dual prevention pill

The Future of Multipurpose Prevention Technologies

In this podcast, Jessica Rodrigues, with AVAC: Global Advocacy for HIV Prevention, provides a description of a Dual Prevention Pill and why it can be used as a case study for future multipurpose technologies (MPTs). She presented these topics at the International AIDS Conference 2022 during a session titled "Demand, delivery, and data for decision-making: How market preparation for the Dual Prevention Pill is reimagining prevention programs for a future with MPTs"

Additional Resources:

  • Rodrigues J. Introduction: Preparing for a future with a range of MPT options. Talk presented at: the International AIDS Conference 2022; July 29-August 2, 2022; Montreal, Canada. Accessed August 19, 2022. https://programme.aids2022.org/Programme/Session/117
  • Rodrigues J. Key takeaways: Ingredients for the successful rollout of MPTs. Talk presented at: the International AIDS Conference 2022; July 29-August 2, 2022; Montreal, Canada. Accessed August 19, 2022. https://programme.aids2022.org/Programme/Session/117

Jessica Rodrigues is the Director of Product Introduction and Access at AVAC: Global Advocacy for HIV Prevention. 


 

TRANSCRIPTION:

Jessica Bard: Hello everyone, and welcome to another installment of Podcast 360, your go-to resource for medical news and clinical updates. I'm your moderator, Jessica Bard with Consultant360, a Multidisciplinary Medical Information Network. Women worldwide are confronted with two significant overlapping health risks: unintended pregnancy and sexually transmitted infections, such as HIV. Jessica Rodrigues is here to speak with us today about her presentations at the International AIDS Conference 2022 during a session titled, "Demand, delivery, and data for decision-making: How market preparation for the dual prevention pill is reimagining prevention programs for our future with MPTs." Jessica is the director of Product Introduction and Access at AVAC. Thank you for joining us today. To start, can you please provide an overview of your presentations titled, "Preparing for a Future With a Range of MPT Options" and "Key Takeaways: Ingredients for the Successful Rollout of MPTs"?

Jessica Rodrigues: Hi, it's a pleasure to be here with you today. I presented a description of the dual prevention pill and why it can be a case study for future multipurpose technologies. The dual prevention pill is a new product that combines HIV prevention and contraception in one co-formulated pill. AVAC is the organization that leads a consortium with a range of partners, including the Children's Investment Fund Foundation, Bill and Melinda Gates Foundation, the Clinton Health Access Initiative, Population Council, the Catalyst Group, and Mann Global Health. As well as the HIV Prevention Trial Network funded by the National Institute of Health in the U.S.

And all of these partners are working to think through access for the dual prevention pill and the implications for other multipurpose technologies or MPTs. And the work on MPTs really builds on a call to action, following the ECHO trial results which were presented at IAS 2019 in Mexico City, which showed high rates of HIV incidents among women of reproductive age who were using contraception. And there was a loud and clear call for the potential of MPTs to respond to the dual need, to prevent HIV and unplanned pregnancies among women. But MPTs can benefit a wide range of populations and individuals. And they can cover not only HIV prevention but also STI prevention, as well as pregnancy prevention.

Jessica Bard: Why is there a need for a DPP product?

Jessica Rodrigues: There are high rates of HIV incidence. Every two minutes in 2021, an adolescent girl or young woman was newly infected with HIV. There are also very high rates of unmet need for family planning, about 20% globally. And this ranges from at the high end 32% in Western Asia and 26% in Sub-Saharan Africa. And there are also high rates of STI incidents in many parts of the world. And some trials show STI incidents can be as high as 30%. And most importantly, from the user perspective, many discrete choice experiments and other research has shown that women are open and really prefer a dual-purpose product. And these studies show that both women and their partners would prefer using a dual-purpose product compared to one for a single indication. So, all of these factors combined have really prompted much more investment and interest recently in the potential of MPTs.

Jessica Bard: So, where are we today with MPT options?

Jessica Rodrigues: MPT products and development include a range of modalities, oral pills, vaginal rings, vaginal films, intrauterine devices, implants, inserts, and gels. And while there are many MPT candidates in the pipeline, most are still in the early stages of development. I would say about a third focus on HIV and other STIs, another third on HIV and contraception. And the rest are a combination of triple protection against HIV, STIs, and unplanned pregnancy, as well as combining contraception and other STIs. So, there's a range of different configurations and different MPT pipelines, MPT products in the pipeline. But most of these are really in pre-clinical and early clinical development.

I would say there are two exceptions. One is the combined Levenorgestrel ring, which is in again, phase one trials. So that's an exciting option that is being tracked closely, but still quite a long ways from being available to the market.

And then there is the dual prevention pill, which is the furthest along in the R&D process, because both TRUVADA Tenofovir and FTC, and Levonorgestrel, Ethinyl Estradiol, which are the active pharmaceutical ingredients that form the dual prevention pill have been previously approved. So this means that the R&D process is much faster because they are approved and available. So the DPP could be the first MPT to reach the market after the condom. And I'm happy to talk to you a little bit more about what the DPP is and where we are in the process.

