The café was held at the HEJNU offices on the 6 th December 2025 focusing on the new preventive drug known as lenacapavir which is still under study at 2 sites in Masaka and Mityana proving 100% efficacy.
The café that was attended by 24 kampala journalists including covering all media outlets, radio, television, online and paper.
The café centered on the efficacy of the of this new preventive injectable drug that will be administered twice a year when rolled out in the country .
The Panelists/Guests:
➢ Dr. Flavia kiweewa, Lead reasercher in the study at Mujhu
➢ Assimwe Stephen, HIV preventive officer Uganda AIDS Commisiion
➢ Alice Vivian, Person living with HIV and activists with ACTS 101
DR FLAVIA
The study involved administering injections and oral medications to participants, with a focus on HIV prevention. Out of over 2,000 participants in the FTAF group, 39 contracted HIV, while 16 out of a smaller group contracted HIV in the FTDF group. Notably, there were zero infections in the injection group (Lenacapavir).
The injection group demonstrated 100% protection against HIV, marking a significant breakthrough in HIV prevention methods. This level of efficacy is unprecedented in the history of HIV prevention, as previous methods have only achieved 30-80% effectiveness.
The results were presented at a conference in Munich, where they received an overwhelmingly positive response from attendees, highlighting the excitement surrounding this breakthrough.
The introduction of the Lenacapa injection represents a monumental advancement in HIV prevention, achieving 100% efficacy, which has not been seen before in any HIV prevention strategy.
– This breakthrough could change the landscape of HIV prevention, potentially leading to wider adoption and improved health outcomes for at-risk populations.
– The positive reception of the study results indicates a strong interest and hope within the medical and scientific communities for future developments in HIV prevention.
1. **Study Overview**: The discussion revolves around a study involving 2,134 young women and girls aged 16 to 25 on the lenacapavir injection, compared to those on other treatments like FTAF (DISCOVEY) and TDF (Truvada).
2. **Treatment Recommendations**: LEN (Lenacapavir) is not recommended as a first-line treatment due to potential resistance issues. It is reserved as a last resort for patients who have failed multiple other treatments.
3. **Open Label Extension Phase**: The study has transitioned into an open label extension phase, allowing participants to continue receiving the lenacapabir injection after initial trials showed its effectiveness in preventing HIV infection.
4. **High Acceptance Rates**: There has been a high acceptance rate for the lenacapavir injection among participants in Uganda and South Africa, with nearly 100% acceptance in Uganda.
5. **Regulatory and Licensing Process**: Gilead is compiling data from two studies (purpose 1 and purpose 2 ) to file for FDA licensing of the lenacapavir They plan to visit sites in Uganda and South Africa to ensure the study’s integrity before licensing.
6. **Cost and Accessibility**: The drug is expensive (around $40,000 in the U.S.), which poses challenges for resource-limited countries. Gilead is working with generic manufacturers to provide a more affordable version of the drug.
7. **Future Availability**: Gilead has committed to providing the drug at a lower cost to 18 high-risk countries, including Uganda and South Africa. The hope is to have the drug available within two years, pending regulatory approvals and funding.
8. **Demand and Economic Impact**: Increased demand for the drug could lead to lower prices, making it more accessible to those in need.
– **Strategic Treatment Approach**: LEN should be used judiciously as a last resort, emphasizing the importance of preserving treatment options for HIV patients.
– **Positive Study Outcomes**: The transition to an open label extension phase indicates confidence in the KAPAVA injection's efficacy, with high acceptance rates suggesting strong community support.
– **Regulatory Pathway**: The ongoing efforts to secure FDA licensing and the collaboration with generic manufacturers are crucial steps toward making lenacapavir accessible in resource-limited settings.
– **Financial Considerations**: The high cost of lenacapavir presents a significant barrier, but Gilead’s commitment to lower pricing in high-risk countries and the potential for generic alternatives offer hope for improved access.
– **Future Outlook**: With proactive measures from Gilead and local health authorities, there is optimism for the drug’s availability within two years, contingent on successful regulatory processes and funding acquisition.
The licensing agreements, voluntary licensing agreements with fixed generic manufacturers, they have already signed this year.
And as soon as there are approvals, the process is going to start, and then they will look at how to manufacture enough drugs for everyone who needs it, and at a cheaper cost. But before then, because also that takes a while.
They have also passed an agreement, a statement, dedicating to providing Lenacapavir to 16 countries, including Uganda and South Africa, where the study was conducted, the brand drug at a low cost, not what it would cost in the US or Europe, but at a lower cost to these countries.
As the generic manufacturers come up with the generic versions, we shall be able to access Lenacapavir, the branded drug at a cheap cost from the manufacturer for the 18 countries, including Uganda and South Africa. So we hope that in the next, probably two years, we should be having
available, but before then, at least, we have the participants, the young girls and women who participated in purpose one in Uganda and South Africa, accessing lenacapavir.
