Health Officials: No Promiscuous Use for HIV Prevention Drug
A study from late last year demonstrated that Truvada, a drug used to treat HIV, could also help protect HIV- people from contracting the virus. But the U.S. Centers for Disease Control and Prevention (CDC) now says that only those at high risk of infection should take the drug as a preventative measure, Reuters reported on Jan. 27.
Truvada, which is made by Gilead, is made from two HIV medications. The Food and Drug Administration has not approved "pre-exposure prophylaxis" (PrEP) for Tuvada, but some doctors have begun prescribing it to HIV- patients as a preventative measure in the wake of the study, which indicated that taking the drug could reduce the risk of contracting the virus by nearly half, especially if taken regularly.
In response, the CDC issued guidelines for doctors, Reuters reported.
"Concerns exist that without early guidance, various unsafe and potentially less effective PrEP-related practices could develop among health-care providers and MSM (men who have sex with men) beginning to use PrEP in the coming weeks and months," the CDC’s guidelines say.
Among other concerns: the drug might be taken by those who have not been tested to determine their HIV status, and they might use the drug intermittently, a practice that had led in the past to the rise of antibiotic-ressitant strains of disease.
Moreover, people seeking a preventative effect might mistakenly believe they can take any HIV medication and achieve the same results as those demonstrated for Truvada. The CDC also expressed concern that people might turn to the drug without also seeking counseling, or mistakenly think that taking Truvada will ensure that they never become HIV+.
"Let’s be really clear," said Kaiser Permanente’s Dr. Michael Horberg, who is also the vice chairman of the HIV Medicine Association. "The use of this medication is not a license for unsafe sex... You can’t just pop a pill as you are getting ready to go out Saturday night."
The CDC’s newly released guidelines for physicians stresses that the drug’s effectiveness at reducing risk of HIV infection needs further testing. "Until the safety and efficacy of PrEP is determined in trials now under way with populations at high risk for HIV acquisition by other routes of transmission, PrEP should be considered only for men who have sex with men," the CDC cautions. Reuters noted that among "high risk" individuals are gay men, bisexuals, and MSM (men who have sex with men, regardless of their sexual orientation) who have many sexual partners and who do not always adhere to safer sex practices such as using condoms.
Horberg also cautioned that Truvada’s prescription for prophylactic use should only be done by physicians experienced with HIV+ patients and the pharmaceuticals they take, saying, "This really is going to have fall in the hands of HIV and infection specialists." Added Horberg, "The drug is only one element of the whole process. There is the monitoring, the office visits, correct prevention counseling--trying to ensure that the patients are also using condoms, etc." Horberg also noted that over the long term, HIV medications can lead to harmful side effects--another factor that HIV- people considering prophylactic use of the drug consider.
The drug is also expensive--it costs more than $1,000 per month, and insurance typically will not cover treatments that the FDA has not yet approved.
A Jan. 28 TopNews story noted that Truvada has not been shown to be effective at preventing infection for women, and even when used by MSM it should be part of a larger program to ensure sexual health. "The study results did present a major advance, and they’re encouraging, but it’s not time for gay and bisexual men to throw out their condoms," said CDC spokesperson Jennifer Horvath, who added that the drug "should never be seen as a first line of defense against HIV."
According to the CDC, MSMs are most at risk out of the general population for contracting HIV.