Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial

The Lancet Gastroenterology and Hepatology

Volumn 2, Issue 7, 2017, Pages 494-500

  Welzel, Tania M ^a   Asselah, Tarik ^b   Dumas, Emily O ^c   Zeuzem, Stefan ^a   Shaw, David ^d   Hazzan, Rawi ^e   Forns, Xavier ^f   Pilot Matias, Tami ^c   Lu, Wenjing ^c   Cohen, Daniel E ^c   Feld, Jordan J ^g  

^a GOETHE UNIVERSITY   (Germany)

^b BEAUJON HOSPITAL   (France)

^c ABBVIE INC   (United States)

^d ROYAL ADELAIDE HOSPITAL   (Australia)

^e HAEMEK MEDICAL CENTER   (Israel)

^f UNIVERSITY OF BARCELONA   (Spain)

^g UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; DASABUVIR; NONSTRUCTURAL PROTEIN 3; NONSTRUCTURAL PROTEIN 5; OMBITASVIR; PARACETAMOL; PARITAPREVIR; RITONAVIR; VIRUS RNA; ABT-267; ABT-333; ABT-450; ANILIDE; ANTIVIRUS AGENT; CARBAMIC ACID DERIVATIVE; MACROCYCLIC COMPOUND; SULFONAMIDE; URACIL;

ADULT; AGED; ARTICLE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FAINTNESS; FATIGUE; FEMALE; FEVER; GENETIC POLYMORPHISM; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS SUBTYPE 1B; HUMAN; HYPERBILIRUBINEMIA; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; SUSTAINED VIROLOGICAL RESPONSE; TREATMENT RESPONSE; VIRUS LOAD; ANALOGS AND DERIVATIVES; ANTIVIRAL RESISTANCE; CHRONIC HEPATITIS C; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DRUG ADMINISTRATION; GENETICS; GENOTYPE; HEPACIVIRUS; MIDDLE AGED; SUSTAINED VIROLOGIC RESPONSE; TREATMENT FAILURE; VERY ELDERLY; VIROLOGY;

ADULT; AGED; AGED, 80 AND OVER; ANILIDES; ANTIVIRAL AGENTS; CARBAMATES; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; MACROCYCLIC COMPOUNDS; MALE; MIDDLE AGED; POLYMORPHISM, GENETIC; RITONAVIR; SULFONAMIDES; SUSTAINED VIROLOGIC RESPONSE; TREATMENT FAILURE; URACIL;

EID: 85020818018     PISSN: 24681253     EISSN: None     Source Type: Journal    
DOI: 10.1016/S2468-1253(17)30071-7     Document Type: Article

References (26)

1. Messina, JP, Humphreys, I, Flaxman, A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 61 (2015), 77–87.
2. van der Meer, AJ, Veldt, BJ, Feld, JJ, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA 308 (2012), 2584–2593.
3. European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol 63 (2015), 199–236.
4. Panel, AIHG, Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology 62 (2015), 932–954.
5. Asselah, T, Boyer, N, Saadoun, D, Martinot-Peignoux, M, Marcellin, P, Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives. Liver Int 36:suppl 1 (2016), 47–57.
6. The Medical letter on drugs and therapeutics. A 4-drug combination (Viekira Pak) for hepatitis C. JAMA 313 (2015), 1857–1858.
7. VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). Package insert. http://www.rxabbvie.com/pdf/viekirapak_pi.pdf, June, 2016 (accessed Dec 1, 2017).
8. Ferenci, P, Bernstein, D, Lalezari, J, et al. ABT-450/r–ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 370 (2014), 1983–1992.
9. Andreone, P, Colombo, MG, Enejosa, JV, et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology 147 (2014), 359–365.
10. Razavi, H, Waked, I, Sarrazin, C, et al. The present and future disease burden of hepatitis C virus (HCV) infection with today's treatment paradigm. J Viral Hepat 21:suppl 1 (2014), 34–59.
11. Younossi, ZM, Kanwal, F, Saab, S, et al. The impact of hepatitis C burden: an evidence-based approach. Aliment Pharmacol Ther 39 (2014), 518–531.
12. Kowdley, KV, Lawitz, E, Poordad, F, et al. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med 370 (2014), 222–232.
13. Di Marco, V, Covolo, L, Calvaruso, V, et al. Who is more likely to respond to dual treatment with pegylated-interferon and ribavirin for chronic hepatitis C? A gender-oriented analysis. J Viral Hepat 20 (2013), 790–800.
14. Suraweera, D, Weeratunga, AN, Saab, S, Spotlight on grazoprevir-elbasvir once-daily combination and its potential in the treatment of hepatitis C. Drug Des Devel Ther 10 (2016), 2119–2127.
15. 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 61 (2015), 1127–1135.
16. Thompson, AJ, Muir, AJ, Sulkowski, MS, et al. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology 139 (2010), 120–129.
17. European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol 66 (2017), 153–194.
18. Gilead Sciences. HARVONI (ledipasvir and sofosbuvir) tablets. Package insert. https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf, March, 2015 (accessed April 6, 2017).
19. Feld, JJ, Kowdley, KV, Coakley, E, et al. Treatment of HCV with ABT-450/r–ombitasvir and dasabuvir with ribavirin. N Engl J Med 370 (2014), 1594–1603.
20. Zeuzem, S, Jacobson, IM, Baykal, T, et al. Retreatment of HCV with ABT-450/r–ombitasvir and dasabuvir with ribavirin. N Engl J Med 370 (2014), 1604–1614.
21. Poordad, F, Hezode, C, Trinh, R, et al. ABT-450/r–ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 370 (2014), 1973–1982.
22. Vermehren, J, Maasoumy, B, Maan, R, et al. Applicability of hepatitis C virus RNA viral load thresholds for 8-week treatments in patients with chronic hepatitis C virus genotype 1 infection. Clin Infect Dis 62 (2016), 1228–1234.
23. Kowdley, KV, Gordon, SC, Reddy, KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 370 (2014), 1879–1888.
24. Claherty, GA SC, Holzmayer, V, et al. Hepatitis C RNA assay differences in results around 6 million IU/mL: potential clinincal implications for shortened ledipasvir/sofosbuvir therapy. Hepatology, 62(suppl), 2015, 1084.
25. Noppornpanth, S, Sablon, E, De Nys, K, et al. Genotyping hepatitis C viruses from southeast Asia by a novel line probe assay that simultaneously detects core and 5′ untranslated regions. J Clin Microbiol 44 (2006), 3969–3974.
26. Yang, R, Cong, X, Du, S, Fei, R, Rao, H, Wei, L, Performance comparison of the versant HCV genotype 2.0 assay (LiPA) and the abbott realtime HCV genotype II assay for detecting hepatitis C virus genotype 6. J Clin Microbiol 52 (2014), 3685–3692.