Assessment of Pharmacokinetic Interactions of the HCV Ns5A Replication Complex Inhibitor Daclatasvir with Antiretroviral Agents: Ritonavir-Boosted Atazanavir,Efavirenz and Tenofovir

Alter M.J. Epidemiology of viral hepatitis and HIV co-infection. J Hepatol 2006; 44: S6–S9.

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services (Updated 12 February 2013. Accessed 20 November 2013.) Available from http://aidsinfo.nih.gov/guidelines.

Clumeck N. , Pozniak A. , Raff F. the EACS Executive Committee. European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of HIV-infected adults. HIV Med 2008; 9: 65–71.

Reiberger T. , Ferlitsch A. , Sieghart W. HIV-HCV co-infected patients with low CD4+ cell nadirs are at risk for faster fibrosis progression and portal hypertension. J Viral Hepat 2010; 17: 400–409.

Macías J. , Berenguer J. , Japon M.A. Fast fibrosis progression between repeated liver biopsies in patients coinfected with human immunodeficiency virus/hepatitis C virus. Hepatology 2009; 50: 1056–1063.

Thein H.H. , Yi Q. , Dore G.J. , Krahn M.D. Natural history of hepatitis C virus infection in HIV-infected individuals and the impact of HIV in the era of highly active antiretroviral therapy: a meta-analysis. AIDS 2008; 22: 1979–1991.

Weber R. , Sabin C.A. , Friis-Moller N. Liver-related deaths in persons infected with the human immunodeficiency virus: the D:A:D study. Arch Intern Med 2006; 166: 1632–1641.

Chung R.T. , Andersen J. , Volberding P. Peginterferon alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons. N Engl J Med 2004; 351: 451–459.

Torriani F.J. , Rodriguez-Torres M. , Rockstroh J.K. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004; 351: 438–450.

Carrat F. , Bani-Sadr F. , Pol S. Pegylated interferon alfa-2b vs standard interferon alfa-2b, plus ribavirin, for chronic hepatitis C in HIV-infected patients: a randomized controlled trial. JAMA 2004; 292: 2839–2848.

BHIVA Writing Committee. British HIV Association (BHIVA) guidelines for the treatment of HIV-1 positive adults with antiretroviral therapy 2012. (Accessed 20 November 2013.) Available from http://www.bhiva.org/TreatmentofHIV1_2012.aspx.

Tseng A. , Foisy M. Important drug-drug interactions in HIV-infected persons on antiretroviral therapy: an update on new interactions between HIV and non-HIV drugs. Curr Infect Dis Rep 2012; 14: 67–82.

Thompson M.A. , Aberg J.A. , Cahn P. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. JAMA 2010; 304: 321–333.

Reiberger T. , Obermeier M. , Payer B.A. Considerable under-treatment of chronic HCV infection in HIV patients despite acceptable sustained virological response rates in a real-life setting. Antivir Ther 2011; 16: 815–824.

Ghany M.G. , Nelson D.R. , Strader D.B. , Thomas D.L. , Seef L.B. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guidelines by the American Association for the Study of Liver Diseases (Updated 11 January 2013. Accessed 3 July 2013.) Available from http://www.aasld.org/practiceguidelines/Documents/AASLDUpdateTreatmentGenotype1HCV11113.pdf.

Leroy V. , Serfaty L. , Bourliere M. Protease inhibitor-based triple therapy in chronic hepatitis C: guidelines by the French Association for the Study of the Liver. Liver Int 2012; 32: 1477–1492.

Zuckerman E. , Safadi R. , Oren R. Israeli guidelines for the treatment of chronic hepatitis C infection–2012 Israeli Association for the Study of the Liver. Harefuah 2012; 151: 709–714.

Myers R.P. , Ramji A. , Bilodeau M. , Wong S. , Feld J.J. An update on the management of hepatitis C: consensus guidelines from the Canadian Association for the Study of the Liver. Can J Gastroenterol 2012; 26: 359–375.

Ramachandran P. , Fraser A. , Agarwal K. UK consensus guidelines for the use of the protease inhibitors boceprevir and telaprevir in genotype 1 chronic hepatitis C infected patients. Aliment Pharmacol Ther 2012; 35: 647–662.

Garg V. , Chandorkar G. , Farmer H.F. , Smith F. , Alves K. , van Heeswijk R.P. Effect of telaprevir on the pharmacokinetics of midazolam and digoxin. J Clin Pharmacol 2012; 52: 1566–1573.

Chu X. , Cai X. , Cui D. In vitro assessment of drug-drug interaction potential of boceprevir associated with drug metabolizing enzymes and transporters. Drug Metab Dispos 2013; 41: 668–681.

Wilby K.J. , Greanya E.D. , Ford J.A. , Yoshida E.M. , Partovi N. A review of drug interactions with boceprevir and telaprevir: implications for HIV and transplant patients. Ann Hepatol 2012; 11: 179–185.

