In the world of HIV care, there are few sets of documents more widely respected and universally used than the clinical practice guidelines issued by the U.S. Department of Health and Human Services (HHS).
As the number of HIV treatment options has burgeoned and patient management has democratized well beyond HIV specialists into fields such as primary and family care, the need has only grown for a single, authoritative source of up-to-date clinical guidance. The family of documents referred to colloquially as the HHS guidelines has filled that pivotal need.
HHS maintains more than a dozen HIV medical practice guideline documents, but five sets of guidelines in particular comprise the core of clinical HIV treatment and management wisdom in the U.S.:
- HIV treatment guidelines for adults and adolescents (updated 7/10/19)
- Opportunistic infection prevention and treatment guidelines for HIV-positive adults and adolescents (updated 10/10/19)
- Perinatal HIV prevention guidelines (updated 12/7/18)
- Pediatric HIV treatment guidelines (updated 9/12/19)
- Pediatric opportunistic infection prevention and treatment guidelines (updated 8/29/19)
Here's a rundown of the most recent adjustments made to each of these critically important reference materials.
HIV Treatment Guidelines for Adults and Adolescents
Full title: "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV"
Last updated: July 10, 2019
The U.S. HHS treatment guidelines are authored and revised regularly by a rotating panel of dozens of practicing HIV clinicians, HIV researchers, HHS officials, HIV community members, and expert consultants. They represent the "gold standard" of our accumulated knowledge regarding the optimal approaches to antiretroviral therapy within the U.S.
The most recent update to this document featured adjustments in three areas:
- Gender-affirming care. The guidelines were updated to explicitly call attention to the need for services to improve the continuum of care for transgender and nonbinary patients, including greater awareness of the interplay between HIV, antiretrovirals, and gender-affirming hormonal therapy.
- Substance use. Information has been added to the guidelines regarding the provision of HIV care among people with a substance use disorder, with a particular focus on the relationship between HIV and alcohol; tobacco; benzodiazepines; cannabinoids; stimulants such as cocaine, methamphetamines, and other party drugs; and opioids.
- HIV-2. The guidelines now recommend more aggressive treatment of HIV-2 than had previously been suggested, and they also recommend the use of integrase inhibitor-based therapy in an initial antiretroviral regimen.
Prior to the July 2019 update, the HIV treatment guidelines had been last revised in October 2018. That revision included updated guidance regarding:
- resistance testing
- co-receptor tropism testing
- virologic failure options in treatment-experienced patients
- optimizing antiretroviral therapy in the setting of viral suppression
- the use of dolutegravir (Tivicay, part of the fixed-dose drugs Juluca and Triumeq) in people who are pregnant
- the use of newly approved antiretroviral regimens
Opportunistic Infection Prevention and Treatment Guidelines for HIV-Positive Adults and Adolescents
Full title: "Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV"
Last updated: Oct. 10, 2019
Opportunistic infection (OI) management remains a pivotal component of HIV patient care in the U.S., even in an era replete with highly effective and tolerable antiretroviral treatment options. The HHS OI guidelines are crafted by a panel of dozens of clinical and research experts, divided into groups by infection-specific expertise.
The OI guidelines document itself is divided into more than two dozen sections, each focusing on a discrete infection. As a result, the guidelines tend to be updated frequently, as each individual panel group completes a review of the recommendations regarding its particular section.
Just since April 2019, the OI guidelines have been updated eight times. From most to least recent, here is a brief rundown of those revisions:
- Community-acquired pneumonia. On Oct. 10, this section (which had previously been titled "Bacterial Respiratory Disease") was overhauled, with substantive changes to guidance on risk factors, testing, pathogenesis, and treatment.
- Mycobacterium tuberculosis. On Sept. 27, this section was updated significantly to reflect recent research findings on a range of issues related to tuberculosis treatment and patient management.
- Histoplasmosis. On Sept. 13, this section was revised to include updated guidance regarding prophylaxis cessation, treatment intolerance, and diagnostics.
