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Expert Opinion on Drug Safety Volume 14, 2015 - Issue 11
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Drug Evaluation

The safety of daclatasvir for the treatment of hepatitis C

Syed-Mohammed JafriDivision of Gastroenterology, Henry Ford Hospital, Detroit, MI48202, USA
&
Stuart C. GordonDivision of Gastroenterology, Henry Ford Hospital, Detroit, MI48202, USACorrespondence[email protected]
Pages 1787-1797 | Published online: 16 Nov 2015

Bibliography

  • Papers of special note have been highlighted as either of interest (*) or of considerable interest (**) to readers.
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  • American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C; 2015 [cited 2015 Aug 29]. Available from: http://www.hcvguidelines.org/.

** These guidelines serve as a key management tool for the therapy of hepatitis C and have driven early use of combination DAA therapy

  • 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;370:1973–1982.
  • Janssen Therapeutics. OLYSIO™ (simeprevir) prescribing information [Internet]. 2015 [cited Oct 14]. Available from: https://www.olysio.com/shared/product/olysio/prescribing-information.pdf
  • 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. 2015;61(4):1127–1135.
  • Schinazi R, Halfon P, Marcellin P, et al. HCV direct-acting antiviral agents: the best interferon-free combinations. Liver Int. 2014;34(Suppl 1):69–78.
  • Asselah T, Marcellin P. Interferon free therapy with direct acting antivirals for HCV. Liver Int. 2013;33:93–104.
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  • Wang C, Jia L, O’Boyle DR 2nd, et al. Comparison of daclatasvir resistance barriers on NS5A from hepatitis C virus genotypes 1 to 6: implications for cross-genotype activity. Antimicrob Agents Chemother. 2014;58(9):5155–5163.
  • Gao M, Nettles RE, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature. 2010;465(7294):96–100.
  • McGivern DR, Masaki T, Williford, S, et al. Kinetic analyses reveal potent and early blockade of hepatitis C virus assembly by NS5A inhibitors. Gastroenterology. 2014;147:453–462.
  • Lee C, Ma H, Hang JQ, et al. The hepatitis C virus NS5A inhibitor (BMS-790052) alters the subcellular localization of the NS5A non-structural viral protein. Virology. 2011;414:10–18.
  • Gao M, Nettles RE, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature. 2010;465:96–100.
  • Fridell RA, Qiu D, Valera L, et al. Distinct functions of NS5A in hepatitis C virus RNA replication uncovered by studies with the NS5A inhibitor BMS-790052. J Virol. 2011;85:7312–7320.
  • Nettles RE, Gao M, Bifano M, et al. Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology. 2011;54:1956–1965.
  • Ke R, Loverdo C, Qi H, et al. Modelling clinical data shows active tissue concentration of daclatasvir is 10-fold lower than its plasma concentration. J Antimicrob Chemother. 2014;69:724–727.
  • Berger C, Romero-Brey I, Radujkovic D, et al. Daclatasvir-like inhibitors of NS5A block early biogenesis of HCV-induced membranous replication factories, independent of RNA replication. Gastroenterology. 2014;147:1094–1105.
  • Poole RM. Daclatasvir + asunaprevir: first global approval. Drugs. 2014;74:1559–1571.
  • Bristol–Myers Squibb Company. Daklinza tablets (tavaborole) Japanese prescribing information [Internet]. 2014 [cited 2015 Oct 14]. Available from: http://packageinserts.bms.com/pi/pi_daklinza.pdf
  • Pol S, Ghalib RH, Rustgi VK, et al. Daclatasvir for previously untreated chronic hepatitis C genotype 1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012;12:671–677.
  • Hézode C, Hirschfield GM, Ghesquiere W, et al. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015;64(6):948–956.

** Key study outlining efficacy and side effects seen with daclatasvir

  • Jacobson I, Dimitrova D, Hughes EA, et al. 1203 safety profile of daclatasvir in combination with peginterferon alfa and ribavirin in 1100 patients with chronic HCV infection treated in phase 2 studies. J Hepatol. 2013;58(Suppl 1):S489.

* Provided composite safety data especially useful as regards cytopenias

  • Gao M, Nettles RE, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature. 2010;465:96–100.
  • Pawlotsky JM. New hepatitis C therapies: the toolbox, strategies, and challenges. Gastroenterology. 2014;146:1176–1192.
  • Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014;59:2083–2091.
  • Manns M, Pol S, Jacobson IM, et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014;384(9954):1597–1605.
  • Chayama K, Kawakami Y, Suzuki F, et al. All-oral dual combination of daclatasvir plus asunaprevir compared with telaprevir plus peginterferon alfa/ribavirin in treatment-naive Japanese patients chronically infected with HCV genotype 1b: results from a phase 3 study. Hepatology. 2014;60(Suppl S1):1135A.

