CDC Recommends PrEP Truvada "CDC recommends that PrEP is indicated for people who do not have HIV and are at substantial risk for HIV"
NY Times: "Officials at the Centers for Disease Control and Prevention have long been frustrated that the number of H.I.V. infections in the United States has barely changed in a decade, stubbornly holding at 50,000 a year, despite 30 years of official advice to rely on condoms to block transmission...... Although there is no guarantee that gay men will adopt the drug regimen, federal officials say something must be done because condom use is going down. In a C.D.C. survey in November, the number of gay men reporting recent unprotected sex rose nearly 20 percent from 2005 to 2011."
CDC Link - PrEP for HIV Prevention -
If you think you are at risk of getting HIV, ask your health care provider if PrEP is right for you. Along with other prevention methods like condoms, PrEP can offer good protection against HIV if taken every day.
Pre-exposure prophylaxis, or PrEP, is a way for people who don't have HIV to prevent HIV infection by taking a pill every day. The pill contains two medicines that are also used to treat HIV. If you take PrEP and are exposed to HIV through sex or injection drug use, these medicines can work to keep the virus from taking hold in your body.
In several studies of PrEP, the risk of getting HIV infection was lower-up to 92% lower-for participants who took the medicines consistently than for those who didn't take the medicines. PrEP does not work nearly as well if it is not taken daily.
For those who are sexually active, no prevention strategy is 100% effective, but PrEP can be combined with other HIV prevention methods to provide even greater protection than when used alone. These include:
· Using condoms consistently and correctly.
· Getting HIV testing with your partners.
· Getting STD testing with your partners.
· Choosing less risky sexual behaviors, such as oral sex.
· If you inject drugs, participating in a drug treatment program or using sterile injection equipment.
Who Should Consider Taking PrEP?
CDC recommends that PrEP is indicated for people who do not have HIV and are at substantial risk for HIV.
For sexual transmission, this includes anyone who is in an ongoing relationship with a partner who has HIV. It also includes anyone who 1) is not in a mutually monogamous* relationship with a partner who recently tested HIV-negative, and 2) is
· a gay or bisexual man who has had anal sex without a condom or been diagnosed with an STD in the past 6 months; or
· a heterosexual man or woman who does not regularly use condoms during sex with partners of unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or have bisexual male partners).
For people who inject drugs, this includes those who have injected illicit drugs in the past 6 months and who have shared injection equipment or been in drug treatment for injection drug use in the past 6 months.
For heterosexual couples where one partner has HIV and the other does not, PrEP can help protect the uninfected partner during conception and pregnancy.
People who use PrEP must take the drug every day and return to their provider every 3 months for a repeat HIV test, prescription refills, and follow-up.
Some people on PrEP have side effects like an upset stomach or loss of appetite but these are mild and usually go away in the first month.
PrEP is only for people who are at ongoing substantial risk of HIV infection. For people who need to prevent HIV after a single high-risk event of potential HIV exposure-such as sex without a condom, needle-sharing injection drug use, or sexual assault-there is another option called postexposure prophylaxis, or PEP. PEP must begin within 72 hours of exposure. See our PEP Q&A for more information.
* Mutually monogamous means that you and your partner only have sex with each other and do not have sex outside the relationship.
What Can You Do?
· Ask your health care provider about PrEP if you are HIV-negative and at substantial risk of getting HIV.
· If you are precribed PrEP, take your medicine every day, report any side effects to your provider, and return for follow-up visits and HIV testing every 3 months.
· If you are on PrEP, remember that the more prevention options you choose, the greater your protection. Using condoms, for example, not only adds to your HIV protection but can also prevent other STDs. See our Prevention Q&As for more prevention options.
What Can Health Care Providers Do?
Providers play a central role in increasing awareness and uptake of PrEP. They can:
· Prescribe PrEP to those patients with indications for its use.
· Use the guidelines and providers' supplement to get information about counseling patients who use PrEP about adherence and HIV risk reduction, including condom use.
· Regularly monitor HIV infection status, side effects, adherence and sexual or injection risk behaviors for patients being prescribed PrEP.
What Will CDC Do?
CDC will lead efforts to support PrEP research, uptake, and delivery by:
· Supporting provider and user awareness and education through the new guidelines and a providers' supplement, which includes information sheets and checklists.
· Implementing a pilot study examining practical requirements, costs, and impact of PrEP at four federally qualified health centers.
· Supporting state and local health departments through webinars and program guidance on using CDC funds for PrEP support activities.
