condom use! We have repeated it since the first cases of AIDS appeared. Is it worth insisting on this message? Sure, but let’s be real: Most guys don’t.
In 2010, an international study was conducted that proposed a preventive strategy (PReP), based on the daily administration of pills containing two antivirals: tenofovir and encitrabin – which we will call from now on TE.
The results were impressive: compared to the placebo group (an inactive tablet), those who took a TE tablet had a 90% reduced risk of HIV infection.
The numbers are so important that the World Health Organization considers PReP the ideal prevention strategy for the population most vulnerable to HIV infection. Today, it is certified by SUS and more than 70 countries.
However, in the real world, having to take a pill every day is a problem. First, because of stigma, the risk of provoking violence by partners, family members, and the community.
Then for biological reasons: the concentration of the two drugs in the rectal mucosa is higher than in the vagina, a condition that forces women to take six or seven weekly doses for maximum protection, while MSM actually reach this level of protection of four or more Five ports.
Therefore, the British laboratory ViiV developed cabotegravir. It is an inhibitor of HIV, an enzyme necessary for the genes of the virus to be able to integrate into the DNA of our cells. It is a safe drug that is well tolerated and is able to maintain its inhibitory effect for eight weeks, starting with an injection of 600 mg intramuscularly.
In May of this year, the HPTN 084 study was published in The Lancet, which recruited women, ages 18 to 45, at 20 clinical research centers in countries in the sub-Saharan region — Botswana, Kenya, Malawi and the south. Africa, Zimbabwe, Eswatini and Uganda.
In this phase 3 study, participants needed to have had a history of vaginal intercourse at least twice in the last 30 days, to use a long-acting method of contraception and to be classified in the high-risk group for HIV infection, according to the assessment score.
The participants were divided into two groups. The first consisted of 1,586 subjects who received an intramuscular capotegravir injection every eight weeks, accompanied by a daily placebo tablet. In the placebo group, 1,592 women took one ET tablet daily and one injection of placebo (saline) every eight weeks. Neither the doctors nor the participants knew who to take
Placebo, injectable, or oral medication (double-blind).
From January 2017 to November 2020, there were 40 HIV infections: four of them in the group receiving capotegravir; 36 in the TD-treated group. Therefore, cabotegravir reduced the risk by 88% compared to those who took a daily TE pill.
At this point, the study was stopped because it had already reached statistical significance. Conclusion: In the field of prevention, we now have a drug, injected every two months, capable of reducing nearly 90% of the already very low risk, taking a daily tablet of the combination of tenofovir and entetrapine.
The results of HPTN 084, together with the results of the HPTN 083 study, conducted previously among men who have had sex with men – which showed similar results – allow us to conclude that due to its effectiveness and ease of administration, cabotegravir will revolutionize the field of AIDS prevention.
The problem is that each dose of capotegravir costs $3,700 in the United States, a price that makes its use in almost all countries unfeasible.
ViiV pledges to market it without profit to the poorest countries in Africa. Societies like the Clinton Health Access Initiative estimate that generic drug manufacturers will be able to produce it for $20, while others suggest that a dose should cost $60 to attract the interest of generic manufacturers.
And Brazil? Brazil is not a candidate to benefit from the price cuts. We already experienced this situation in 1995, when the so-called “anti-HIV cocktail” was developed. At that time, we negotiated with pharmaceutical companies, we broke patents, but the Brazilians received the drugs through SUS.
At that time…
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