What 2014 Development Has the Biggest Impact on HIV Care?

Executive Editor
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Each year we see new developments in HIV that improve the lives of those living with the disease and make it easier for providers to care for patients. We asked some of the leading HIV experts what development this year would have the biggest impact on HIV care.

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.

Two different things, in particular, both of them kind of getting away from having to use tenofovir (Viread) or abacavir (Ziagen). One of them is the OLE and the SALT studies, which show that you can maintain virologic suppression with a boosted protease inhibitor plus lamivudine (3TC, Epivir).

And the other is the recent press release on the results of the phase-3 TAF studies, because the results, at least in preliminary form, look outstanding and show that it probably offers safety benefits that are real.

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 the whole concept of long-acting injectable HIV medicine is something that will echo and resonate for years to come. And it was this year that I think people really started to appreciate that: (a) There are long-acting injectable agents being developed; (b) That they've been studied now in phase-2 trials and look actually really good, and we're going to see some data not too long from now, phase 3.

So whether we use it for pre-exposure prophylaxis (PrEP) or we use it for antiretroviral therapy for people living with HIV, I think the seed was planted this year and it's now on people's radar. A year ago people wouldn't even have known what I was talking about if I talked about injecting HIV medicines every two to three months.

Jen Kates, Ph.D.

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

I think two recent developments that show the power of antiretrovirals are together having the biggest impact. The first being treatment as prevention (TasP) and HPTN 052 confirming what many working in the HIV field have long believed to be the case -- that antiretrovirals significantly reduce the risk of HIV transmission to a negative partner, underscoring the importance of achieving viral suppression.

This lights a fire under the imperative to get more people with HIV on treatment, which of course is a goal in and of itself for the health of those who are positive. But HPTN 052 showed why this should be a goal for helping to reach the tipping point in the epidemic. This is perhaps the most far-reaching finding we’ve had in a long time.

The second is pre-exposure prophylaxis (PrEP), not just because of the powerful clinical trial results showing PrEP efficacy and the recent follow-up studies on effectiveness, but because it functions at the critical juncture of behavior and biomedical intervention. And PrEP has the power to alter how HIV is experienced in the lives of those at high risk, particularly gay and bisexual men.

Our recent national survey of U.S. gay and bisexual men on HIV, however, showed that there is a lot of awareness-raising that needs to happen about both TasP and PrEP. Only about a quarter of gay and bisexual men knew about TasP or PrEP.

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.

The concept of monthly injections of antiretrovirals will have a huge impact on HIV treatment. I am not clear [how] the projected timeline fits into 2015, but not too far in the future. Otherwise, the additional choices for a one- or two-pill regimen once daily are great.

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.

I think hepatitis C treatment, the fact that we already have single drugs that are highly potent and now we have the ledipasvir and sofosbuvir (Sovaldi) coformulation -- so you already have the beginnings of HAART-like regimens for hepatitis C, and the ability to cure hepatitis C. So I think it's a major development because the costs are so high, but the opportunity is so great to really have a huge impact on the hepatitis C epidemic.

I think the progression in terms of the way people are responding to PrEP is a big deal as well, where initially they was so much hostility. There's a sort of sensible middle ground now, of people in the community who really don't like to use condoms beginning to understand what PrEP offers them, and clinicians starting to get more informed. So I think the numbers of PrEP users have gone up. There's not one new finding in the past year, but I think that's a big sea change I've noticed.

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.

The approval of dolutegravir (Tivicay, DTG) is a major advance in the field, as the first integrase inhibitor that's highly potent, is given once a day and doesn't require a booster. Dolutegravir was approved on the basis of studies where it challenged some of our top-recommended regimens, and head-to-head with efavirenz (Sustiva, Stocrin) it was significantly better, in terms of virologic response. And head-to-head versus darunavir (Prezista), same result. So this is the first time we really had a new agent that's challenged the agents we've been using for years and actually was superior in the primary endpoint.

Lisa Fitzpatrick, M.D., M.P.H.

Dr. Fitzpatrick is a professorial lecturer for the George Washington University School of Pubic Health, and an adjunct faculty member in the Howard University College of Medicine.

