All-oral combination of ledipasvir, vedroprevir, tegobuvir, and ribavirin in treatment-naïve patients with genotype 1 HCV infection

Hepatology

Volumn 60, Issue 1, 2014, Pages 56-64

  Wyles, David L ^a   Rodriguez Torres, Maribel ^b   Lawitz, Eric ^c   Shiffman, Mitchell L ^d   Pol, Stanislas ^e   Herring, Robert W ^f   Massetto, Benedetta ^g   Kanwar, Bittoo ^g   Trenkle, James D ^g   Pang, Phil S ^g   Zhu, Yanni ^g   Mo, Hongmei ^g   Brainard, Diana M ^g   Subramanian, G Mani ^g   Mchutchison, John G ^g   Habersetzer, François ^h   Sulkowski, Mark S ⁱ  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Fundación de Investigación de Diego   (United States)

^c Texas Liver Institute   (United States)

^d Liver Institute of Virginia   (United States)

^e Hôpital Cochin ^*  (France)

^f PLLC   (United States)

^g GILEAD SCIENCES   (United States)

^h UNIVERSITÉ DE STRASBOURG   (France)

ⁱ JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; LEDIPASVIR; PEGINTERFERON ALPHA2A; RIBAVIRIN; TEGOBUVIR; VEDROPREVIR; VIRUS RNA;

ACUTE PSYCHOSIS; ADULT; AGED; ALCOHOL INTOXICATION; ANTIVIRAL ACTIVITY; ARTICLE; BILIRUBIN BLOOD LEVEL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DYSPEPSIA; FATIGUE; FEMALE; GENOTYPE; HEADACHE; HEPATITIS C; HUMAN; IRITIS; LIMIT OF QUANTITATION; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; MEDICAL PARAMETERS; MUSCLE ATROPHY; NAUSEA; PANCREATITIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT OUTCOME; VERY RAPID VIROLOGIC RESPONSE; VITRITIS;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; BENZIMIDAZOLES; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; FLUORENES; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; MALE; MIDDLE AGED; PURINES; PYRIDAZINES; QUINOLINES; RIBAVIRIN; TREATMENT OUTCOME; VIRAL NONSTRUCTURAL PROTEINS; YOUNG ADULT;

EID: 84903301263     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.27053     Document Type: Article

References (14)

1. Poordad F, McCone J, Jr., Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1195-1206.
2. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364:2405-2416.
3. Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol 2013;13:535-542.
4. Chen EY, Sclair SN, Czul F, Apica B, Dubin P, Martin P, et al. A small percentage of patients with hepatitis C receive triple therapy with boceprevir or telaprevir. Clin Gastroenterol Hepatol 2013;11:1014-1020.
5. Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012;366:216-224.
6. Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Mullhaupt B, et al. Efficacy of the protease inhibitor BI 201335, polymerase inhibitor BI 207127, and ribavirin in patients with chronic HCV infection. Gastroenterology 2011;141:2047-2055.
7. Lawitz EJ, Gruener D, Hill JM, Marbury T, Moorehead L, Mathias A, et al. A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C. J Hepatol 2012;57:24-31.
8. Lawitz E, Hill JM, Marbury TC, Rodriguez-Torres M, DeMicco MP, Quesada J, et al. Three-day, dose-ranging study of the HCV NS3 protease inhibitor GS-9451 [Abstract]. Hepatology 2010;52(Suppl):714A-715A.
9. Harris J, Bae A, Sun S, Svarovskaia E, Miller M, Mo H. Antiviral response and resistance analysis of treatment-naïve HCV infected subjects receiving single and multiple doses of GS-9190 [Abstract]. Hepatology 2010;52(Suppl):772A.
10. Everson GT, Lawitz E, Thompson A, Sulkowski M, Zhu Y, Brainard D, et al. The NS5A inhibitor GS-5885 is safe and well tolerated in more than 1000 patients treated in phase 2 studies [Abstract]. Hepatology 2012;56(Suppl):572A.
11. Chen J, Florian J, Carter W, Fleischer RD, Hammerstrom TS, Jadhav PR, et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology 2013;144:1450-1455.
12. Tong L, Mwangi J, Roy A, Murray B, Delaney W, Yang C, et al. In vitro studies on the potential for the hepatitis c virus protease inhibitors GS-9256 and GS-9451 to affect bilirubin elimination [Abstract]. J Hepatol 2011;54(Suppl):S487.
13. Poordad F, Lawitz E, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, et al. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med 2013;368:45-53.
14. Butt AA, McGinnis KA, Skanderson M, Justice AC. Hepatitis C treatment completion rates in routine clinical care. Liver Int 2010;30:240-250.