C. Gastroenterology 149 (2015), 1345–1360.