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Infectious Disorders - Drug Targets

Author(s): Amal Ahmed Mohamed, Naglaa El-Toukhy Ramadan El-Toukhy, Ebada Mohamed Said, Hoda Mohamed Rabie Gabal, Hossameldin AbdelAziz, Wahid Doss, Hadeel El-Hanafi, Hala H. El Deeb, Seham Mahmoud, Mahmoud Elkadeem, Hassan Salama Shalby and Sherief Abd-Elsalam*

DOI: 10.2174/1871526519666190121114003

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Hepatitis C Virus: Efficacy of New DAAs Regimens

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Abstract

Background: HCV treatment showed dramatical change due to the introduction of potent, strong, direct antiviral drugs. Before the appearance of Direct-acting antivirals, multiple therapeutic interventions were used for hepatitis C, but none of these interventions were effective on patient-centered outcomes. Direct-acting antivirals cause disruption of viral replication because they target specific nonstructural viral proteins.

Aim: To review the advantages of efficient HCV therapy and its long term drawbacks.

Methods: A search of the literature published in indexed databases (PubMed, Medline In-Process, and Embase) within the last 5 years was conducted. Any duplicated citations were excluded before first-pass screening. Citations (titles and abstracts) were screened for eligibility by a single reviewer. Full texts (including congress abstracts, posters and other congress communications) of citations deemed relevant during title and abstract screening were retrieved for second-pass review.

Results: Studies on the clinical effects of DAAs for hepatitis C show better tolerance, improved survival and fewer complications when compared to previous interferon therapy.

Conclusion: HCV treatment has improved dramatically. Since that time, there are multiple approved oral therapies all with high efficacy. The most important factor which should be considered during choosing appropriate therapy is to ensure that it covers the viral genotype of the infected patients.

Keywords: Direct-acting antivirals, HCV therapy, HCV treatment, sofosbuvir, interferon, DAA.

