Latest pharmacotherapy options for treating hepatitis C in HIV-infected patients

Expert Opinion on Pharmacotherapy

Volumn 15, Issue 13, 2014, Pages 1837-1848

  Macías, Juan ^a,b   Neukam, Karin ^a,b   Merchante, Nicolás ^a,b   Pineda, Juan A ^a,b  

^a HOSPITAL UNIVERSITARIO DE VALME   (Spain)

^b Instituto de Biomedicina de Sevilla   (Spain)

Author keywords

Direct acting antiviral drug; Hepatitis C virus; HIV; Treatment

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTIVIRUS AGENT;

DISEASE COURSE; HEPATITIS C; HEPATITIS C, CHRONIC; HIV INFECTIONS; HUMAN; MIXED INFECTION; PHASE 3 CLINICAL TRIAL (TOPIC);

ANTI-HIV AGENTS; ANTIVIRAL AGENTS; CLINICAL TRIALS, PHASE III AS TOPIC; COINFECTION; DISEASE PROGRESSION; HEPATITIS C; HEPATITIS C, CHRONIC; HIV INFECTIONS; HUMANS;

EID: 84905869523     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2014.934810     Document Type: Review

References (66)

1. Kim AY, Onofrey S, Church DR. An epidemiologic update on hepatitis C infection in persons living with or at risk of HIV infection. J Infect Dis 2013;207(Suppl 1):S1-6
2. Pineda JA, Romero-Gömez M, Díaz-García F, et al. HIV coinfection shortens the survival of patients with hepatitis C virus-related decompensated cirrhosis. Hepatology 2005;41:779-89
3. van der Helm J, Geskus R, Sabin C, et al. Effect of HCV infection on causespecific mortality after HIV seroconversion, before and after 1997. Gastroenterology 2013;144:751-60
4. Merchante N, Girön-Gonzälez JA, Gonzälez-Serrano M, et al. Survival and prognostic factors of HIV-infected patients with HCV-related end-stage liver disease. AIDS 2006;20:49-57
5. Mira JA, Rivero-Juärez A, Löpez-Cortes LF, et al. Benefits from sustained virologic response to pegylated interferon plus ribavirin in HIV/hepatitis C virus-coinfected patients with compensated cirrhosis. Clin Infect Dis 2013;56:1646-53
6. Pineda JA, Caruz A, Rivero A, et al. Prediction of response to pegylated interferon plus ribavirin by IL28B gene variation in patients coinfected with HIV and hepatitis C virus. Clin Infect Dis 2010;51:788-95
7. Mira JA, García-Rey S, Rivero A, et al. Response to pegylated interferon plus ribavirin among HIV/hepatitis C virus-coinfected patients with compensated liver cirrhosis. Clin Infect Dis 2012;55:1719-26
8. Mira JA, Rivero A, de Los Santos-Gil I, et al. Hepatitis C virus genotype 4 responds better to pegylated interferon with ribavirin than genotype 1 in HIV-infected patients. AIDS 2012;26:1721-4
9. Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA). Recommendations for Testing, Managing, and Treating Hepatitis C. American. Available from: http://hcvguidelines.org/[Last accessed 14 March 2014]
10. European Association for the Study of the Liver (EASL). EASL Recommendations on Treatment of Hepatitis C 2014. Available from: http://files.easl.eu/easl-recommendations-ontreatment-of-hepatitis-C.pdf [Last accessed 10 May 2014]
11. Hare CB, Sherman KE, Talal A, et al. Simplified dosing and response-guided therapy using telaprevir combination treatment for genotype 1 HCV treatment-Naíve or-experienced HIV Co-infected patients: UNITE interim analysis. Global Antiviral J 2013;9(Suppl 2); HEP DART. Frontiers in Drug Development for Viral Hepatitis. December 8-12, 2013. Hawaii. Abstract 64
12. European AIDS Clinical Society. Clinical Management and Treatment of Chronic HBV and HCV Co-infection in HIV-positive Persons. Available from: http://eacsociety.org/Portals/0/Guidelines-Online-131014.pdf [Last accessed 12 March 2014]
13. A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon/Ribavirin. Available from: http://clinicaltrials.gov/show/NCT01718301 [Last accessed 12 March 2014]
14. Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C. Available from: http://clinicaltrials.gov/show/NCT01925183 [Last accessed 12 March 2014]
