What Does 2015 Hold in Store for HIV Research?

Executive Editor
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While current HIV treatment allows patients to live long, healthy lives, there are still concerns over tolerability, adherence and general quality of life. We also continue to see new infections, despite prevention efforts. Therefore, we asked some of the leading HIV experts what research they're most looking forward to over the next year.

David Wohl, M.D.

Dr. Wohl is an associate professor of medicine at the University of North Carolina School of Medicine and the co-director of HIV services at the North Carolina Department of Corrections.

I think you're going to see more of the long-acting [injectables]. I think you're going to see the battles over hepatitis C, and how we treat hepatitis C, for coinfected and non-coinfected [patients].

I think we're going to be treating people but it's going to be the whole: What are the restrictions? If I drink alcohol, why can't I get therapy and get cured? Are the restrictions going to be too restrictive?

And then there's going to be all new therapies. And how does the marketplace deal with that? And what happens with the pricing? It's obviously not clear-cut, so I think the hepatitis C thing is a big deal.

I'm really into the single-tablet regimens. I think coformulation helps. And I think that we have a cobicistat/darunavir, and eventually maybe a cobicistat/darunavir/TAF mega combination that does almost all things to all people.

I think TAF [tenofovir alafenamide] will be really great because the nucleoside/nucleotide family that we've been living with for so long just hasn't kept up with our expectations.

Sharon Dian Lee, M.D.

Dr. Lee is an assistant clinical professor of medicine at the University of Kansas and the founder and director of Southwest Boulevard Family Health Care.

More about nucleoside-free treatment options. I look forward to having more treatment choices that are focused on viral mechanisms and have fewer interactions with human enzymes/metabolism. Also, additional pre-exposure prophylaxis [PrEP] options will be forthcoming.

Henry Masur, M.D.

Dr. Masur is a clinical professor of medicine at George Washington University and chief of the Critical Care Medicine Department at the NIH Clinical Center.

There are many issues inherent to operational research, in terms of what's effective for changing behavior, what's effective for getting people onto therapy. In terms of HIV research, I think we're all fascinated by the potential to cure HIV. There's so little that is promising in terms of data. The clinical arena is a little bit disappointing. Yet we're understanding more about reservoirs; we're understanding more about drugs that might be able to eradicate this retrovirus. So what I'm looking for in the next few years is both animal and human data on how we might be able to get closer to not suppressing HIV, but actually curing it.

Paul Sax, M.D.

Dr. Sax is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.

Well, it will be interesting to see what happens with two-drug maintenance therapy, in general, and in particular with cabotegravir [CAB, GSK1265744] and rilpivirine [Edurant], whether it's as a single, tiny little pill, or it's as an injectable -- if that premise works out. It could really give patients and providers a lot to think about. Whether that's the right approach, we'll see.

[In terms of injectable HIV drugs], as initial treatments, we're not even close. But as a way of maintaining virologic suppression, I do think there will be a subset of patients who will really prefer that it be taken out of their hands, that they're tired of taking pills, that they're not good at taking pills. But if you said to them, "We can give you an injection once a month, or once every two months, and have someone come to your house and do it for you, or have just a community center that you can get it," then they're going to offer that. And that would be very much a change in what we've done.

Michael Saag, M.D.

Dr. Saag is a physician and HIV researcher at the University of Alabama at Birmingham.

What's happening inside the cell at the molecular level that inflammation is either inducing, or is causing the inflammation itself? We need to just dive deep, because otherwise we aren't going to have targeted therapies for these types of disorders. And it transcends HIV, or even hepatitis. It's for all of us as we age. Inflammation is a driving common factor. And if we can understand inflammation better at a molecular level, I think we can start finding targeted therapies to combat that.

Jen Kates, Ph.D.

Dr. Kates is vice president and director of Global Health Policy and HIV at the Kaiser Family Foundation.

