Dear All,

"We are updating our press release in light of announcement made today by Viiv and MPP on an agreement that will allow for generic production of CAB-LA. We will share the updated version of our release shortly with you."

Thanks

Shailly

+41-79 203 13 02 

 

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Despite WHO recommendation, ViiV’s sluggish response may delay access to new game-changing HIV prevention drug

New MSF report details barriers to access to long-acting cabotegravir

Montreal/Geneva, 28 July 2022– As the World Health Organization (WHO) recommends long-acting injectable cabotegravir (CAB-LA) for HIV prevention, Médecins Sans Frontières/Doctors Without Borders (MSF) called on governments in low- and middle-income countries (LMICs) to urgently include this drug in national HIV guidelines and accelerate its roll out to prevent HIV transmission, and called on the producer of CAB-LA – the UK pharmaceutical corporation ViiV Healthcare – to take swift actions to support countries’ access for everyone who needs it.

Administered as an injection every two months,CAB-LA is the most effective form of pre-exposure prophylaxis(PrEP) for people at high risk of HIV. However, as detailed in a new MSF reportreleased ahead of the 2022 International AIDS Conference, the lack of transparency around the pricing and plans for registration of the drug; unnecessary delays over agreeing a voluntary license; and implementation-science conditions for procurement, set by ViiV, pose as barriers to access to this medicine, particularly in LMICs.

“WHO’s recommendation for use of long-acting injectable cabotegravir offers a more effective option for people in countries like Mozambique, where there is a high prevalence of HIV, who would hugely benefit from rollout of this drug to help reduce new infections,” said Dr Zaid Seni, Medical Activity Manager, MSF Mozambique. “While the current oral preventive treatment available in low- and middle-income countries is effective, taking a daily pill can be challenging for some. CAB-LA offers a more discreet option that can facilitate better adherence for people at risk of HIV infection. We urge ViiV to make the drug available at an affordable price to support timely use of this game-changing drug to help avoid millions of new HIV infections.”

CAB-LA was approved for the prevention of HIV infection by the US Food and Drug Administration (FDA) in December 2021, and ViiV currently charges US$3,700 per vial in the US($22,200 per person per year). Researchfrom the Clinton Health Access Initiative (CHAI) has shown that generic manufacturers could produce this drug for around $2.60 per vial (less than $20 per person per year). Although ViiV has publicly said they would provide CAB-LA for their at-cost price in many LMICs, they have yet to announce the price. 

ViiV holds patents on CAB-LA in multiple middle-income countries, including Brazil, India, Nigeria and South Africa. The patent monopolies of the pharmaceutical corporation will block access to more affordable generic formulations and allow Viiv to sell CAB-LA at high prices, keeping the medicine out of reach for many who need it. In May 2022, ViiV announced that it is finally engaged in negotiations for a voluntary license on CAB-LA with the Medicines Patent Pool (MPP) for generic manufacturers to bring the drug into the market. It will be essential for MPP and ViiV to include not just low-income and lower middle-income countries but also upper-middle-income countries in the territory of the license for CAB-LA. 

Also, ViiV currently makes CAB-LA available in LMICs only under implementation-science proposals that are approved by the corporation,wherein the drug is donated based on approval by ViiV to the organisations submitting protocols for studying the drug for PrEP. Granting access exclusively for research purposes may deny the most vulnerable populations, particularly in humanitarian settings, from accessing CAB-LA.

“ViiV has been dragging its feet in making cabotegravir supply available for low- and middle-income countries despite repeated calls from public health activists, treatment providers and civil society,” said Jessica Burry, HIV/HCV Pharmacist, MSF Access Campaign. “Following WHO’s recommendation for the use of CAB-LA as PrEP, ViiV must take immediate steps to publicly announce the price for this drug for all low- and middle-income countries, finalise its licensing deal with the Medicines Patent Pool, and ensure sufficient supply everywhere by allowing procurement without any conditions to treatment providers and countries, until generics are available. It’s high time that the corporation fulfil its promise of making CAB-LA widely available to those in need, as further delays will only result in new HIV infections.” 

 

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Shailly Gupta

+41-79 203 13 02