15. Janssen Therapeutics. OLYSIO- (Simeprevir) full prescribing information. Titusville, NJ, USA. Issued 2013. Available from: http://www.accessdata.fda.gov/ drugsatfda-docs/label/2013/205123s000lbl.pdf [Last accessed 13 March 2014]
16. Dieterich D, Rockstroh JK, Orkin C, et al. Simeprevir plus PegIFN/rivabirin in HCV genotype-1/HIV-1 co-infection (Study C212) [abstract 24]. 21st Congress on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, MA, USA.
17. Dieterich D, Tural C, Nelson M, et al. Faldaprevir plus pegylated interferon Alfa-2a/ribavirin in HIV/HCV coinfection: STARTVerso4 [abstract 23]. 21st Congress on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, MA, USA.
18. A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 (HIV-1) Coinfection (TURQUOISE-I). ClinicalTrials.gov Identifier: NCT01939197
19. Sulkowski M, Pol S, Mallolas J, et al. Boceprevir versus placebo with pegylated interferon alfa-2b and ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a randomised, double-blind, controlled phase 2 trial. Lancet Infect Dis 2013;13:597-605
20. Poizot-Martin I, Bellissant E, Piroth L, et al. W48 response rate of boceprevir-Peg-IFN-RBV in treatment-experienced HIV coinfected patients with HCV genotype 1: ANRS-HC27 BocepreVIH Study [abstract 1105]. 64th Annual Meeting of the American Association for the Study of Liver Diseases; 1-5 November 2013; Washington, DC, USA.
21. Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection. Available from: http://clinicaltrials.gov/show/NCT01482767 [Last accessed 12 March 2014]
22. Sulkowski MS, Sherman KE, Dieterich DT, et al. Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV: a randomized trial. Ann Intern Med 2013;159:86-96 23.
23. Cotte L, Braun J, Sogni P, et al. High end-of-treatment (EOT) response rate with telaprevir-Peg-IFN-RBV in treatment-experienced HIV coinfected patients with HCV genotype 1: ANRS HC26 [abstract 1108]. 64th Annual Meeting of the American Association for the Study of Liver Diseases; 1-5 November 2013; Washington, DC, USA
24. Multicenter, Open-Label, Study of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Human Immunodeficiency Virus/Genotype 1 Chronic Hepatitis C Coinfected Subjects With Severe Fibrosis or Compensated Cirrhosis. Available from: http://clinicaltrials.gov/show/NCT01500616 [Last accessed 12 March 2014]
25. Montes M, Nelson M, Girard M, et al. Telaprevir combination therapy in treatment-naive and-experienced patients co-infected with hepatitis C virus and HIV: week 12 analysis of INSIGHT [abstract 38]. Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; 1-5 November 2013; Washington, DC, USA.
26. Jacobson IM, Dore GJ, Foster GR, et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naive patients: efficacy in difficult-to-treat patient sub-populations in the QUEST 1 and 2 phase III trials [abstract 1122]. 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2013); 1-5 November 2013; Washington, DC.
27. Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/rombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370:1594-603
28. Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/rombitasvir and dasabuvir withribavirin. N Engl J Med 2014;370:1604-14
29. 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):1973-82
30. de Kanter CT, Blonk MI, Colbers AP, et al. Lack of a clinically significant drugdrug interaction in healthy volunteers between the hepatitis C virus protease inhibitor boceprevir and the HIV integrase inhibitor raltegravir. Clin Infect Dis 2013;56:300-6
31. Rhee E, Feng H-P, Xuan F, et al. Absence of a significant pharmacokinetic interaction between the hepatitis C virus protease inhibitor boceprevir and HIV-1 NNRTI rilpivirine [abstract 537]. 20th Conference on Retroviruses and Opportunistic Infections; 3-6 March 2013; Atlanta, GA, USA.
32. Hammond KP, Wolfe P, Burton JR Jr, et al. Pharmacokinetic interaction between boceprevir and etravirine in HIV/HCV seronegative volunteers. J Acquir Immune Defic Syndr 2013;62:67-73