Qiu D. , Lemm J.A. , O'Boyle D.R. II The effects of NS5A inhibitors on NS5A phosphorylation, polyprotein processing and localization. J Gen Virol 2011; 92: 2502–2511.

Fridell R.A. , Qiu D. , Valera L. , Wang C. , Rose R.E. , Gao M. 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 R.E. , Gao M. , Bifano M. Multiple ascending dose study of BMS-790052, an NS5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology 2011; 54: 1956–1965.

Pol S. , Ghalib R.H. , Rustgi V.K. 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.

Hezode C. , Hirschfield G.M. , Ghesquiere W. BMS-790052, a NS5A replication complex inhibitor, combined with peginterferon-alfa-2a and ribavirin in treatment-naive HCV-genotype 1 or 4 subjects: Phase 2b AI444010 study interim week 12 results. Hepatology 2011; 54 Suppl 4: 474A–475A.

Ratziu V. , Gadano A. , Pol S. Triple therapy with daclatasvir (DCV; BMS-790052), peginterferon alfa-2a and ribavirin in HCV-infected prior null and partial responders: 12-week results of phase 2b COMMAND-2 trial. J Hepatol 2012; 56 Suppl 2: S478–S479.

Suzuki F. , Ikeda K. , Toyota J. Dual oral therapy with the NS5A inhibitor daclatasvir (BMS-790052) and NS3 protease inhibitor asunaprevir (BMS-650032) in HCV genotype 1B-infected null responders or ineligible/intolerant to peginterferon/ribavirin. J Hepatol 2012; 56 Suppl 2: S7.

Lok A.S. , Gardiner D.F. , Lawitz E. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012; 366: 216–224.

Izumi N. , Asahina Y. , Yokosuka O. Combination therapy of treatment-naive and nonresponder patients with HCV genotype 1 infection with BMS-790052, an NS5A replication complex inhibitor, in combination with peginterferon alfa-2a and ribavirin. Hepatology 2011; 54 Suppl 4: 1439A–1440A.

Bifano M. , Sevinsky H. , Stonier M. , Jiang H. , Bertz R.J. Daclatasvir, an HCV NS5A replication complex inhibitor, has minimal effect on pharmacokinetics of midazolam, a sensitive probe for cytochrome P450 3A4. 8th International Workshop on Clinical Pharmacology of Hepatitis Therapy. 26–27 June 2013, Cambridge, MA, USA. Abstract O_15.

Williams E.J. Experimental designs balanced for the estimation of residual effects of treatments. Austral J Sci Res (Series A) 1949; 2: 149–168.

Jiang H. , Zeng J. , Kandoussi H. A sensitive and accurate liquid chromatography-tandem mass spectrometry method for quantitative determination of the novel hepatitis C NS5A inhibitor BMS-790052 (daclatasvir) in human plasma and urine. J Chromatogr A 2012; 1245: 117–121.

Gao X. , Stephens J.M. , Carter J.A. , Haider S. , Rustgi V.K. Impact of adverse events on costs and quality of life in protease inhibitor-based combination therapy for hepatitis C. Expert Rev Pharmacoecon Outcomes Res 2012; 12: 335–343.

Zhu L. , Persson A. , Mahnke L. Effect of low-dose omeprazole (20 mg daily) on the pharmacokinetics of multiple-dose atazanavir with ritonavir in healthy subjects. J Clin Pharmacol 2011; 51: 368–377.

Agarwala S. , Gray K. , Nettles R. , Wany Y. , Persson A. , Bertz R. Lack of pharmacokinetic interaction between atazanavir, ritonavir and fluconazole dosed to steady-state in healthy subjects. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy. 27–30 September 2006, San Francisco, CA, USA. Abstract A-382.

SUSTIVA™ (efavirenz) prescribing information 2011. Bristol–Myers Squibb Company Princeton, NJ, USA.

REYATAZ™ (atazanavir sulfate) prescribing information 2012. Bristol–Myers Squibb Company Princeton, NJ, USA.

VIREAD™ (tenofovir disoproxil fumarate) prescribing information 2012. Gilead Sciences Foster City, CA, USA.

Taburet A.M. , Piketty C. , Chazallon C. Interactions between atazanavir-ritonavir and tenofovir in heavily pretreated human immunodeficiency virus-infected patients. Antimicrob Agents Chemother 2004; 48: 2091–2096.

Pruvost A. , Negredo E. , Theodoro F. Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir. Antimicrob Agents Chemother 2009; 53: 1937–1943.

Chan P. , Tafoya E. , Bifano M. Exposure-response analysis of daclatasvir in patients with genotype 1 chronic HCV infection: dose selection for phase 3 clinical trials. Reviews in Antiviral Therapy and Infectious Diseases 2012; 6: 14.