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3D regimen plus ribavirin yields high SVR in patients with HIV/HCV

In the TURQUOISE-1 pilot study, a majority of patients coinfected with hepatitis C virus infection genotype 1 and HIV-1 achieved sustained virologic response after treatment with Viekira Pak plus ribavirin, according to newly published data in JAMA.

“The TURQUOISE-1 trial assessed the adverse event profile and virologic outcomes of the [three direct-acting antiviral] regimen with ribavirin for 12 or 24 weeks in patients coinfected with HCV genotype 1 and HIV-1, including those with prior [pegylated interferon] plus ribavirin treatment experience and with cirrhosis,” the researchers wrote.

Mark Sulkowski

Researchers, including Mark Sulkowski, MD, medical director of the Johns Hopkins Center for Viral Hepatitis and an HCV Next Editorial Board member, enrolled 63 patients in the study and randomly assigned to co-formulated Viekira Pak (ombitasvir, paritaprevir and ritonavir plus dasabuvir sodium, AbbVie) plus ribavirin for 12 or 24 weeks. All patients received at least one dose of the study drugs, according to the research.

Of 31 patients who received the regimen for 12 weeks, 29 achieved an SVR at 12 weeks (94%; 95% CI, 79-98). Of 32 patients who received the regimen for 24 weeks, 29 achieved SVR at 12 weeks (91%; 95% CI, 76-97). Five patients did not reach SVR due to one withdrawing consent, two experiencing virologic relapse or breakthrough and two patients with phylogenetic evidence consistent with HCV reinfection, according to the research.

Fifty-six patients experienced adverse events due to treatment, although most were mild or moderate in severity. No serious adverse events or discontinuations of HCV therapy related to an adverse event were observed. The most common adverse events seen among the patients were fatigue (30%), insomnia (19%), nausea (17%) and headache (16%).   

None of the patients experienced HIV-1 breakthrough of 200 copies/mL or more during therapy.

“In this open-label, randomized uncontrolled study, treatment with the all-oral, interferon-free 3D-plus-ribavirin regimen resulted in high SVR rates among patients coinfected with HCV genotype 1 and HIV-1 whether treated for 12 or 24 weeks,” the researchers concluded. “Further phase 3 studies of this regimen are warranted in patients with coinfection.” – by Melinda Stevens

Disclosure: Sulkowski reports having been a consultant or on the advisory board for AbbVie, Achillon, Bristol-Myers Squibb, Gilead, Janssen and Merck; served on a data and safety monitoring board for Gilead; and received grant or research support from AbbVie, Bristol-Myers Squibb, Gilead, Merck and Janssen. Please see the study for a full list of other authors’ relevant financial disclosures.