Two regions have now approved a monthly injectable ARV, a move that could transform HIV treatment.
On Friday, the United States approved the Cabenuva (cabotegravir and rilpivirine) which is administered once a month, joining the Europe Union, which approved the same last month.
The approvals are supported by findings from clinical trials showing 94 per cent of participants injected with the regimens achieved fully suppressed viral loads for at least six months.
The injectables are administered by a health care provider as two separate shots in the buttocks once a month.
“Cabenuva reduces the treatment dosing days from 365 days to 12 days per year,” said a statement from Lynn Baxter, head of North America at ViiV Healthcare - the company behind the Cabenuva combination - immediately after the US approval.
The monthly injectable regime was first approved in Canada in March 2020, then by the European Union in December last year.
Benefitting patients will do away with the daily ARV pills.
However, Viiv set a strict criteria on who can be put on the monthly injectable.
The patients must already be virologically suppressed, 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,” Viiv said in a statement.
Monthly ARVs are a victory to patients, who say the daily pills act as a constant reminder of HIV and can lead to their HIV status being disclosed.
In the US, the new injectable will cost Sh400,000 ($3,960) a month, or more than (Sh4.8 million) $47,500 a year.
Viiv says the price is “within the range” of HIV treatment pills in the US, where HIV medicines are already scandalously expensive.
In Kenya, a full dose of ARVs for one year costs about Sh20,000 ($200).
However, this is because the drugs sold here are generics, whose cost has been subsidised further through price deals between governments and HIV drug companies.
Unless such deals are negotiated for the long-acting injectables, they are likely to take years before reaching developing countries, where they will still be too expensive.
Long-acting injectables have been proven to work before.
In 2019, US-based Kenyan scientist Prof Benson Edagwa created a new, once-a-year formulation of cabotegravir.
In November last year, a study done partly in Kenya showed that cabotegravir, administered by injection every two months, is 89 per cent more efficient in preventing HIV in women compared to daily tablets of pre-exposure prophylaxis (PrEP).
Edited by Henry Makori
