AbbVie Dual Regimen Highly Effective Against HCV Genotype 1b

A 2-drug combination consisting of AbbVie's ritonavir-boosted HCV protease inhibitor parataprevir and NS5A inhibitor ombitasvir -- part of the Viekira Pak regimen -- demonstrated a 95% cure rate for people with hepatitis C virus genotype 1b, the most common type in Japan, according to a recent company announcement.

The full Viekira Pak regimen approved by the U.S. Food and Drug Administration contains paritaprevir, ombitasvir, and ritonavir in a once-daily coformulation, plus the twice-daily HCV polymerase inhibitor dasabuvir. The European Union recently approved the regimen as two separate components, Viekirax (the paritaprevir/ombitasvir coformulation) and Exviera (dasabuvir). AbbVie plans to request approval for only the coformulation in Japan.

The complete 3-drug regimen -- taken with ribavirin for more challenging patients such as those with liver cirrhosis or prior treatment failure -- produced sustained virological response rates between 90% and 100% in clinical trials of people with HCV genotype 1.

Now, the GIFT-I study in Japan has shown that boosted paritaprevir plus ombitasvir, without dasabuvir, taken for 12 weeks cured 95% of non-cirrhotic patients with easier-to-treat HCV genotype 1b. The full regimen is indicated for people with harder-to-treat HCV 1a, which is most common in the U.S.

Below is an edited excerpt form an AbbVie press release describing the study findings in more detail.

Abbvie Announces Top-line Results from Phase 3 Study of All-oral Treatment for Hepatitis C in Japan

• 95 percent SVR12 rate achieved in Japanese patients new to therapy with genotype 1b chronic hepatitis C virus infection without cirrhosis and with a high viral load
• Regulatory filing in Japan planned for the first quarter of 2015

North Chicago, Ill. -- January 30, 2015 -- AbbVie (NYSE: ABBV) released top-line Phase 3 results for its investigational, all-oral, ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan. The primary endpoint of the GIFT-I study was achieved, demonstrating a 95 percent (n=106/112) sustained virologic response rate at 12 weeks post treatment (SVR12) in the sub-group of previously untreated, non-cirrhotic adult GT1b Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load.

"AbbVie is committed to advancing HCV care with the goal of evaluating our treatment in a broad range of patients around the world," said Scott Brun, MD, vice president, pharmaceutical development, AbbVie. "The GIFT-I results are encouraging and support moving forward with our Japan development program, with a local regulatory submission anticipated in the first quarter of 2015."

In Japan, up to two million people are currently living with hepatitis C. Genotype 1b is the most common sub-genotype, affecting nearly half of the people infected with HCV.

In the GIFT-I study, the primary efficacy population comprised a sub-group of treatment-naive GT1b chronic HCV infected patient population. This sub-group consisted of treatment-naive patients without cirrhosis who were eligible for therapy with IFN with or without RBV, had a high viral load (>100,000 IU/mL) and received at least one dose of the double-blind active study drug. The primary endpoint was assessed at 12 weeks post treatment (SVR12).

In patients without cirrhosis, the most commonly reported adverse events in the treatment arm were nasopharyngitis (16.7 percent OBV/PTV/r vs. 13.2 percent placebo), headache (8.8 percent OBV/PTV/r vs. 9.4 percent placebo), and oedema peripheral (5.1 percent OBV/PTV/r vs. 0 percent placebo). Two patients without cirrhosis (0.9 percent) discontinued treatment due to adverse events.

Within the primary efficacy patient population, there were no on-treatment virologic failures and 2.8 percent of patients (n=3/109) experienced relapse.

AbbVie will disclose detailed GIFT-I study results at future scientific congresses and in publications.

About GIFT-I Study 

GIFT-I (M13-004) is a Phase 3, multi-center study designed to evaluate the efficacy and safety of 12 weeks of treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in adult Japanese patients (n=363) with chronic genotype 1b hepatitis C virus infection. Patients included those without cirrhosis and with compensated cirrhosis who were new to therapy (treatment-naive) or had failed previous treatment with interferon with or without ribavirin (treatment-experienced). The study consists of two sub-studies. Sub-study one included patients without cirrhosis randomized to OBV/PTV/r or placebo. Sub-study two included patients with compensated cirrhosis, who received open-label treatment with OBV/PTV/r.

Additional information about AbbVie's GIFT-I study can be found on www.clinicaltrials.gov.

About AbbVie's Investigational Two Direct-Acting Antiviral HCV Treatment

For the treatment of genotype 1b chronic hepatitis C virus (HCV) infection in Japan, AbbVie's investigational two direct-acting antiviral treatment consists of the fixed-dosed combination of paritaprevir/ritonavir (150/100 mg) with ombitasvir (25 mg), dosed once daily.

AbbVie's chronic HCV treatment combines two direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.

About AbbVie's HCV Clinical Development Program in Japan 

AbbVie's HCV clinical development program in Japan will focus on our investigational, two direct-acting antiviral treatment and is designed with the goal of achieving high sustained virologic response rates in chronic HCV infected patients, including additional genotypes and patients with compensated cirrhosis.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV 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 hepatitis C.

Ombitasvir/paritaprevir/ritonavir is an investigational product and its safety and efficacy have not been established in Japan.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

2/20/15

Source

AbbVie. Abbvie Announces Top-line Results from Phase 3 Study of All-oral Treatment for Hepatitis C in Japan. Press release. January 30, 2015.