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Items: 38

1.

Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection.

Lawitz E, Flisiak R, Abunimeh M, Sise ME, Park JY, Kaskas M, Bruchfeld A, Wörns MA, Aglitti A, Zamor PJ, Xue Z, Schnell G, Jalundhwala YJ, Porcalla A, Mensa FJ, Persico M.

Liver Int. 2019 Dec 10. doi: 10.1111/liv.14320. [Epub ahead of print]

PMID:
31821716
2.

Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial.

Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horváth G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbánek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F.

J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.

3.

Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials.

Brown A, Welzel TM, Conway B, Negro F, Bräu N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T.

Liver Int. 2019 Sep 30. doi: 10.1111/liv.14266. [Epub ahead of print]

PMID:
31568620
4.

Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis.

Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F.

J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.

5.

Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease.

Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Wörns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ.

Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022.

6.

Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection.

Naganuma A, Chayama K, Notsumata K, Gane E, Foster GR, Wyles D, Kwo P, Crown E, Bhagat A, Mensa FJ, Otani T, Larsen L, Burroughs M, Kumada H.

J Gastroenterol. 2019 Aug;54(8):752-761. doi: 10.1007/s00535-019-01569-7. Epub 2019 Mar 13.

7.

Drug-Drug Interactions of Tacrolimus or Cyclosporine With Glecaprevir and Pibrentasvir in Healthy Subjects.

Kosloski MP, Zhao W, Li H, Pugatch D, Asatryan A, Kort J, Mensa FJ, Liu W.

Clin Pharmacol Drug Dev. 2019 Aug;8(6):779-789. doi: 10.1002/cpdd.671. Epub 2019 Mar 12.

PMID:
30861340
8.

Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection.

Wyles D, Weiland O, Yao B, Weilert F, Dufour JF, Gordon SC, Stoehr A, Brown A, Mauss S, Zhang Z, Pilot-Matias T, Rodrigues L Jr, Mensa FJ, Poordad F.

J Hepatol. 2019 May;70(5):1019-1023. doi: 10.1016/j.jhep.2019.01.031. Epub 2019 Mar 8. No abstract available.

PMID:
30857780
9.

Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C genotypes 1-6 receiving opioid substitution therapy.

Grebely J, Dore GJ, Alami NN, Conway B, Dillon JF, Gschwantler M, Felizarta F, Hézode C, Tomasiewicz K, Fredrick LM, Dumas EO, Mensa FJ.

Int J Drug Policy. 2019 Apr;66:73-79. doi: 10.1016/j.drugpo.2019.01.011. Epub 2019 Feb 6.

10.

Safety and efficacy of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in patients aged 65 years or older.

Foster GR, Asselah T, Kopecky-Bromberg S, Lei Y, Asatryan A, Trinh R, Zadeikis N, Mensa FJ.

PLoS One. 2019 Jan 2;14(1):e0208506. doi: 10.1371/journal.pone.0208506. eCollection 2019.

11.

Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies.

Foster GR, Dore GJ, Wang S, Grebely J, Sherman KE, Baumgarten A, Conway B, Jackson D, Asselah T, Gschwantler M, Tomasiewicz K, Aguilar H, Asatryan A, Hu Y, Mensa FJ.

Drug Alcohol Depend. 2019 Jan 1;194:487-494. doi: 10.1016/j.drugalcdep.2018.11.007. Epub 2018 Nov 24.

PMID:
30529905
12.

Glecaprevir/pibrentasvir for the treatment of chronic hepatitis C virus infection.

Mensa FJ, Lovell S, Pilot-Matias T, Liu W.

Future Microbiol. 2019 Jan;14:89-110. doi: 10.2217/fmb-2018-0233. Epub 2018 Nov 30. Review.

PMID:
30499343
13.

Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis.

Flamm S, Mutimer D, Asatryan A, Wang S, Rockstroh J, Horsmans Y, Kwo PY, Weiland O, Villa E, Heo J, Gane E, Ryder SD, Welzel TM, Ruane PJ, Agarwal K, Ng TI, Xue Z, Lovell SS, Krishnan P, Kopecky-Bromberg S, Trinh R, Mensa FJ, Wyles DL.

J Viral Hepat. 2019 Mar;26(3):337-349. doi: 10.1111/jvh.13038. Epub 2018 Dec 11.

PMID:
30421537
14.

Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial.

Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K.

Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2.

PMID:
30393106
15.

Pharmacokinetics and safety of glecaprevir and pibrentasvir in HCV-negative subjects with hepatic impairment.

Kosloski MP, Wang H, Pugatch D, Mensa FJ, Gane E, Lawitz E, Marbury TC, Preston RA, Kort J, Liu W.

