Access questions hang over Gilead's HIV shot

• "For all of the wonders of product development, PrEP has not even begun to have the impact we need it to," said Mitchell Warren, executive director of international HIV prevention nonprofit AVAC.

The big picture: More than 40 years after it was discovered, HIV is still a global scourge affecting nearly 40 million people.

• New treatments have made HIV and AIDS, the most advanced stage of the virus, less transmissible and easier to live with. Seven people around the world have now been cured of HIV through stem cell transplants.
• But there's no scalable cure, and while AIDS-related deaths are down 69% since their peak in 2004, around 630,000 people globally still died from the illness last year.
• New HIV infections are on the rise in Eastern Europe and Central Asia, Latin America and the Middle East and North Africa, according to the United Nations.

Where it stands: The new shot from Gilead, known as lenacapavir, is already approved to treat HIV in the U.S. Gilead is now testing how well the drug works to prevent infections in the first place, and the results are promising.

• The company announced in September that the shots prevented HIV infection in 99.9% of participants in a trial of cisgender men, transgender men, transgender women and gender nonbinary individuals.
• A separate trial showed the drug to be 100% effective in preventing new HIV infections among cisgender women.
• Analysts expect Food and Drug Administration approval for HIV prevention next year.

Driving the news: Gilead announced an agreement last week under which six generic drug companies will manufacture and sell lenacapavir in 120 low-income countries, pending the necessary regulatory approvals.

• The deal includes countries in sub-Saharan Africa with the highest rates of HIV. But it doesn't allow for generic manufacturing in middle-income countries where cases are rising, the New York Times reported.
• "One of the things that we've been advocating to Gilead ... is that pricing and access should be determined by public health need, not by World Bank economic status," Warren said.

What they're saying: Gilead is still figuring out how to make its injectable PrEP more accessible, a company spokesperson told Axios. Tiered pricing, or selling a drug at a lower price in developing countries, could be one solution.

• "Access in middle-income and upper-middle income countries, including those in Latin America, is a priority for Gilead," the spokesperson said in a statement.

State of play: Truvada, the daily PrEP pill also made by Gilead, has been available for more than a decade. In the last five years, three other prevention methods, including a shot that's administered every two months, have also come on the market.

• The United Nations estimates that only about 3.5 million people worldwide took PrEP last year.
• While Truvada is 99% effective at stopping new HIV infections in clinical trials, real-world evidence indicates the effectiveness of daily PrEP can be as low as 26% among young people who don't always adhere to the medication schedule.
• In the U.S., most private health insurance plans must cover PrEP without cost-sharing, but more federal guidance is needed to make sure plans cover both pills and injectables without prior authorization, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute.

The bottom line: "Lenacapavir is on everybody's lips" AVAC's Warren said at this week's HIV Research for Prevention Conference in Lima, Peru.

• "That's probably the second-most popular word this week. I think the most popular word is access," he told Axios from the conference.