Juliet Chinelo
Jan 25, 20212 min
In a new historic feat, The food and Drug Administration of the United States approved the first monthly shots to treat adults with HIV.
This would mean that instead of daily drugs, people living with HIV can now receive one dose of injection a month reducing issues of drug compliance by people living with HIV and would ultimately improve their quality of life.
The drug Cabenuva (cabotegravir and rilpivirine), which is given as two separate shots, was approved for patients who are HIV-suppressed on a stable antiretroviral regimen, have no history of treatment failure, and don’t have known or suspected resistance to either cabotegravir or rilpivirine, the FDA said.
The FDA also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral Edurant (rilpivirine) for one month before starting treatment with Cabenuva, to ensure the medications are well-tolerated by patients before they switch to the extended-release monthly injection.
The FDA’s approval of Cabenuva is based on two randomized, open-label, controlled clinical trials that included nearly 1,200 HIV-infected adults who had HIV suppression before they began treatment with Cabenuva.
The patients in both trials continued to show HIV suppression at the end of each study, according to the FDA.
Cabotegravir, inhibits HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Rilpivirine works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
The most common side effects with Cabenuva were :
injection-site reactions
fever
fatigue
headache
musculoskeletal pain
nausea
sleep disorders
dizziness and
rash.
Cabenuva should not be given to patients with known previous hypersensitivity reaction to cabotegravir or rilpivirine, or to patients who are not virally suppressed ie only people who have their viral loads suppressed are allowed to commence treatment with Cabenuva.
Credit: Blueweals.