· Conducting research on PrEP use and effectiveness.
What Can HIV Prevention Partners Do?
· Medical and professional associations can educate providers and disseminate their experiences in providing PrEP.
· Advocates can raise PrEP awareness in the at-risk groups they serve.
· Groups implementing HIV prevention efforts can integrate PrEP education into existing programs.
CDC Recommends Anti-HIV Pill for High-Risk Groups
Time.com May 14 2014
The daily medication, sold in generic form as Truvada, could transform AIDS prevention in America. If taken regularly, the drug can reduce risk of infection in high-risk populations by up to 92%, the Centers for Disease Control and Prevention says
The U.S. government has recommended that hundreds of thousands of people at risk for AIDS take a daily drug that is effective in preventing the virus.
The Centers for Disease Control and Prevention issued an official recommendation Wednesday that people at high risk of contracting AIDS take a combination of two medicines called Pre-exposure prophylaxis (PrEP), which is known to help prevent infection of HIV, the virus that causes the deadly, incurable disease.
If taken regularly, the drug can reduce risk of infection in high-risk populations by up to 92%, the CDC says.
PreP comes in a generic version called Truvada and is used widely in AIDS treatment programs in poor countries. The CDC's recommendation could, if followed widely, increase the number of people taking the drug in the U.S. from fewer than 10,000 to half a million, the New York Times reported.
The CDC recommends the drug, in combination with condom use, to gay men who have sex without using condoms, heterosexuals who sleep with intravenous drug users or bisexuals, and anyone who has sex with someone they know to be HIV-positive, as well as anyone who shares needles or injects drugs.
HIV rates have held stubbornly flat for the past decade, and a sharp decline in condom usage has raised concerns among health officials.
U.S. health officials urge use of HIV pill for at-risk individuals
CHICAGO Wed May 14, 2014 7:11pm EDT
(Reuters) - U.S. health officials on Wednesday issued new recommendations urging healthcare workers to consider offering an HIV prevention pill to healthy individuals who are at substantial risk for HIV infection.
The guidelines, issued by the U.S. Centers for Disease Control and Prevention and the U.S. Public Health Service, involve the use of pre-exposure prophylaxis or PrEP, a strategy in which at-risk individuals take a daily dose of an antiretroviral drug to reduce their risk of HIV infection.
Advocating Pill, U.S. Signals Shift to Prevent AIDS
NY Times By DONALD G. McNEIL Jr. MAY 14, 2014
Federal health officials recommended Wednesday that hundreds of thousands of Americans at risk for AIDS take a daily pill that has been shown to prevent infection with the virus that causes it.
If broadly followed, the advice could transform AIDS prevention in the United States - from reliance on condoms, which are effective but unpopular with many men, to a regimen that relies on an antiretroviral drug.
It would mean a 50-fold increase in the number of prescriptions for the drug, Truvada - to 500,000 a year from fewer than 10,000. The drug costs $13,000 a year, and most insurers already cover it.
The guidelines tell doctors to consider the drug regimen, called PrEP, for pre-exposure prophylaxis, for gay men who have sex without condoms; heterosexuals with high-risk partners such as drug injectors or male bisexuals who have unprotected sex; patients who regularly have sex with anyone they know is infected; and anyone who shares needles or injects drugs.
Officials at the Centers for Disease Control and Prevention have long been frustrated that the number of H.I.V. infections in the United States has barely changed in a decade, stubbornly holding at 50,000 a year, despite 30 years of official advice to rely on condoms to block transmission.
Mr. Zeboski, at home, is a counselor for the San Francisco AIDS Foundation. Credit Thor Swift for The New York Times
Although there is no guarantee that gay men will adopt the drug regimen, federal officials say something must be done because condom use is going down. In a C.D.C. survey in November, the number of gay men reporting recent unprotected sex rose nearly 20 percent from 2005 to 2011.
Nevertheless, advocates for the drug regimen were elated at Wednesday's announcement.
"This is wonderful," said Damon L. Jacobs, a therapist in Manhattan who is HIV negative, has been on the regimen since 2011 and runs a Facebook page promoting it. "When an institution like the C.D.C. makes a statement, it makes a profound difference to the doctors who are ambivalent."
Dr. Jonathan Mermin, director of the C.D.C.'s national center for AIDS and other sexually transmitted diseases, said the new guidelines should save many lives.
"On average, it takes a decade for a scientific breakthrough to be adopted," he said. "We hope we can shorten that time frame and increase people's survival."
