MEXICO CITY — A new groundbreaking vaccine against the AIDS virus, known as lenacapavir, has shown remarkable promise in clinical trials, demonstrating 100% effectiveness in preventing HIV infections among women. Recent findings indicate that the vaccine is also nearly equally effective in men. Gilead Sciences, the pharmaceutical company behind this development, announced plans to allow affordable, generic formulations of the vaccine to be available in 120 underprivileged countries that have high rates of HIV, primarily located in Africa, Southeast Asia, and the Caribbean. However, Latin America, which has lower but rising infection rates, has been notably excluded from this agreement, raising alarms that a critical window of opportunity to combat the disease may be overlooked.
Winnie Byanyima, the executive director of UNAIDS, praised the vaccine’s efficacy, stating that it surpasses any other prevention method available and is an unprecedented advancement. She acknowledged Gilead’s initiative but stressed that the global success against AIDS hinges on the adoption of this vaccine in regions most at risk.
UNAIDS also provided alarming statistics on the state of AIDS-related deaths, reporting an estimated 630,000 in the previous year, marking the lowest rate since 2004. This suggests the world is at a pivotal point, with a real chance to eradicate the epidemic.
Lenacapavir, marketed as Sunlenca, is currently used to treat HIV infections in the U.S., Canada, Europe, and various other regions. Gilead plans to apply for regulatory approval to utilize Sunlenca for HIV prevention soon.
Although alternative preventive measures exist, including condoms, daily pills, vaginal rings, and bi-monthly injections, experts believe Gilead’s twice-yearly shot could significantly benefit marginalized populations hesitant to seek regular care, such as gay men, sex workers, and young women. Byanyima expressed optimism that this method could provide much-needed security for these vulnerable groups, allowing them to visit clinics just twice a year for protective shots.
One participant in a recent study, Luis Ruvalcaba, a 32-year-old from Guadalajara, Mexico, shared his fears regarding discrimination when trying to obtain the government-issued daily prevention pills. His involvement in the study ensures he will continue receiving the shots for an additional year. Dr. Alma Minerva Pérez, who enrolled participants in the research, emphasized the overwhelming stigma surrounding HIV treatment in Latin America, where individuals often feel ashamed to seek assistance.
The extent of Sunlenca’s availability within Mexico’s health care framework remains uncertain. Health officials have not disclosed any intentions to procure the vaccine for residents, although the public health system began offering daily preventative pills for free in 2021. “If the option for generics is viable, I trust that Mexico can be included,” stated Dr. Pérez.
Many countries participating in the research, such as Brazil, Peru, and Argentina, have also been excluded from the generics deal. Byanyima criticized this decision, calling it unacceptable. Gilead reiterated its commitment to enhancing access to HIV prevention and treatment where the necessity is most urgent, with 18 countries across Africa bearing the majority of the global HIV burden qualifying for the generic versions.
Advocacy groups in countries like Peru, Argentina, Ecuador, Chile, Guatemala, and Colombia recently urged Gilead to make generics available in Latin America, highlighting the concerning inequities in accessing new HIV prevention strategies against a backdrop of rising infection rates. While some nations, including Norway and France, have been paying over $40,000 a year for Sunlenca, experts estimate that with the expansion of generic production to cover 10 million individuals, the cost could drop to around $40 per treatment.
Dr. Chris Beyrer, director of the Global Health Institute at Duke University, emphasized the need for Sunlenca in the areas hardest hit by HIV in Africa and Asia, pointing out the public health emergency represented by rising infection rates in Latin America, particularly among gay men and transgender individuals. Hannya Danielle Torres, a 30-year-old artist and participant in the Sunlenca study, expressed hope that the Mexican government would develop a means to provide the vaccine broadly, underscoring the stark contrast between wealth and vulnerability in the country.
Another pharmaceutical firm, Viiv Healthcare, has similarly excluded many Latin American nations from its generics program for its HIV prevention shot, Apretude, which boasts an 80% to 90% effectiveness but is prohibitively expensive at $1,500 annually, beyond the means of many.
Asia Russell, executive director of the advocacy organization Health Gap, pointed out the urgent need for more than just existing prevention strategies, urging countries like Brazil and Mexico to issue “compulsory licenses” that could temporarily suspend patents during health crises. This approach has been utilized historically in response to previous public health emergencies.
Experts like Dr. Salim Abdool Karim from South Africa’s University of KwaZulu-Natal considered the effectiveness of Sunlenca unparalleled in HIV prevention. He emphasized the critical challenge ahead: how to ensure access to this life-changing vaccine for everyone in need.
