New Indication and Boxed Warning for Technivie
March 3, 2017 – The U.S. FDA approved a new indication for Technivie® (ombitasvir/paritaprevir/ritonavir), based on results from the phase III AGATE-1 clinical trial. Technivie, manufactured by AbbVie can now be used along with ribavirin to treat patients who have both type 4 chronic hepatitis C and compensated cirrhosis. After 12 weeks, nearly all study participants (all were taking the Technivie/ribavirin regimen) achieved a sustained virologic response (SVR). Extending treatment for an additional four weeks did not improve SVR rates. Recommended dosing is two Technivie tablets taken once each morning. Ribavirin is divided into two daily doses and taken with food. Dosing for ribavirin is determined by the patient’s weight --1,000mg per day for patients who weigh less than 75 Kg (165 pounds) or 1,200mg per day for those who weigh more. The FDA also added a boxed warning that using Technivie could activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be tested for HBV before, during and for several months after treatment.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
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