With affordable generics likely years away, ViiV must make information public on supply of long-acting cabotegravir and global distribution plan to ensure access for people in high HIV burden low- and middle-income countries
Geneva, 30 March 2023 – Today Médecins Sans Frontières/Doctors Without Borders (MSF) called on the pharmaceutical corporation ViiV to immediately provide transparency on the current available volume and planned geographic distribution of the HIV prevention medicine long-acting cabotegravir (CAB-LA) in order to urgently expedite the drug’s access for people in high-HIV-burden low- and middle-income countries (LMICs), where it could have the biggest impact on preventing HIV infections. This call comes on the heels of a welcome announcement by ViiV and the Medicines Patent Pool (MPP) of the three generic-drug manufacturers selected to produce CAB-LA under a July 2022 voluntary license agreement.
As shown in clinical trials, CAB-LA is currently the most effective form of pre-exposure prophylaxis (PrEP) for people at high risk of contracting HIV*, and was recommended for HIV prevention by the World Health Organization (WHO) in July 2022. However, ViiV’s continued lack of transparency around CAB-LA's current available supply and how they plan to distribute the drug geographically, as well as the implementation-science conditions set by ViiV for procurement, pose as barriers to accessing this medicine, particularly in LMICs. Currently, the corporation has been unable to assure MSF of the availability of any amount of CAB-LA for MSF medical programmes in Eswatini and Mozambique in 2023, where MSF plans to start offering the drug to people at high risk of HIV. With ViiV needing a six-month lead-time to process MSF’s order, the corporation’s failure thus far to provide transparency on CAB-LA's availability, and its price, may result in the drug not reaching people in MSF’s care in 2023. With CAB-LA first approved by the US Food and Drug Administration (FDA) in December 2021, the wait time for many people to be able to access this lifesaving drug may be over two years.
“For over eight months, we’ve been in contract negotiations with ViiV to procure CAB-LA for use in MSF programmes and the corporation has been adamant that there would be sufficient supply of CAB-LA – astonishingly even arguing that demand for the drug would be low. And yet, we’re currently unable to procure CAB-LA to meet the demand we’re seeing in MSF’s medical programmes – and hearing about in our discussions with health officials in low- and middle-income countries,” said Dr Helen Bygrave, Chronic Disease Advisor for MSF’s Access Campaign. “Honestly, ViiV should be ashamed: it has a lifesaving HIV prevention drug at its fingertips but is failing to ensure there’s enough available for people who need it, and is providing no transparency as to where currently available supplies of CAB-LA are being used.”
For people who need CAB-LA, ViiV’s access strategy is irresponsible and short-sighted. Despite repeated calls from civil society to increase CAB-LA's supply, ViiV’s current global monopoly is unable to meet urgent global health needs. This is especially concerning as it may take as long as four to five years for the announced generic companies, of which there are only three, to make generic CAB-LA commercially available. Also, ViiV’s efforts to scale up its own manufacturing and supply capacity by increasing batch size and opening a second manufacturing facility are overdue and unlikely to see results until sometime in 2024.
In addition, until recently, access to CAB-LA in high-HIV-burden LMICs was also restricted by the conditions surrounding procurement mechanisms. Initially, ViiV agreed to only supply CAB-LA to organisations that submitted research protocols through the corporation’s own research mechanism, even though the drug was approved by the FDA and is no longer an experimental drug. After months of high-level discussions, ViiV has finally agreed for the US President's Emergency Plan for AIDS Relief programme (PEPFAR) to procure a limited supply of CAB-LA. MSF’s own implementation science plans are proceeding in collaboration with ministries of health, but despite eight months of negotiations, ViiV has still not provided a publicly available procurement price or certainty that it can supply CAB-LA in 2023.
“It is infuriating that ViiV is deciding on its own where CAB-LA is available regardless of urgent health needs: until there are more producers on the market and normal procurement can proceed with appropriate supplies of CAB-LA, the corporation must do more and reprioritise its global distribution to people at highest risk of contracting HIV, especially in low- and middle-income countries, so there can be the biggest impact in terms of preventing disease,” said Bygrave.
CAB-LA, administered as an injection every two months, is more discreet than the once-daily oral PrEP pill and could be key to turning the tide against new HIV infections, particularly as the daily oral PrEP pill can be a burden that undermines adherence.
“Oral PrEP is very important in my life because if I happen to sleep with an HIV positive partner, it protects me from getting HIV. The main challenge that I face as I take PrEP is that I sometimes forget to take my PrEP pill,” said Lindokuhle Dlamini, a woman taking oral PrEP through MSF’s programmes in Eswatini. “If there were injectable PrEP every two months, it would make it easier to take it because there would be no need to be constantly worrying about taking my pill every day.”
*People at high risk of contracting HIV are determined by a clinical risk assessment and can include key populations (sex workers, men who have sex with men, people who inject drugs, people in prisons and transgender people) and their sexual partners, as well as people in general populations, such as women and girls.