Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV a randomized trial

Annals of Internal Medicine

Volumn 159, Issue 2, 2013, Pages 86-96

  Sulkowski, Mark S ^a   Sherman, Kenneth E ^b   Dieterich, Douglas T ^c   Bsharat, Mohammad ^d   Mahnke, Lisa ^d   Rockstroh, Jürgen K ^e   Gharakhanian, Shahin ^f   Mccallister, Scott ^g   Henshaw, Joshua ^h   Girard, Pierre Marie ⁱ   Adiwijaya, Bambang ^h   Garg, Varun ^h   Rubin, Raymond A ^h   Adda, Mathalie ^j   Soriano, Vincent ^k  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^c MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^d VERTEX PHARMACEUTICALS   (United States)

^e UNIVERSITY HOSPITAL BONN   (Germany)

^f CIC: Cambridge Innovation Center   (United States)

^g GILEAD SCIENCES   (United States)

^h Rue du Faubourg Saint Antoine ^*  (United States)

ⁱ HÔPITAL SAINT ANTOINE   (France)

^j NONE   (United States)

^k HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

more..

Author keywords

Vertex pharmaceuticals and janssen pharmaceuticals

Indexed keywords

ATAZANAVIR; EFAVIRENZ; PEGINTERFERON ALPHA2A PLUS RIBAVIRIN; PLACEBO; TELAPREVIR; TENOFOVIR; VIRUS RNA;

ABDOMINAL PAIN; ACNE; ACUTE OTITIS MEDIA; ACUTE PYELONEPHRITIS; ACUTE SINUSITIS; ADULT; ALOPECIA; ANUS PRURITUS; ANXIETY DISORDER; APHTHOUS STOMATITIS; APPENDICITIS; ARTICLE; ATTENTION DISTURBANCE; BRONCHITIS; CELLULITIS; CHEILITIS; CHILL; CHRONIC HEPATITIS C VIRUS GENTOYPE 1 INFECTION; COGNITIVE DEFECT; CONDYLOMA ACUMINATUM; CONJUNCTIVITIS; CONSTIPATION; CONTACT DERMATITIS; CONTROLLED STUDY; DEPRESSION; DERMATITIS; DERMATOMYCOSIS; DIARRHEA; DISORIENTATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSGEUSIA; DYSPEPSIA; ECZEMA; EMOTIONAL DISORDER; ERYTHEMA; FAINTNESS; FATIGUE; FEMALE; FEVER; FLATULENCE; FLU LIKE SYNDROME; FURUNCULOSIS; GASTROESOPHAGEAL REFLUX; GINGIVA BLEEDING; HEADACHE; HEMORRHOID; HEPATITIS C; HERPANGINA; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERESTHESIA; HYPERHIDROSIS; INFLUENZA; INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INSOMNIA; LETHARGY; LIBIDO DISORDER; LOWER RESPIRATORY TRACT INFECTION; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NIGHT SWEAT; NONCARDIAC CHEST PAIN; ONYCHOMYCOSIS; OUTCOME ASSESSMENT; PAINFUL DEFECATION; PAPULAR RASH; PARESTHESIA; PARONYCHIA; PAROSMIA; PAROTITIS; PERIPHERAL EDEMA; PERITONITIS; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PILONIDAL SINUS; PNEUMONIA; PRIORITY JOURNAL; PROCTALGIA; PRURIGO; PRURITUS; PURPURA; RANDOMIZED CONTROLLED TRIAL; RASH; RECTUM HEMORRHAGE; RELAPSE; RESPIRATORY TRACT INFECTION; RETCHING; RHINOPHARYNGITIS; SECONDARY SYPHILIS; SINUSITIS; SKIN DEFECT; SKIN IRRITATION; SKIN ULCER; SLEEP DISORDER; SUICIDAL IDEATION; SURGICAL INFECTION; THRUSH; TOOTH PAIN; TREATMENT RESPONSE; TREMOR; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; VOMITING; XEROSTOMIA;

EID: 84879799809     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-159-2-201307160-00654     Document Type: Article

References (31)