[1]
WHO Hepatitis C. WHO fact sheet N 164, 2017.Available from: . http://www.who.int/mediacentre/factsheets/ fs164/en/
[2]
Manns, M.P.; McHutchison, J.G.; Gordon, S.C.; Rustgi, V.K.; Shiffman, M.; Reindollar, R.; Goodman, Z.D.; Koury, K.; Ling, M.; Albrecht, J.K. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet, 2001, 358(9286), 958-965.
[http://dx.doi.org/10.1016/S0140-6736(01)06102-5] [PMID: 11583749]
[3]
Fried, M.W.; Shiffman, M.L.; Reddy, K.R.; Smith, C.; Marinos, G.; Gonçales, F.L., Jr; Häussinger, D.; Diago, M.; Carosi, G.; Dhumeaux, D.; Craxi, A.; Lin, A.; Hoffman, J.; Yu, J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N. Engl. J. Med., 2002, 347(13), 975-982.
[http://dx.doi.org/10.1056/NEJMoa020047] [PMID: 12324553]
[4]
Spengler, U. Direct antiviral agents (DAAs) - A new age in the treatment of hepatitis C virus infection. Pharmacol. Ther., 2017, 183, 118-126.
[http://dx.doi.org/10.1016/j.pharmthera.2017.10.009] [PMID: 29024739]
[5]
Ahmed, O.A.; Kaisar, H.H.; Hawash, N.; Samir, H.; Shabana, S.S.T.; Hassan A Fouad, M.; Rizk, F.; Abd-Elsalam, S. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in treatment of a cohort of Egyptian patients with hepatitis C virus infection. Infect. Disord. Drug Targets, 2017, 17(2), 95-100.
[http://dx.doi.org/10.2174/1871526517666170417143216] [PMID: 28413993]
[6]
Abd-Elsalam, S.; Sharaf-Eldin, M.; Soliman, S.; Elfert, A.; Badawi, R.; Ahmad, Y.K. Efficacy and safety of sofosbuvir plus ribavirin for treatment of cirrhotic patients with genotype 4 hepatitis C virus in real-life clinical practice. Arch. Virol., 2018, 163(1), 51-56.
[http://dx.doi.org/10.1007/s00705-017-3573-0] [PMID: 28983675]
[7]
Ahmed, O.A.; Elsebaey, M.A.; Fouad, M.H.A.; Elashry, H.; Elshafie, A.I.; Elhadidy, A.A.; Esheba, N.E.; Elnaggar, M.H.; Soliman, S.; Abd-Elsalam, S. Outcomes and predictors of treatment response with sofosbuvir plus daclatasvir with or without ribavirin in Egyptian patients with genotype 4 hepatitis C virus infection. Infect. Drug Resist., 2018, 11, 441-445.
[http://dx.doi.org/10.2147/IDR.S160593] [PMID: 29628768]
[8]
Ahmed, O.A.; Kaisar, H.H.; Badawi, R.; Hawash, N.; Samir, H.; Shabana, S.S.; Fouad, M.H.A.; Rizk, F.H.; Khodeir, S.A.; Abd-Elsalam, S. Efficacy and safety of sofosbuvir-ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection. Infect. Drug Resist., 2018, 11, 295-298.
[http://dx.doi.org/10.2147/IDR.S153060] [PMID: 29535545]
[9]
Ahmed, O.A.; Safwat, E.; Khalifa, M.O.; Elshafie, A.I.; Fouad, M.H.A.; Salama, M.M.; Naguib, G.G.; Eltabbakh, M.M.; Sherief, A.F.; Abd-Elsalam, S. Sofosbuvir Plus daclatasvir in treatment of chronic hepatitis C genotype 4 infection in a cohort of egyptian patients: An experiment the size of egyptian village. Int. J. Hepatol., 2018, 20189616234
[http://dx.doi.org/10.1155/2018/9616234] [PMID: 29755792]
[10]
Das, D.; Pandya, M. Recent advancement of Direct-acting antiviral agents (DAAs) in Hepatitis C therapy. Mini Rev. Med. Chem., 2018, 18(7), 584-596.
[http://dx.doi.org/10.2174/1389557517666170913111930] [PMID: 28901852]
[11]
WHO.WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection updated version april 2016., 2016. Available from: . http://apps.who.int/iris/bitstream/10665/ 205035/1/9789241549615_eng.pdf
[12]
Bartenschlager, R.; Ahlborn-Laake, L.; Mous, J.; Jacobsen, H. Nonstructural protein 3 of the hepatitis C virus encodes a serine-type proteinase required for cleavage at the NS3/4 and NS4/5 junctions. J. Virol., 1993, 67(7), 3835-3844.
[http://dx.doi.org/10.1128/JVI.67.7.3835-3844.1993] [PMID: 8389908]
