Cape Town, A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis medication gives young women complete protection against HIV infection.
The trial tested whether the six-month lenacapavir injection would provide better protection against HIV infection than two other drugs, both in daily pill form. All three medications are pre-exposure prophylaxis (or PrEP) medications.
Physician and scientist Linda-Gail Bekker, principal investigator for the South African part of the study, tells Nadine Dreyer what makes this breakthrough so significant and what to expect next. Tell us about the trial and what it set out to achieve.
The Purpose 1 trial with 5,000 participants was carried out at three sites in Uganda and 25 sites in South Africa to test the effectiveness of lenacapavir and two other drugs.
Lenacapavir (Len LA) is a fusion capsid inhibitor. It interferes with the HIV capsid, a protein coat that protects HIV genetic material and the enzymes necessary for replication. It is administered just under the skin, once every six months. The randomized controlled trial, sponsored by drug developers Gilead Sciences, tested several things.
The first was whether a semiannual injection of lenacapavir was safe and would provide better protection against HIV infection as PrEP for women ages 16 to 25 than Truvada F/TDF, a widely used daily PrEP pill that has been available. for more than a decade.
Second, the trial also tested whether Descovy F/TAF, a newer daily pill, was as effective as F/TDF. The newer F/TAF has superior pharmacokinetic properties than F/TDF. Pharmacokinetics refers to the movement of a drug in, through and out of the body. F/TAF is a smaller pill and is used among transgender men and women in high-income countries. The trial had three arms. Young women were randomly assigned to one of the arms in a 2:2:1 ratio (Len LA: oral F/TAF: oral F/TDF) in a double-blind manner. This means that neither the participants nor the researchers knew what treatment the participants were receiving until the clinical trial ended.
In eastern and southern Africa, young women bear the brunt of new HIV infections. They also find it difficult to maintain a daily PrEP regimen, for a number of social and structural reasons.
During the randomized phase of the trial, none of the 2,134 women who received lenacapavir contracted HIV. There was 100 percent efficiency. In comparison, 16 of 1,068 women (or 1.5%) who took Truvada (F/TDF) and 39 of 2,136 (1.8%) who received Descovy (F/TAF) contracted the HIV virus.
The results of a recent independent data safety monitoring board review led to the recommendation that the “blinded” phase of the trial should be stopped and all participants should be offered the option of PrEP.
This board is an independent committee of experts that is established at the beginning of a clinical trial. They view unblinded data at stipulated times during the test to monitor progress and safety. They say that a trial does not continue if there is clear harm or benefit in one arm over others. What is the meaning of these judgments?
This advance raises high hopes that we will have a proven and highly effective prevention tool to protect people from HIV.
Last year there were 1.3 million new HIV infections worldwide. Although that is less than the 2 million infections seen in 2010, it is clear that at this rate we will not reach the target of new HIV infections that UNAIDS set for 2025 (less than 500,000 worldwide) or potentially even the goal of ending AIDS by 2030. PrEP is not the only prevention tool.
PrEP should be provided alongside HIV self-testing, access to condoms, screening and treatment for sexually transmitted infections, and access to contraceptives for women of childbearing age.
Additionally, young men should be offered medical male circumcision for health reasons. But despite these options, we have not reached the point where we have been able to stop new infections, especially among young men.
For young people, the daily decision to take a pill or use a condom or take a pill at the time of sexual intercourse can be very challenging.
HIV scientists and activists hope that young people will discover that having to make this “prevention decision” just twice a year can reduce unpredictability and barriers. For a young woman struggling to get to an appointment at a clinic in a people or who cannot keep the pills without facing stigma or violence, an injection just twice a year is the option that could keep them free of HIV.
What happens now?
The plan is for the Purpose 1 trial to continue, but now in an “open label” phase. This means that study participants will not be “masked”: they will be told whether they have been in the “injectable” or oral TDF or oral TAF groups. They will be offered their preferred PrEP option as the trial continues.
A sister trial is also underway: Purpose 2 is being carried out in several regions, including some sites in Africa, among cisgender men and transgender and non-binary people who have sex with men.
It is important to conduct trials between different groups because we have seen differences in efficacy. Whether sex is anal or vaginal is important and can have an impact on effectiveness. How long until the drug is launched?
We have read in a press release from Gilead Sciences that within the next few months the company will present the dossier with all the results to several national regulators, in particular the regulators in Uganda and South Africa.
The World Health Organization will also review the data and may issue recommendations. We hope then that this new drug will be adopted in WHO and country guidelines.
We also hope that we can begin testing the drug in more studies to better understand how to incorporate it into real-world settings.
Price is a critical factor in ensuring access and distribution in the public sector where it is urgently needed. Gilead Sciences has said it will offer licenses to companies that make generic drugs, which is another key way to lower prices.
