NIH Ends Support for HIV Clinical Guidelines


The National Institutes of Health (NIH) intends to discontinue its support for federal HIV clinical guidelines by next summer, according to a memo from the NIH Office of AIDS Research (OAR). It is not yet clear whether maintenance of the guidelines will be taken over by another government agency.

“In the climate of budget decreases and revised priorities, OAR is beginning to explore options to transfer management of the guidelines to another agency within the U.S. Department of Health and Human Services,” the memo, sent to current guidelines panel members, reads in part.

Developed by a panel of volunteer medical experts and community members, the guidelines are “living documents” that are updated frequently to incorporate new findings from clinical trials and real-world experience. Many clinicians who treat people with HIV consider the U.S. federal guidelines the definitive source for timely information about treatment and care. The guidance is especially important for primary care providers who don’t specialize in HIV.

“Hundreds of thousands of clinicians have counted on the federal HIV guidelines to deliver high-quality HIV care and treatment for more than 30 years. The decision by the National Institutes of Health to stop supporting the guidelines will hurt people with HIV,” HIV Medicine Association chair Colleen Kelley, MD, MPH, said in a statement. “At a time when all facets of the HIV prevention, treatment, research and public health infrastructure are under attack, the unbiased, expert clinical guidance provided by the guidelines is needed more than ever.” 

The motivation for ending NIH support for the guidelines is unclear, as maintaining the information is a trivial expense in the massive federal budget. The expert panelists are unpaid and the cost of providing administrative and technical support for the work is only a small budget line item.

The letter sent to panel members did not specify whether or how the clinical guidelines might change, stating, “Together, we now have an opportunity to develop a proactive, careful transition plan for each panel,” the Washington Post first reported.

The clinical guidelines, available at HIV.gov, provide detailed recommendations about antiretroviral treatment and care for adults and adolescents, children and pregnant women as well as the prevention and treatment of opportunistic infections.

As Paul Sax, MD, of Brigham and Women’s Hospital, noted in his New England Journal of Medicine Journal Watch column, the federal guidelines provided the first recommendation for opportunistic infection prophylaxis before the advent of effective antiretrovirals, the first perinatal guidelines after the ACTG 076 trial showed that AZT prevents mother-to-child HIV transmission and the first antiretroviral guidance incorporating modern combination therapy in the mid-1990s.

“What impressed me most was the care, rigor and collegiality of the process,” wrote Sax, who served on the HIV treatment panel from 2008 to 2016 and contributed to the opportunistic infection guidelines. “Every recommendation was debated, refined and re-reviewed, always with the goal of helping clinicians deliver the best possible care.”

Coming amid a dramatic restructuring of federal health agencies under Secretary of Health and Human Services Robert F. Kennedy Jr., the move calls into question the government’s continued commitment to HIV/AIDS. Kennedy has previously questioned whether HIV is the cause of AIDS and has suggested that the government should take a break from infectious diseases in favor of chronic conditions.  

But as people living with HIV and their clinicians well know, infectious and chronic diseases are intertwined. As HIV treatment has evolved, the federal guidelines have expanded beyond recommendations for antiretroviral therapy and now include extensive information about managing chronic conditions, such as cardiovascular disease, in the aging HIV population.

Other Guidelines

Fortunately, even as NIH withdraws its support for the Department of Health and Human Services guidelines, other good resources are available.

The International Antiviral Society-USA (IAS-USA) offers its own guidelines and recommendations. Drawing on the same pool of experts that develops the federal guidelines, the IAS-USA guidance is similar in most respects. (Sax, in fact, is now part of the IAS-USA guidelines group.)

Other countries also provide national guidelines. The British HIV Association, for example, offers comprehensive care and treatment recommendations. Here, too, the guidance is generally similar, although there is sometimes a lag in adding new antiretrovirals that are approved first in the United States.

The World Health Organization (WHO) also develops guidelines for HIV prevention, treatment and care. Intended to be relevant for low- and middle-income countries, the WHO guidelines place more emphasis on service delivery and the cost and availability of HIV medications.

Clinicians and advocates expressed dismay about the NIH ending its support for the federal guidelines, but relying on U.S. government resources is fraught in the current political climate. While the expertise and intentions of the panel members are not in question, government officials can slant or change the guidance to reflect administration biases and priorities, as seen with the removal of information about and recommendations for transgender people—one of the groups at highest risk for HIV.

Click here for more news about federal funding for HIV.






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