Evaluation of drug-drug interactions between direct-acting anti-hepatitis C virus combination regimens and the HIV-1 antiretroviral agents raltegravir, tenofovir, emtricitabine, efavirenz, and rilpivirine

Antimicrobial Agents and Chemotherapy

Volumn 60, Issue 5, 2016, Pages 2965-2971

  Khatri, Amit ^a   Dutta, Sandeep ^a   Dunbar, Martin ^a   Podsadecki, Thomas ^a   Trinh, Roger ^a   Awni, Walid ^a   Menon, Rajeev ^a  

^a ABBVIE INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; ANTIVIRUS AGENT; DASABUVIR; DIRECT ACTING ANTIVIRAL AGENT; EFAVIRENZ; EMTRICITABINE; OMBITASVIR; PARITAPREVIR; RALTEGRAVIR; RILPIVIRINE; RITONAVIR; TENOFOVIR DISOPROXIL; UNCLASSIFIED DRUG; BENZOXAZINE DERIVATIVE; TENOFOVIR;

ABDOMINAL PAIN; ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ANTIVIRAL THERAPY; AREA UNDER THE CURVE; ARTICLE; CONSTIPATION; CONTROLLED STUDY; DIZZINESS; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG EFFECT; DRUG EXPOSURE; DRUG POTENCY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DYSPEPSIA; FEMALE; HEADACHE; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NAUSEA; PHARMACOKINETIC PARAMETERS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; VOMITING; DRUG EFFECTS; DRUG INTERACTION; HEPACIVIRUS; HUMAN IMMUNODEFICIENCY VIRUS 1;

ANTI-RETROVIRAL AGENTS; ANTIVIRAL AGENTS; BENZOXAZINES; DRUG INTERACTIONS; EMTRICITABINE; HEPACIVIRUS; HIV-1; HUMANS; RALTEGRAVIR POTASSIUM; RILPIVIRINE; TENOFOVIR;

EID: 84964904230     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.02605-15     Document Type: Article

References (31)

