The Centers for Disease Control and Prevention (CDC) on Tuesday released a report that estimates about 1.2 million people in the United States should be on pre-exposure prophylaxis, or PrEP, in order to protect against HIV.
As part of the report, the CDC strongly encouraged primary care providers to provide counseling to populations at high risk of acquiring HIV — including gay and bisexual men — about the possibility of using PrEP as one of many tools to avoid transmission of the virus. The CDC estimates that 1 out of every 4 gay or bisexual men in the United States, or about 492,000 people; almost 1 in 5 intravenous drug users, or 115,000 people; and 1 of every 200 sexually-active heterosexual men and women, or approximately 620,000 people, would benefit from access to PrEP. Those estimates are based on data on various risk behaviors taken from the National Health and Nutrition Examination Survey, the National Survey on Drug Use and Health, and the National Survey of Family Growth.
“CDC has recommended pre-exposure prophylaxis as one of several effective actions for reducing the rate of HIV infections,” Dr. Anne Schuchat, principal deputy director for the CDC, told reporters on a Tuesday afternoon conference call. “When taken daily, PrEP can reduce the risk of sexually-acquired HIV infections by more than 90 percent, and by more than 70 percent among people who inject drugs.”
The CDC currently estimates that about 1 million people in the United States are currently HIV-positive, and that about 40,000 people are newly infected each year, the bulk of whom belong to members of the most at-risk populations.
The regimen for those PrEP consists of a daily pill, taken orally, known as Truvada, which is made from a combination of two antiretroviral drugs and is manufactured by Gilead Sciences. Although PrEP as a form of HIV prevention was approved by the Food & Drug Administration in 2012 and the CDC has established clinical guidelines for its use, a recent unpublished study from this year found that more than a third, or 34 percent, of primary health care providers had never heard of or were unaware of PrEP. Additionally, she said, other doctors may be aware of it, but may be uncomfortable prescribing it. As such, health care providers may need more education to become familiar with the treatment.
“Here’s the bottom line: Doctors need more prep about PrEP,” Schuchat said. She added that the CDC is recommending that PrEP be used in conjunction with other prevention methods, such as: HIV testing, to determine people’s serostatus and get those who are HIV-positive into treatment; medication for those who are HIV-positive, in order to achieve viral suppression, which reduces the risk of transmitting the virus to others; correct and consistent use of condoms; and the use of sterile injection equipment or clean needles by intravenous drug users.
When taken consistently, Schuchat said, PrEP is “highly effective” in preventing HIV infection. While using the medication inconsistently leads to much lower levels of protection, she also noted that so far studies have not shown that those who are less compliant on PrEP develop resistance.
Dr. Jonathan Mermin, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, stressed to reporters that Truvada as PrEP is intended for adults who do not have HIV, but particularly those who meet several risk factors. Such populations include sexually active adults with an HIV-positive partner; gay and bisexual men who are not in a monogamous relationship with a partner who has recently tested negative for HIV; gay and bisexual men who don’t use condoms regularly or have been diagnosed recently with another STD (as this makes it easier to contract HIV); intravenous drug users, and heterosexual men and women who are lax in using condoms consistently, particularly those who engage in unrpotected sex with bisexual men or known IV drug users.
Mermin also re-emphasized that PrEP is just one of many tools or methods that can be used to prevent the spread of HIV. For instance, he noted, treating those who are HIV-positive with antiretrovirals until they achieve viral suppression — also known as “undetectable” status — is effective in preventing transmission, but recent studies indicate that only 30 percent of HIV-positive people have successfully achieved viral suppression. Studies also indicate that other methods, such as the use of clean needles by drug users or condoms for sex, are not always used consistently.
“PrEP can fill an important gap, but to fill that gap, we must achieve greater awareness among clinicians, and help them connect PrEP to the people who could most benefit from it.”
In response to reporters’ questions, Schuchat noted that the biggest side effect of Truvada is its effect on the kidneys, which is why the CDC recommends that people taking Truvada as PrEP get tested every few months to check that their kidneys are functioning properly and their body is tolerating the medication. She also noted that the cost of Truvada as PrEP can cost up to $10,000 a year, but said that there are “other negotiating tools” — such as various drug assistance programs — that make it more affordable. She added that Medicaid and most private insurers do cover the drug, though some may require pre-approval.
“There are some examples of PrEP programs that have had high access for the people who need the medication,” added Mermin. “For example, in Seattle, where it’s one of the priority HIV-prevention tools, a program providing PrEP found that less than 1 percent of patients needed to pay for co-pays for the medication itself.
“The science clearly calls out that PrEP works,” said Mermin. “In addition, the lives of Americans are too important not to get PrEP to those who really need it.”