Updated HIV Guidelines Integrate Treatment and Prevention for the First Time

By Megan Brooks

July 13, 2016

NEW YORK (Reuters Health) - Updated recommendations from the International Antiviral Society-USA panel on antiretroviral (ARV) drug therapy for HIV infection integrate treatment and prevention for the first time.

"This reflects the emergence of data over the past decade from 10 efficacy trials regarding the use of antiretrovirals for preexposure prophylaxis (PrEP), which was found to be highly effective in protecting diverse populations at risk of HIV, including men who have sex with men, younger heterosexuals, and injecting drug users," note the authors of an editorial published with the new guidelines today in JAMA.

In an interview with Reuters Health, guideline author Dr. Paul Volberding from University of California San Francisco said the guidelines are revised every couple of years and there is always a conversation about whether there has been enough new data to warrant new guidelines. "But we thought that this is really the time to say we aren't just talking about treatment, we are talking about prevention," he said.

There is strong evidence that there is "no transmission in people who are on suppressive therapy so we see this as really settling in as the amazing benefits of treatment and the same benefits now in the field of prevention. That alone was a strong part of why we decided to go forward with the update," Dr. Volberding said.

"But also in terms of treatment, the gains in the last two years in simplifying and reducing the side effects of treatment are also really astounding," he added. "We have more and more combinations of drugs available in one or at most two pills a day. We've managed to get rid of almost all the side effects that bothered us in the past and the treatments are so potent that we see really very few cases of drug resistance anymore. So a lot of the things that were real challenges until fairly recently are now pretty well dealt with," Dr. Volberding said.

"I think in two years we might have another conversation about whether we should do another revision but I think this time there was no question that this is an important moment," he added.

The guidelines state that newer data support the "widely accepted" recommendation to initiate ARV therapy in all people with HIV infection with detectable viremia regardless of CD4 cell count.

They say optimal initial regimens for most patients are two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). "The integrase inhibitors have risen to the top and stand by themselves really as obvious components of treatment," Dr. Volberding told Reuters Health.

"The reason InSTIs have moved into a key position as first-line therapy is because these drugs have been shown to be highly effective, with the highest and most rapid rates of virologic suppression compared with protease inhibitors and nonnucleoside reverse transcriptase inhibitors, which previously had been mainstays of the antiretroviral 'cocktail,'" write editorialists Dr. Kenneth Mayer and Dr. Douglas Krakower, of Fenway Health in Boston, Massachusetts. "Moreover, InSTIs are extremely well tolerated and several are coformulated with nucleoside analogs, allowing for potent, well-tolerated treatment to be delivered as a single pill taken once a day."

Other effective regimens include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with two NRTIs, the guidelines say.

The guidelines provide recommendations for special populations such as pregnant women and in the settings of opportunistic infections and concomitant conditions such as hepatitis B or C coinfection.

They recommend laboratory assessments before treatment, and monitoring during treatment to assess response, adverse effects, and adherence. The guidelines provide advice on how and when to switch ARV regimens and say reasons for switching therapy include convenience, tolerability, simplification, anticipation of potential new drug interactions, pregnancy or plans for pregnancy, elimination of food restrictions, virologic failure, or drug toxicities.

The guidelines encourage PrEP with daily tenofovir disoproxil fumarate/emtricitabine to prevent HIV infection in individuals at high risk. When indicated, postexposure prophylaxis should be started as soon as possible after exposure.

Drs. Mayer and Krakower say the "Achilles heel of PrEP has been medication adherence and next-generation PrEP studies of long-acting injectable and infusible approaches that may offer alternatives to daily pill use are under way."

"Nonetheless, the recognition by the IAS-USA panel that treatment and prevention can be achieved using antiretrovirals is important. Clinicians who take care of people living with HIV should become local experts regarding biobehavioral HIV prevention, especially because they may be taking care of partners of HIV-infected people. A challenge for effective HIV prevention will be to educate and engage primary care clinicians who do not see themselves as specialists in this realm, because they may be taking care of patients who may benefit from PrEP," they write.

"The current IAS-USA guidelines reflect the hard-won success of 35 years of clinical research," Drs. Mayer and Krakower add.

"Although challenges remain to optimize the cascade of care and to prevent new infections, and an aging epidemic will present new challenges, these concerns reflect the successes of highly effective antiretroviral therapy. Historians may wonder whether the pace of discovery in the early days of the epidemic could have been accelerated, but no one can doubt the signal accomplishments of biobehavioral research and community engagement in forging a common strategy to deal with this global pandemic, one that continues to pose new challenges," they conclude.

SOURCE: http://bit.ly/29MZVvm and http://bit.ly/29tCHvW

JAMA 2016.


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