Two Doses, 99.9% Effective: World's First HIV Prevention Vaccine Approved By FDA
- Lidi Garcia
- Jun 20
- 4 min read
HIV is the virus that causes AIDS and still infects more than 1 million people a year worldwide. Now, a new medicine called lenacapavir promises to help prevent new infections: it is administered as an injection only twice a year and provides protection for six months. This method may be easier than taking medication every day. But the high price and difficulty in accessing it may prevent it from reaching those who need it most, especially in poorer countries. Despite the challenges, the new drug brings hope in the fight to end HIV.
HIV, the human immunodeficiency virus, is the cause of AIDS, a disease that attacks the immune system and makes the body more vulnerable to infections and certain types of cancer. Since it emerged in the 1980s, HIV has caused the deaths of millions of people worldwide.
HIV can infect cells in the central nervous system, such as microglial cells (which are like “defenders” of the brain) and other cells that help protect the nervous system.
These regions, such as the brain and spinal cord, are part of the so-called “viral reservoir.” This means that the virus can hide there in a “dormant” (latent) state, where current medications have more difficulty reaching and destroying it completely. Furthermore, when the medication enters these areas, side effects increase, such as hallucinations, dizziness, and insomnia, which cause the patient to abandon treatment.
Although current treatments allow those living with the virus to live a long and healthy life, the number of new infections is still high: every year, more than 30,000 new cases appear in the United States and around 1.3 million worldwide.
The costs of HIV treatment and prevention represent a huge burden for public and private health systems. In the US alone, billions of dollars are invested each year in medications, medical monitoring and educational campaigns.
Therefore, finding more effective ways to prevent HIV transmission, such as vaccines or long-acting medications, is essential to reduce the number of cases, costs and the impact of the disease on society. Recently, an important breakthrough was announced in the United States: the approval of the first medication in injection form that offers protection against HIV for six months with just two injections per year.
This medication, called lenacapavir, was developed by the company Gilead Sciences and could be a powerful alternative to prevent new infections, while a vaccine against the virus does not yet exist.
Studies have shown that lenacapavir virtually eliminated new infections among people who used the medication in research, with better results than pills taken every day. This is very important because many people end up forgetting to take their daily pills or abandoning treatment due to tiredness, embarrassment or difficulty in accessing them.
How lenacapavir works is simple to understand. The medication is administered as two injections under the skin of the abdomen. The substance forms a small deposit at the injection site and is gradually released into the body over the course of six months, protecting the person against HIV.
However, before taking the injection, it is necessary to undergo a test to ensure that the person does not have the virus, as the medication is intended to prevent infection and not to treat those who are already infected.
It is also important to remember that lenacapavir only protects against HIV and does not prevent other sexually transmitted diseases, such as syphilis, gonorrhea or herpes. Therefore, the use of condoms continues to be recommended as a complementary form of prevention.
Despite the revolutionary potential of this drug, there are challenges in ensuring that it reaches those who need it most. The price of lenacapavir in the United States is high: more than $28,000 per year before discounts or health insurance.
Although the manufacturer says that the price is similar to other prevention drugs and that financial assistance programs are available, the cost can be a barrier for many people.
In addition, cuts in public health budgets and HIV prevention programs in the United States and other countries may make it harder for the most vulnerable populations to access the drug.
Another concern is that while Gilead has reached agreements to offer cheaper versions of the drug in poor countries, such as in Africa, Southeast Asia and the Caribbean, many middle-income countries, such as several in Latin America, have been left out of these plans.
This means that millions of people in regions where HIV is still a major problem may continue to be without access to lenacapavir. Public health experts warn that to truly reduce HIV transmission worldwide, it is necessary to ensure that all people at risk can use effective preventive medicines, regardless of where they live or how much money they have.
Finally, the data from studies on lenacapavir are encouraging. In a study of more than 5,000 young women and adolescents in South Africa and Uganda, none of the participants who received the injection every six months contracted HIV, while about 2% of those who took daily pills became infected.
Another study of gay men and non-binary people in the United States and other countries also showed that the drug was highly effective. In addition, many people who participated in the studies reported that the convenience of taking an injection every six months is much better than remembering to take a pill every day or making frequent visits to the doctor.
This new method thus represents a concrete hope for stopping the transmission of HIV in the world, as long as access to the drug is guaranteed for everyone who needs it.
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