New agreement to boost access to long-acting HIV prevention drug

In a move to expand access to an HIV prevention drug, the United Nations-backed Medicines Patent Pool and pharmaceutical company ViiV Healthcare have announced a new voluntary licensing agreement that would allow for generic manufacturing and distribution of long-acting cabotegravir for preexposure prophylaxis.

Long-acting cabotegravir, known as Apretude in the United States, is an injectable form of preexposure prophylaxis, or PrEP, that can provide two months of protection against HIV infection with a single shot. Most other HIV PrEPs are in pill form and taken daily, or in some cases before and after sex.

Long-acting cabotegravir is currently approved for use in HIV prevention only in the U.S., where it received its first regulatory approval in December 2021. It’s reportedly priced at $3,700 per injection, which is unaffordable for many low- and middle-income countries. Access advocates have been calling on ViiV Healthcare, which developed the drug, to voluntarily license the drug — which experts say is a game changer in HIV prevention — for generic production and to make it affordable elsewhere.

The licensing agreement with MPP, announced Thursday, means select generic manufacturers can apply for sublicensing to develop, manufacture, and supply generic versions of the drug for PrEP in 90 countries, pending regulatory approvals. The countries include all low-income and lower-middle-income countries as classified by the World Bank, as well as seven sub-Saharan African countries — Botswana, Equatorial Guinea, Gabon, Mauritius, Namibia, South Africa, and Seychelles — that are classified as upper-middle-income and high-income countries, according to a list seen by Devex.

“The licensing territory is focused on countries where the HIV burden and potential use of cabotegravir LA for PrEP is the highest,” an MPP spokesperson wrote to Devex.

“It should be noted that other upper middle-income countries where there are no patents on CAB-LA may also be able to benefit, as was the case in our previous licence with ViiV healthcare on dolutegravir,” the spokesperson added.

There were approximately 1.5 million new HIV infections in 2021, with an adolescent girl or young woman being newly infected with HIV every two minutes, according to a new report by UNAIDS, a joint U.N. program advocating for global action to address the HIV and AIDS epidemic. Its data shows HIV infections have increased since 2015 in 38 countries globally, and that every day, 4,000 people become infected with HIV, including 1,100 young people aged 15 to 24 years old.

“If current trends continue, 1.2 million people will be newly infected with HIV in 2025 — three times more than the 2025 target of 370 000 new infections,” according to the report.

Given complexities in developing the drug, however, MPP and Unitaid don’t expect generic versions to be available in the near term.

“Following the signing of the sublicence agreements, and with the tech transfer package, we hope that a product will be available well within 5 years with 4 years as the aim,” Hervé Verhoosel, Unitaid spokesperson, wrote to Devex by email. Unitaid is the principal funder of MPP, which negotiates with companies for access to lifesaving medicines in low- and middle-income countries.

“Although we all want a product quickly, we have set a realistic time limit in line with the technical ability needed to develop a long-acting formulation,” he said.

In 2014, ViiV Healthcare and MPP also signed voluntary licensing agreements to accelerate access to dolutegravir, a first-line HIV treatment medication. But Verhoosel said it took approximately three years to get the first generic version approved and launched following that agreement.

But ViiV Healthcare has submitted marketing applications to sell the drug in several countries, including in the majority of countries where the drug underwent clinical trials. The company is working with various health agencies and NGOs, along with government and community partners, to understand the needs in countries. It’s also supporting implementation science projects to ensure the successful introduction of the product in national programs, including for its future genetic versions, according to a news release.

“Today’s announcement is an exciting milestone, but we know much work is still needed to ensure CAB-LA is widely available in our settings. We now eagerly and anxiously await a bridging price to make CAB-LA accessible in LMICs NOW,” said Jacque Wambui, a Kenyan HIV activist with AfroCAB, in the same news release.

Verhoosel said MPP and Unitaid have committed to supply long-active cabotegravir for PrEP at a “non-profit price for public programmes in low-income, least developed and all sub-Saharan African countries until a generic is available.”

“As both originator and generic versions are not yet on the market, we do not know at this stage what the price might be. However, with competition among licensees, we are expecting prices for the finished product in the licensed countries that will enable countries to include CAB-LA as an additional prevention tool,” he said.

“We are advocating for an affordable price for all low and middle income countries - both for the Viiv product and for the generic once available,” he added. 

In March, Unitaid announced it will fund the introduction of the drug in Brazil and South Africa, working with partners to integrate it in the two countries’ national sexual health programs. It hopes the initiative would lay the groundwork in scaling up the use of the drug globally, once it’s widely available. ViiV Healthcare donated supplies of long-acting cabotegravir for the project.