FDA Approves VIEKIRA XR for Adults with GT1 HCV

The US Food and Drug Administration has approved VIEKIRA XR, the first co-formulated three direct-acting antiviral for adults diagnosed with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

AbbVie, a global biopharmaceutical company, just announced yesterday that a New Drug Application (NDA), VIEKIRA XR, has just been approved by the US Food and Drug Administration (FDA). VIEKIRA XR is the “first all-oral, co-formulated treatment containing the three direct-acting antiviral components of VIEKIRA PAK for adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.” GT1 HCV is the most prevalent of the six major HCV genotypes, accounting for approximately 74% of cases, according to a press release on the AbbVie website. This approval follows last month’s approval of Gilead Sciences, Inc.’s Epclusa, a regimen that treats the six genotypes of chronic HCV through a fixed-dose combination therapy and like VIEKIRA XR, can also be used with ribavirin (RBV).

HCV is a virus that causes inflammation to the liver and can be transmitted from person-to-person from an infected person’s blood. HCV remains a critical public health issue. According to the Centers for Disease Control and Prevention (CDC), 2.7 million people are chronically infected by the virus and 5-20% of infected persons will eventually develop cirrhosis. Out of the six major HPV genotypes (GT1-6), GT1 HCV remains the most dominant type in the United States.

VIEKIRA XR is supported by the Phase III clinical trials for VIEKIRA PAK that included 1,076 GT1a and GT1b HCV patients who received a recommended regimen of VIEKIRA XR. Both were given three tablets to be taken once daily with a meal. GT1a patients with compensated cirrhosis used VIEKIRA XR in combination with ribavirin (RBV) taken twice daily, whereas GT1b patients did not. The results showed that GT1b patients showed 100% sustained virologic response (SVR12) 12 weeks post-treatment and GT1a patients who used RBV for 12 to 24 weeks of therapy had a 95% SVR12; the hepatitis C virus was not detected in the patients’ blood 3 months post-treatment.

According to the press release, the known side effects of VIEKIRA XR with RBV are tiredness, nausea, itching, and other skin reactions such as redness or rash, and without RBV, the side effects consist of nausea, itching, and sleep problems.