Biktarvy Approved to Treat HIV
February 8, 2018 – The U.S. FDA has approved Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide), manufactured by Gilead Pharmaceuticals. The drug is indicated as a complete regimen for the treatment of HIV-1 infection in adults with no history of antiretroviral treatment, or as a replacement for the current antiretroviral regimen of adult patients. When used as a replacement therapy, Biktarvy should only be used in adult patients whose HIV has been virologically suppressed for at least three months on a stable antiretroviral regimen. These patients should have no history of treatment failure, and no known substitutions associated with resistance to the individual components of Biktarvy.
Consisting of a new integrase inhibitor (bictegravir) and two older nucleoside reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide), Biktarvy was well-tolerated by patients in clinical trials. None of the patients who participated in the trials developed resistance to any of the drug’s components. Recommended dosing with Biktarvy is one 50mg tablet per day.
Unlike some available HIV-1 treatments, Biktarvy does not require HLA-B*5701 testing, has no baseline viral load or CD4 count restrictions, and can be taken either with or without food. It does, however, carry a black box warning, indicating that there is a risk of acute exacerbations of hepatitis B in patients who are coinfected with HIV-1 and hepatitis B, and who have discontinued products that contain emtricitabine and/or tenofovir disoproxil fumarate. Acute exacerbation of hepatitis B may occur in these patients if they discontinue treatment with Biktarvy.
ViiV Healthcare has filed a lawsuit against Gilead, on the grounds that the new drug may infringe upon ViiV’s patent on one of its components. However, ViiV is currently seeking only financial compensation for the alleged patent violation, and has not moved to block distribution of the product. Biktarvy has already been launched, at an average wholesale cost of approximately $35,840 per year.
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.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.