Eur J Clin Pharmacol. 2019 Feb;75(2):217-226. doi: 10.1007/s00228-018-2576-4. Epub 2018 Oct 19.

PMID:
30341499
16.

Pooled Resistance Analysis in Patients with Hepatitis C Virus Genotype 1 to 6 Infection Treated with Glecaprevir-Pibrentasvir in Phase 2 and 3 Clinical Trials.

Krishnan P, Pilot-Matias T, Schnell G, Tripathi R, Ng TI, Reisch T, Beyer J, Dekhtyar T, Irvin M, Xie W, Larsen L, Mensa FJ, Collins C.

Antimicrob Agents Chemother. 2018 Sep 24;62(10). pii: e01249-18. doi: 10.1128/AAC.01249-18. Print 2018 Oct.

17.

Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection.

Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ.

Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10.

18.

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

Puoti M, Foster GR, Wang S, Mutimer D, Gane E, Moreno C, Chang TT, Lee SS, Marinho R, Dufour JF, Pol S, Hezode C, Gordon SC, Strasser SI, Thuluvath PJ, Zhang Z, Lovell S, Pilot-Matias T, Mensa FJ.

J Hepatol. 2018 Aug;69(2):293-300. doi: 10.1016/j.jhep.2018.03.007. Epub 2018 Mar 16.

19.

Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.

Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, Asselah T, Bourlière M, Ruane PJ, Wedemeyer H, Pol S, Flisiak R, Poordad F, Chuang WL, Stedman CA, Flamm S, Kwo P, Dore GJ, Sepulveda-Arzola G, Roberts SK, Soto-Malave R, Kaita K, Puoti M, Vierling J, Tam E, Vargas HE, Bruck R, Fuster F, Paik SW, Felizarta F, Kort J, Fu B, Liu R, Ng TI, Pilot-Matias T, Lin CW, Trinh R, Mensa FJ.

N Engl J Med. 2018 Jan 25;378(4):354-369. doi: 10.1056/NEJMoa1702417.

20.

Proton-pump inhibitors and glecaprevir plus pibrentasvir in HCV infection - Authors' reply.

Forns X, Mensa FJ.

Lancet Infect Dis. 2017 Dec;17(12):1240. doi: 10.1016/S1473-3099(17)30644-8. No abstract available.

PMID:
29173884
21.

Glecaprevir/Pibrentasvir in patients with hepatitis C virus genotype 1 or 4 and past direct-acting antiviral treatment failure.

Poordad F, Pol S, Asatryan A, Buti M, Shaw D, Hézode C, Felizarta F, Reindollar RW, Gordon SC, Pianko S, Fried MW, Bernstein DE, Gallant J, Lin CW, Lei Y, Ng TI, Krishnan P, Kopecky-Bromberg S, Kort J, Mensa FJ.

Hepatology. 2018 Apr;67(4):1253-1260. doi: 10.1002/hep.29671. Epub 2018 Jan 30.

22.

Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment.

Gane E, Lawitz E, Pugatch D, Papatheodoridis G, Bräu N, Brown A, Pol S, Leroy V, Persico M, Moreno C, Colombo M, Yoshida EM, Nelson DR, Collins C, Lei Y, Kosloski M, Mensa FJ.

N Engl J Med. 2017 Oct 12;377(15):1448-1455. doi: 10.1056/NEJMoa1704053.

23.

Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis.

Asselah T, Kowdley KV, Zadeikis N, Wang S, Hassanein T, Horsmans Y, Colombo M, Calinas F, Aguilar H, de Ledinghen V, Mantry PS, Hezode C, Marinho RT, Agarwal K, Nevens F, Elkhashab M, Kort J, Liu R, Ng TI, Krishnan P, Lin CW, Mensa FJ.

Clin Gastroenterol Hepatol. 2018 Mar;16(3):417-426. doi: 10.1016/j.cgh.2017.09.027. Epub 2017 Sep 22.

PMID:
28951228
24.

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

Wyles D, Poordad F, Wang S, Alric L, Felizarta F, Kwo PY, Maliakkal B, Agarwal K, Hassanein T, Weilert F, Lee SS, Kort J, Lovell SS, Liu R, Lin CW, Pilot-Matias T, Krishnan P, Mensa FJ.

Hepatology. 2018 Feb;67(2):514-523. doi: 10.1002/hep.29541. Epub 2018 Jan 4.

25.

Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial.

Forns X, Lee SS, Valdes J, Lens S, Ghalib R, Aguilar H, Felizarta F, Hassanein T, Hinrichsen H, Rincon D, Morillas R, Zeuzem S, Horsmans Y, Nelson DR, Yu Y, Krishnan P, Lin CW, Kort JJ, Mensa FJ.

