Viekira Pak Regimen Cures 100% of Genotype 1b Hepatitis C Patients with Cirrhosis

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All participants in the TURQUOISE-III trial, which enrolled HCV genotype 1b patients with compensated liver cirrhosis, achieved sustained virological response using AbbVie's Viekira Pak or "3D" regimen without ribavirin, according to a company announcement this week.

The advent of interferon-free direct-acting antiviral therapy has revolutionized hepatitis C treatment. But challenges remain for the most difficult-to-treat patients, including those with advanced liver disease.

TURQOUISE-III evaluated the 3D regimen in 60 cirrhotic patients with HCV genotype 1b. This is the most prevalent subtype in Europe and by far the most common in Japan, though harder-to-treat subtype 1a is more common in the U.S.

The 3D regimen consists of the HCV protease inhibitor paritaprevir with a ritonavir booster plus the NS5A inhibitor ombitasvir in a once-daily coformulation, taken with the NS5B polymerase inhibitor dasabuvir twice-daily. In the U.S. the full regimen is sold together under the brand name Viekira Pak, while in Europe the coformulation (Viekirax) and dasabuvir (Exviera) are sold separately.

Study results, presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases this week in Berlin, showed that 100% of patients treated with the 3D combo without ribavirin for 12 weeks had undetectable HCV viral load at 12 weeks after completion of treatment.

Below is an edited excerpt from an AbbVie press release describing the findings.

AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis

100 percent SVR12 rate achieved with Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) without ribavirin

North Chicago, Ill. --June 24, 2015 -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.1 Patients received 12 weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) without ribavirin (RBV). These new results from AbbVie's Phase 3b study will be presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases in Berlin, Germany.

Approximately 160 million people worldwide are infected with HCV. Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide and in Europe, the most prevalent genotype is 1b (47 percent). Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in about 10-20 percent of people infected.

"Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens," said Jordan J. Feld, MD, MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada. "The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks."

Patients in TURQUOISE-III were either treatment-naive or treatment-experienced (failed previous therapy with pegylated interferon and RBV). No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).

"In the TURQUOISE-III study, GT1b patients with compensated liver cirrhosis achieved a 100 percent cure rate with VIEKIRAX + EXVIERA without ribavirin," said Scott Brun, MD, vice president, pharmaceutical development, AbbVie. "TURQUOISE-III is part of our Phase 3b program, which aims to further enhance our understanding of AbbVie's regimen in HCV populations seen in clinical practice, and supports our commitment to continued investigation in this field."

About TURQUOISE-III Study

TURQUOISE-III is a multi-center, open-label Phase 3b study to evaluate the safety and efficacy of 12 weeks of treatment with VIEKIRAX + EXVIERA without ribavirin (RBV) in adult patients (n=60) with genotype 1b chronic hepatitis C virus infection and compensated liver cirrhosis who were treatment-naive or treatment-experienced (failed previous therapy with pegylated interferon and RBV). The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR12).

No patients experienced virologic failure during treatment and no patients experienced virologic relapse following the end of treatment.

About VIEKIRAX + EXVIERA

VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.

VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150 mg (NS3/4A protease inhibitor) and ritonavir 100 mg with ombitasvir 25 mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250 mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.

The full press release, including the European Union indication is available online. U.S. prescribing information is available at www.viekira.com.

6/26/15

Reference

JJ Feld, C Morena, R Trinh, et al. Turquoise-III: safety and efficacy of 12-week ribavirin-free treatment for patients with HCV genotype 1b and cirrhosis. 15th Annual International Symposium on Viral Hepatitis and Liver Diseases. Berlin, June 26-28, 2015. Abstract P226.

Other Source

AbbVie. AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis. Press release. June 24, 2015.