The International Antiviral Society-USA released updated guidelines today for the treatment and prevention of HIV, outlining new findings, regimens, approaches and data.
“We continue to see great progress in HIV treatments that are potent, convenient and safe,” said Paul Volberding, MD, Infectious Disease News Chief Medical Editor and director of the AIDS Research Institute at the University of California, San Francisco. “[And we see] amazing data that treatments are controlling new infections, giving hope for the ‘getting to zero’ efforts.”
The new recommendations, drafted by a panel of experts, update guidance published in 2016. They focus on adults aged 18 years or older with or at risk for HIV infection with access to most antiretroviral drugs. Volberding, who is also chair of the board of directors of IAS-USA and a senior author of the guidelines, noted that the new guidelines recommend beginning treatment as soon as possible after diagnosis and using integrase inhibitors for initial treatment.
“It has been well-established that all patients diagnosed with HIV infection should receive antiretroviral therapy (ART) as soon as possible, with very few exceptions,” James Riddell IV, MD, professor of infectious diseases at the University of Michigan Medical Center, wrote in a related editorial. “In these updated guidelines, this concept is developed further to support immediate treatment when feasible.”
Riddell explained that this recommendation is based on studies from the United States and elsewhere showing the benefits of prompt ART initiation, including positive effects on viral suppression and linkage to care.
“Based on these studies and others, the time at which ART is recommended to be started has become as soon as is feasible based on availability of medication without waiting for results of supporting laboratory tests, including resistance testing,” he wrote.
Recommendations for initial treatment have changed based on the availability of new, high-potency, single-tablet ART regimens, Riddell noted. Now, integrase single-strand transfer inhibitors (INSTIs) combined with two nucleoside reverse transcriptase inhibitors are preferred in most circumstances, he said.
The FDA issued a safety alert in May warning patients and providers of the potential risk for neural tube defects in babies born to women who received the INSTI dolutegravir early in their pregnancy. The FDA said there is no evidence that starting dolutegravir later in pregnancy would result in these defects.
“The guidelines note the new data suggesting a link between dolutegravir and neural tube defects in infants born to mothers receiving the drug during pregnancy,” Voldberding said. “It’s very new and not yet confirmed.”
Michael S. Saag
Other updates suggest expanding alternatives for pre-exposure prophylaxis (PrEP), explained Michael S. Saag, MD, director of the University of Alabama at Birmingham’s Center for AIDS Research, and lead author of the guidelines. This includes so-called “on-demand” PrEP for men who have sex with men who have infrequent sexual exposures. In a “2-1-1” dosing approach, they can take two ART pills before exposure, followed by one pill daily for 2 days after exposure.
Saag said one of the biggest changes to the guidelines is the discontinuation of testing for CD4 cell counts in certain patients.
“I think the major changes are the recommendation to stop checking CD4 counts in those patients who have achieved and maintained a viral load suppression for 1 year and have CD4 count values less than 250 cells/µl,” he told Infectious Disease News.
Riddell called the guidelines “a starting point, as evidenced by the fact that implementation has proved to be much more challenging.”
“It is now clear that to effectively address the HIV epidemic, a multipronged approach is needed that includes new HIV prevention strategies, expanded HIV testing, rapid and immediate linkage to care when possible, viral suppression for persons who are HIV infected, and strategies to enhance adherence to therapy and retention in care,” Riddell wrote. – by Caitlyn Stulpin
Disclosures: Riddell reports no relevant financial disclosures. Saag reports receiving research support and acting as a scientific advisor to Gilead, Merck and ViiV. Volberding reports receiving personal fees from Merck. Please see the study for all other authors’ relevant financial disclosures.