- The human immunodeficiency virus (HIV), which can lead to acquired immunodeficiency syndrome (AIDS) if not treated, is currently treated by taking antiretroviral medications.
- However, there is currently no approved vaccine for HIV.
- The World Health Organization (WHO) recently issued new guidelines recommending the use of injectable lenacapavir to help prevent HIV.
According to UNAIDS, in 2024, about 40.8 million people around the world were living with the human immunodeficiency virus (HIV) — a virus that can lead to acquired immunodeficiency syndrome (AIDS) if not treated.
The World Health Organization (WHO) reports that
While there is currently no approved vaccine for HIV, the WHO has recently issued new
Lenacapavir is a medication originally designed to treat HIV infection. It is currently sold under the brand names Sunlenca for HIV treatment, and Yeztugo for HIV prevention.
According to Carolyn Chu, MD, MSc, FAAFP, AAHIVS, chief medical officer of the American Academy of HIV Medicine, lenacapavir is a novel antiviral medication — belonging to the “HIV capsid inhibitor” class — which was initially developed for use as part of a combination treatment regimen for people with HIV.
“The initial product (brand name Sunlenca) was approved for treatment in late 2022 based on the CAPELLA Study that examined its safety and efficacy among study participants with HIV who were heavily treatment-experienced and had multidrug-resistant infection,” Chu explained to Medical News Today.
“Because of its unique molecular properties, scientists were very interested in determining whether lenacapavir could also be developed for use as an HIV prevention intervention,“ she added.
“[Lenacapavir] disrupts multiple stages of the HIV life cycle, which makes it an attractive drug to study further — it is also very potent (with effective concentrations at pico-molar ranges) and is active against viruses which may be resistant to HIV medications that have been commonly used over the last decade.”
— Carolyn Chu, MD
Chu said that when lenacapavir was studied as a long-acting pre-exposure prophylaxis (PrEP) HIV preventive option in the PURPOSE clinical trials, investigators found an almost 100% reduction in new HIV infections among participants who received it as a twice-yearly injectable.
“These findings led to its recent approval under a new indication, i.e., used as a prevention medication, brand name Yeztugo,” she added.
Through its new guidelines, the WHO recommends the use of injectable lenacapavir twice a year as an additional PrEP option to help prevent HIV.
Examples of currently used PrEP options include the oral medications Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide), and the injectable drug Apretude (cabotegravir).
The WHO also recommended the
The guidelines are based on safety and efficacy findings for lenacapavir from various studies and clinical trials, most notably PURPOSE 1 and PURPOSE 2.
Phase 3 of the PURPOSE 1 trial in cisgender women resulted in no cases of HIV infection among study participants given lenacapavir.
Further, the PURPOSE 2 trial found 99.9% of cisgender men and gender-diverse people did not become infected with HIV after receiving the drug.
In addition to the lenacapavir recommendation, the WHO also recommends a public health approach to HIV testing through the use of HIV rapid tests.
According to the WHO’s new guidelines, offering injectable lenacapavir twice a year may help overcome potential barriers to current PrEP options, such as unwillingness to take a regular oral pill and a wish for lower amounts of clinic visits.
“Lenacapavir represents a major scientific advance — it’s the first long-acting injectable HIV prevention strategy that requires dosing just twice a year,” Chu told MNT.
“For some individuals, especially those who have difficulty adhering to daily or even bimonthly prevention strategies like oral PrEP or cabotegravir, this would be especially welcome,” she noted.
Edward Liu, MD, MPH, FACP, FIDSA, chief of infectious diseases at Hackensack Meridian Jersey Shore University Medical Center in New Jersey, explained to MNT that:
“Across the world HIV remains a serious disease and preventing new infection is critical. Lenacapavir is an injectable antiviral that lasts 6 months, protecting people for long periods of time. Oral antivirals that are approved for preventing HIV require daily dosing to be effective.”
“People don’t like storing oral HIV antivirals at home, where there is stigma attached to those medications, and people forget to take medications or use condoms,” Liu continued. “Large-scale treatment of people with lenacapavir will be the most efficient way yet to prevent HIV infection until an effective vaccine is produced.”
HIV and AIDS continue to be a global problem. According to UNAIDS, although the number of new global HIV infections has decreased by about 39% since 2010, there are still areas around the world where numbers are increasing, making the need for HIV prevention critical.
“Prevention of HIV is much less expensive than treating people with HIV infection with expensive antivirals for the rest of their lives,” commented Paul E. Sax, MD, clinical director of the Division of Infectious Diseases at the Brigham and Women’s Hospital, and professor of medicine at Harvard Medical School.
That is another reason why prevention is important. “Treatment with antivirals is very difficult to sustain, particularly in poorer countries,” said Sax.
“The ideal situation is to have multiple options for preventing HIV among those at risk — this includes not only available PrEP strategies, but also other novel PrEP approaches such as an investigational once-monthly pill for those who don’t like or want injections,” he explained.
“Of course, we still hope that the HIV vaccine research will advance to the point of giving us an effective vaccine, but the scientific hurdles have proven very high, so we are not anticipating any major breakthroughs in this area in the near future,” Sax added, on a cautionary note.
Finally, Chu noted that:
“Right now, a lot of conversations are centered on ensuring that everyone who is interested in (lenacapavir) will have access to it. Multiple studies have confirmed that interest in this new option is high, and so our systems and policymakers need to be forward-thinking and work in close collaboration with community members and other stakeholders to ensure that all the necessary pieces to initiate and continue this new PrEP option (e.g., HIV screening/testing, obtaining the medication from pharmacies, training people on how to administer the doses, relaying medication/appointment reminders, etc.) are identified soon and can be rolled out equitably.”