The U.S. Preventive Services Task Force's recommendation shift on routine testing and the ACA focus on preventive services, because these have incited a shift in how insurance companies consider reimbursement for screening. It's another step to help us eliminate perceived barriers to routine screening.

Theo Katsivas, M.D.

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

I think we have great treatment. The problem is not really treatment efficacy. The problem is treatment availability and uptick. So that's going to be the battle in the following years. Get many people on treatment, as many as we can, and then also expand treatment to prophylaxis, as has been suggested.

There are a lot of barriers to that. It feels sometimes defeating, working in the clinic and being a clinician, where you see really only the people that come to clinic regularly -- what we call engaged in care. But really, studies have shown that 60% or more of people are not really engaged in care. And these are the people I cannot work with. And I would like to work with these people.

This work that we did here and we're presenting is one step toward getting to that by testing, and by expanding testing opportunities for people. Unfortunately, even our medical students don't seem to know, or to be very much aware, of the guidelines for universal testing. And these are the doctors of the future. That's going to be an issue that needs to be addressed. So, expand testing opportunities, expand treatment opportunities, and make treatment available for many more people within the U.S., let alone worldwide.

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.

Hepatitis C coinfection is a very significant problem in the HIV-infected population, particularly in some areas of the country, and in some particular age groups. And the treatment for hepatitis C has changed dramatically in the last few months. We are approving new drugs. That's going to affect, I would say, 30% to 40% of HIV-infected patients that have coinfection. We have treatments now that can cure hepatitis C. That's going to be huge.

And, of course, the other thing that has been very important in the last year has been all the focus on trying to cure and eradicate HIV where, naturally, we are not in any way closer to a cure for everybody. But it's an advancement. Like we're talking now about hepatitis C treatment, it's going to change everything. Maybe in a few years we will be talking about how to cure HIV. That will be the way that we will be talking in a few years. But we're not there yet.

If you had asked me this question a few years ago I would have said, "No, we're never going to cure HIV." And now I will say, not cure, in the sense of a sterilizing cure, removing every single copy of the HIV genome, but I think we will see treatments that will allow people not to have to take medicines and, yes, be controlled and not be infectious. I think I will see it before I end my career.

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.

Over the next few years, what I'm looking for as having the greatest impact in the United States and worldwide are efforts to operationalize antiretroviral therapies. There has been more and more attention to have few patients that are actually on effective antiretroviral therapy, despite the fact that many patients know they have HIV, and many patients -- not all, unfortunately -- have options to receive care; and yet they don't consistently stay in care, and they're not virally suppressed.

I think we understand how to monitor populations better. We are understanding how to develop and fund programs that link people to care. I think that's going to have the most impact.

In the world of research, understanding prevention better, developing longer-term antiretroviral agents that could be preventive, I think could have an impact. But getting people who are infected onto therapy and developing prevention messages which resonate with the at-risk population of people, the younger people -- that, I think is going to have a large impact, in addition to getting people who are known infected onto therapy.

Michael Saag, M.D.

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

Well, clearly, the heaviest impacts are going to be the release of more and more direct-acting agents for hepatitis C, one better than the other. Just Oct. 10, ledipasvir was released, an NS5A inhibitor. When you combine that with sofosbuvir (Sovaldi)or other agents, you're going to get 95% to 100% cure rates for a lot of genotype-1 people.

But that's just the beginning. That's the tip of the iceberg. There's going to be many more drugs coming. And my hope is, for the coming year, that we'll find some degree of microeconomics at play, where there's competition and that leads to lower pricing. It will be a really interesting test to see if that plays out.The real need in HIV now is really just a lot of implementation. We have enough tools to bring this under control; it's really a question of case finding, linkage, retention in care, getting people on treatment and keeping them on treatment.

As far as new drugs, there's not nearly the type of revolution there used to be. But there are several. Paul Sax talked about that. But I think that really our stress is going to be in doing our job better, in terms of reaching out to communities of people at risk, getting them tested, getting them into care, and keeping them in it.