Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection
NCT ID: NCT03098121
Last Updated: 2018-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2017-10-20
2018-11-30
Brief Summary
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Detailed Description
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Secondary Objective
•To assess the tolerability of grazoprevir 100mg and elbasvir 50mg in peginterferon alfa plus ribavirin experienced patients by measuring frequency of SAEs and AEs leading to discontinuation.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Genotype 1 HCV and HIV co-infection
Patients with chronic Genotype 1 HCV and HIV co-infection, with or without resistance-associated substitution (RAS) of NS5A, received grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and patients with chronic genotype 1b received grazoprevir and elbasvir once daily for 12 weeks.
grazoprevir and elbasvir
For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and for patients with chronic genotype 1b are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily for 12 weeks.
Interventions
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grazoprevir and elbasvir
For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and for patients with chronic genotype 1b are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* HCV RNA \> 10,000 IU/mL
* Stable antiretroviral therapy (ARV) with confirmed plasma HIV-1 RNA \< 200 copies/mL
* CD4 T-cell count \> 100 cells/L
* peginterferon alfa plus ribavirin failure: null response \<1 log10 IU/mL reduction in HCV RNA at week 4; detectable HCV RNA since week 12 to the end of treatment; detectable HCV RNA for 12 to 24 weeks after the end of treatment; or discontinuation of peginterferon alfa plus ribavirin due to grade 3 or grade 4 adverse effects at any moment.
Exclusion Criteria
* Liver cirrhosis with Child-Pugh class B or C, or with a Child-Turcotte-Pugh score of more than 6 points and albumin below 3 g/dL or platelet count below 75,000/ μL
* History of malignant disease, or evidence of hepatocellular carcinoma
* ARV with protease inhibitor containing regimen HBsAg and HBV core antibody should be checked in all patients. HBsAg positive patients should be excluded from the study. HBV core antibody positive patients should be closely monitored for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Appropriate patient management should be instituted for HBV infection as clinically indicated.
20 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Taoyuan General Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Chien-Yu Cheng
Role: PRINCIPAL_INVESTIGATOR
Taoyuan General Hospital
Locations
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Taoyuan general hospital
Taoyuan District, , Taiwan
Countries
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References
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Laguno M, Cifuentes C, Murillas J, Veloso S, Larrousse M, Payeras A, Bonet L, Vidal F, Milinkovic A, Bassa A, Villalonga C, Perez I, Tural C, Martinez-Rebollar M, Calvo M, Blanco JL, Martinez E, Sanchez-Tapias JM, Gatell JM, Mallolas J. Randomized trial comparing pegylated interferon alpha-2b versus pegylated interferon alpha-2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients. Hepatology. 2009 Jan;49(1):22-31. doi: 10.1002/hep.22598.
Chung RT, Andersen J, Volberding P, Robbins GK, Liu T, Sherman KE, Peters MG, Koziel MJ, Bhan AK, Alston B, Colquhoun D, Nevin T, Harb G, van der Horst C; 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 Jul 29;351(5):451-9. doi: 10.1056/NEJMoa032653.
Torriani FJ, Rodriguez-Torres M, Rockstroh JK, Lissen E, Gonzalez-Garcia J, Lazzarin A, Carosi G, Sasadeusz J, Katlama C, Montaner J, Sette H Jr, Passe S, De Pamphilis J, Duff F, Schrenk UM, Dieterich DT; APRICOT Study Group. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med. 2004 Jul 29;351(5):438-50. doi: 10.1056/NEJMoa040842.
Liu JY, Lin HH, Liu YC, Lee SS, Chen YL, Hung CC, Ko WC, Huang CK, Lai CH, Chen YS, Shih YL, Chung HC, Liang SH, Lin JN. Extremely high prevalence and genetic diversity of hepatitis C virus infection among HIV-infected injection drug users in Taiwan. Clin Infect Dis. 2008 Jun 1;46(11):1761-8. doi: 10.1086/587992.
Liu CH, Sheng WH, Sun HY, Hsieh SM, Lo YC, Liu CJ, Su TH, Yang HC, Liu WC, Chen PJ, Chen DS, Hung CC, Kao JH. Peginterferon plus Ribavirin for HIV-infected Patients with Treatment-Naive Acute or Chronic HCV Infection in Taiwan: A Prospective Cohort Study. Sci Rep. 2015 Nov 30;5:17410. doi: 10.1038/srep17410.
Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, Marks K, Luetkemeyer A, Baden RP, Sax PE, Gane E, Santana-Bagur J, Stamm LM, Yang JC, German P, Dvory-Sobol H, Ni L, Pang PS, McHutchison JG, Stedman CA, Morales-Ramirez JO, Brau N, Jayaweera D, Colson AE, Tebas P, Wong DK, Dieterich D, Sulkowski M; ION-4 Investigators. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):705-13. doi: 10.1056/NEJMoa1501315. Epub 2015 Jul 21.
Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21.
Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, Matthews GV, Saag MS, Zamor PJ, Orkin C, Gress J, Klopfer S, Shaughnessy M, Wahl J, Nguyen BY, Barr E, Platt HL, Robertson MN, Sulkowski M. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015 Aug;2(8):e319-27. doi: 10.1016/S2352-3018(15)00114-9. Epub 2015 Jul 9.
Bunchorntavakul C, Chavalitdhamrong D, Tanwandee T. Hepatitis C genotype 6: A concise review and response-guided therapy proposal. World J Hepatol. 2013 Sep 27;5(9):496-504. doi: 10.4254/wjh.v5.i9.496.
Lin YC, Li SW, Ku SY, Hsieh HT, Lin MH, Chang SY, Wu WW, Sun NL, Cheng SH, Cheng CY. Grazoprevir/elbasvir in peginterferon alfa plus ribavirin experienced patients with chronic genotype 1 HCV/HIV co-infection: a non-randomized, open-label clinical trial. Infect Drug Resist. 2019 Apr 18;12:937-945. doi: 10.2147/IDR.S206938. eCollection 2019.
Other Identifiers
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TYGH105034
Identifier Type: -
Identifier Source: org_study_id