Europe backs a drug

LONDON (AP) — The European Medicines Agency has recommended authorizing a six-monthly injectable HIV prevention drug that scientists say could help end transmission of the virus.

In a statement issued yesterday, the European Union's drug regulator said its assessments of lenacapavir, sold as Yeytuo in Europe by Gilead Sciences, showed the drug to be "highly effective" and "considered to be of significant public health interest."

Once the regulator's guidance is accepted by the European Commission, the authorization will be valid in all 27 EU member states, as well as Iceland, Norway, and Liechtenstein.

Last year, several studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective at stopping transmission in women and men.

Winnie Byanyima, executive director of the UN AIDS agency (UNAIDS), said the drug would “change the trajectory of the HIV epidemic” if made available to all who need it.

Last June, the U.S. Food and Drug Administration (FDA) authorized lenacapavir for HIV prevention. Earlier this month, the World Health Organization (WHO) recommended that national governments offer the drug as an additional option for people at risk of contracting the virus.

When used correctly, condoms help protect against HIV infection. Other medications to prevent transmission of the virus include pills taken daily and an injectable drug called cabotegravir, administered every two months.

Lenacapavir's six-month protection makes it the longest-lasting option, which could make it attractive to people who don't want more visits to health centers or who shy away from the stigma of taking daily pills.

However, critics have expressed concerns that the drug might not be widely available enough to stem global HIV outbreaks. Gilead has said it will allow cheaper generic versions to be sold in 120 poor countries with high HIV rates, primarily in Africa, Southeast Asia, and the Caribbean.

But it has excluded almost all of Latin America, where rates are much lower but rising, raising concerns that the world is missing a major opportunity to stop the disease.

Last year, there were an estimated 630,000 deaths from AIDS worldwide, and more than 40 million people are estimated to be living with HIV.

Byanyima has suggested that the U.S. presidency reach an agreement with Gilead to produce and license its drug for the millions of people who need it.

At a glance

Generic version

The pharmaceutical company Gilead has said it will allow the sale of cheap generic versions of the drug in 120 poor countries with high HIV rates, mainly in Africa, Southeast Asia, and the Caribbean. But it has excluded almost all of Latin America, where rates are low but rising.