- Varicella-zoster virus. On Sept. 5, this section received a significant revision, including the addition of recommendations regarding the use of recombinant zoster vaccine (Shingrix) and zoster vaccine live (Zostavax) to prevent herpes zoster in older people living with HIV.
- Immunization scheduling. On Aug. 7, the guidelines were updated to reflect new recommendations from the Advisory Committee on Immunization Practices -- but the panel noted that further updates would soon follow that include information regarding newer vaccines.
- Cryptosporidiosis. On July 16, updated information was added to this section regarding cryptosporidiosis risk, the importance of food and water safety precautions, the efficacy of multiplex molecular testing, and the relative efficacy of therapeutic agents among people living with HIV.
- Microsporidiosis. On June 14, this section was revised with a range of updated information regarding microsporidia epidemiology, pathogenesis, and treatment.
- Terminology and organization. On May 15, the full document was retitled from "Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents" to "Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV," reflecting the growing use of destigmatizing people-first language within the HIV clinical realm. A number of sections within the guidelines were also renamed or re-ordered for greater accuracy and ease of use.
Perinatal HIV Prevention Guidelines
Full title: "Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States"
Last updated: Dec. 7, 2018
The HHS guidelines regarding the prevention of mother-to-child HIV transmission are typically updated once or twice each year. They are updated by a panel of over two dozen experienced clinicians and researchers from across the U.S., including individuals at universities, in private practice, and in the federal government. The guidelines are aimed at further reducing the U.S.'s extremely low perinatal HIV transmission rate while avoiding toxicities and adverse outcomes.
The perinatal HIV prevention guidelines received a substantial update in late 2018 across a number of areas, including:
- extensive information regarding the use of dolutegravir
- updated recommendations regarding other antiretroviral regimens
- HIV testing and risk assessment recommendations for all women and their partners
- CD4 and viral load monitoring suggestions
- additional intrapartum and postpartum recommendations
- specific information regarding management of acute HIV infection and hepatitis C coinfection
Pediatric HIV Treatment Guidelines
Full title: "Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection"
Last updated: Sept. 12, 2019
The HHS guidelines for the treatment of children living with HIV in the U.S. have been updated several times since mid-2018. Taken together, these represent a substantial revision to the recommendations, which are reviewed by a panel of more than two dozen knowledgeable HIV clinicians and researchers located throughout the country.
The most recent update featured several changes related to two specific developments:
- the June 2019 approval of a fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy) for pediatric use
- additional data regarding dolutegravir use in children
Among other adjustments to the recommendations, Biktarvy was added to lists of preferred regimens (for adolescents ages 12 and up weighing at least 25 kg) and alternative regimens (for children ages 6 and up weighing at least 25 kg). Meanwhile, the weight range for the recommendation of dolutegravir plus two NRTIs as an alternative regimen was expanded to include children weighing between 20 and 25 kg.
These adjustments reflect only the latest of a series of changes over the past couple of years to the lists of preferred and alternative regimens, as a range of new data have become available regarding the safety and efficacy of newer antiretrovirals, particularly integrase inhibitors such as dolutegravir and raltegravir (Isentress, part of the fixed-dose drug Dutrebis).
Pediatric Opportunistic Infection Prevention and Treatment Guidelines
Full title: "Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children"
Last updated: Aug. 29, 2019
After being largely left untouched for much of this decade, HHS recommendations regarding the prevention and treatment of opportunistic infections in children have seen a flurry of updates since mid-2018, as the panel (of dozens of experts) shifted to a more modular approach that allowed them to update smaller subsections as needed, rather than complete a comprehensive review of the entire document only once every few years.
That said, most of the changes to these guidelines in 2019 have been relatively minor, focusing on updated information regarding epidemiology, pathogenesis, and testing methodology. The specific sections receiving these updates are:
- cryptosporidiosis (on Aug. 29, 2019)
- cystoisosporiasis, formerly known as isosporiasis (on Feb. 8, 2019)
- giardiasis (on Aug. 22, 2019)
- Mycobacterium avium complex disease (on Jan. 8, 2019)