[13]
Poordad, F.; Dieterich, D. Treating hepatitis C: current standard of care and emerging direct-acting antiviral agents. J. Viral Hepat., 2012, 19(7), 449-464.
[http://dx.doi.org/10.1111/j.1365-2893.2012.01617.x] [PMID: 22676357]
[14]
Behara, R.; Reau, N. Updates on hepatitis C virus therapy in the direct-acting antiviral era. Curr. Opin. Gastroenterol., 2017, 33(3), 115-119.
[http://dx.doi.org/10.1097/MOG.0000000000000350] [PMID: 28350558]
[15]
FDA. 2017:FDA approves Vosevi for Hepatitis C.,, Available from:. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm
[16]
Lawitz, E.; Matusow, G.; DeJesus, E.; Yoshida, E.M.; Felizarta, F.; Ghalib, R.; Godofsky, E.; Herring, R.W.; Poleynard, G.; Sheikh, A.; Tobias, H.; Kugelmas, M.; Kalmeijer, R.; Peeters, M.; Lenz, O.; Fevery, B.; De La Rosa, G.; Scott, J.; Sinha, R.; Witek, J. Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3 study (OPTIMIST-2). Hepatology, 2016, 64(2), 360-369.
[http://dx.doi.org/10.1002/hep.28422] [PMID: 26704148]
[17]
Lawitz, E.; Reau, N.; Hinestrosa, F.; Rabinovitz, M.; Schiff, E.; Sheikh, A.; Younes, Z.; Herring, R., Jr; Reddy, K.R.; Tran, T.; Bennett, M.; Nahass, R.; Yang, J.C.; Lu, S.; Dvory-Sobol, H.; Stamm, L.M.; Brainard, D.M.; McHutchison, J.G.; Pearlman, B.; Shiffman, M.; Hawkins, T.; Curry, M.; Jacobson, I. Efficacy of sofosbuvir, velpatasvir, and GS-9857 in patients with genotype 1 hepatitis C virus infection in an openlabel, phase 2 trial. Gastroenterology, 2016, 151(5), 893-901.e1.
[http://dx.doi.org/10.1053/j.gastro.2016.07.039] [PMID: 27486034]
[18]
Lawitz, E.; Sulkowski, M.S.; Ghalib, R.; Rodriguez-Torres, M.; Younossi, Z.M.; Corregidor, A.; DeJesus, E.; Pearlman, B.; Rabinovitz, M.; Gitlin, N.; Lim, J.K.; Pockros, P.J.; Scott, J.D.; Fevery, B.; Lambrecht, T.; Ouwerkerk-Mahadevan, S.; Callewaert, K.; Symonds, W.T.; Picchio, G.; Lindsay, K.L.; Beumont, M.; Jacobson, I.M. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet, 2014, 384(9956), 1756-1765.
[http://dx.doi.org/10.1016/S0140-6736(14)61036-9] [PMID: 25078309]
[19]
Afdhal, N.; Reddy, K.R.; Nelson, D.R.; Lawitz, E.; Gordon, S.C.; Schiff, E.; Nahass, R.; Ghalib, R.; Gitlin, N.; Herring, R.; Lalezari, J.; Younes, Z.H.; Pockros, P.J.; Di Bisceglie, A.M.; Arora, S.; Subramanian, G.M.; Zhu, Y.; Dvory-Sobol, H.; Yang, J.C.; Pang, P.S.; Symonds, W.T.; McHutchison, J.G.; Muir, A.J.; Sulkowski, M.; Kwo, P. ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N. Engl. J. Med., 2014, 370(16), 1483-1493.
[http://dx.doi.org/10.1056/NEJMoa1316366] [PMID: 24725238]
[20]
Afdhal, N.; Zeuzem, S.; Kwo, P.; Chojkier, M.; Gitlin, N.; Puoti, M.; Romero-Gomez, M.; Zarski, J.P.; Agarwal, K.; Buggisch, P.; Foster, G.R.; Bräu, N.; Buti, M.; Jacobson, I.M.; Subramanian, G.M.; Ding, X.; Mo, H.; Yang, J.C.; Pang, P.S.; Symonds, W.T.; McHutchison, J.G.; Muir, A.J.; Mangia, A.; Marcellin, P. ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N. Engl. J. Med., 2014, 370(20), 1889-1898.
[http://dx.doi.org/10.1056/NEJMoa1402454] [PMID: 24725239]
[21]
Reddy, K.R.; Bourlière, M.; Sulkowski, M.; Omata, M.; Zeuzem, S.; Feld, J.J.; Lawitz, E.; Marcellin, P.; Welzel, T.M.; Hyland, R.; Ding, X.; Yang, J.; Knox, S.; Pang, P.; Dvory-Sobol, H.; Subramanian, G.M.; Symonds, W.; McHutchison, J.G.; Mangia, A.; Gane, E.; Mizokami, M.; Pol, S.; Afdhal, N. Ledipasvir and sofosbuvir in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis: An integrated safety and efficacy analysis. Hepatology, 2015, 62(1), 79-86.
[http://dx.doi.org/10.1002/hep.27826] [PMID: 25846144]
[22]
