U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus.
Replacement For HIV Specific ART Treatment
This is the first Food and Drug Administration approved injectable, complete regimen for HIV-infected adults that is administered once a month. This shall replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
Cabenuva is provided as a co-pack with two injectable medicines – ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine – dosed once monthly, as an option to replace the current antiretroviral or ARV regimen.
The U.S. Food and Drug Administration approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva. The treatment is taken in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.
Dosage And Side Effects
Lynn Baxter, Head of North America, ViiV Healthcare, noted that Cabenuva reduces the treatment dosing days to 12 days per year from 365 days. ViiV Healthcare will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February 2021.
The most common adverse reactions with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter).
The agency also approved a pill version of cabotegravir to be taken with rilpivarine for a month before switching to the shots to be sure the drugs are well tolerated.