AbbVie hep C drug combo enters market
In an era when legislators, pharmacy benefit managers and others continue to protest the high cost of hepatitis C drugs, new drugs to treat the disease are welcomed. FDA recently approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira XR, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, including those with cirrhosis. AbbVie already markets Viekira Pak, which competes with Harvoni and Sovaldi (Gilead Sciences).
At a time when legislators, pharmacy benefit managers and others are protesting the high cost of hepatitis C drugs, new drugs to treat the disease are welcomed.
FDA recently approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira XR, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, including those with cirrhosis. AbbVie already markets Viekira Pak, which competes with Harvoni and Sovaldi (Gilead Sciences).
Related: Cheaper Hep C drug enters competitive market
Plus, in June, FDA granted priority review and breakthrough therapy designation to Gilead’s combination product for hepatitis C, Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg). The drug is the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic HCV infection and the first single-tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin.
Meanwhile, Viekira XR is the first co-formulated, three direct-acting antiviral (DAA) treatment for adult patients with GT1 HCV. Its wholesale acquisition cost is $83,319, consistent with Viekira Pak.
"The approval of Viekira XR provides a new treatment option for genotype 1 hepatitis C patients in the United States, with clinical trial data using the components of Viekira XR demonstrating 100% cure rates in genotype 1b patients,” said Rob Scott, MD, vice president, development and chief medical officer, AbbVie.
Related: Hepatitis C therapies, compounded meds drive increase in US drug spending
The medication, given once-daily as three oral tablets, is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients.
The approval is supported by phase 3 clinical trials for Viekira Pak which include data that demonstrated 100% sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients with 12 weeks of therapy without ribavirin and 95 percent SVR12 in GT1a patients when used with ribavirin for 12 or 24 weeks of therapy.
There are six major HCV genotypes (GT1-6) and GT1 is the most prevalent form of HCV in the United States, accounting for approximately 74% of all cases. Hepatitis C continues to be an important public health issue, with the Centers for Disease Control and Prevention (CDC) estimating that around 2.7 million Americans are chronically infected with HCV.
Read more: FDA warns about serious reactions to Harvoni, Sovaldi
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
Read More
