VIEKIRAX Receives Approval in Japan

AbbVie a global biopharmaceutical company, announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved VIEKIRAX^® (ombitasvir/paritaprevir/ritonavir), as a new interferon and ribavirin-free treatment option for adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis. VIEKIRAX consists of a 12-week, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir, dosed once daily. 

Japan has one of the highest rates of hepatitis C infection in the industrialized world, with approximately 1.5 to 2 million people living with HCV. Genotype 1 is the most common HCV genotype in Japan with 60 to 70 percent of patients infected and, of those, about 95 percent are infected with the genotype 1b (GT1b) sub-type.

The approval is supported by the Phase 3 GIFT-I study. An overall 95 percent (n=140/148) of treatment-naïve and 94 percent (n=102/109) of treatment-experienced GT1b HCV infected patients achieved SVR₁₂ with VIEKIRAX. The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR₁₂ in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load. A secondary endpoint in GT1b HCV patients with compensated cirrhosis achieved 91 percent (n=38/42) SVR₁₂.

Across all treatment arms three patients (n=3/363) experienced on-treatment virologic failure, eight patients (n=8/354) experienced post-treatment relapse and three patients discontinued treatment due to adverse events. The most commonly reported adverse events (>5 percent in any arm) were nasopharyngitis, headache, peripheral edema, nausea, pyrexia and decreased platelet count. In April 2015, AbbVie was granted priority review by the MHLW for VIEKIRAX, on the basis of clinical usefulness of the treatment and recognizing the severity and unmet need of the disease in Japan.

Reports suggest that HIGH SUSTAINED VIRAL RESPONSE RATES WITH VIEKIRAX

New real world interim data from the independent AMBER study were presented for AbbVie's VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) with or without ribavirin (RBV) in genotype 1 (GT1) chronic hepatitis C virus (HCV) infected patients. The primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR₁₂). This study of Polish patients who reached post-treatment at week 12 (n=40 of 186 enrolled to date), demonstrated 98 percent (n=39/40) SVR₁₂.¹ These results further help to support the GT1 data shown in AbbVie's Phase 3 clinical trial development program. Interim data from the AMBER study were presented at the Viral Hepatitis Congress in Frankfurt, Germany.

Interim safety analysis of the enrolled 186 patients reported that adverse events experienced were mostly mild, most commonly (>10%) fatigue, nausea and headache. Serious adverse events were infrequent (4%, n=186), which included hepatic decompensation, anemia, kidney insufficiency hepatotoxicity.

The AMBER study is a multicenter, independent investigator-initiated, open-label study that was conducted in Poland. Patients infected with GT1 (n=186) or genotype 4 (n=10) chronic HCV received VIEKIRAX + EXVIERA (co-formulated ombitasvir/paritaprevir/ritonavir (25/150/100 mg QD) ± dasabuvir (250 mg BID) ± RBV) for 12 or 24 weeks according to current product prescribing information. Patient visits were scheduled on day zero, end of treatment and at follow-up week 12. The study population included treatment naïve as well as pegylated-interferon/ribavirin treatment-experienced patients with varying levels of liver fibrosis. Of the 186 enrolled GT1 patients, at baseline, 21 percent of patients were treatment-naïve, 70 percent had been previously treated and 75 percent had levels of liver fibrosis of F3 or F4.