33. Vourvahis M, Plotka A, Kantaridis C, et al. The effect of boceprevir and telaprevir on the pharmacokinetics of maraviroc: an open-label, fixed-sequence study in healthy volunteers [abstract O-17]. 14th International Workshop on Clinical Pharmacology of HIV Therapy; 15-17 April 2013; Amsterdam, The Netherlands.
34. Hulskotte EG, Feng HP, Xuan F, et al. Pharmacokinetic interactions between the hepatitis C virus protease inhibitor boceprevir and ritonavir-boosted HIV-1 protease inhibitors atazanavir, DRV/r, and lopinavir. Clin Infect Dis 2013;56:718-26
35. British HIV Association. British HIV Association guidelines for the management of hepatitis viruses in adults infected with HIV 2013. HIV Med 2013;14(Suppl 4):1-71
36. Grupo de Estudio del SIDA-SEIMC (GeSIDA). Documento de consenso de GeSIDA/Plan Nacional sobre el Sida respecto al tratamiento antirretroviral en adultos infectados por el virus de la inmunodeficiencia humana (Actualizaciön enero 2014). Available from: http://www.gesida-seimc.org/ contenidos/guiasclinicas/2014/gesida-guiasclinicas-2014-tar.pdf [Last accessed at 2 April 2014]
37. US Food and Drug Administration. FDA Drug Safety Communication: updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs. Available from: http://www.fda.gov/Drugs/ DrugSafety/ucm301616.htm [Last accessed 12 March 2014]
38. European Medicines Agency. European Medicines Agency informs doctors and patients about drug interaction between Victrelis and ritonavir-boosted HIV protease inhibitors. Available from: http://www.ema.europa.eu/docs/en-GB/ document-library/Press-release/2012/02/WC500122880.pdf [Last accessed 12 March 2014]
39. Van Heeswijk R, Vandevoorde A, Boogaerts G, et al. Pharmacokinetic interactions between ARV agents and the investigational HCV protease inhibitor telaprevir in healthy volunteers [abstract 119]. 18th Conference on Retroviruses and Opportunistic Infections; February 27-March 2 2011; Boston, MA, USA
40. Van Heeswijk R, Garg V, Boogaerts G, et al. The pharmacokinetic interaction between telaprevir and raltegravir in healthy volunteers [abstract A1-1738a]. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy; 17-20 September 2011; Chicago, IL, USA.
41. Kakuda T, Leopold L, Nijs S, et al. Pharmacokinetic interaction between etravirine or rilpivirine and telaprevir in healthy volunteers: a randomised, twoway crossover trial [abstract O-18]. 13th International Workshop on Clinical Pharmacology of HIV Therapy; 16-18 April 2012; Barcelona, Spain.
42. Ouwerkerk-Mahadevan S, Sekar V, Simion A, et al. The pharmacokinetic interactions of the HCV protease inhibitor simeprevir (TMC435) with HIV antiretroviral agents in healthy volunteers [abstract 1618]. 50th Infectious Diseases Society of America Annual Meeting; 17-21 October 2012; San Diego, CA, USA.
43. Sabo JP, Kort J, Haschke M, et al. Pharmacokinetic interactions of darunavir/ritonavir, EFV, and tenofovir with the HCV protease inhibitor faldaprevir in healthy volunteers [abstract 25]. 20th Conference on Retroviruses and Opportunistic Infections; 3-6 March 2013; Atlanta, GA, USA.
44. Rockstroh JK, Valantin MA, Mallolas J, et al. Pharmacokinetics of faldaprevir and antiretrovirals in patients with HIV/HCV [abstract 497]. Coinfection. 21st Congress on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, MA, USA.
45. Nelson M, Arasteh K, Jain MK, et al. Effect of faldaprevir on atazanavir pharmacokinetics in patients with HIV/HCV [abstract 499]. Coinfection. 21st Congress on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, MA, USA.
46. Gilead Sciences, Inc. SOVALDI (Sofosbuvir) full prescribing information. Foster City, CA, USA. Issued 2013. Available from: http://www.accessdata.fda. gov/drugsatfdadocs/label/2013/204671s00lbl.pdf [Last accessed 13 March 2014]
47. Kirby B, Mathias A, Rossi S, et al. No clinically significant pharmacokinetic interactions between sofosbuvir (GS-7977) and HIV antiretrovirals atripla, rilpivirine, darunavir/ritonavir, or raltegravir in healthy volunteers [abstract 1877]. Program and abstracts of the 63rd Annual Meeting of the American Association for the Study of Liver Diseases; 9-12 November 2012; Boston, MA.
