Once-Daily Hepatitis C Treatment Approved by FDA

The FDA recently approved Veikira XR extended-release tablets for genotype 1 (GT1) chronic hepatitis C virus (HCV).

This once-daily drug treats patients with GT1 HCV, including patients with compensated cirrhosis, according to a press release from AbbVie. But, the drug is not indicated for use in patients GT1 HCV who also have decompensated cirrhosis.

Veikira XR is a combination of ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets. It can be used in conjunction with ribavirin for patients with GT1a, but is not used with ribavirin in patients with GTIb.

The approval is based on 7 phase 3 clinical trials that enrolled more than 2300 patients with GT1 HCV. AbbVie reports that 95% to 100% of patients achieved SVR12, depending on the patient’s subtype of HCV.

Patients with certain liver problems other than HCV are advised to refrain from taking the medication. When used with ribavirin, the most common side effects are tiredness, nausea, skin reaction, sleep problems, and feeling week.

When used without ribavirin, the most common side effects are nausea, itching, and sleep problems.

“AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients,” said Rob Scott, MD, vice president, development and chief medical officer, AbbVie. “The approval of VIEKIRA XR provides a new treatment option for genotype 1 hepatitis C patients in the US with clinical trial data using the components of VIEKIRA XR demonstrating 100% cure rates in genotype 1b patients.”