Known active ingredient protects against HIV infection
Lenacapavir is a well-known and already approved HIV medication. It is now being tested in a clinical study as a preventative measure. The results are noteworthy.
At the end of the month, scientists and researchers from all over the world will meet at the International AIDS Conference in Munich. There will be excellent news. It seems a substance has been found that offers 100% protection against an HIV infection. Preliminary results of a worldwide clinical study with the drug Lenacapavir have already been celebrated as a "gamechanger" in the fight against HIV and AIDS. With the joy comes the responsibility to make the medication widely and affordably available, especially in developing countries. The pharmaceutical company Gilead is responsible for ending the ongoing HIV epidemic.
Katherine Gill can't stop smiling. "We've been researching and testing for decades. Effectiveness rates of forty, sometimes even sixty percent, that's normal in HIV research," says the clinical study leader of the Desmond Tutu Health Foundation in South Africa. "But 100%? That's incredibly exciting!" Katherine Gill laughs.
It's a deep-seated relief that is being released in the international medical and scientific community these days. For decades, researchers have been searching for a way to ward off the tenacious HIV virus, which can cause AIDS. Surprisingly, an already approved, medication in both the US and the EU is now bringing a breakthrough. The drug Lenacapavir has so far only been used in specific cases for treating HIV patients and patients with resistances to other medications.
"Lenacapavir is a turning point, as it allows long-lasting protection against the HIV virus with an injection every six months," says Antonio Flores, the leading HIV advisor at Doctors Without Borders in South Africa. "It's a 'gamechanger,' a breakthrough in the fight against the HIV epidemic."
Young Women are infected most frequently
Living with an infection is now possible, albeit with significant health restrictions, according to the World Health Organization (WHO). Approximately 37.7 million people lived with an HIV infection or AIDS worldwide at the end of 2020. "As long as people continue to get infected with the virus, the epidemic will not end," says Gill. The virus caused 630,000 deaths in 2022. An estimated 1.3 million people became newly infected. Approximately 2,000 of these new infections occurred in Germany (2020). Young women and teenagers in developing countries are the most affected. Young women in Sub-Saharan Africa account for 77% of new infections.
This group has been the focus of the so-called Purpose 1 HIV Prevention Study in the past two years. 5,000 women aged 16-25 in regions with high virus incidence in Uganda and South Africa participated. 2,100 of these women received Lenacapavir, the drug from the manufacturer Gilead, subcutaneously twice a year, that is, under the skin in their abdominal fat. The results show: Not a single woman became infected during this time. "That means Lenacapavir is 100% effective," says Dr. Linda-Gail Bekker also from the Desmond Tutu Health Foundation. "When I saw the first evaluation, I trembled. After all the years of grief and the difficult search for a vaccine, this is really surreal."
Women in the control groups of the Purpose 1 Study received well-known PrEP pills Truvada and Descovy, which also showed high efficacy. New infections in these groups were at 1.5 and 1.8 percent.
Tablet intake is difficult for some
"I think many young women find it simply difficult to take a pill every day," said Bekker. This was also a research topic in the Purpose 1 Study. Early insights are interesting as they reveal the limits of oral prevention methods for HIV. The results have not been published yet. "There were clear dropouts in oral prevention use," said pharmacist Ngosa Nulubwe. She was responsible for the medicinal administration and control of the test group in the Cape Town township of Msiphumelele. "Our social workers did excellent work and the test subjects confirmed it." Regardless of how effective PrEP is in pill form, a preventive method is only effective if it is accepted by the majority of consumers.
HIV infections are still a taboo topic in many parts of African cultures. "If you take a pill every day, it looks like HIV treatment," explains social worker Olwethu Kemele. "That puts a teenager in a difficult explanation situation with her parents and friends. But a shot every six months at a clinic, that's simple and private." That's why Lenacapavir will make a big difference. "Women now have the choice of how they want to protect themselves, just like with contraception," says Katherine Gill. Lenacapavir will not be the right solution for everyone, but for a majority, a new solution.
Lenacapavir is not a vaccine, but an antiretroviral medication that has so far been marketed under the name Sunlenca. It is approved for HIV treatment in the EU and therefore in Germany, but due to the strict pricing policy of the German government and low patient numbers in this segment, Gilead has decided against market introduction in Germany. Now that it is becoming clear that Lenacapavir can do much more than previously assumed, its effective global impact will primarily depend on how cooperative the pharmaceutical company is in offering its product broadly and affordably.
Lenacapavir study with men is ongoing
A second ongoing clinical Lenacapavir study named Purpose 2 is currently being conducted in the USA and Latin America with men who have sex with men and male sex workers. The results could still be published this month. Both studies must still undergo review by other scientists. "We must be cautious and cannot say that HIV has been defeated," warns South African Gill. "The active ingredient is currently only approved for HIV treatment. Now it must be licensed as a preventive agent against the virus." That could still take years.
Bekker and Gill will present the results of the Purpose 1 Study's findings at the AIDS Conference in Munich. "We need to make this medication available quickly to save lives," says Bekker. "There are initial good signs," adds Gill. "Gilead has promised us two things: First, all participants in the clinical study will receive Lenacapavir for free until it is officially approved as an HIV protective agent in their home country. That's unusual, according to Gill. Second, they have promised to make the patent available so that the medication can be produced and distributed quickly and cheaply where it is most needed."
It all sounds too good to be true. But there's no one who doesn't want to believe in this turn of events. Nevertheless, lobbying efforts are now more important than ever. On many levels.
"Now is the time when we must hold governments and manufacturers accountable," says Antonio Flores from Doctors Without Borders. The organization is relentless in advocating for price reductions and broad access to life-saving medications for developing countries. "We are witnessing the beginning of a new era, a new moment in the fight against HIV. We now have the opportunity to drastically reduce this epidemic." The use of condoms could not achieve this before, and neither could PrEP pills. "We have effective treatment methods and now also a long-lasting protection with high efficiency," says Flores and adds: "It's time to act." It cannot happen fast enough.
- The groundbreaking results from the worldwide clinical study with Lenacapavir have brought hope to the fight against HIV and AIDS, particularly in developing countries like Africa, where young women and teenagers account for a significant percentage of new infections.
- Antonio Flores, the leading HIV advisor at Doctors Without Borders in South Africa, hailed Lenacapavir as a "gamechanger" and a "turning point" in the battle against the HIV epidemic, praising its potential for long-lasting protection with an injection every six months.
- Katherine Gill, the clinical study leader of the Desmond Tutu Health Foundation in South Africa, highlighted the significance of Lenacapavir for young women in Africa, stating that it provides them with the choice to protect themselves against HIV, similar to how they choose contraception, and that it will make a big difference in their lives.
