FDA Roundup: New Options for Hepatitis C, PAD, Nausea
Harvoni: Chronic Hepatits C Virus
The FDA has approved Harvoni1 (ledispasvir and sofosbuvir) as the first combination pill for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni does not require administration with interferon or ribavirin.
The drugs within Harvoni work by disrupting the enzymes that allows HCV to multiply.
In 3 clinical trials, a total of 1518 participants with HCV were randomly assigned to receive Harvoni, with or without ribavirin. In the 3 respective trials, 94%, 99%, and 96% of participants achieved sustained virologic response after 12 weeks of treatment, with or without ribavirin.
The most common side effects associated with Harvoni are headache and fatigue.
Hepatitis C Treatment Guidelines and Cost Concerns of New Drugs
Performance Measures for Peripheral Artery Disease
Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter: Peripheral Artery Disease
The FDA has approved the use of the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) for use to re-open thigh and knee arteries in patients with peripheral artery disease.2
The Lutonix DCB is a balloon coated with paclitaxel, which helps to prevent recurrent narrowing of the arteries after the product is inflated to help unblock the artery.
The safety and effectiveness of the Lutonix DCB was demonstrated in 3 clinical studies comparing it against traditional balloon angioplasty.
The Lutonix DCB outperformed traditional treatment methods in all 3 trials.
Lutonix DCB should not be used in patients with bleeding disorders, those with hypersensitivities to paclitaxel, women who are pregnant, or men intending to father children.
Akynzeo: Chemotherapy-Associated Nausea and Vomiting
The FDA has approved Akynzeo, a combination of netupitant and palonosetron, for the treatment of nausea and vomiting associated with chemotherapy.3
Palonosetron works to prevent nausea and vomiting during the first 24 hours of treatment, while netupitant combats the symptoms between 25 and 120 hours after therapy begins.
In 2 clinical trials, 1720 participants undergoing chemotherapy were randomly assigned to either Akynzeo or oral palonosetron.
Overall, 98.5%, 90.4%, and 89.6% of Akynzeo-treated patients experienced no vomiting during the acute, delayed, and overall phases of treatment, respectively, compared with 89.7%, 80.1%, and 76.5%, respectively, in the oral palonosetron group.
Side effects of Akynzeo include headache, weakness, fatigue, indigestion, and constipation.
- FDA. FDA approves first combination pill to treat hepatitis C [press release]. October 10, 2014. www.fda.gov. Accessed October 14, 2014.
- FDA. FDA approves first drug-coated angioplasty balloon catheter to treat vascular disease [press release]. October 10, 2014. www.fda.gov. Accessed October 14, 2014.
- FDA. FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy [press release]. October 10, 2014. www.fda.gov. Accessed October 14, 2014.