New Drug Provides Total Protection From H.I.V.in Trial of Young African Women
An injection given just twice a year could herald a breakthrough in protecting the population that has the highest infection rates.
Researchers and activists in the trenches of the long fight against H.I.V. got a rare piece of exciting news this week: Results from a large clinical trial in Africa showed that a twice-yearly injection of a new antiviral drug gave young women total protection from the virus.
“I got cold shivers,” said Dr. Linda-Gail Bekker, an investigator in the trial of the drug, lenacapavir, describing the startling sight of a line of zeros in the data column for new infections. “After all our years of sadness, particularly over vaccines, this truly is surreal.”
Yvette Raphael, the leader of a group called Advocacy for Prevention of H.I.V. and AIDS in South Africa, said it was “the best news ever.”
The randomized controlled trial, called Purpose 1, was conducted in Uganda and South Africa. It tested whether the every-six-months injection of lenacapavir, made by Gilead Sciences, would provide better protection against H.I.V. infection than two other drugs in wide use in high-income countries, both daily pills.
The results were so convincing that the trial was halted early at the recommendation of the independent data review committee, which said all participants should be offered the injection because it clearly provided superior protection against the virus.
None of the 2,134 women in the arm of the trial who received lenacapavir contracted H.I.V. By comparison, 16 of the 1,068 women (or 1.5 percent) who took Truvada, a daily pill that has been available for more than a decade, and 39 of 2,136 women (1.8 percent) who received a newer daily pill called Descovy were infected.
The findings were announced by Gilead. The data has not yet been subject to peer review. A second trial, conducted in six other countries, including Brazil and the United States, is assessing the effectiveness of lenacapavir in men who have sex with men, in transgender people and in those who use injection drugs. Midterm review of those results will take place later this year.
While Truvada, taken daily, provides high levels of protection against H.I.V. infection and has been widely used by gay men in the United States and other high-income countries for years, it has not proved to be a potent prevention tool in Africa, where uptake has been low, particularly among young African women, the group with the highest rates of new infection.
The hope is that a twice-a-year injection, which women can put on their calendars and then not think about for months, will prove more effective.
“For a young woman who can’t get to an appointment at a clinic in a town, a young woman who can’t keep pills without facing stigma or violence — an injection just twice a year is the option that could keep her free of H.I.V.,” said Lillian Mworeko, who leads a group called the International Community of Women Living With H.I.V. Eastern Africa.
