"A new HIV drug can stop the epidemic, but it must become widespread"
A new HIV drug can stop the global epidemic of the virus if its use becomes widespread. However, so far the cost of the drug per patient per year exceeds $ 40 thousand, so its use will be limited. Mikhail Bolkov, a researcher at the Institute for the Study of Aging at the Russian Gerontological Research and Clinical Center at Pirogov University, told Izvestia in an interview. The American company Gilead Sciences has received approval for its drug for the prevention of the immune deficiency virus from the American Food and Drug Administration (FDA). Lenacapavir can now enter the market.
"The new drug only works as a prevention, not as a treatment"
— What is the uniqueness of the new medicine?
— Lenacapavir, a drug developed by Gilead Sciences, has shown 100% efficacy in clinical trials. That is, when taking medication, a person can be sure that they will not become infected with HIV, even in the case of unprotected sexual contact with an infected person. Technically, it stops the development of the virus in humans, does not allow it to multiply. The new drug could stop the development of the HIV epidemic in the world or, at least, reduce its pace, but its use needs to become widespread. It won't happen instantly. After all, the medicine works only as prevention, not as treatment. To defeat smallpox, it was necessary to vaccinate the entire population of the planet. And in those places where they didn't get vaccinated, the vaccine strain got transmitted from person to person.
— What is the principle of action of the medicine?
— The difficulty of fighting HIV is that the virus is constantly mutating. But the new drug is embedded between the proteins of the capsid. A capsid is simply a virus shell that surrounds the virus and protects its enzymes and genetic material. The drug molecule interferes with interactions between other proteins that are necessary for several phases of the viral replication cycle. As a result, the drug deforms the shell of new viruses and prevents their introduction, unpacking and assembly. This creates defective copies of the virus, which are unstable, crumble and cannot leave the cell. No new viruses are formed in the cell. After taking the medicine, it is in the body, and if a virus enters it, it is activated. Theoretically, new HIV strains may arise that can circumvent this action. But this is pure theory.
I must say that this is not a very new development, its research has been going on for a long time, and there are mentions of drug trials in 2020.
— Can a person who takes medicine without becoming infected himself become a carrier of the virus and transmit it to others?
— Practically not. Under the influence of the drug, after entering the cell, the virus remains in it and dies. Therefore, the drug will prevent the spread of infection.
— And how did the developers manage to prove the high effectiveness of their drug?
— The company itself conducted clinical trials of its medicine in Africa. We received all the information we know from the developer himself. Gilead was supposed to submit the test reports to the US Food and Drug Administration, which, in turn, would have to verify them.
The two-year study involved 5,300 women aged 16-25 in 25 locations in South Africa and three locations in Uganda. The safety and efficacy of three drugs were tested in parallel. Lenacapavir and two other medications from the same manufacturer. There were no cases of HIV infection among 2,134 women in the group taking the medication. I must say that the situation with the virus in Africa is difficult, it is very widespread there. A lot of unprotected sexual intercourse.
However, to confirm these results, full-fledged independent clinical trials should be conducted under external supervision. And we will certainly see them in the future. In particular, in other countries where the drug will be used.
— Why did an American company conduct clinical trials in Africa?
— Due to the epidemiological prevalence and insecurity of the population. There is no healthcare there like in Russia or the USA. Residents are willing to participate in drug trials for a small compensation. There is a severe HIV epidemic there and a lot of people need help. They simply have no choice, as in more developed countries, where they can rely on different types of therapy. We should not forget that regulatory authorities are always more accommodating in such a situation.
At the same time, Gilead compared the effectiveness of the new drug with its own developments, which is also not very objective. Understanding all the specifics of Africa, there may be a high probability of unfair results, so they need to be rechecked in a different population and under different conditions.
— Will such studies be needed for the use of the drug in the Russian Federation?
— Yes, in order for us to apply it, we will need to conduct clinical trials in our country as standard.
"Now the main disadvantage is the price"
— Does the medicine have any side effects?
— There is no data on this yet. However, it is quite possible that after the start of mass use, millions of people will receive information that could not have been obtained from experiments with thousands of participants. This happens with many medications. Theoretically, side effects cannot be predicted, but according to Gilead, no complications have been identified when used with other HIV medications. However, there is no data yet on the effect of the drug on the immune system or other body systems.
We also do not know how the drug will work in case of infection through a syringe, as it happens among drug addicts, since the studies were conducted only with sexual transmission.
"Is it really a 'magic pill' that doesn't have any flaws?"
— Now its main disadvantage is the price. Two doses of the drug, which will last for a year, will cost more than $ 40 thousand. It is unlikely to become widespread quickly, as this is a very high cost for a simple patient. But over time, with an increase in production and the appearance of similar drugs from competitors, the price may decrease. And now the developer is trying to make up for his expenses. It is still unknown how expensive and difficult the production of lenacapavir is. The cost was set by its creators. But if they are willing to give out licenses, then there is a great chance of getting cheaper.
— Then who should start taking it first?
— Spouses of HIV-infected people, when only one of them is sick. Medical staff who often come into contact with patients and have a high chance of infection, for example, during surgical operations. People with free views who also take more risks. However, they need to remember that in addition to HIV, through unprotected contact, many other dangerous diseases can be infected, for which there are still no such effective remedies.
— Will the use in individual groups somehow affect the epidemiological situation with HIV in general?
— Naturally, this will slow down the epidemic process.
— Can this medicine somehow help people who are already infected?
— If there are no complications with the combination of different drugs, primarily toxic complications, then you can try combination therapy with other antiretroviral drugs. This is logical. After all, our task is to stop the reproduction of the virus, its replication and mutational activity. The medicine is suitable to disrupt one of the stages of virus assembly and somehow stop its growth inside the body. Of course, it can be used not for a final cure, but to improve the condition. Research on the technology on which lenacapavir is based continues, and perhaps in the future we will see new drugs with great potential.
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