DR ASSIMWE
Dr Assimwe started his presentation with a brief about Uganda Aids commision’ Uganda aids commission is a government agency. It is the overall coordinator for the HIV response in Uganda, and they do some oversight. The programs like leadership, but a lot of coordination, because the interventions are done by different groups, and there is a need to kind of bring all the groups together in that coordination mechanism. That coordination mechanism is managed by Uganda aids commission.
About prevention interventions Dr Assimwe noted that there are a number however Uganda aids commission develops what is called the National HIV and AIDS strategic plan, and then it has different kinds of interventions. So prevention is just one of them, but there is also care and treatment,
there is social support, and there are systems building or systems strengthening. So the interventions that are coordinated in the overall response and also done by different partners will fall under those different areas.
It is not just about prevention, but there are also other aspects. Prevention is meant to be a combination approach and the saying that one intervention may not be enough, at least at the population level.
A person may benefit from lenacapavir but it could be that there is another person who, for some reason, cannot benefit from that intervention. And so we need a number approaches.
So when we talk about that combination approach, it has different things that we can keep as the biomedical interventions in that way, we recover the medicines, the drugs, so the difference is in what they got for prep which is pre exposure prophylaxis, for people that are at risk, but maybe they have not been exposed to give them something that could prevent them from acquiring the infection.
There are other things, like post exposure prophylaxis, like, let’s say, young girl gets wrecked, but there is worry that they could have been exposed, and so they get an intervention to prevent that from happening. The hope is that they become suppressed and they are not transmitted. So that is also another way of preventing infections.
And then there are the good old condoms that hopefully help and when needed maybe. So that is part of the biomedical approaches to prevention. But beyond that, you have then the social and behavior interventions. So I can also mention the good old faithfulness and abstinence.
There are structural problems, and so we try to do some interventions especially to do with the stigma.
So normally, when a disease has just come, people fear it. There is a lot of stigma, and that fuels the disease somehow, and it limits the understanding of the disease. And so there interventions specifically to reduce stigma, to reduce discrimination against the persons that are HIV positive, and the interventions that deal with laws. So when we have laws that are restrictive and make it difficult for maybe groups at risk to access prevention interventions, we may also need to intervene there.
VIVIAN
Vivian spoke about PMTCT, or prevention of mother to child transmission.
By the time Vivian birthed her child while she already knew she was living positively. She says, “I cannot say I really had the experience, maybe, or I enjoyed it, but most of it was worrying. I was really worried the whole time, much as I had some information of prevention of mother to child transmission, which really has taken my ARV, which is a very big aspect when it comes to prevention of mother to child transmission.
I knew that if I took the medication, my baby would be safe. However, even when that information was within, it was I was never comfortable with the situation I had my baby while I was still in school. I was old enough I was at campus, so I decided to go with my baby to school.
I had to leave her with someone, but this person I would leave with the child who did not know about my status, because it’s not easy to disclose all that everywhere. And that time I was not really this open, so I had not told her, and she would feed the baby with other things. Maybe, if I leave and the baby is crying, and maybe I didn’t give keep some breast milk in the bottle for her, so she would give her things.
And at first I didn’t;t know. So one day, I found out that she was giving my baby things, I didn’t want to go through the hustle of having to live with a positive child, because even I as an adult, it would get hard for me to take my medicine. So I didn’t want to imagine myself forcing my baby to take medication. So I decided to wean her, because I thought my baby would be infected. I took her home to my mom to take care of her.
And so this may brings me to the point that I want to say that it’s very important for mothers that are living positively to have a support system to help them through that situation. To deal with stigma, the support system helps you deal with the stigma because, partly, the stigma affects us so much.
Because if I had disclosed to the person that was taking care of the baby, maybe those things wouldn’t happen, and my baby would have best fed for some good time. And then antenatal care, that time, when were looking at prevention of mother to child transmission or elimination I know there are mothers who do not know that they are infected, or they are living with the virus, or there are those who come and do the first test at the beginning, and then when they go back, I’m not sure if the tests are really done for all that time someone is pregnant, because the first
test will say yes, you’re negative, but then that doesn’t mean that they will stop engaging in things that will maybe bring the virus to them.
So maybe that would also be something that we should look into to make these follow up tests while the mother is going for the antenatal care visits
It should be something that we give attention to always test those that are negative, to ensure that they have kept negative the whole time, and then those of us that are living positively, and we know we should have educations, because sometimes it is assumed that we know or that we are fully
equipped with the information.
But also, how do you gage that this information is enough, or she knows enough? Because even as adults, we still go to school, So it’s important that we do not stop educating people about HIV infections and PMCTs.
