Ombitasvir, Paritaprevir Co-dosed with Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected with HIV-1 a Randomized Trial

Mark Sulkowski, Oseph J. Eron, David Wyles, Roger Trinh, Jay Lalezari, Chia Wang, Jihad Slim, Laveeza Bhatti, Joseph Gathe, Peter J. Ruane, Richard Elion, Fritz Bredeek, Robert Brennan, Gary Blick, Amit Khatri, Krystal Gibbons, Yiran B. Hu, Linda Fredrick, Gretja Schnell, Tami Pilot-MatiasRakesh Tripathi, Barbara Da Silva-Tillmann, Barbara McGovern, Andrew L. Campbell, Thomas Podsadecki

Research output: Contribution to journalArticle

Abstract

IMPORTANCE: Patients co-infected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) are at high risk for liver disease progression. However, interferon-based treatments for HCV infection have significant toxicities, limiting treatment uptake. OBJECTIVE: To assess the all-oral 3 direct-acting antiviral (3D) regimen of ombitasvir, paritaprevir (co-dosed with ritonavir [paritaprevir/r]), dasabuvir, and ribavirin in HCV genotype 1-infected adults with HIV-1 co-infection, including patients with cirrhosis. DESIGN, SETTING, AND PARTICIPANTS: TURQUOISE-I is a randomized, open-label study. Part 1a of this pilot study was conducted at 17 sites in the United States and Puerto Rico between September 2013 and August 2014 and included 63 patients with HCV genotype 1 and HIV-1 co-infection who were HCV treatment-naive or had history of prior treatment failure with peginterferon plus ribavirin therapy. The study allowed enrollment of patients, including those with cirrhosis, with a CD4+ count of 200/mm3 or greater or CD4+ percentage of 14% or more and plasma HIV-1 RNA suppressed while taking a stable atazanavir- or raltegravir-inclusive antiretroviral regimen. INTERVENTIONS: Ombitasvir/paritaprevir/r, dasabuvir, and ribavirin for 12 or 24 weeks of treatment as randomized. MAIN OUTCOMES AND MEASURES: The primary assessmentwas the proportion of patients with sustained virologic response (HCV RNA

Original languageEnglish (US)
Pages (from-to)1223-1231
Number of pages9
JournalJournal of the American Medical Association
Volume313
Issue number12
DOIs
StatePublished - Mar 24 2015

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Ritonavir
Ribavirin
Hepatitis C
Hepacivirus
HIV-1
Coinfection
Fibrosis
Genotype
RNA
Therapeutics
Puerto Rico
Virus Diseases
CD4 Lymphocyte Count
Treatment Failure
Interferons
Antiviral Agents
Disease Progression
ABT-450
ABT-333
ABT-267

ASJC Scopus subject areas

  • Medicine(all)

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Ombitasvir, Paritaprevir Co-dosed with Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected with HIV-1 a Randomized Trial. / Sulkowski, Mark; Eron, Oseph J.; Wyles, David; Trinh, Roger; Lalezari, Jay; Wang, Chia; Slim, Jihad; Bhatti, Laveeza; Gathe, Joseph; Ruane, Peter J.; Elion, Richard; Bredeek, Fritz; Brennan, Robert; Blick, Gary; Khatri, Amit; Gibbons, Krystal; Hu, Yiran B.; Fredrick, Linda; Schnell, Gretja; Pilot-Matias, Tami; Tripathi, Rakesh; Da Silva-Tillmann, Barbara; McGovern, Barbara; Campbell, Andrew L.; Podsadecki, Thomas.

In: Journal of the American Medical Association, Vol. 313, No. 12, 24.03.2015, p. 1223-1231.

Research output: Contribution to journalArticle

Sulkowski, M, Eron, OJ, Wyles, D, Trinh, R, Lalezari, J, Wang, C, Slim, J, Bhatti, L, Gathe, J, Ruane, PJ, Elion, R, Bredeek, F, Brennan, R, Blick, G, Khatri, A, Gibbons, K, Hu, YB, Fredrick, L, Schnell, G, Pilot-Matias, T, Tripathi, R, Da Silva-Tillmann, B, McGovern, B, Campbell, AL & Podsadecki, T 2015, 'Ombitasvir, Paritaprevir Co-dosed with Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected with HIV-1 a Randomized Trial', Journal of the American Medical Association, vol. 313, no. 12, pp. 1223-1231. https://doi.org/10.1001/jama.2015.1328
Sulkowski, Mark ; Eron, Oseph J. ; Wyles, David ; Trinh, Roger ; Lalezari, Jay ; Wang, Chia ; Slim, Jihad ; Bhatti, Laveeza ; Gathe, Joseph ; Ruane, Peter J. ; Elion, Richard ; Bredeek, Fritz ; Brennan, Robert ; Blick, Gary ; Khatri, Amit ; Gibbons, Krystal ; Hu, Yiran B. ; Fredrick, Linda ; Schnell, Gretja ; Pilot-Matias, Tami ; Tripathi, Rakesh ; Da Silva-Tillmann, Barbara ; McGovern, Barbara ; Campbell, Andrew L. ; Podsadecki, Thomas. / Ombitasvir, Paritaprevir Co-dosed with Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected with HIV-1 a Randomized Trial. In: Journal of the American Medical Association. 2015 ; Vol. 313, No. 12. pp. 1223-1231.
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AU - Eron, Oseph J.

AU - Wyles, David

AU - Trinh, Roger

AU - Lalezari, Jay

AU - Wang, Chia

AU - Slim, Jihad

AU - Bhatti, Laveeza

AU - Gathe, Joseph

AU - Ruane, Peter J.

AU - Elion, Richard

AU - Bredeek, Fritz

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AU - Fredrick, Linda

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AU - Pilot-Matias, Tami

AU - Tripathi, Rakesh

AU - Da Silva-Tillmann, Barbara

AU - McGovern, Barbara

AU - Campbell, Andrew L.

AU - Podsadecki, Thomas

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