European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu. Electronic address: easloffice@easloffice.eu.: EASL recommendations on treatment of hepatitis C 2016. J. Hepatol., 2017, 66(1), 153-194.
[http://dx.doi.org/10.1016/j.jhep.2016.09.001] [PMID: 27667367]
[23]
The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America Present: HCV guidance:recommendations for testing, managing, and treating hepatitis C.2014-2018 AASLD and IDSA, 2017.
[24]
Pawlotsky, J.M.; Aghemo, A.; Back, D. European association for study of liver. EASL recommendations on treatment of hepatitis C 2015. J. Hepatol., 2015, 63(1), 199-236.
[http://dx.doi.org/10.1016/j.jhep.2015.03.025] [PMID: 25911336]
[25]
Kowdley, K.V.; Gordon, S.C.; Reddy, K.R.; Rossaro, L.; Bernstein, D.E.; Lawitz, E.; Shiffman, M.L.; Schiff, E.; Ghalib, R.; Ryan, M.; Rustgi, V.; Chojkier, M.; Herring, R.; Di Bisceglie, A.M.; Pockros, P.J.; Subramanian, G.M.; An, D.; Svarovskaia, E.; Hyland, R.H.; Pang, P.S.; Symonds, W.T.; McHutchison, J.G.; Muir, A.J.; Pound, D.; Fried, M.W. ION-3 Investigators.Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N. Engl. J. Med., 2014, 370(20), 1879-1888.
[http://dx.doi.org/10.1056/NEJMoa1402355] [PMID: 24720702]
[26]
Backus, L.I.; Belperio, P.S.; Shahoumian, T.A.; Loomis, T.P.; Mole, L.A. Real-world effectiveness and predictors of sustained virological response with all-oral therapy in 21,242 hepatitis C genotype-1 patients. Antivir. Ther. (Lond.), 2017, 22(6), 481-493.
[http://dx.doi.org/10.3851/IMP3117] [PMID: 27934775]
[27]
Ingiliz, P.; Christensen, S.; Kimhofer, T.; Hueppe, D.; Lutz, T.; Schewe, K.; Busch, H.; Schmutz, G.; Wehmeyer, M.H.; Boesecke, C.; Simon, K.G.; Berger, F.; Rockstroh, J.K.; Schulze zur Wiesch, J.; Baumgarten, A.; Mauss, S. Sofosbuvir and ledipasvir for 8 weeks for the treatment of chronic hepatitis C virus (HCV) Infection in HCV-monoinfected and HIV-HCV-coinfected individuals: Results from the german hepatitis C cohort (GECCO-01). Clin. Infect. Dis., 2016, 63(10), 1320-1324.
[http://dx.doi.org/10.1093/cid/ciw567] [PMID: 27535952]
[28]
Ioannou, G.N.; Beste, L.A.; Chang, M.F.; Green, P.K.; Lowy, E.; Tsui, J.I.; Su, F.; Berry, K. Effectiveness of sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir and dasabuvir regimens for treatment of patients with hepatitis c in the veterans affairs national health care system. Gastroenterology, 2016, 151(3), 457-471.e5.
[http://dx.doi.org/10.1053/j.gastro.2016.05.049] [PMID: 27267053]
[29]
Kowdley, K.V.; Sundaram, V.; Jeon, C.Y. Eight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infection. Hepatology, 2017, 65(4), 1094-1103.
[PMID: 28027579]
[30]
Terrault, N.A.; Zeuzem, S.; Di Bisceglie, A.M.; Lim, J.K.; Pockros, P.J.; Frazier, L.M.; Kuo, A.; Lok, A.S.; Shiffman, M.L.; Ben Ari, Z.; Akushevich, L.; Vainorius, M.; Sulkowski, M.S.; Fried, M.W.; Nelson, D.R. HCV-TARGET Study Group.Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response. Gastroenterology, 2016, 151(6), 1131-1140.e5.
[http://dx.doi.org/10.1053/j.gastro.2016.08.004] [PMID: 27565882]
[31]
Su, F.; Green, P.K.; Berry, K.; Ioannou, G.N. The association between race/ethnicity and the effectiveness of direct antiviral agents for hepatitis C virus infection. Hepatology, 2017, 65(2), 426-438.
[http://dx.doi.org/10.1002/hep.28901] [PMID: 27775854]
[32]
Wilder, J.M.; Jeffers, L.J.; Ravendhran, N.; Shiffman, M.L.; Poulos, J.; Sulkowski, M.S.; Gitlin, N.; Workowski, K.; Zhu, Y.; Yang, J.C.; Pang, P.S.; McHutchison, J.G.; Muir, A.J.; Howell, C.; Kowdley, K.; Afdhal, N.; Reddy, K.R. Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data. Hepatology, 2016, 63(2), 437-444.