There is much to anticipate in a variety of areas, but one that I am particularly anticipating is emerging data on the role and effect of the Affordable Care Act on access to health insurance coverage for people with HIV in the U.S. With almost one year of experience behind us and the next open enrollment just ahead, we will soon be able to examine its impact.

How many people with HIV have gained new coverage? Where do barriers still exist? How are state decisions about Medicaid expansion affecting coverage?

We have baseline data on some of these questions and going forward, it will be important to assess how coverage is changing.

Kenneth Mayer, M.D.

Dr. Mayer is a professor of medicine and community health at Brown University and an attending infectious disease physician at Miriam Hospital.

In the next year or so the biggies are that there's a tiebreaker vaginal microbicide that's called the FACTS 001 study. So, if the FACTS 001 study shows efficacy, even if it's not a total home run, it will lead towards a path towards licensure of the vaginal gel. If there's compelling data that gel can make a difference in the epidemic, you might see rapid uptake of gel.

The implication of that may be that some of the work in rectal microbicides will move more quickly, as well, because you'll have proof of concept. On the flip side, if the study is negative because of poor adherence, it may be harder to convince people to do studies of rectal microbicides.

And then the other biggie for women is the whole issue of vaginal rings. There are two studies now that are efficacy trials going on. If both studies show consistent data, you might have then a ring formulation. The reason why that's particularly relevant is that there already are hormonal contraceptive rings so the vaginal ring would have immediate implications for men who have sex with men, or people who engage in anal intercourse.

But the idea that you could co-formulate preventive technology, where you could have one ring that could be only hormonal contraception; the same looking ring could have hormonal contraception and anti-HIV protection; and a third could be only anti-HIV protection alone. And that might destigmatize women going in for family planning and being able to get the right ring. So I think those are biggies in terms of the field of HIV prevention.

Theo Katsivas, M.D.

Dr. Katsivas is an associate physician at the Owen Clinic at the University of California, San Diego.

It would be interesting to see treatment that would be available with less, smaller pill burdens. Possible injectable, possible long-acting [treatment] -- those are very promising initial research that we've heard about.

Then also the ability of doing point-of-care testing for HIV, and identifying more cases. I'm really focusing on testing because the people that we're really treating we tend to treat really well. Once someone gets to clinic, gets clinical care and gets connected to clinical care, I think they fare very well. But the problem is getting people into treatment.

The other possibility is to use treatment as prevention -- the concept of PrEP. And there's controversies regarding that. I share the concerns of some of my colleagues, claiming that this could lead into increase in STDs [sexually transmitted diseases], liberalization of sexual behavior, less use of condoms, and might actually drive rates higher up for other STDs as well as HIV. It's a concern. But I think overall getting people in treatment will have a positive effect.

Pablo Tebas, M.D.

Dr. Tebas is an associate professor of medicine at the University of Pennsylvania School of Medicine and principal investigator in the AIDS Clinical Trials Unit (ACTU) at the University of Pennsylvania.

I'm very excited about neutralizing antibodies, in both prevention and therapeutics. I think they are going to change the way we approach this disease. I am very excited also about implementation of PrEP in the community, and implementation of hepatitis C treatment in the community, both in the hepatitis C monoinfected, and HIV infected. I think those will be the big themes over the next year. It's going to be how we deliver what we know now about PrEP and hepatitis C treatment, and then how these new classes of antibodies, as we're understanding how they fit in our prevention efforts, and how they fit in our therapeutic efforts.

Roy Gulick, M.D.

Dr. Gulick is a professor of medicine and chief of the Division of Infectious Diseases at Weill Medical College of Cornell University, and an attending physician at the New York Presbyterian Hospital in New York City.

One interesting investigational drug is cabotegravir, which is the injectable integrase inhibitor that you only have to dose every three months. And so we are expecting to see some phase-2 data on that compound in prevention, as well as treatment, in combination with the injectable rilpivirine. If we really had two long-acting injectables, that could be a strategy, both for treatment and, importantly, for prevention. So I'm interested in that.