MSF: ViiV must allow the generic production of new HIV prevention drug

NEW YORK/GENEVA, MARCH 4, 2022—US-based pharmaceutical corporation ViiV recently announced that it will not make its newly approved HIV prevention drug available for generic production in low- and middle-income countries (LMICs), including many in which the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) operates. CAB-LA—the first long-acting injectable approved for the prevention of HIV infection by the US Food and Drug Administration (FDA) in December 2021—is patented in many countries, including India, Brazil, and South Africa, which has a chilling effect on the global development of more affordable versions.

“What good is HIV prevention if the people who need it can’t afford it?” said Amanda Banda, infectious diseases policy and advocacy advisor at MSF’s Access Campaign. “This is the most effective form of HIV prevention for vulnerable and marginalized communities, and yet ViiV is delaying the ability of generic manufacturers to supply the drug, meaning that many people across low- and middle-income countries who would benefit from the medicine to prevent HIV infection won’t be able to access it.”

The price ViiV charges for this game-changing product keeps the medicine out of reach for many people across the world. The company currently charges $3,700 per vial in the US ($22,200 per person per year), despite research from the Clinton Health Access Initiative showing 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 what that price is.

“CAB-LA will need to be available at a price that is comparable to currently available oral pre-exposure prophylaxis (PReP) if country treatment programs and donors are expected to scale up its use to the levels needed—and it’s hard to imagine that ViiV will make CAB-LA available at less than $40 per year,” Banda said.

Experience has shown that generic manufacturer prices are frequently drastically lower than the patented drug, and that generic manufacturers have the capacity for developing even complicated formulations like CAB-LA. Even in the case of ViiV’s pediatric formulation of the HIV drug dolutegravir, also sold at their at-cost price in LMICs, the generic equivalent costs 22 times less than ViiV’s version.

MSF would like to urgently make this drug available for people at high risk of HIV infection in its programs in sub-Saharan Africa. This long-lasting treatment would be easier for people at risk of contracting HIV to adhere to since they don’t have to take it daily—which is important in low-resource settings where accessing health care can be difficult. Once someone is initiated onto CAB-LA, they only need to get the injection again every two months. This could help increase adherence to this form of prevention, which is critical in making sure it’s effective.

“We don’t want a donation with strings attached from the corporation,” said Dr. Tom Ellman, head of MSF’s South African Medical Unit. “It is not the role of ViiV to control the use of a drug that is approved by the US FDA. We want ViiV to sell us this drug at an affordable price.”

March 9 Update: ViiV updated its statement with a mention that the company is "open to voluntary licensing."