[http://dx.doi.org/10.1002/hep.28334] [PMID: 26547499]
[33]
O’Brien, T.R.; Lang Kuhs, K.A.; Pfeiffer, R.M. Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C. Open Forum Infect. Dis., 2014, 1(3)ofu110
[http://dx.doi.org/10.1093/ofid/ofu110] [PMID: 25734178]
[34]
Feld, J.J.; Kowdley, K.V.; Coakley, E.; Sigal, S.; Nelson, D.R.; Crawford, D.; Weiland, O.; Aguilar, H.; Xiong, J.; Pilot-Matias, T.; DaSilva-Tillmann, B.; Larsen, L.; Podsadecki, T.; Bernstein, B. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N. Engl. J. Med., 2014, 370(17), 1594-1603.
[http://dx.doi.org/10.1056/NEJMoa1315722] [PMID: 24720703]
[35]
Ferenci, P.; Bernstein, D.; Lalezari, J.; Cohen, D.; Luo, Y.; Cooper, C.; Tam, E.; Marinho, R.T.; Tsai, N.; Nyberg, A.; Box, T.D.; Younes, Z.; Enayati, P.; Green, S.; Baruch, Y.; Bhandari, B.R.; Caruntu, F.A.; Sepe, T.; Chulanov, V.; Janczewska, E.; Rizzardini, G.; Gervain, J.; Planas, R.; Moreno, C.; Hassanein, T.; Xie, W.; King, M.; Podsadecki, T.; Reddy, K.R. PEARL-III Study; PEARL-IV Study.ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N. Engl. J. Med., 2014, 370(21), 1983-1992.
[http://dx.doi.org/10.1056/NEJMoa1402338] [PMID: 24795200]
[36]
AbbVieInc. VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) [Package insert]., 2017.
[37]
Zeuzem, S.; Ghalib, R.; Reddy, K.R.; Pockros, P.J.; Ben Ari, Z.; Zhao, Y.; Brown, D.D.; Wan, S.; DiNubile, M.J.; Nguyen, B.Y.; Robertson, M.N.; Wahl, J.; Barr, E.; Butterton, J.R. Grazoprevir-Elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1, 4, or 6 infection: a randomized trial. Ann. Intern. Med., 2015, 163(1), 1-13.
[http://dx.doi.org/10.7326/M15-0785] [PMID: 25909356]
[38]
Sulkowski, M.S.; Hézode, C.; Gerstoft, J.; Vierling, J.M.; Mallolas, J.; Pol, S. Efficacy and safety of 8 wks versus 12 wks oftreatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with HCV GT1 mono-infection and HIV/HCV coinfection (C-WORTHY): a randomised, open-label phase 2 trial. Lancet, 2015, 385(9973), 1087-1097.
[http://dx.doi.org/10.1016/S0140-6736(14)61793-1] [PMID: 25467560]
[39]
Zeuzem, S.; Mizokami, M.; Pianko, S.; Mangia, A.; Han, K.H.; Martin, R.; Svarovskaia, E.; Dvory-Sobol, H.; Doehle, B.; Hedskog, C.; Yun, C.; Brainard, D.M.; Knox, S.; McHutchison, J.G.; Miller, M.D.; Mo, H.; Chuang, W.L.; Jacobson, I.; Dore, G.J.; Sulkowski, M. NS5A resistance-associated substitutions in patients with genotype 1 hepatitis C virus: Prevalence and effect on treatment outcome. J. Hepatol., 2017, 66(5), 910-918.
[http://dx.doi.org/10.1016/j.jhep.2017.01.007] [PMID: 28108232]
[40]
Kwo, P.; Gane, E.J.; Peng, C.Y.; Pearlman, B.; Vierling, J.M.; Serfaty, L.; Buti, M.; Shafran, S.; Stryszak, P.; Lin, L.; Gress, J.; Black, S.; Dutko, F.J.; Robertson, M.; Wahl, J.; Lupinacci, L.; Barr, E.; Haber, B. effectiveness of elbasvir and grazoprevir combination, with or without ribavirin, for treatment-experienced patients with chronic hepatitis C infection. Gastroenterology, 2017, 152(1), 164-175.e4.
[http://dx.doi.org/10.1053/j.gastro.2016.09.045] [PMID: 27720838]
[41]
Jacobson, I.M.; Asante-Appiah, E.; Wong, P.; Black, T.; Howe, A.; Wahl, J. Prevalence and impact of baseline NSA resistance associated variants (RAVs) on the efficacy of elbasvir/grazoprevir (EBR/GZR) against GT1a infection [abstract lb-22]. 66th annual meeting of the American Association For The Study Of Liver Diseases (AASLD), November 13-17, 2015., 2015.
[42]
