Juluca Approved for HIV
November 21, 2017 – The U.S. FDA has approved Juluca® (dolutegravir and rilpivirine), manufactured by ViiV Healthcare, to treat HIV-1 infection in adults by replacing the current antiretroviral regimen in patients who have been virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
Juluca is the first two-drug combination to receive FDA approval to treat HIV in the United States. Its first component, dolutegravir—sold under the brand name Tivicay® and manufactured by ViiV—is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI). The second component, rilpivirine—sold under the brand name Edurant® and manufactured by Janssen—is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). These two components work by interfering with the enzymes that make it possible for HIV to replicate, thereby reducing the ability of the virus to spread to uninfected cells in the body.
Recommended dosing for Juluca is one tablet daily by mouth, with food. Each tablet contains 50mg of dolutegravir and 25mg of rilpivirine. The manufacturer anticipates that the combination will help patients living with HIV to reduce the number of pills they must take on a daily basis.
Launch is expected by the third of week of December in 2017.
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.