MSF calls on ViiV to take swift action to make cabotegravir available to HIV patients in India and other LMICs

Mumbai, July 30, 2022 :

As the World Health Organization (WHO) recommended long-acting injectable cabotegravir (CAB-LA) for HIV prevention, Médecins Sans Frontières (MSF) India has called on UK pharmaceutical corporation ViiV Healthcare to take swift actions to make the drug available to India and other low- and middle-income countries (LMICs) with the highest rates of HIV.

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, lack of transparency around the pricing and plans for registration of the drug and implementation-science conditions for procurement, set by ViiV, still pose barriers to access to this medicine, particularly in low- and middle-income countries (LMICs) including India.

CAB-LA is priced at USD 3,700 per vial, or USD 22,200 per person per year (6 vials) in the US. While ViiV’s stated policy is to provide their medicines “at cost” for low-income, least developed and sub-Saharan African countries, they have yet to publicly announce what that price is, stated MSF.

ViiV has registered CAB-LA in the US and filed to register in only eight other countries. Many countries with a high burden of existing and new HIV infections are not included in this list. Given the delay in voluntary licensing and potential generic entry into the market, ViiV will likely be the sole supplier of CAB-LA in the short term. This comes with the risk of insufficient supply, the NGO added.

At the International AIDS Conference 2022 underway in Montreal, Canada from July 29-August 2, 2022, the Medicines Patent Pool (MPP) and ViiV Healthcare has announced an agreement to open up generic production and supply of CAB-LA in 90 countries.

“The announcement on ViiV’s agreement with MPP is a welcome yet limited step given its restrictive geographical scope. The license allows only up to 3 generic companies globally to produce and supply,” said Leena Menghaney, South Asia Head, MSF Access Campaign.

“It is disappointing to note that a number of developing countries with generic manufacturing capacities in Latin America and Asia are currently excluded from this license agreement,” added Menghaney.

“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,” she opined.

CAB-LA was approved for the prevention of HIV infection by the US Food and Drug Administration (FDA) in December 2021. Research from the Clinton Health Access Initiative (CHAI) has shown that generic manufacturers could produce this drug for around USD 2.60 per vial (less than USD 20 per person per year) as against its current price of USD 3,700 per vial.

ViiV currently makes this drug available in LMICs only under its own special program, wherein the drug is donated based on approval by the corporation to the organisations submitting protocols for studying the drug for PrEP. Granting access under research conditions may deny the most vulnerable populations, particularly in humanitarian settings, from accessing CAB-LA, added MSF.

“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 and ensure sufficient supply everywhere by allowing procurement without any conditions to treatment providers and countries, until generics are available,” said Jessica Burry, HIV/HCV Pharmacist, MSF Access Campaign.

India has the third largest HIV epidemic in the world, with 2.1 million people living with HIV. Currently, around 1.45 million HIV patients in the country are receiving free treatment from National AIDS Control Organisation (NACO) under government sponsored National AIDS Control Programme (NACP). Pharmabiz