* Outlined effectiveness of combination therapy with daclatasvir compared to prior standard of care therapy

  • Everson GT, Sims KD, Luo W, et al. Daclatasvir in combination with asunaprevir and BMS-791325 for prior null responders with chronic HCV genotype 1 infection. Hepatology. 2014;60(Suppl S1):1139A.
  • Muir AJ, Poordad F, Lalezari J, et al. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis. JAMA. 2015;313(17):1736–1744.
  • McEwan P, Ward T, Yuan Y, et al. Estimating projected costs and quality-adjusted life expectancy associated with daclatasvir plus asunaprevir in difficult to treat Japanese patients chronically infected with hepatitis C genotype 1b. Hepatology. 2014;60(Suppl 1):1046A.
  • Poordad F, Sievert W, Mollison L, et al. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015;313(17):1728–1735.
  • Sulkowski MS 1, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370(3):211–221.
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  • Bzowej NH, Joshi S, Therapondos G, et al. Post-transplant treatment of severe recurrent hepatitis C (HCV) with daclatasvir and sofosbuvir plus or minus ribavirin. Hepatology. 2014;60(Suppl 1):542A.
  • Bahirwani R, Reddy R, Fontana RJ, et al. High efficacy and favorable safety profile of daclatasvir based all oral antiviral therapy in liver transplant recipients with severe recurrent HCV. Hepatology. 2014;60(Suppl):LB–22.

* Demonstrated safety and provided early efficacy data on the use of daclatasvir with DAA combination in difficult-to-treat posttransplant population

  • Leroy V, Dumortier J, Coilly A, et al. High rates of virological response and major clinical improvement during sofosbuvir and daclatasvir-based regimens for the treatment of fibrosing cholestatic HCV-recurrence after liver transplantation: the ANRS CO23 CUPILT study. Hepatology. 2014;60(Suppl 1):207A.
  • Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373(8):714–725.
  • 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. 2015;61(4): 1127–1135.
  • Jensen DM, Jacobson IM, Kumada H, et al. Safety and efficacy outcomes of all-oral daclatasvir-containing regimens in patients with or without cirrhosis in phase 2 and 3 studies. Hepatology. 2014;60(Suppl 1):1147A.
  • Bristol-Myers Squibb Company. Daclinza Capsules (daclatasvir). United States Prescribing Information [Internet]. 2015 [cited Oct 14]. Available from: http://packageinserts.bms.com/pi/pi_daklinza.pdf
  • Bifano M, Sevinsky H, Hwang C, et al. Effect of the coadministration of daclatasvir on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate. Antivir Ther. 2013;19:511–519.
  • Eley T, You X, Wang R, et al. Daclatasvir: overview of drug-drug interactions with antiretroviral agents and other common concomitant drugs. HIV DART [Internet]. Miami (FL); 2014 [cited 2015 Oct 14]. Available from: http://natap.org/2014/HCV/121614_01.htm
  • Bifano M, Hwang C, Oosterhuis B, et al. Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir. Antivir Ther. 2013;18:931–940.
  • Fridell RA, Wang C, Sun JH, et al. Genotypic and phenotypic analysis of variants resistant to hepatitis C virus nonstructural protein 5A replication complex inhibitor BMS-790052 in humans: in vitro and in vivo correlations. Hepatology. 2011;54:1924–1935.
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  • Wang C, Sun JH, O’Boyle DR 2nd, et al. Persistence of resistant variants in hepatitis C virus-infected patients treated with the NS5A replication complex inhibitor daclatasvir. Antimicrob Agents Chemother. 2013;57:2054–2065.
  • McPhee F, Hernandez D, Yu F, et al. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013;58:902–911.

* Key data evaluating resistance testing before and after DAA combination therapy including daclatasvir

  • McPhee F, Toyota J, Chayama K, et al. Analysis of HCV resistance variants in a phase 3 trial of daclatasvir combined with asunaprevir for Japanese patients with genotype 1b infection. Hepatology. 2013;58(S1):749A.
  • Karino Y, Toyota J, Ikeda K, et al. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol. 2013;58:646–654.
  • Suzuki Y, Ikeda K, Suzuki F, et al. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol. 2013;58:655–662.

** Looking at combination therapy efficacy and safety of all-oral combination therapy in patients with hepatitis C

  • Lok AS, Gardiner DF, Hezode C, et al. Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders. J Hepatol. 2014;60:490–499.

** Key study looking at combination therapy efficacy and safety in null responders

  • Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483–1493.
  • Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889–1898.
  • 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. 2014;370:1879–1888.
  • Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r – ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014;370:1594–1603.
  • Ferenci P, Bernstein D, Lalezari J, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014;370:1983–1992.
  • 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;370:1973–1982.
  • Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r – ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014;370:1604–1614.
  • 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.
  • Jacobson I, Dore GJ, Foster GR, et al. Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype-1 infection in treatment-naive patients: results from QUEST-1, a phase III trial. J Hepatol. 2013;58(Suppl 1):S574.
  • Manns M, Marcellin P, Fred Poordad FP, et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype-1 infection in treatment-naive patients: results from QUEST-2, a phase III trial. J Hepatol. 2013;58(Suppl 1):S568.
  • Lawitz E, Zeuzem S, Nyberg LM, et al. Boceprevir (BOC) combined with peginterferon alfa-2b/ribavirin (P/RBV) in treatment-naïve chronic HCV genotype 1 patients with compensated cirrhosis: sustained virologic response (SVR) and safety subanalyses from the Anemia Management Study. Hepatology. 2012;56(Suppl):216A.
  • Belda O, Targett-Adams P. Small molecule inhibitors of the hepatitis C virus-encoded NS5A protein. Virus Res. 2012;170:1–14.
  • Jacobson I, Kumada H, Chayama K, et al. Safety and tolerability of daclatasvir in patients with chronic HCV infection. The 24th Annual Meeting of the Asian Pacific Association for the Study of the Liver APASL; 2015 March 12–15; Istanbul. Poster 1485.

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