224
Views
12
CrossRef citations to date
0
Altmetric
Drug Discovery Case History

Discovery and preclinical development of dasabuvir for the treatment of hepatitis C infection

, , , &
Pages 635-642 | Received 31 Jan 2017, Accepted 21 Apr 2017, Published online: 05 May 2017

References

  • Cooke GS, Lemoine M, Thursz M, et al. Viral hepatitis and the global burden of disease: a need to regroup. J Viral Hepat. 2013;20:600–601.
  • Mohd Hanafiah K, Groeger J, Flaxman AD, et al. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013;57:1333–1342.
  • Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001;345:41–52.
  • Ford N, Kirby C, Singh K, et al. Chronic hepatitis C treatment outcomes in low- and middle-income countries: a systematic review and meta-analysis. Bull WHO. 2012;90:540–550.
  • Ford N, Singh K, Cooke GS, et al. Expanding access to treatment for hepatitis C in resource-limited settings: lessons from HIV/AIDS. Clin Infect Dis. 2012;54:1465–1472.
  • Davies A, Singh KP, Shubber Z, et al. Treatment outcomes of treatment-naïve hepatitis C patients coinfected with HIV: a systematic review and meta-analysis of observational cohorts. PLoS One. 2013;8:e55373.
  • Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405–2416.
  • Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Ned. 2011;364:1195–1206.
  • Lawitz E, Lalezari JP, Hassanein T, et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2013;13:401–408.
  • Lawitz E, Poordad F, Kowdley KV, et al. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol. 2013;59:18–23.
  • Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014;383:515–523.
  • Everson GT, Sims KD, Rodriguez-Torres M, et al. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology. 2014;146:420–429.
  • AbbVie. Dasabuvir investigator’s brochure, Edition 8. 2015 June 10.
  • Kati W, Koev G, Irvin M, et al. In vitro activity and resistance profile of dasabuvir, a nonnucleoside hepatitis C virus polymerase inhibitor. Antimicrob Agents Chem. 2015;59(3):1505–1511.
  • Liu Y1, Lim BH, Jiang WW, et al. Identification of aryl dihydrouracil derivatives as palm initiation site inhibitors of HCV NS5B polymerase. Bioorg Med Chem Lett. 2012;22(11):3747–3750.
  • NewDrugsApproval, Monthly achieves May 2014. Dasabuvir [Online], Available from: https://newdrugapprovals.org/2014/05/page/6/(Accessed 5 January 2017).
  • European Medicines Agency. European public assessment report (EPAR) for Exviera. [Online], Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003837/human_med_001833.jsp&mid=WC0b01ac058001d124. ( Accessed 2 January 2017).
  • Shen J, Serby M, Reed A, et al. Metabolism and disposition of hepatitis C polymerase inhibitor dasabuvir in humans. Drug Metabolism and Disposition. 2016;44(8):1139–1147.
  • Maring C, Wagner D, Hutchinson D, et al. Preclinical potency, pharmacokinetic and ADME characterization of ABT-333, a novel non-nucleoside HCV polymerase inhibitor. J Hepatol. 2009;50(1):S347.
  • Badri PS, King JR, Polepally AR, et al. Dosing recommendations for concomitant medications during 3D anti-HCV therapy. Clin Pharmacokinet. 2016;55:275–295.
  • Trivella JP1, Gutierrez J, Martin P. Dasabuvir: a new direct antiviral agent for the treatment of hepatitis C. Expert Opin Pharmacother. 2015;16(4):617–624.
  • Abbott. A study in healthy adult subjects to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of ABT. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2010. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT00768690
  • Abbott. Study of ABT-333 in both healthy volunteers and hepatitis C virus (HCV) + genotype 1-infected subjects. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US; 2010. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT00696904
  • AbbVie. A follow-up assessment of resistance to ABT-333 in hepatitis C virus (HCV)-infected subjects who have received ABT-333 in ABT-333 studies. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US; 2014. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT00726882
  • Abbott. A study in healthy adult subjects to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of ABT-333. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US; 2010. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT00768690
  • Abbott. A study to assess the safety, tolerability, and pharmacokinetics of multiple ascending doses of the ABT-333 tablet. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US; 2010. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT00909636
  • Abbott. Bioavailability of ABT-333 tablet versus First in Human (FIH) capsule formulation and safety, tolerability and PK study of single doses of ABT-333 in healthy volunteers. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US; 2010. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT00895102
  • AbbVie. Bioavailability of ABT-333 within the gastrointestinal tract in healthy subjects. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US; 2014. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT02052349
  • AbbVie. A follow-up assessment of resistance to ABT-333 in hepatitis C virus (HCV)-infected subjects who have received ABT-333 in ABT-333 studies. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US; 2014. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT02052349
  • AbbVie. A study to evaluate chronic hepatitis C infection. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2015. cited 2016 Dec 11. Available from: https://clinicaltrials.gov/ct2/show/NCT01716585
  • Rodriguez-Torres M, Lawitz E, Cohen D. Treatment-naive, HCV genotype 1-infected subjects show significantly greater HCV RNA decreases when treated with 28 days of ABT-333 plus peg interferon and ribavirin compared to peg interferon and ribavirin alone. Hepatology. 2009;50(Suppl 4):91A.
  • Gaultier I, Cohen D, Dumas E, et al. 12-week efficacy and safety of ABT-072 or ABT-333 with pegylated interferon + ribavirin, following 3-day monotherapy in genotype 1 HCV infected treatment-naive subjects [abstract1329]. 21st Conference of the Asian Pacific Association for the Study of the Liver (APASL); 17-20 February 2011; Bangkok, Thailand.
  • Poordad F, Lawitz E, Kowdley KV, et al. Exploratory study of oral combination antiviral. N Engl J Med. 2013;368(1):45–53.
  • 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. 2014;370(3):222–232.
  • Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir an dasabuvir with ribavirin. N Engl J Med. 2014;370(17):1594–1603.
  • Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/rombitasv and dasabuvir with ribavirin. N Engl J Med. 2014;370(17):1604–1614.
  • Eron JJ, Lalezari J, Slim J, et al. Safety and efficacy of ombitasvir - 450/r and dasabuvir and ribavirin in HCV/HIV-1 co-infected patients receiving atazanavir or raltegravir ART regimens. J Int AIDS Soc. 2014;17(4 Suppl 3):19500.
  • 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. 2014;370(21):1973–1982.
  • Ferenci P, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014;370(21):1983–1992. PEARL III and IV.
  • Ferenci P, Nyberg A, Enayati P, et al. PEARL III: 12 weeks of ABT-450/R/267 + ABT-333 achieved SVR in >99% of 419 treatment-naive HCV genotype 1B-infected adults with or without ribavirin. J Hepatol. 2014;60(1):S527.
  • Kwo PY, Mantry PS, Coakley E, et al. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med. 2014;371:2375–2382.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.