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For more than 40 years, researchers have been trying to end the HIV epidemic. There is no cure yetThe life sciences industry has made great strides, and the new long-term precautions represent an incremental but important step in that direction.
Gilead Study Delivers Breakthrough Results Released last month The company’s pre-exposure prophylaxis (PrEP) drug, lenacapavir, was found to be 100% effective in preventing HIV infection in over 2,000 cisgender women in South Africa and Uganda, requiring only two injections per year. If approved, lenacapavir would be the first prevention option with such a long treatment interval.
“Long-acting PrEP could be key to ending the HIV pandemic,” Dr. Jared Baeten, senior vice president of clinical development and therapeutic area head for virology at Gilead, said in an email interview. “Despite years of progress, the world is still far from stopping the spread of HIV.”
More than 1 million people will be infected with HIV in 2022 alone, 600,000 of them in Africa, Beten said. In the United States, the CDC estimated in 2018 that 400,000 people were taking PrEP, but roughly twice as many people who should benefit from it weren’t. That estimate has likely grown since then, Beten said.
Once-daily medications like Gilead’s Descovy and Truvada were a big step forward in HIV prevention for the past PrEP generation, but a twice-yearly option that doesn’t have to be taken every day could attract new people to take the medication. Black and Latino men, Black cisgender women, and transgender women are more vulnerable to HIV in the U.S., but their PrEP uptake remains low, Baeten said, and an option like lenacapavir “has the potential to fill a critical gap.”
One step at a time towards treatment
A cure for HIV has been discussed since the 1980s, when the medical community first became aware of the virus, but efficacy figures like those for lenacapavir suggest that researchers are finally getting close to achieving it.
“Long-acting formulations of PrEP are the next frontier in HIV prevention innovation,” said Baeten. “We believe the future of HIV treatment and prevention with person-centered medicines, including long-acting injectables, has the potential to improve health outcomes around the world and change the course of the epidemic for future generations.”
Currently, available preventive medications and treatments are not a cure. Beyond PrEP, drug developers are also making progress in the area of long-term HIV treatment. GSK and J&J’s Cabenuva is the first to be approved. FDA approved In 2021, 90% of patients Not detected After 11 months or more of treatment, it becomes effective, just like HIV drugs taken daily, but like PrEP, it only works as long as the patient keeps taking it.
“Treatment is an essential component of ending the HIV epidemic,” Baeten said. “While antiretroviral therapy effectively controls the virus, it does not completely eradicate it from people with HIV, so stopping ART allows the virus to rapidly regrow.”
While complex procedures like stem cell therapy have brought about cures in a small number of patients, the safety, accessibility and scalability of these treatments make them unfeasible, Baeten said.Among several studies to find “permanent freedom from HIV,” Gilead and Merck recently showed that a combination of lenacapavir and islatravir worked for patients in a mid-stage trial. Maintaining viral suppression.
Gilead anticipates results from future late-stage clinical trials of lenacapavir in cisgender men, transgender men and women, and non-binary people who have sex with partners assigned male at birth in late 2024 or early 2025, addressing additional populations at risk of HIV infection.
“This is the most comprehensive and diverse HIV PrEP drug trial program ever conducted,” Baeten said.
