Results from AbbVie's Study of VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Chronic Hepat

AbbVie

today announced that results from part one of the Phase 2 portion of its Phase2/3 open-label study, TURQUOISE-I, in genotype 1 chronic hepatitis C patients with human immunodeficiency virus type 1 (HIV-1) co-infection were published online in The Journal of the American Medical Association (JAMA). Additional sub-analyses also will be presented in both oral and poster presentations on Feb. 26, at the Annual Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Wash. As published today in JAMA, and originally presented at The Liver Meeting® 2014, the TURQUOISE-I study showed patients co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and HIV-1 receiving VIEKIRA PAK™ and ribavirin (RBV) for 12 weeks or 24 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR[12]) of 94 percent (n=29/31) and 91 percent (n=29/32), respectively. The SVR[12] rates were 91 percent (n=51/56) for subjects with HCV GT1a infection and 100 percent (n=7/7) for those with HCV GT1b infection. "It is common for people to live with both GT1 chronic HCV and HIV, but data supporting treatment of chronic HCV in these co-infected patients have been limited," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "TURQUOISE-I is one of the few dedicated studies looking specifically at this historically difficult-to-treat population and we are proud to offer the HCV community an important new treatment option." VIEKIRA PAK is contraindicated with efavirenz (Sustiva) because co-administration is poorly tolerated and results in liver enzyme elevations. The ritonavir component of VIEKIRA PAK is an HIV-1 protease inhibitor and can select for HIV-1 protease inhibitor resistance. To reduce this risk, HCV/HIV-1 co-infected patients should also be on a suppressive antiretroviral (ART) drug regimen. The most common adverse events occurring in at least 10 percent of patients in TURQUOISE-I were fatigue (48%), insomnia (19%), nausea (17%), headache (16%), itching (13%), cough (11%), irritability (10%), and yellowing of the eyes (10%). Sub-analyses of these data will be presented later this week at CROI in oral and poster presentations: o High SVR Regardless of Time to Suppression with Paritaprevir/r/Ombitasvir & Dasabuvir + RBV Oral Presentation #147 February 26, 2015, 10:30-10:45 p.m. PST, Room 6AB Analysis of time to HCV suppression in HCV/HIV co-infected patients in TURQUOISE-I o Hematologic Analysis of Paritaprevir/r/Ombitasvir and Dasabuvir + RBV in TURQUOISE-I Poster #691 February 26, 2015, 2:30-4 p.m. PST, Poster Hall In this analysis of the TURQUOISE-I study, certain laboratory values in patients taking paritaprevir/r/ombitasvir and dasabuvir with RBV were examined, including hemoglobin, CD4+ T cells, and lymphocyte count