Reprieve for HIV patients as first long-acting injectable medication is approved.
The U.S has approved the first long-acting drug combo for HIV, monthly shot that can replace daily pills.
The approval of the two-shot combo which was made on 22nd January 2021 is expected to make it easier for people to stay on track with their HIV medicine and to do so with privacy. It’s a huge change from the current prescription where patients have to take multiple pills par day.
REKAMBYS, a rilpivirine injection developed by pharmaceutical company Janssen, is a prolonged-release suspension administered as an intramuscular injection. When rilpivirine is paired with injections of the integrase inhibitor cabotegravir, the combination of the two – which can both be administered by a medical professional during the same appointment, either once per month or every two months – acts a comprehensive long-acting treatment regimen for virologically-suppressed patients with HIV-1.
“We are delighted with the European Commission’s decision to approve this long-acting injectable treatment,” said Johnson & Johnson’s Chief Scientific Officer and Vice Chair of its Executive Committee, Paul Stoffels, MD.
“At Janssen, we are incredibly proud of this authorization and the progress it marks in achieving our goal to address some of the biggest health threats of our time. We will continue building on our 25-year commitment to make HIV history and to change the course of the epidemic through our passionate pursuit of innovation, from long-term remission to effective prevention of HIV.”
Cabenuva combine rilpivirinee, sold as Edurant by Johnson and Johnson’s Janssen unit, a new drug are packed together and given as separate shots once a month. Dosing every two months is also being tested.
The U.S food and drugs Administration approved Cabenuva for use in adults who have their disease well controlled by conventional HIV medicine and who have not shown any sign of viral resistance to the two drugs in Cabenuva.
The agency also approved a pill version of cabotegravir to be taken with rilpivarine for a month before switching to the shot to be sure the drugs are well tolerated.
A global survey conducted this year of HIV patients found that 55% of respondents specifically indicated that they would prefer a long-acting treatment regimen, with 58% reporting than taking daily doses of oral medication acted as a constant reminder of the impact of HIV on their lives; while 38% expressed concern that taking medication daily presented a risk of exposing their HIV status to other people.
Patient responses in Janssen’s Phase 3 trials showed that the majority of participants in the trials significantly preferred the use of long-acting injectable treatment – which cut the number of ‘treatment days’ from 365 with oral medication to six or 12 – to daily oral therapies.
There has been significant progress in the way HIV is managed and perceived over the past 30 years. However, for many people living with or at risk of HIV, stigma and discrimination remains and often prevents them from speaking out or seeking treatment.
This long-acting regimen could mean people living with HIV no longer need daily therapy, maintaining viral load suppression with just 12 or six injection days a year and eliminating a daily reminder of their condition.
Studies found that patients greatly preferred the shot.
In Kenya, HIV prevalence especially among the youths continues to be an issue that needs close attention, Studies have indicated that majority of Kenyans who succumb to HIV related diseases had a history of failing to take their doses as prescribed.
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