State Endorses HIV-Prevention Drugs for People Who Aren't Infected
CHELSEA — The state's Department of Health has cleared the way for more New Yorkers who have not been diagnosed with HIV/AIDS to use the HIV medication Truvada to try to prevent new infections.
After months of anticipation, the Health Department's AIDS Institute released thorough clinical guidelines for pre-exposure prophylaxis, commonly known as PrEP, which is a daily dose of HIV medication that people who are HIV-negative but at-risk of contracting the virus can take to drastically reduce their chance of infection.
The drug, known by its prescription name Truvada, can reduce the chance of infection by as much as 73 percent, according to studies funded by the Bill and Melinda Gates Foundation.
However, the AIDS Institute stressed that PrEP alone was not enough to prevent new infections.
"PrEP should not be offered as a sole intervention for HIV prevention. PrEP should only be prescribed as part of a comprehensive prevention plan," the report says.
Advocates say the drug is needed, in combination with prophylactics including condoms, because the HIV infection rate in New York is growing among certain populations — including young men who have sex with men and injection drug users — even as the statewide infection rate is shrinking.
"PrEP may be an effective option to augment behavior change in these high-risk populations," according to the report, which found the new infections are primarily in minority communities.
Many AIDS organizations have recommended PrEP since the Food and Drug Administration approved it in July 2012, but the new state guidelines are a major step forward in increasing its use among at-risk populations, officials said. Advocates hope the state's endorsement of the strategy will lead to more doctors prescribing it.
There are still several barriers to the treatment. Truvada, the PrEP drug, is costly, ranging from $8,000 to $14,000 per year, and requires at least four annual medical checkups, along with lab tests. While some insurance companies cover the drugs, others may not, according to the Department of Health.
Gilead, the maker of the drug, provides a program to assist low-income adults with the cost of PrEP.
Use of the drug also has several side effects during the first month, including headaches, abdominal pain and weight loss. PrEP's ability to stave off infection also drops if it's not taken daily, the report says.
While many applauded the report, New York City AIDS group ACT UP said it took too long to come out, since more than 5,000 New Yorkers had contracted HIV since the treatment was approved by the FDA.
“While we’re glad to see the creation and availability of these guidelines by the AIDS Institute, the NYS DOH dragged its heels for months over their release, which was originally promised to us last fall," said ACT UP's Terry Roethlein.
The state report recommends that doctors work with community AIDS organizations to identify high-risk individuals who could benefit from PrEP, then after discussing it with them, begin a 30-day trial before figuring out a longer-term plan.