December 13, 2013
Each year brings us thousands of new studies on HIV, and thousands of additional developments that change our understanding of how HIV works and how we can most effectively fight it.
But only a handful of these studies and developments have the potential to fundamentally alter some of the basic aspects of the way we prevent, treat and address HIV today.
Join us on a brief tour of the study findings and key moments of 2013 that may have (or have already had) the greatest effect on HIV care in the near future.
For the past 15 years, three HIV drug classes have dominated the treatment scene: NNRTIs (such as Sustiva), NRTIs (such as Viread) and protease inhibitors (such as Reyataz). Although drugs from other classes have been approved (fusion inhibitors, CCR5 inhibitors and the like), when it came to choosing what meds to start HIV treatment with, the answer almost always incorporated drugs from two or all three of these classes.
Then the integrase inhibitors came.
The latest update to the U.S.'s official HIV treatment guidelines was published on Oct. 30; the update solidified the place of this newer drug class as a first-line treatment option that's just as solid as the "big three." Isentress (raltegravir), Tivicay (dolutegravir) and elvitegravir (part of the recently approved all-in-one pill Stribild) are the vanguards of the integrase inhibitor class, which generally has proven to be at least as effective as the most popular drugs from other classes, but with fewer side effect risks on the whole.
To be sure, these drugs aren't perfect -- no HIV meds are -- but the treatment picture in 2013 looks better, with more great options, than it's ever looked before.
As you just read on the previous page, integrase inhibitors are on the rise. Does this mean that the long-standing dominance of Sustiva (efavirenz, Stocrin) -- one of the key drugs in Atripla (efavirenz/tenofovir/FTC) -- is coming to an end?
It's much too soon to count Sustiva out; it remains a very potent drug that works wonderfully for a large number of people. But there's no denying that Sustiva's place at the apex of HIV medication mountain got more shaky this year.
One of the key moments in this evolution may have taken place during a research conference in October, where a study revealed that long-term use of Sustiva appeared to be linked with a higher suicide rate. Although the overall rates of suicide in the study were still extremely low, the finding nonetheless cast a new shadow on a drug that has sometimes been associated with neurological side effects.
It's the Viread (tenofovir) you know and love -- only better!
Viread, one of the most widely used HIV drugs in the U.S., is a component of the once-a-day pills Atripla and Truvada (tenofovir/FTC). It's been around a long time -- since 2001, matter of fact. And although it's generally viewed as one of our "friendlier" HIV medications in terms of side effects, it's far from perfect: Over the years, it's been associated with a number of health issues, particularly bone loss and kidney damage, that can make it a challenge to use for people who are already predisposed to those problems.
This year, we learned about encouraging data regarding a new-and-improved form of Viread called tenofovir alafenamide fumarate, or TAF. Doctors have been buzzing about this drug for a while, but studies in 2013 have re-introduced TAF into the conversation, as their data are beginning to show just how much better its side-effect profile appears to be compared to the "old" Viread.
Long-Acting Antiretroviral Therapy Sensation
When once-a-day HIV medications became commonplace several years back, they revolutionized HIV treatment and helped make taking meds a much less intrusive part of people's daily lives.
Now just imagine what once-a-month HIV medications could do.
That pipe dream may not be so far from reality as it once seemed. This year, we learned much about a couple of "long-acting antiretroviral" candidates in the works. Most notable among these is GSK1265744 -- which, although it may need to be injected, is being engineered so that it only has to be taken once every four weeks at the most.
Early clinical trials involving these drugs have shown promising results. Now, to be sure, it's not a guarantee they'll work out, and many months of study lie ahead before we can even begin to entertain the idea that they'll become a part of regular HIV care. But it sure is an exciting concept to consider, all the more because it may be achievable.
Stop us if you've heard this story before: A virus spreads that causes a chronic condition in humans. Over a span of years, it causes progressive damage that can often result in death. Researchers develop drugs to keep the virus at bay, but at first, the drugs are highly toxic and a major hassle to take. Then, seemingly all at once, a new generation of medications is developed that makes living with the virus manageable.
That is, of course, the story of HIV treatment in a nutshell. And now, thanks to major developments in 2013, it may be the story of hepatitis C virus (HCV) treatment as well.
We've known about HCV about as long as we've known about HIV, but treatments for HCV have been much slower to develop. The standard of care throughout the first decade of this century, peg-interferon plus ribavirin, had a low success rate and was often associated with brutal side effects.
Last year, the U.S. approval of Incivek (telaprevir) and Victrelis (boceprevir) opened a new window on HCV treatment for people with HIV (up to a third of whom also have HCV). This year, the approvals of Olysio (simeprevir) and Sovaldi (sofosbuvir) have ushered in a fresh new breeze of hope.
