Roger-Luc Chayer (Image: AI / Gay Globe)
SPECIAL REPORT
HIV/AIDS has been considered a true plague for the LGBTQ+ communities for nearly 50 years. At its onset, the HIV virus decimated our communities, often within a few months. Between 1984 and 1995, it is estimated that nearly 30% of gay men in Western countries, such as Canada, the United States, and Europe, died from complications related to the virus, including AIDS.
In 1995, the discovery and use of antiretroviral therapy (ART) significantly reduced mortality rates, although transmission rates continued to rise. By 2025, we remain trapped in a persistent cycle, marked by spikes in HIV cases followed by some scientific progress. However, globally, these advancements mainly improve the quality of life for those affected, without offering a true cure. Moreover, PrEP, the most effective prevention tool to date, remains unaffordable in many parts of the world or is not taken seriously by populations who feel more invulnerable than ever.
ENTER LENACAPAVIR
In recent months, several studies on a new drug from an entirely new class of HIV treatments have garnered attention: lenacapavir. This revolutionary treatment opens up unprecedented prospects. For a long time, researchers sought a way to control HIV transmission and replication without the virus developing mutations. With this new drug, it seems that this goal has been achieved.
Not only is lenacapavir 98-100% effective as a preventive tool, administered as two injections per year, but it is also highly effective in treating individuals, including those who have developed resistance to current treatments. Why? Because this treatment targets a part of the virus that does not mutate, making the approach far more stable and reliable.
HOW LENACAPAVIR WORKS
According to science journalist Joseph D. Brown of The Mind Unleashed, lenacapavir is a revolutionary drug that belongs to a new class called capsid inhibitors. This treatment targets the capsid, a protective shell of the virus essential to its life cycle.
By binding to specific parts of the capsid, lenacapavir blocks several crucial stages necessary for the virus’s survival. It prevents viral DNA from entering the host cell’s nucleus, halting the virus’s integration into the cell’s genome. Additionally, it disrupts the assembly of new viral particles, leading to the production of defective viruses that cannot infect other cells. Thanks to its unique mechanism, lenacapavir limits HIV replication and slows its spread.
The development of lenacapavir was made possible through advanced structural studies of the HIV capsid, which identified key sites for therapeutic intervention. By targeting these critical areas, lenacapavir offers a highly effective means to suppress HIV replication. This makes it a valuable option not only for patients who have failed existing treatments but also for those seeking preventive measures such as pre-exposure prophylaxis (PrEP).
CONCLUSIVE CLINICAL TRIALS
Lenacapavir has demonstrated remarkable efficacy in preventing HIV infections in various populations through decisive clinical trials.
The Phase 3 PURPOSE 1 trial evaluated the effectiveness of lenacapavir as pre-exposure prophylaxis (PrEP) in cisgender women in sub-Saharan Africa. The interim analysis revealed no HIV infections among participants receiving lenacapavir, indicating 100% effectiveness. This led to the early unblinding of the trial due to the achievement of primary efficacy endpoints.
PURPOSE 2, another Phase 3 trial, studied the effectiveness of lenacapavir in cisgender men, transgender men, transgender women, and non-binary individuals who had sex with male-assigned at-birth partners. Conducted across multiple countries, including Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States, this trial showed a 96% reduction in HIV infections compared to background incidence. Specifically, only two infection cases were recorded among 2,180 participants, meaning 99.9% of the lenacapavir group did not contract HIV.
In both trials, lenacapavir demonstrated superiority over daily oral PrEP options like Truvada. The convenience of semiannual injections helps overcome challenges related to adherence to daily treatments, which could improve its effectiveness in real-world conditions.
OVERCOMING THE COST BARRIER
According to Joseph D. Brown, while lenacapavir represents a promising advance in HIV prevention, its current price poses significant challenges to widespread accessibility, particularly in low- and middle-income countries.
In the United States, lenacapavir is approved for treating multi-drug-resistant HIV, with an annual cost exceeding $40,000 per patient. Such high costs make lenacapavir inaccessible in regions with limited healthcare budgets. For example, in countries like Uganda, where annual healthcare expenditures per person amount to about $12, the current price of lenacapavir is prohibitively expensive.
Research indicates that lenacapavir could be mass-produced at a significantly lower cost. Studies suggest that, with economies of scale and generic manufacturing, the drug could be produced for as little as $41 to $94 per person per year.
ACCESSIBILITY IN CANADA AND EUROPE
According to the CATIE network, the use of lenacapavir was first approved by European Union authorities and was recently approved in Canada by Health Canada. The drug is intended for people who have developed resistance to many treatments and must be used in combination with other medications. Scientists refer to this group as « heavily treated » individuals.
Its use as PrEP or as a stand-alone treatment for HIV remains to be approved. If all goes well and quickly, we could witness, for the first time in history, the possible eradication of HIV.