So the DPP is a co-formulated bi-layer tablet with differentiated colors, dark pink for the first 21 days and light peach for the last seven days. The packaging will be a cold-form blister pack that folds up like a wallet, with instructions for use printed on the back.

And women will be able to tear off weekly sheets for ease of use. And the pill colors and packaging were selected based on end-user research in Zimbabwe and South Africa with young women themselves. So these colors are different from ARVs, which can be usually blue or white and what the color of oral prep. And this was because there is a lot of stigmas associated with ARVs. So young women really preferred colors that were more similar to what is used for oral contraception and felt more comfortable, and that they could be more discreet in using pills that were their color.

And lastly, in terms of where we are in the regulatory and R&D process, a bioequivalence study is currently being conducted, which is the pathway for approval of most and any generic drug. And results are expected in the next few months. Assuming positive BE results, Viatris, formerly Mylan, who is the manufacturer of the co-formulated pill, hopes to receive FDA approval. Again, assuming it is a positive decision by 2024.

So again, this could be the first MPT to reach the market after the condom. And as well, we're thinking ahead and Population Council of Medicines360, who form part of the consortium are right now testing a combination of F/TAF, another formulation for HIV prevention and the same oral contraceptive combination, which would mean that the pill could be much smaller and closer to the size of what's commonly used for oral contraception. So again, would enable women to use it more just discreetly. That is very early in development, but it is also an exciting prospect.

So in conclusion, again, the DPP is furthest along in terms of R&D, and we're really excited that if BE results are positive, and there's a positive FDA decision, the pill could be available in 2024.

Jessica Bard: Right. You mentioned approval there. What else would you say really needs to happen to prepare for a future with a range of MPT options?

Jessica Rodrigues: That's a great question. I think investing in manufacturing capacity, both in terms of the number of suppliers, but also mixing hormonal and non-hormonal drugs is quite complex and requires a significant investment. So I think first really shoring up that capacity across a wide range of manufacturers. Thinking through clinical trials, particularly for innovator products and the regulatory process, because clinical trials will have to look at multiple outcomes across a range of conditions. And the design might be more complicated. I would say another factor or another variable that needs to happen is engaging in and leveraging multidisciplinary partnerships across HIV, STIs, and contraceptives. And using collaborative models like we've established for the DPP to advance R&D and market access. And lastly, I'd say looking at cost-effectiveness and keeping products affordable, and so that people are more willing and able to use them.

Jessica Bard: Now, one of your presentations was titled ingredients for the successful rollout of MPTs. What would you say are the ingredients for a successful rollout?

Jessica Rodrigues: So post regulatory approval, I think one of the keys will be breaking down silos between HIV and FP delivery channels and services. And at the same time, we recognize integration might be facilitated and catalyzed with a tangible product that meets multiple health needs. Along with breaking down silos or a part of that is ensuring and enhancing coordination across HIV and SRH departments at the global and national levels. Currently, their fragmented funding streams, fragmented procurement systems and policy development tends to be quite separate. And so ensuring really close formation. And that's starting to happen more and more. That along with integration of services at the point of care, which will demand integrated training, demand creation, and monitoring, and evaluation and surveillance systems. And training all providers in preventative care. MPTs will really require our providers to be much more polyvalent.

Jessica Bard: Now I recognize this next one could be a difficult question because there are quite a few, but what knowledge gaps exist in this area?

Jessica Rodrigues: Yeah, like you said, because the area is really nascent, but growing, I think there are so many knowledge gaps, but some of which I have mentioned. I think one that we're looking at is switching across different products and MPTs. So for example, if a person would start on the dual prevention pill, but their fertility intention changes. Really supporting them to then move off of an MPT to a single indicated product, I think requires really sophisticated counseling and support. And providers again, who are able to counsel across different prevention areas. A link to that is optimal training for providers who might be specialists in one particular area and supporting counseling, and really trying to, we did talk about in our presentation, how do you provide counseling that doesn't compromise the safety or efficacy, of one of the indications of the product. And then lastly, I think that the health systems, like I was saying before, in terms of integration, integrating procurement, integrating M&E, integrating service delivery.

Jessica Bard: And in that same vein, what would you say is next for research on this?

Jessica Rodrigues: A really exciting area is long-acting MPTs, namely injectables and implants, which are in the pipeline. And which are leveraging and building on active pharmaceutical ingredients and current drugs that are available like Cabotegravir, for example. That's just one another is dapivirine And looking at long-acting formulations, because we know that many people do prefer across populations, at least in theory, long-acting products.

And another interesting area is, and a question that we've received frequently by women themselves and by advocates is the combination of HIV treatment. So treatment for HIV, STIs, and contraception. So that's an area that I don't believe is being explored, but it's an area we're hearing quite a lot of questions about in the field.

Jessica Bard: What would you say are the overall take-home messages from our conversation today?

Jessica Rodrigues: The dual prevention pill has a potential to be the first multipurpose technology, excluding the condom to reach people. Therefore it can generate critical lessons for MPTs of the future. And really lay the groundwork for the smoother and faster introduction of other MPTs. And making products more responsive to the whole person. And delivery more convenient and integrated will appeal to a much broader range of people. So in conclusion, I'm really convinced that MPTs has the potential to transform healthcare, not only for women, but for a wide range of populations.