PrEP is a single blue tablet containing a combination of two antiretroviral medicines – tenofovir and emtricitabine – that has been shown in several clinical studies to be effective, when taken daily, in preventing HIV infection. File picture: Dylan Martinez/Reuters
Doctors Without Borders (MSF) is calling on pharmaceutical corporation ViiV to urgently dismantle the barriers hindering broad access to the most effective form of HIV pre-exposure prophylaxis (PrEP) that exists, the humanitarian aid organisation said on Wednesday.
The organisation said this could turn the tide against new HIV infections globally.
CAB-LA (cabotegravir long-acting) is administered as an injection every two months and has shown to be more effective than once-daily oral PrEP pills, but ViiV is not making the drug affordable or available in places where it is urgently needed.
In December 2021, ViiV Healthcare, a global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer and Shionogi Limited as shareholders, announced that the US Food and Drug Administration (FDA) had approved Apretude, a brand of CAB-LA, the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1.
The long-acting injectable was approved for use in adults and adolescents weighing at least 35kg who are at risk of sexually acquiring HIV and who have a negative HIV-1 test before starting treatment.
The organisation says that with about 1.5 million people newly infected with HIV in 2021, which is far from the global target of reducing new annual infections to 370 000 by 2025, affordable access to CAB-LA could play a major role in reducing infections and saving more lives.
“The roll out of long-acting injectable cabotegravir would be hugely beneficial for reducing new HIV infections for people at risk and break the cycle of transmission, particularly in places where HIV prevalence is high,” said Dr Mounia Amrani, of MSF Southern Africa.
“The implementation of daily PrEP programmes in Africa that have been so far hindered by inconsistent visit attendance and low adherence can be greatly overcome by the use of CAB-LA, which is more discreet and easier for people to stick to than the daily preventative pill. ViiV must lower and publish the price of this transformative drug and ensure that it is available and registered everywhere: no corporation should be prioritising profits over preventing HIV.”
Doctors Without Borders said ViiV’s still prohibitive so-called “access price” could hinder government treatment programmes from being able to roll out CAB-LA for use at the scale needed.
The organisation alleged that ViiV had not been transparent about the “access-price” and had not published it themselves.
“However, according to publicly available information, ViiV’s ‘access price’ will be from R4 112.80 – R4 732.07 per person per year, which is 12 times higher than the Clinton Health Access Initiative estimates a generic price could be, namely less than R342.04 per year,” MSF said.
According to Doctors Without Borders, today’s oral HIV PrEP pills are priced at R683.62 for a year.
It said ViiV should publicly announce its access price and ensure that it was comparable to the current price of oral PrEP in low- and middle-income countries so that governments and treatment providers could accelerate the rollout of this lifesaving intervention.
In December 2021, CAB-LA's registration was approved for the prevention of HIV infection by the US Food and Drug Administration (FDA) and was then approved in August 2022 in Australia, followed by Zimbabwe and Uganda.
The organisation is further calling on ViiV to do more to register CAB-LA globally as it is still not available in almost every country in the world.
“This is particularly concerning as ViiV will be the only supplier of CAB-LA until generic versions are developed, registered and commercially available, which will take at least four to five years following the announcement of a voluntary licence agreement between ViiV and the Medicines Patent Pool in July 2022.”
CAB-LA is currently produced at only one manufacturing site in the UK.
“Until generics are registered and available, ViiV should ensure a sufficient supply of CAB-LA and should be transparent about its manufacturing capacity.”
The organisation said that to mitigate the risk of shortages should there be any issues at the current site, ViiV should ensure that a second manufacturing site could produce CAB-LA.
MSF also said it wanted to start using CAB-LA for HIV PrEP in several pilot projects and negotiated around this requirement, and urged ViiV to cease this requirement in general to allow normal procurement, import and use as per World Health Organization (WHO) recommendations, and for independent research.
“CAB-LA could significantly reduce new HIV infections globally, so it is beyond frustrating that ViiV is not doing more to get this drug to the places where it is needed most,” said Jessica Burry, MSF Access Campaign pharmacist. “MSF has been able to negotiate out of many of ViiV’s cumbersome constraints, but we should not be the exception here. ViiV should urgently prioritise increasing access to CAB-LA by reducing and publishing its price, ensuring sufficient supply until generics are available, and getting rid of unwieldy requirements for governments and others who want to use this ground-breaking HIV PrEP.”
IOL