HIVR4P2024: Lenacapavir brings hope to ending HIV epidemic, says Dr Colleen Kelley
By Avit Ndayiziga
Nicknamed a miracle HIV prevention tool, Lenacapavir stands out among other existing long-acting injectable options due to its biannual dosing regimen.
While there is currently no vaccine or single-shot cure for HIV, the global scientific community has made significant strides in developing a range of HIV prevention tools facilitating choices. These include tools currently in use, newly approved, and some in development and trial phases.
One of the recent and promising HIV prevention tools is lenacapavir. It is a long-acting pre-exposure prophylaxis (PrEP) twice-yearly injectable that is highly effective and safe.
It has demonstrated a 96% reduction in HIV infections with a geographically diverse population of cisgender gay, bisexual, and other men, transgender women, transgender men, and gender nonbinary individuals aged 16 years or older who have sex with partners assigned male at birth in preventing HIV acquisition.
“These data reinforce that twice-yearly Lenacapavir could be a highly effective and potentially game-changing HIV prevention choice that we have long hoped for in our efforts to end the HIV epidemic,” said Colleen Kelley, MD, MPH, Professor of Medicine at Emory University and a PURPOSE 2 Principal Investigator at Gilead Science, adding that “PURPOSE 2 was intentionally designed to reflect the lives and locations of many people.
This innovative prevention tool reduces the risk of getting HIV from sex by about 99% and from injection drug use by at least 74%.
On October 2, 2024, Gilead signed a royalty-free voluntary licensing agreement with six generic manufacturers to increase access to Lenacapavir for HIV prevention in high-incidence, resource-limited countries.
This came after UNAIDS Executive Director Winnie Byanyima, who described Gilead’s twice-yearly injectable Lenacapavir for HIV prevention as a “miracle prevention tool,” cried out over its exorbitant price of $42,500 per year in the USA, directly and indirectly excluding people from low-income countries.
However, the UNAIDS Director welcomed Gilead’s statement of commitment to non-profit pricing, urging Gilead to disclose a specific price. “We urge Gilead to disclose it and to provide full transparency on the costs.
The UN official argued that “respected researchers have shown that it is possible to produce and sell Lenacapavir for $100 per patient per year, falling to as little as $40.” She concluded.
The former IAS President Sharon Lewin pointed out that “breakthroughs in medicine are only meaningful when the people who need those medicines can access them.”
In the official HIVR4P press conference, Colleen Kelley, principal investigator from Gilead, did not reveal its price, which remains sceptical.
Lenacapavir comes after other HIV prevention tools that have been in use, including male and female condoms, which reduce the risk of HIV transmission during sexual intercourse. Pre-exposure prophylaxis (PrEP): daily oral medication for HIV-negative individuals to reduce the risk of infection. Post-exposure prophylaxis (PEP): emergency treatment started within 72 hours after potential exposure to HIV, typically taken for 28 days.
Antiretroviral Therapy (ART): For individuals living with HIV, effective treatment can reduce viral load to undetectable levels, preventing sexual transmission (U=U).
Dapivirine Vaginal Ring: A long-acting vaginal ring that releases Dapivirine to help prevent HIV in women. This female-initiated option reduces the risk of HIV infection. To properly use the ring, it must be worn inside the vagina for 28 days, after which a new ring should replace it. The ring is made of silicone and is easy to bend and insert. The ring works by releasing the antiretroviral drug dapivirine from the ring into the vagina slowly over 28 days.
Cabotegravir Injections: Long-acting injectable formulation administered once a month or every two months for HIV prevention.
Syringe Services Programs: Providing sterile needles and syringes to people who inject drugs to reduce the risk of HIV transmission.Microbicides: antiretroviral gels or creams that can be applied vaginally or rectally to reduce the risk of HIV transmission (still under research).
The International AIDS Society funded this story through the HIVR4P Journalist Fellowship programme