In an ideal world, governments will be able to purchase it at an affordable price and it will be offered to all who want it and need protection against HIV. (The conversation) NSA
NSA
The trial tested whether the six-month lenacapavir injection would provide better protection against HIV infection than two other drugs, both in daily pill form. All three medications are pre-exposure prophylaxis (or PrEP) medications.
Physician and scientist Linda-Gail Bekker, principal investigator for the South African part of the study, tells Nadine Dreyer what makes this breakthrough so significant and what to expect next. Tell us about the trial and what it set out to achieve.
The Purpose 1 trial with 5,000 participants was carried out at three sites in Uganda and 25 sites in South Africa to test the effectiveness of lenacapavir and two other drugs.
Lenacapavir (Len LA) is a fusion capsid inhibitor. It interferes with the HIV capsid, a protein coat that protects HIV genetic material and the enzymes necessary for replication. It is administered just under the skin, once every six months. The randomized controlled trial, sponsored by drug developers Gilead Sciences, tested several things.
The first was whether a semiannual injection of lenacapavir was safe and would provide better protection against HIV infection as PrEP for women ages 16 to 25 than Truvada F/TDF, a widely used daily PrEP pill that has been available. for more than a decade.
Second, the trial also tested whether Descovy F/TAF, a newer daily pill, was as effective as F/TDF. The newer F/TAF has superior pharmacokinetic properties than F/TDF. Pharmacokinetics refers to the movement of a drug in, through and out of the body. F/TAF is a smaller pill and is used among transgender men and women in high-income countries. The trial had three arms. Young women were randomly assigned to one of the arms in a 2:2:1 ratio (Len LA: oral F/TAF: oral F/TDF) in a double-blind manner. This means that neither the participants nor the researchers knew what treatment the participants were receiving until the clinical trial ended.
In eastern and southern Africa, young women bear the brunt of new HIV infections. They also find it difficult to maintain a daily PrEP regimen, for a number of social and structural reasons.
During the randomized phase of the trial, none of the 2,134 women who received lenacapavir contracted HIV. There was 100 percent efficiency. In comparison, 16 of 1,068 women (or 1.5%) who took Truvada (F/TDF) and 39 of 2,136 (1.8%) who received Descovy (F/TAF) contracted the HIV virus.
The results of a recent independent data safety monitoring board review led to the recommendation that the “blinded” phase of the trial should be stopped and all participants should be offered the option of PrEP.
This board is an independent committee of experts that is established at the beginning of a clinical trial. They view unblinded data at stipulated times during the test to monitor progress and safety. They say that a trial does not continue if there is clear harm or benefit in one arm over others. What is the meaning of these judgments?
This advance raises high hopes that we will have a proven and highly effective prevention tool to protect people from HIV.
Last year there were 1.3 million new HIV infections worldwide. Although that is less than the 2 million infections seen in 2010, it is clear that at this rate we will not reach the target of new HIV infections that UNAIDS set for 2025 (less than 500,000 worldwide) or potentially even the goal of ending AIDS by 2030. PrEP is not the only prevention tool.
PrEP should be provided alongside HIV self-testing, access to condoms, screening and treatment for sexually transmitted infections, and access to contraceptives for women of childbearing age.
Additionally, young men should be offered medical male circumcision for health reasons. But despite these options, we have not reached the point where we have been able to stop new infections, especially among young men.
For young people, the daily decision to take a pill or use a condom or take a pill at the time of sexual intercourse can be very challenging.
HIV scientists and activists hope that young people will discover that having to make this “prevention decision” just twice a year can reduce unpredictability and barriers. For a young woman struggling to get to an appointment at a clinic in a people or who cannot keep the pills without facing stigma or violence, an injection just twice a year is the option that could keep them free of HIV.
What happens now?
The plan is for the Purpose 1 trial to continue, but now in an “open label” phase. This means that study participants will not be “masked”: they will be told whether they have been in the “injectable” or oral TDF or oral TAF groups. They will be offered their preferred PrEP option as the trial continues.
A sister trial is also underway: Purpose 2 is being carried out in several regions, including some sites in Africa, among cisgender men and transgender and non-binary people who have sex with men.
It is important to conduct trials between different groups because we have seen differences in efficacy. Whether sex is anal or vaginal is important and can have an impact on effectiveness. How long until the drug is launched?
We have read in a press release from Gilead Sciences that within the next few months the company will present the dossier with all the results to several national regulators, in particular the regulators in Uganda and South Africa.
The World Health Organization will also review the data and may issue recommendations. We hope then that this new drug will be adopted in WHO and country guidelines.
We also hope that we can begin testing the drug in more studies to better understand how to incorporate it into real-world settings.
Price is a critical factor in ensuring access and distribution in the public sector where it is urgently needed. Gilead Sciences has said it will offer licenses to companies that make generic drugs, which is another key way to lower prices.
In an ideal world, governments will be able to purchase it at an affordable price and it will be offered to all who want it and need protection against HIV. (The conversation) NSA
NSA