CD4 Count Rejection
Every few months, HIV-positive people with consistent access to health care get a blood test to measure the number of CD4 cells in their blood. This "CD4 count" is one of the primary means by which a doctor gauges the immune health of a person with HIV. For many years, it's been the key measurement we've used to assess how far a person's HIV disease has progressed.
But is it really as important as we've been treating it?
A major study published earlier this year found that, among people who are on HIV medications and have a suppressed viral load, CD4 counts are extremely unlikely to fall. That calls into question the value of getting a CD4 count taken as often as people tend to have them done.
Now, you might think: If a CD4 count is still valuable info to have, why not keep doing the testing? The answer: cost. The same study estimated that, if a person with a CD4 count over 300 who's on effective HIV treatment only got a CD4 test once a year instead of every few months, it would save the health care system $41,000 per person per year.
At Last, PEP Modernization
It's been eight years -- an eon in the HIV medical world -- since the last time the U.S. updated its official guidelines for post-exposure prophylaxis (PEP), the process an HIV-negative person undergoes when he or she has very recently had a high-risk exposure to HIV.
In that time, we've seen dramatic improvements in HIV treatment, developed a better understanding for how HIV works, and grown more mature and knowledgeable in our strategies regarding how to prevent HIV transmission.
Finally, this year, our PEP guidelines were brought in line with modern medical science. Featuring reasonable recommendations regarding what medications to prescribe, what HIV testing approach to use and what other key considerations to keep in mind, the updated guidelines should finally make this important document worth regularly referring to once again.
Last year at this time, we were embroiled in a debate over pre-exposure prophylaxis (PrEP), the practice of prescribing HIV meds to HIV-negative people before they've even been exposed to the virus. The idea behind PrEP is that a constant flow of antiretrovirals within a person's body would help protect the person against infection if he or she ever becomes exposed.
Although PrEP was approved for use in the U.S. in 2012, questions swirled over who should use it, how effective it truly was, how well people would adhere to the pills, and whether using PrEP would tacitly "encourage" people to have unsafe sex knowing they'd be protected from HIV.
We're now a full year into the PrEP era, and the sky hasn't fallen. PrEP has proven popular among a wide swath of people -- not just gay men, who many presumed would be the primary beneficiaries, but also women, many of whom live in the U.S. South, a region particularly hard-hit by today's HIV epidemic.
Many questions remain regarding this new strategy, but it's clearly shown itself to be a desirable option among motivated groups of people -- no doubt including HIV-negative women in mixed-status, heterosexual relationships who are looking to safely conceive a baby with their HIV-positive partners.
HIV+ Organ Donation
It's sobering to realize the number of ways in which old, outdated information about HIV continues to hurt people living with the virus. For instance, a U.S. law on the books since 1988 had forbidden organ donations from HIV-positive people -- even if those organs were going to end up in other HIV-positive people.
Finally, this year, President Obama signed the HIV Organ Policy Equality (HOPE) Act, which gave health care professionals permission to explore how to safely make use of the organs that HIV-positive people are willing to donate.
This might seem like a minor victory, but keep in mind that a large number of HIV-positive people are in need of transplants (often due to long-term liver or kidney damage), and the number of organs available for donation in the U.S. is always far short of the number needed. This policy change could save many lives.
This also represents one more step taken against HIV stigma, and one more vestige eliminated from an era of fear and ignorance that too often still finds its way into our modern discourse about HIV.
Baby Cure Commotion
Ah, yes. How could we not mention the miracle baby?
Here's the thing: The revelation this past March that an HIV-positive baby apparently had the virus eradicated from its body thanks to aggressive, early treatment is without doubt a big deal. It's an important medical and symbolic milestone in our tireless hunt for a cure.
But the implications for an HIV cure are only part of the story here -- and they're certainly not the most important takeaway from the standpoint of our everyday fight against HIV. Of much more immediate relevance to us is the idea that more aggressive treatment of babies born to HIV-positive women may further reduce the risk of transmission (a risk that is already very low, provided the mom-to-be gets full access to effective treatment and HIV care prior to giving birth).
Also of potentially greater importance are some of the difficult, disturbing questions that this case raises, such as: What flaws exist in our health care system that lead to a woman not being diagnosed with HIV until she's in labor? How does that woman -- and her HIV-positive baby -- end up being completely lost to care not long after the baby is born? How can we do better by the people most in need of good health care in this country?
For More Information
Each of these stories is part of our "Top 10 HIV Clinical Developments of 2013" article written by David Wohl, M.D., and published on TheBodyPRO.com, TheBody.com's sister site for health professionals.
To stay up on the latest, clinically relevant news and research in HIV -- and to access in-depth examinations of other critical issues in HIV care -- stop in at TheBodyPRO.com regularly, and sign up to receive email newsletters and research alerts.