An influential government task force has drafted a recommendation that would for the first time urge doctors to offer a daily prophylactic pill to patients who are at risk for contracting H.I.V. The recommendation would include all men and women whose sexual behavior, sex partners or drug use place them at high risk of contracting the virus that causes AIDS.
The United States Preventive Services Task Force’s draft recommendation gave an “A” grade, the highest possible, to the regimen, known as PrEP, for pre-exposure prophylaxis. If approved, it would greatly expand access to the $20,000-a-year drug regimen, since most private health plans are required under the Affordable Care Act to cover the full cost of the preventive services recommended by the panel.
“This is definitely fantastic news and validates everything science has been saying all along,” said Dr. Aaron Lord, a physician at New York University School of Medicine who co-founded the PrEP4All Collaboration, which aims to expand access to PrEP for all Americans. “We’ve known this is a very effective medication for quite a while, and feel we could be a lot further along in using it to reduce infections. The potential is absolutely tremendous.”
“When taken daily, there’s very good evidence that the chance of acquiring H.I.V. is essentially zero,” Dr. Lord said.
Dr. Kenneth Mayer, co-chairman and medical research director at the Fenway Institute in Boston, agreed. “This is big news. There is no cure for H.I.V., and there is no vaccine, but we have these medications that can have an effect on the epidemic,” he said. “The data are very clear that PrEP works if you take it.”
Over a million people in the United States are living with H.I.V., and 40,000 new people are infected every year. Yet only a minority of those at risk for H.I.V. in the United States currently use PrEP, according to the Centers for Disease Control and Prevention, which estimates that of 1.2 million Americans eligible for the medication, only about 78,360 people used it in 2016.
The panel’s new draft recommendation reiterated its call for physicians to screen all patients aged 15 to 65 for H.I.V. but, for the first time, also proposed they offer PrEP. Groups at risk include:
Men who have sex with men and who have a sex partner living with H.I.V., or who were recently infected with another sexually transmitted disease, or who do not use condoms consistently;
Sexually active heterosexual men and women whose sex partner is living with H.I.V., or who don’t use condoms consistently with a partner who is at high risk for H.I.V. or whose H.I.V. status is not known, or who recently had syphilis or gonorrhea;
People who inject drugs and share needles or other drug equipment, or whose sexual behavior puts them at risk.
Sex workers and sexually active bisexual men and transgender women and men should also be considered for PrEP, the draft says.
PrEP, a preventive treatment regimen that interferes with viral infection and replication, is a daily pill that contains the drug Truvada, a combination of two medications, tenofovir disoproxil fumarate and emtricitabine (TDF-FTC). (For pregnant women it is a category B drug, meaning no risks are known, though no clinical trials have included pregnant women.)
Consistent use of condoms is also protective against infection and, unlike PrEP, also helps prevent other sexually transmitted illnesses.
Clinical trials that followed participants from four months to four years found PrEP cut the risk of contracting H.I.V. by more than half. But many people forget to take their pill every day and may not have adhered to treatment during those studies. The task force’s draft notes that other analyses find that people who stick to the treatment have higher rates of protection. Public comments are being accepted through Dec. 26.
The regimen does carry a risk of side effects that include gastrointestinal complications, mostly nausea; reversible kidney problems; and bone loss that can lead to fractures. Another concern is that people using antiretroviral drugs like PrEP could acquire or develop a drug-resistant strain of H.I.V. infection.
About 80 percent of new H.I.V. infections occur in men, and men who have sex with men, blacks and Hispanics are disproportionately burdened by the infection. In recent years, H.I.V. rates have increased in young adults in their late 20s, as well as in American Indian/Alaska Native and Asian populations.
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