Thompson, A.; Zeuzem, S.; Rockstroh, J.K.; Kwo, P.Y.; Roth, D.; Lawitz, E.J. The combination of Grazoprevir and Elbasvir +RBV is highly effective for the treatment of GT1a-Infected patients. American Association for the Study of Liver Diseases., The Liver Meeting.San Francisco, CA, USA, 2015.
[43]
Kwo, P.Y.; Poordad, F.; Asatryan, A.; Wang, S.; Wyles, D.L.; Hassanein, T.; Felizarta, F.; Sulkowski, M.S.; Gane, E.; Maliakkal, B.; Overcash, J.S.; Gordon, S.C.; Muir, A.J.; Aguilar, H.; Agarwal, K.; Dore, G.J.; Lin, C.W.; Liu, R.; Lovell, S.S.; Ng, T.I.; Kort, J.; Mensa, F.J. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J. Hepatol., 2017, 67(2), 263-271.
[http://dx.doi.org/10.1016/j.jhep.2017.03.039] [PMID: 28412293]
[44]
Zeuzem, S.; Feld, J.; Wang, S. ENDURANCE-1: Efficacy and safety of 8- versus 12-week treatment with ABT-493/ABT-530 in patients with chronic HCV genotype 1 infection [Abstract 253]. 67th Annual Meeting of the American Association for the Study of Liver diseases, November 11-15, 2016
[45]
Forns, X.; Lee, S.S.; Valdes, J.; Lens, S.; Ghalib, R.; Aguilar, H.; Felizarta, F.; Hassanein, T.; Hinrichsen, H.; Rincon, D.; Morillas, R.; Zeuzem, S.; Horsmans, Y.; Nelson, D.R.; Yu, Y.; Krishnan, P.; Lin, C.W.; Kort, J.J.; Mensa, F.J. 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. Lancet Infect. Dis., 2017, 17(10), 1062-1068.
[http://dx.doi.org/10.1016/S1473-3099(17)30496-6] [PMID: 28818546]
[46]
Rockstroh, J.; Lacombe, K.; Viani, R.M.; Orkin, C.; Wyles, D.; Luetkemeyer, A. Efficacy and safety of Glecaprevir/Pibrentasvir in patients co-infected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 Study [Abstract LBP-522]. International Liver Congress, 2017.
[47]
Kwo, P.; Gitlin, N.; Nahass, R.; Bernstein, D.; Etzkorn, K.; Rojter, S.; Schiff, E.; Davis, M.; Ruane, P.; Younes, Z.; Kalmeijer, R.; Sinha, R.; Peeters, M.; Lenz, O.; Fevery, B.; De La Rosa, G.; Scott, J.; Witek, J. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology, 2016, 64(2), 370-380.
[http://dx.doi.org/10.1002/hep.28467] [PMID: 26799692]
[48]
Wyles, D.L.; Ruane, P.J.; Sulkowski, M.S.; Dieterich, D.; Luetkemeyer, A.; Morgan, T.R.; Sherman, K.E.; Dretler, R.; Fishbein, D.; Gathe, J.C., Jr; Henn, S.; Hinestrosa, F.; Huynh, C.; McDonald, C.; Mills, A.; Overton, E.T.; Ramgopal, M.; Rashbaum, B.; Ray, G.; Scarsella, A.; Yozviak, J.; McPhee, F.; Liu, Z.; Hughes, E.; Yin, P.D.; Noviello, S.; Ackerman, P. ALLY-2 Investigators. Daclatasvir plus sofosbuvir for HCV inpatients coinfected with HIV-1. N. Engl. J. Med., 2015, 373(8), 714-725.
[http://dx.doi.org/10.1056/NEJMoa1503153] [PMID: 26196502]
[49]
Sulkowski, M.S.; Gardiner, D.F.; Rodriguez-Torres, M.; Reddy, K.R.; Hassanein, T.; Jacobson, I.; Lawitz, E.; Lok, A.S.; Hinestrosa, F.; Thuluvath, P.J.; Schwartz, H.; Nelson, D.R.; Everson, G.T.; Eley, T.; Wind-Rotolo, M.; Huang, S.P.; Gao, M.; Hernandez, D.; McPhee, F.; Sherman, D.; Hindes, R.; Symonds, W.; Pasquinelli, C.; Grasela, D.M. AI444040 Study Group.Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N. Engl. J. Med., 2014, 370(3), 211-221.
[http://dx.doi.org/10.1056/NEJMoa1306218] [PMID: 24428467]
[50]
Wyles, D.L.; Rodriguez-Torres, M.; Lawitz, E.; Shiffman, M.L.; Pol, S.; Herring, R.W.; Massetto, B.; Kanwar, B.; Trenkle, J.D.; Pang, P.S.; Zhu, Y.; Mo, H.; Brainard, D.M.; Subramanian, G.M.; McHutchison, J.G.; Habersetzer, F.; Sulkowski, M.S. All-oral combination of ledipasvir, vedroprevir, tegobuvir, and ribavirin in treatment-naïve patients with genotype 1 HCV infection. Hepatology, 2014, 60(1), 56-64.
[http://dx.doi.org/10.1002/hep.27053] [PMID: 24501005]