48. Naggie S, Sulkowski M, Lalezari J, et al. All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients Co-infected with HIV (PHOTON-1) [abstract 26]. 21st Congress on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, MA, USA.
49. Jacobson IM, Ghalib RM, Rodriguez-Torres M, et al. SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naive and prior null responder patients: the COSMOS study [abstract LB-3]. 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2013); 1-5 November 2013; Washington, DC.
50. Lawitz E, Poordad FF, Lawitz E, 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 openlabel, randomised, phase 2 trial. Lancet 2014;383:515-23
51. Kohli A, Sims Z, Nelson A, et al. Combination oral hepatitis C antiviral therapy for 6 or 12 weeks: final results of the SYNERGY trial [abstract 27LB]. 21st Congress on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, MA, USA.
52. Hezode C, Hirschfield G, Ghesquiere W, et al. Daclatasvir, an NS5A replication complex inhibitor, combined with peginterferon alfa-2a and ribavirin in treatment-naive HCV-genotype 1 or 4 patients: phase 2b COMMAND-1 SVR12 results [abstract]. 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2012); 9-12 November 2012; Boston, MA, USA.
53. Dore GJ, Lawitz E, Hezode C, et al. Daclatasvir combined with peginterferon alfa-2a and ribavirin for 12 or 16 weeks in patients with HCV genotype 2 or 3 infection: COMMAND GT2/3 study [abstract 1418]. 48th Annual Meeting of the European Association for the Study of the Liver (EASL 2013); 24-28 April 2013; Amsterdam.
54. Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012;366:216-24
55. Chayama K, Suzuki Y, Ikeda K, et al. All-oral combination of daclatasvir plus asunaprevir in interferon ineligible naive/intolerant and non responder japanese patients chronically infected with HCV genotype 1b: Results from a phase 3 trial [abstract 211]. Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; 1-5 November 2013; Washington, DC.
56. Everson GT, Sims KD, Rodríguez-Torres M, et al. Efficacy of an interferon and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naíve patients with HCV genotype 1 infection. Gastroenterology 2014;146:420-9
57. Sulkowski MS, Gardiner DF, Rodríguez-Torres M, et al. Daclatasvir plus Sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014;370:211-21 58.
58. Zeuzem S, Hezode C, Bronowicki J-P P, et al. Daclatasvir in combination with simeprevir? ribavirin for hepatitis C virus genotype 1 infection [abstract 28LB]. 21st Congress on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, MA, USA
59. Safety and Efficacy Study of BMS-790052 Plus Peg-Interferon Alfa-2a and Ribavirin in Untreated Hepatitis C Patients Coinfected With HIV Virus (COMMAND-HIV). Available from: http://clinicaltrials.gov/show/NCT01471574 [Last accessed 13 March 2014]
60. Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, To Treat naíve Subjects With Chronic HCV Genotypes 1,2,3, and 4 Who Are Co-infected With HIV (DIMENSION). Available from: http://clinicaltrials.gov/show/NCT01866930 [Last accessed 13 March 2014]
61. Pilot study to evaluate QUAD therapy (Peg/RBV+DCV+asunaprevir [ASV] for HIV/HCV null responders. Available from: http://clinicaltrials.gov/show/ NCT01725542 [Last accessed 13 March 2014]
62. 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, EFV and tenofovir. Antivir Ther 2013;18:931-40
63. A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus-1 Co-infection. Available from: http://clinicaltrials.gov/show/NCT0207365 [Last accessed 1 April 2014]
64. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014;370:1889-98
65. Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014;370:1483-93
66. 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;370:1879-88