1. Smith C, Sabin CA, Lundgren JD, Thiebaut R, Weber R, Law M, et al; Data Collection on Adverse Events of Anti-HIV drugs (D:A:D) Study Group.Factors associated with specific causes of death amongst HIV-positive individuals in the D:A:D Study. AIDS. 2010;24:1537-1548. [PMID: 20453631]
2. Berenguer J, Alvarez-Pellicer J, Martin PM, Lopez-Aldeguer J, Von- Wichmann MA, Quereda C, et al; GESIDA3603/5607 Study Group. Sustained virological response to interferon plus ribavirin reduces liver-related complications and mortality in patients coinfected with human immunodeficiency virus and hepatitis C virus. Hepatology. 2009;50:407-413. [PMID: 19575364]
3. Morgan TR, Ghany MG, Kim HY, Snow KK, Shiftman ML, De Santo JL, et al; HALT-C Trial Group. Outcome of sustained virological responders with histologically advanced chronic hepatitis C. Hepatology. 2010;52:833-844. [PMID: 20564351]
4. Soriano V, Labarga P, Ruiz-Sancho A, Garcia-Samaniego J, Barreiro P. Regression of liver fibrosis in hepatitis C virus/HIV-co-infected patients after treatment with pegylated interferon plus ribavirin [Editorial]. AIDS. 2006;20: 2225-2227. [PMID: 17086063]
5. Tien PC; Veterans Affairs Hepatitis C Resource Center Program. Management and treatment of hepatitis C virus infection in HIV-infected adults: recommendations from the Veterans Affairs Hepatitis C Resource Center Program and National Hepatitis C Program Office. Am J Gastroenterol. 2005;100:2338-2354. [PMID: 16181388]
6. Soriano V, Puoti M, Sulkowski M, Cargnel A, Benhamou Y, Peters M, et al. Care of patients coinfected with HIV and hepatitis C virus: 2007 updated recommendations from the HCV-HIV International Panel. AIDS. 2007;21:1073-1089. [PMID: 17502718]
7. Rockstroh JK, Bhagani S, Benhamou Y, Bruno R, Mauss S, Peters L, et al; EACS Executive Committee. European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of chronic hepatitis B and C coinfection in HIV-infected adults. HIV Med. 2008;9:82-88. [PMID: 18257771]
8. Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49:1335-1374. [PMID: 19330875]
9. Alberti A, Clumeck N, Collins S, Gerlich W, Lundgren J, Palu G, et al; ECC Jury. Short statement of the first European Consensus Conference on the treatment of chronic hepatitis B and C in HIV co-infected patients. J Hepatol. 2005; 42:615-624. [PMID: 15916745]
10. Chung RT, Andersen J, Volberding P, Robbins GK, Liu T, Sherman KE, et al; AIDS Clinical Trials Group A5071 Study Team. 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. [PMID: 15282352]
11. Torriani FJ, Rodriguez-Torres M, Rockstroh JK, Lissen E, Gonzalez-Garcia J, Lazzarin A, et al; APRICOT Study Group. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med. 2004;351:438-450. [PMID: 15282351]
12. Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, et al; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1207-1217. [PMID: 21449784]
13. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, et al; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-2416. [PMID: 21696307]
14. Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1195-1206. [PMID: 21449783]
15. Sherman KE, Flamm SL, Afdhal NH, Nelson DR, Sulkowski MS, Everson GT, et al; ILLUMINATE Study Team. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011;365:1014-1024. [PMID: 21916639]
16. Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, et al; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011;364:2417-2428. [PMID: 21696308]
17. Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB; American Association for the StudyofLiver Diseases. An update on treatment ofgenotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology. 2011;54:1433-1444. [PMID: 21898493]
18. Garg V, Chandorkar G, Yang Y, Adda N, McNair L, Alves K, et al. The effect of CYP3A inhibitors and inducers on the pharmacokinetics of telaprevir in healthy volunteers. Br J Clin Pharmacol. 2013;75:431-439. [PMID: 22642697]
19. Cachay ER. Hepatitis C cure after 6 months of telaprevir-based therapy in an HIV-infected man [Letter]. Clin Infect Dis. 2013;56:163-164. [PMID: 23001703]
20. Le MP, Gervais A, Le Beller C, Long K, Larrouy L, Papy E, et al. Serious neuropsychiatric adverse effects in a hepatitis C virus/hepatitis B virus/HIV- coinfected patient receiving bosentan and telaprevir. J Antimicrob Chemother. 2013;68:1208-1209. [PMID: 23335198]
21. Genentech. Copegus (ribavirin) Tablets [package insert]. San Francisco: Ge- nentech; 2013. Accessed at www.gene.com/download/pdf/copegus_prescribing.pdf on 2 May 2013.
22. Merck. Pegetron [product monograph]. Kirkland, Quebec, Canada: Merck Canada; 2011. Accessed at www.merck.ca/assets/en/pdf/products/Pegetron-PM_E.pdf on 2 May 2013.
23. Rodriguez-Torres M, Slim J, Bhatti L, Sterling R, Sulkowski M, Hassanein T, et al. Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. HIV Clin Trials. 2012;13:142-52. [PMID: 22592094]
24. Ribavirin Teva [EMEA Summary of Product Characteristics]. London: European Medicines Agency; 16 November 2009 (updated 12 March 2013). Accessed at www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001018/WC500056547.pdf on 2 May 2013.
25. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011;55:245-264. [PMID: 21371579]
26. Vertex Pharmaceuticals. Incivek [package insert]. Cambridge, MA: Vertex Pharmaceuticals; 2012. Accessed at http://pi.vrtx.com/files/uspi_telaprevir.pdf, on May 2013.
27. Naggie S, Sulkowski MS. Management of patients coinfected with HCV and HIV: a close look at the role for direct-acting antivirals. Gastroenterology. 2012; 142:1324.e3-1334.e3. [PMID: 22537439]
28. Mira JA, Lopez-Cortes LF, Merino D, Arizcorreta-Yarza A, Rivero A, Collado A, et al; Grupo para el Estudio de las Hepatitis Viricas de la Sociedad Andaluza de Enfermedades Infecciosas. Predictors of severe haematological toxicity secondary to pegylated interferon plus ribavirin treatment in HIV-HCV- coinfected patients. Antivir Ther. 2007;12:1225-1235. [PMID: 18240862]
29. Butt AA, Umbleja T, Andersen JW, Chung RT, Sherman KE; ACTG A5178 StudyTeam. The incidence, predictors and management of anaemia and its association with virological response in HCV/HIV coinfected persons treated with long-term pegylated interferon alfa 2a and ribavirin. Aliment Pharmacol Ther. 2011;33:1234-1244. [PMID: 21535051]
30. Alvarez D, Dieterich DT, Brau N, Moorehead L, Ball L, Sulkowski MS. Zidovudine use but not weight-based ribavirin dosing impacts anaemia during HCV treatment in HIV-infected persons. JViral Hepat. 2006;13:683-689. [PMID: 16970600]
31. Incivo [Summary of Product Characteristics]. London: European Medicines Agency; 10 March 2011 (updated 12 April 2013). Accessed at www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002313/WC500115529.pdf on 2 May 2013.