While many antiretroviral drugs could in theory be used for the drug regimen, the only pill approved for that purpose by the Food and Drug Administration is Truvada, made by Gilead Sciences.
Truvada, a mix of tenofovir and emtricitabine, is considered relatively safe with few side effects. Generic versions are made in India, and it has become the backbone of AIDS treatment in poor countries.
Common side effects include headache, stomach pain and weight loss. Rare but serious ones include liver and kidney damage.
Officially, the C.D.C. is endorsing the drug regimen only in conjunction with condoms. But health officials say they know that some people will stop using them. Many gay men, including Mr. Jacobs, report doing just that.
That raises their risk of contracting other diseases, like syphilis and gonorrhea. But health officials argue that the benefits of taking the drug regimen outweigh the risks.
"Making the perfect the enemy of the good is something we've got to get over," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases and the country's best-known AIDS doctor. "I strongly support the C.D.C. doing this."
Syphilis and gonorrhea can usually be cured with antibiotics, but H.I.V. lasts for life and is fatal if left untreated. Even those treated properly often develop early heart disease and other problems.
Since 2010, three separate studies using Truvada have shown that when taken daily it can vastly reduce the chances of infection. That held true for gay men, heterosexual couples and drug injectors. In the study of gay men, known as iPrEx, men whose blood tests showed they had taken their pill every day were 99 percent protected.
The new guidelines say patients should have an H.I.V. test before starting the regimen, to make sure they are not already infected. (Prophylaxis involves doses of two drugs, but anyone with the disease should be on triple therapy.)
Patients should be retested every three months to be sure that they are still H.I.V. negative, that they are not developing side effects from the drug and that they have not caught any other sexually transmitted diseases.
While many AIDS specialists endorse the drug regimen, it has not caught on among doctors as a whole.
A survey of 1,175 infectious disease specialists in the United States and Canada published in December showed that 74 percent supported it, but only 9 percent had actually prescribed it.
"There's a lot of inertia among doctors, and a strong statement from the C.D.C. will be pretty valuable for overcoming that," said Dr. Demetre C. Daskalakis, an AIDS specialist at Mount Sinai Hospital in New York who has many patients on the regimen.
Also, the drug regimen has not caught on among gay men, who are by far the largest risk group.
By analyzing pharmacy databases, Gilead has tried to track how many Truvada prescriptions are for the drug regimen, rather than AIDS treatment. As of last September, the company said, it knew of only 2,319 - of which 49 percent were for women.
Advocates said there were several reasons there had been little clamor for the drug regimen. First, while many doctors prescribe statins as prophylaxis against heart attacks, for example, only AIDS specialists are likely to prescribe AIDS drugs as prophylaxis. But uninfected gay men have no reason to see AIDS specialists, and usually see general practitioners if they see doctors at all.
Also, Truvada is expensive. However, private insurers and state Medicaid programs have thus far generally covered such prescriptions, and Gilead has a program covering co-pays and giving Truvada to the uninsured.
"In my experience, it's a simple process to get the meds approved," Dr. Daskalakis said.
Another reason is that Gilead does not advertise Truvada for prophylaxis, even though the F.D.A. approved it for that use in 2012 and Gilead does advertise it for treatment, for which it was approved in 2004.
A company spokeswoman said it had no plans to do so, but it does make grants to gay organizations that espouse the drug regimen.
Not advertising helps Gilead avoid controversy.
Michael Weinstein, president of the AIDS Healthcare Foundation, has called Truvada a "party drug" and argued that the drug regimen would encourage men to avoid condoms and thus increase the infection rate. He called the release of the guidelines "a shameful chapter in the history of the C.D.C."
That debate has played out on gay websites, where men favoring the drug regimen are often stigmatized as "Truvada whores." (The term was coined in a 2012 Huffington Post article whose author has since publicly regretted his stance.)
"People are reacting out of fear," Mr. Jacobs said. "Gay men who embraced the condom message and survived the trauma of 30 years ago have PTSD. This is a paradigm shift, and people don't like change."
Recently, a lash against the backlash has emerged, with a few men proudly wearing "Truvada Whore" T-shirts, just as others proudly wear "Queer" or "H.I.V. Positive" ones.
Adam Zeboski, a test counselor for the San Francisco AIDS Foundation, makes and sells "Truvada Whore" T-shirts to raise money for the foundation.
"People are both very supportive and very offended," he said. "By reclaiming the 'Truvada Whore' term, we're taking the power away from those who use it against us."