1. Centers for Disease Control and Prevention. 2014. HIV and viral hepatitis fact sheet. Centers for Disease Control and Prevention Atlanta, GA.
2. Monga HK, Rodriguez-Barradas MC, Breaux K, Khattak K, Troisi CL, Velez M, Yoffe B. 2001. Hepatitis C virus infection-related morbidity and mortality among patients with human immunodeficiency virus infection. Clin Infect Dis 33:240-247. http://dx.doi.org/10.1086/321819.
3. Taylor LE, Swan T, Matthews GV. 2013. Management of hepatitis C virus/HIV coinfection among people who use drugs in the era of directacting antiviral-based therapy. Clin Infect Dis 57(Suppl 2):S118-S124. http://dx.doi.org/10.1093/cid/cit326.
4. Gonzalez-Colominas E, Broquetas T, Retamero A, Garcia-Retortillo M, Canete N, Coll S, Pellicer R, Gimenez MD, Cabrero B, Bory F, Knobel H, Salas E, Sola R, Carrion JA. 2015. Drug-drug interactions of telaprevir and boceprevir in HCV-monoinfected and HIV/HCV-coinfected patients can modify the adherence. Liver Int 35:1557-1565. http://dx.doi.org/10.1111/liv.12729.
5. Gilead Sciences, Inc. 2015. Harvoni prescribing information. Gilead Sciences, Inc., Forest City, CA. https://www.gilead.com/-/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni-pi.pdf.
6. Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, Mullhaupt B, Horsmans Y, Weiland O, Reesink HW, Rodrigues L, Jr, Hu YB, Podsadecki T, Bernstein B. 2014. 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 147:359-365.e1. http://dx.doi.org/10.1053/j.gastro.2014.04.045.
7. Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR. 2014. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 370:1983-1992. http://dx.doi.org/10.1056/NEJMoa1402338.
8. Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. 2014. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 370:1973-1982. http://dx.doi.org/10.1056/NEJMoa1402869.
9. Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. 2014. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 370: 1594-1603. http://dx.doi.org/10.1056/NEJMoa1315722.
10. Menon R, Badri P, Wang T, Polepally A, Zha J, Khatri A, Wang H, Hu B, Coakley E, Podsadecki T, Awni W, Dutta S. 2015. Drug-drug interaction profile of the all-oral anti-hepatitis C virus regimen of paritaprevir/ritonavir, ombitasvir and dasabuvir. J Hepatol 63:20-29. http://dx.doi.org/10.1016/j.jhep.2015.01.026.
11. AbbVie, Inc. 2015 Viekira Pak prescribing information. AbbVie, Inc., North Chicago, IL. http://www.accessdata.fda.gov/drugsatfda-docs/label/2014/206619lbl.pdf.
12. Gilead Sciences, Inc. 2013. Truvada prescribing information. Gilead Sciences, Inc., Foster City, CA. http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/021752s030lbl.pdf.
13. Cihlar T, Ho ES, Lin DC, Mulato AS. 2001. Human renal organic anion transporter 1 (hOAT1) and its role in the nephrotoxicity of antiviral nucleotide analogs. Nucleosides Nucleotides Nucleic Acids 20:641-648. http://dx.doi.org/10.1081/NCN-100002341.
14. Ray AS, Cihlar T, Robinson KL, Tong L, Vela JE, Fuller MD, Wieman LM, Eisenberg EJ, Rhodes GR. 2006. Mechanism of active renal tubular efflux of tenofovir. Antimicrob Agents Chemother 50:3297-3304. http://dx.doi.org/10.1128/AAC.00251-06.
15. Merck Sharp and Dohme Corp. 2014. Isentress prescribing information. Merck Sharp and Dohme Corp., Whitehouse Station, NJ. http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/022145s018lbl.pdf.
16. Janssen Therapeutics. 2014. Edurant prescribing information. Janssen Therapeutics, Titusville, NJ. http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/202022s000lbl.pdf.
17. Mouly S, Lown KS, Kornhauser D, Joseph JL, Fiske WD, Benedek IH, Watkins PB. 2002. Hepatic but not intestinal CYP3A4 displays dosedependent induction by efavirenz in humans. Clin Pharmacol Ther 72: 1-9. http://dx.doi.org/10.1067/mcp.2002.124519.
18. Bristol-Myers Squibb Pharmaceutical, Ltd. 2015. Sustiva prescribing information. Bristol-Myers Squibb Pharmaceutical, Ltd., Uxbridge, United Kingdom. http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/202022s000lbl.pdf.
19. Polepally AR, Dutta S, Hu B, Podsadecki TJ, Awni WM, Menon RM. 24 January 2016. Drug-drug interaction of omeprazole with the HCV directacting antiviral agents paritaprevir/ritonavir and ombitasvir with and without dasabuvir. Clin Pharmacol Drug Develop http://dx.doi.org/10.1002/cpdd.246.
20. Rodriguez-Torres M, Lawitz E, Cohen D, Larsen LM, Menon R, Collins C, Marsh T, Gibbs S, Bernstein B. 2009. Treatment-naïve, HCV genotype 1-infected subjects show significantly greater HCV RNA decreases when treated with 28 days of ABT-333 plus peginterferon and ribavirin compared to peginterferon and ribavirin alone. Hepatology 50(Suppl 4):91A.
21. Sullivan GJ, Rodrigues-Torres M, Lawitz E, Poordad F, Kapoor M, Campbell A, Setze C, Xie W, Khatri A, Dumas E, Krishnan P, Pilot-Matias T, Williams L, Bernstein B. 2012. ABT-267 combined with pegylated interferon alpha-2a/ribavirin in genotype 1 (GT1) HCV-infected treatment-naive subjects: 12 week antiviral and safety analysis. J Hepatol 56:S480. http://dx.doi.org/10.1016/S0168-8278(12)61222-7.
22. Poordad F, Lawitz E, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Heckaman M, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. 2013. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med 368:45-53. http://dx.doi.org/10.1056/NEJMoa1208809.
23. Epstein M, Felizarta F, Marbury T, Badri P, Mullally V, Pilot-Matias T, Liu X, Setze CM, Campbell AL, Bernstein B. 2013. Study of ABT-267 2-day monotherapy followed by 12-week combination therapy in treatment-naive patients with chronic HCV genotype 1 infection. J Hepatol 58:S484. http://dx.doi.org/10.1016/S0168-8278(13)61191-5.
24. Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W, Pilot-Matias T, Liossis G, Larsen L, Khatri A, Podsadecki T, Bernstein B. 2014. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med 370:222-232. http://dx.doi.org/10.1056/NEJMoa1306227.
25. Center for Drug Evaluation and Research. 2014. Summary review for regulatory action, NDA 206619. Food and Drug Administration, Rockville, MD. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/206 619Orig1s000SumR.pdf.
26. Center for Drug Evaluation and Research. 2007. Decisional review for NDA 22-128. Food and Drug Administration, Rockville, MD. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2007/022145-SumR.pdf.
27. Iwamoto M, Wenning LA, Nguyen BY, Teppler H, Moreau AR, Rhodes RR, Hanley WD, Jin B, Harvey CM, Breidinger SA, Azrolan N, Farmer HF, Jr, Isaacs RD, Chodakewitz JA, Stone JA, Wagner JA. 2009. Effects of omeprazole on plasma levels of raltegravir. Clin Infect Dis 48:489-492. http://dx.doi.org/10.1086/596503.
28. Nijland HM, L'homme RF, Rongen GA, van Uden P, van Crevel R, Boeree MJ, Aarnoutse RE, Koopmans PP, Burger DM. 2008. High incidence of adverse events in healthy volunteers receiving rifampicin and adjusted doses of lopinavir/ritonavir tablets. AIDS 22:931-935. http://dx.doi.org/10.1097/QAD.0b013e3282faa71e.
29. Jamois C, Riek M, Schmitt C. 2009. Potential Hepatotoxicity of efavirenz and saquinavir/ritonavir coadministration in healthy volunteers. Arch Drug Inf 2:1-7. http://dx.doi.org/10.1111/j.1753-5174.2009.00016.x.
30. Schmitt C, Riek M, Winters K, Schutz M, Grange S. 2009. Unexpected hepatotoxicity of rifampin and saquinavir/ritonavir in healthy male volunteers. Arch Drug Inf 2:8-16. http://dx.doi.org/10.1111/j.1753-5174.2009.00017.x.
31. Wyles DL, Sulkowski MS, Eron JJ, Trinh R, Lalezari J, Slim J, Gathe JC, Wang CC, Elion R, Bredeek F, Brennan RO, Blick G, Khatri A, Gibbons K, Hu Y, Fredrick L, Pilot-Matias T, Da Silva-Tillmann B, McGovern B, Campbell AL, Podsadecki T. 2014. TURQUOISE-I: 94% SVR12 in HCV/HIV-1 coinfected patients treated with ABT-450/r/ombitasvir, dasabuvir and ribavirin. Hepatology 60:1136A.