November 28, 2018, 03:09 pm Chris Crawford – On Nov. 20, the U.S. Preventive Services Task Force (USPSTF) posted draft recommendation statements and evidence reports on screening for and preventing HIV infection.
Based on its review of the evidence on nonpregnant adolescents and adults, as well as pregnant women, the USPSTF recommended that clinicians should routinely screen people ages 15-65 for HIV infection; younger adolescents and older adults at increased risk for infection should also be screened. These are both "A" recommendations.
In addition, the task force recommended that physicians screen all pregnant women for HIV infection, including those who present in labor or at delivery whose HIV status is unknown. This is also an "A" recommendation.
This draft recommendation statement is consistent with the USPSTF's 2013 final recommendation. When that previous recommendation was released, the AAFP issued its own recommendation that differed only on the age (18 instead of 15) at which to initiate routine screening for HIV infection.
Jennifer Frost, M.D., medical director for the AAFP's Health of the Public and Science Division, told AAFP News the Academy recommends screening in low-risk individuals starting at age 18 instead of 15 because of the low prevalence of infection and low rate of new infection in adolescents, as well as the lack of data on the benefits of screening this age group.
In a separate draft recommendation statement, the USPSTF recommended that clinicians offer pre-exposure prophylaxis (PrEP) with effective antiretroviral therapy to patients at high risk of acquiring HIV; an "A" recommendation.
This is the first time the task force has conducted an evidence review regarding PrEP use and issued a statement on this topic.
HIV continues to be a significant public health issue, the USPSTF said in an accompanying news release. And although overall HIV infection rates, including mother-to-baby transmission, have been decreasing, rates among some groups are on the rise -- notably, among people ages 25-29.
According to the task force, screening for HIV is the only way to know whether a patient has been infected with the virus, because after initial flu-like symptoms, HIV infection doesn't cause signs or symptoms for several years.
Current CDC guidelines recommend testing for HIV infection with an antigen/antibody immunoassay approved by the FDA that detects HIV-1 and HIV-2 antibodies and HIV-1 antigen, the draft statement noted, with supplemental testing after a reactive assay to differentiate between HIV-1 and HIV-2 antibodies.
If supplemental testing for HIV-1/HIV-2 antibodies is nonreactive or indeterminate (or if acute HIV infection or recent exposure is suspected or reported), an HIV-1 nucleic acid test is recommended to differentiate acute HIV-1 infection from a false-positive test result, the draft recommendation said.
Antigen/antibody tests for HIV are highly accurate, with reported sensitivities of 99.76 percent to 100 percent and specificities of 99.50 percent to 100 percent, and results are available in two days or less.
Rapid antigen/antibody tests may also be used, but positive results should be confirmed.
"About 40,000 people are diagnosed with HIV each year. This is why the task force, once again, calls for universal screening for HIV in adolescents and adults ages 15 to 65 years and in all pregnant women," said USPSTF member John Epling, M.D., M.S.Ed., in the release. "People deserve to know their HIV status so, if needed, they can start treatment early and live long, healthy lives."
The task force found insufficient evidence to determine appropriate or optimal time intervals or strategies for repeat HIV screening.
"Repeat testing is reasonable for persons known to be at increased risk for HIV infection, such as sexually active men who have sex with men, persons who have a sex partner living with HIV or persons who engage in behaviors that may convey an increased risk of HIV infection, such as injection drug use, commercial sex work or having one or more new (i.e., since a previous HIV test) sex partners of unknown HIV status," said USPSTF members.
The CDC recommends annual screening for patients at increased risk, but clinicians may want to screen more frequently (e.g., every three or six months) depending on the patient's risk factors, prevalence of HIV infection in the community and local policies.
Patients diagnosed with HIV infection need to start treatment as soon as possible to suppress the virus and prevent HIV-related disease. Treatment also reduces the risk of transmission to other people.
For patients at highest risk for HIV, PrEP is an additional preventive strategy that the USPSTF found to be highly effective when the medication is taken daily. It's important for clinicians to support patients taking PrEP to help them follow the daily regimen for maximum protection.
A once-daily oral treatment that combines tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) is the only formulation of PrEP approved by the FDA for use in patients at risk of acquiring HIV infection through sex.
However, the USPSTF said several studies reviewed for this draft recommendation statement found that tenofovir alone was also effective as PrEP, and U.S. Public Health Service (USPHS) guidelines note that, given this trial data, tenofovir alone may be considered as an alternative regimen for high-risk heterosexual men and women and people who inject drugs.
According to its product label, TDF-FTC may be considered for use as PrEP during pregnancy, although no trials involving PrEP have included pregnant women. USPHS guidelines recommend shared decision-making for pregnant women who are considering starting or continuing PrEP during pregnancy.
Overall, the benefits of PrEP far outweigh the possible harms, the task force said, which can include kidney problems and nausea.
"The evidence is clear: When taken as prescribed, PrEP is highly effective at preventing HIV," said USPSTF member Seth Landefeld, M.D., in the release. "To make a difference in the lives of people at high risk for HIV, clinicians need to identify patients who would benefit and offer them PrEP."
The first step in implementing PrEP is to identify patients at high risk of acquiring HIV who may benefit from the medication regimen, the draft recommendation said.
"It is important that clinicians routinely take a sexual and injection drug use history for all their patients. If a person is identified as potentially belonging to a high-risk group, then further discussion can identify behaviors that may make that person an appropriate candidate for PrEP," the authors said.
The CDC provides a complete discussion of implementation considerations for PrEP, including information about baseline and follow-up testing and monitoring, time to achieving protection, and discontinuing PrEP.
The AAFP's Frost said the CDC has recommended prescribing PrEP since 2017, but this is the first time that the USPSTF has considered it.
"Adherence to PrEP is generally high, and side effects are usually well tolerated and improve with time," she said. "Whether or not someone takes PrEP, they should be counseled about other strategies to reduce the risk of HIV, including the consistent use of condoms and sterile needles."
The USPSTF is inviting comments on its draft recommendation statement and draft evidence reviews for nonpregnant adolescents and adults and pregnant women on screening for HIV.
The task force also is accepting comments on its draft recommendation statement and draft evidence review on preventing HIV infection with PrEP.
The public comment window for the draft recommendations is open until 8 p.m. EST on Dec. 26. All comments received will be considered as the USPSTF prepares its final recommendation.
The AAFP will review the task force's draft recommendation statements and supporting evidence and provide comments to the task force. The Academy will release its own recommendations on the topic after the task force finalizes its guidance.
Related AAFP News Coverage
PrEP Your High-risk Patients to Help Protect Them From HIV