WASHINGTON (AP) – The US has given the green light to the world's first preventive shot for HIV. This marks a significant step towards a global rollout aimed at safeguarding millions. Discover more about this powerful new option.
While vaccines to prevent HIV are still necessary, some experts believe that Gilead Science’s Lenacapavir could be a strong contender. It’s on the way, with the potential to eliminate new infections. Two innovative studies have shown that it may outperform daily preventative medications for those at high risk.
Greg Millett, director of public policy at AMFAR, the AIDS Research Foundation, commented:
Condoms are effective in preventing HIV when used correctly, but PREP is gaining importance with consistent use of preventative medications, including daily pills and an injection every two months. Lenacapavir provides six months of protection, making it the longest-lasting option available. This could be appealing for individuals hesitant about frequent doctor visits and the stigma associated with daily pills.
However, the tumultuous healthcare landscape in the US—including cuts to public health and changes to Medicaid—is limiting access for potential patients. The reduction in foreign assistance for HIV is further complicating the situation.
Millett referred to this as “the hole in the system” both in the US and globally.
Gilead’s drug is currently available for HIV treatment under the brand name Sunlenca, while the preventive dosage goes by Yeztugo. Administered as two injections under the skin of the abdomen, it creates a small “depot” that gradually delivers medication into the bloodstream. According to Gilead, individuals must test negative for HIV before receiving the two annual doses. It only prevents HIV transmission and does not guard against other sexually transmitted infections. Some researchers involved in the drug’s testing recommend using cold packs to alleviate injection discomfort.
Efforts to conclude the HIV pandemic by 2030 are stagnating. Annually, over 30,000 new infections occur in the United States, with approximately 1.3 million globally.
Currently, only around 400,000 Americans are using some form of PREP. Recent studies have indicated that HIV infections have dropped in states with high PREP usage, while they continue to rise elsewhere.
Women account for about half of new infections, often needing protective measures that can be used without their partner’s knowledge or consent. A comprehensive study conducted in South Africa and Uganda compared over 5,300 sexually active young women, administering Lenacapavir or daily pills every six months. Participants receiving the shot reported no new HIV infections, while approximately 2% from the comparison group contracted HIV from infected partners.
The second study demonstrated that the biannual shots were similarly effective in gay men and among various gender identities across the US and in other countries with high HIV prevalence.
Houston’s Ian Huddock, who has been involved in PREP since 2015, eagerly participated in the Lenacapavir study, continuing with the biannual injections as part of his follow-up.
“We don't have to carry a pill bottle around, so we forget we're on PREP,” said Huddock, who leads the initiative, a nonprofit supporting the black LGBTQ+ community. “It really broadens the opportunities for prevention, for everyone—men, women, gay, straight.” He added that it requires just remembering biannual clinic visits, making it a powerful tool without the daily effort of pill adherence like with condoms.
Gilead’s pre-insurance list price in the US is $28,218 per year, similar to other PREP options. The company not only anticipates insurance coverage but also offers several financial assistance programs.
Despite potential Supreme Court decisions that could impact coverage requirements, private insurers are expected to pay for PREP options without copays. Congress is also evaluating significant cuts to Medicaid. While community health centers remain an option, the previous administration significantly weakened HIV prevention efforts at the CDC, which typically disseminates information to vulnerable groups eligible for the shot, according to Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute.
Schmid expressed concern that such shots may fall short of availability as they “essentially undermine HIV prevention, testing, and outreach programs.”
Gilead is also awaiting applications for the biannual shots in additional countries. Last fall, the company entered agreements with six generic manufacturers to produce low-cost versions of the shots for 120 low-income nations, especially in Africa, Southeast Asia, and the Caribbean. Gilead aims to manufacture enough shots to assist two million people without profits until generics can be provided, said Dr. Jared Baeten, senior vice president of the company.
Winnie Byanyima, executive director of UNAIDS, remarked that the prices remain prohibitively high. To instigate change, she claimed, “affordability is crucial.”
HIV experts are also voicing concerns regarding Gilead’s arrangements to lower costs in certain regions, particularly in parts of Latin America, while excluding middle-income countries.
“Everyone in countries with HIV risk should have access to PREP,” emphasized Dr. Gordon Crohoot of Houston. “We need to simplify access to this highly effective preventative measure.”
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Source: apnews.com