Lancet Infect Dis. 2017 Oct;17(10):1062-1068. doi: 10.1016/S1473-3099(17)30496-6. Epub 2017 Aug 14.

PMID:
28818546
26.

Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis.

Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ.

J Hepatol. 2017 Aug;67(2):263-271. doi: 10.1016/j.jhep.2017.03.039. Epub 2017 Apr 13.

PMID:
28412293
27.

Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment.

Poordad F, Felizarta F, Asatryan A, Sulkowski MS, Reindollar RW, Landis CS, Gordon SC, Flamm SL, Fried MW, Bernstein DE, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ.

Hepatology. 2017 Aug;66(2):389-397. doi: 10.1002/hep.29081. Epub 2017 Apr 10. Erratum in: Hepatology. 2017 Nov;66(5):1708.

28.

HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection.

Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR.

Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. eCollection 2016.

29.

Resistance Analyses of HCV NS3/4A Protease and NS5B Polymerase from Clinical Studies of Deleobuvir and Faldaprevir.

Berger KL, Sarrazin C, Nelson DR, Scherer J, Sha N, Marquis M, Côté-Martin A, Vinisko R, Stern JO, Mensa FJ, Kukolj G.

PLoS One. 2016 Aug 5;11(8):e0160668. doi: 10.1371/journal.pone.0160668. eCollection 2016.

30.

High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis.

Gane E, Poordad F, Wang S, Asatryan A, Kwo PY, Lalezari J, Wyles DL, Hassanein T, Aguilar H, Maliakkal B, Liu R, Lin CW, Ng TI, Kort J, Mensa FJ.

Gastroenterology. 2016 Oct;151(4):651-659.e1. doi: 10.1053/j.gastro.2016.07.020. Epub 2016 Jul 25.

PMID:
27456384
31.

Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study.

Zeuzem S, Mantry P, Soriano V, Buynak RJ, Dufour JF, Pockros PJ, Wright D, Angus P, Buti M, Stern JO, Kadus W, Vinisko R, Böcher W, Mensa FJ.

Eur J Gastroenterol Hepatol. 2016 Aug;28(8):923-6. doi: 10.1097/MEG.0000000000000649.

PMID:
27140229
32.

ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection.

Asselah T, Zeuzem S, Soriano V, Bronowicki JP, Lohse AW, Müllhaupt B, Schuchmann M, Bourlière M, Buti M, Roberts SK, Gane EJ, Stern JO, Voss F, Baum P, Gallivan JP, Böcher WO, Mensa FJ.

PLoS One. 2015 Dec 9;10(12):e0144004. doi: 10.1371/journal.pone.0144004. eCollection 2015.

33.

Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis.

Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Müllhaupt B, Roberts S, Schuchmann M, Manns M, Bourlière M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Böcher W, Mensa FJ; SOUND-C2 Study Group.

Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.

34.

Interferon-free treatment of chronic hepatitis C with faldaprevir, deleobuvir and ribavirin: SOUND-C3, a Phase 2b study.

Zeuzem S, Dufour JF, Buti M, Soriano V, Buynak RJ, Mantry P, Taunk J, Stern JO, Vinisko R, Gallivan JP, Böcher W, Mensa FJ; SOUND-C3 study group.

Liver Int. 2015 Feb;35(2):417-21. doi: 10.1111/liv.12693. Epub 2014 Oct 16.

PMID:
25263751
35.

Steady-state pharmacokinetics of nevirapine extended-release tablets in HIV-1-infected children and adolescents: an open-label, multiple-dose, cross-over study.

Giaquinto C, Anabwani G, Feiterna-Sperling C, Nuttall J, Mompati K, Königs C, Mensa FJ, Sabo JP, Yong CL, MacGregor TR, Nguyen T, Quinson AM.

Pediatr Infect Dis J. 2014 Jul;33(7):e173-9. doi: 10.1097/INF.0000000000000241.

PMID:
24378938
36.

Faldaprevir and deleobuvir for HCV genotype 1 infection.

Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Müllhaupt B, Schuchmann M, Bourlière M, Buti M, Roberts SK, Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Böcher WO, Mensa FJ.

N Engl J Med. 2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.

37.

Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results.

Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Müllhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Böcher WO, Mensa FJ.

Antivir Ther. 2013;18(8):1015-9. doi: 10.3851/IMP2567. Epub 2013 Apr 4.

PMID:
23558093
38.

Concordance between sustained virologic response week 12 (SVR12) and SVR24 in genotype 1 hepatitis C virus patients receiving interferon-free treatment in the SOUND-C2 study.

Zeuzem S, Mensa FJ.

Hepatology. 2013 Oct;58(4):1516. doi: 10.1002/hep.26363. Epub 2013 Aug 14. No abstract available.

PMID:
23471832

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