PrEP Patient’s Drug-resistant HIV Infection; Bone Loss, Fractures in Others, Suggest Caution

In News by AHF

No mention of condom use—as FDA guidelines for PrEP indicate—in the report on PrEP incident presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

 On the heels of the CDC’s recent recommendation that 1.2 million high-risk Americans go on PrEP, AHF expresses concern about a more drug resistant strain of HIV entering the community-at-large.

LOS ANGELES (February 25, 2016) An article in POZ Magazine today reported that for the first time, an individual on the HIV-prevention protocol pre-exposure prophylaxis or PrEP for over two years not only became infected with HIV, but became infected with a drug resistant strain of the virus. In a case presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, researchers found that a 43 year-old man whose blood serum levels suggested had been adherent to the medication portion of the HIV prevention regimen nevertheless became infected with HIV and that “… his drug resistance had been transmitted from another person, rather than acquired post-transmission.”

There was no mention of condom use—as FDA guidelines for PrEP indicate—in the report on the case at CROI.

In addition, a day earlier at CROI, other presentations documented bone fractures among HIV patients taking tenofovir and bone loss—albeit reversible—associated with the use of tenofovir in pre-exposure prophylaxis (PrEP).

“Due to issues surrounding medication adherence with PrEP, AHF has always been concerned about the potential for overall spread of the virus as well as other STDs for which PrEP offers no protection,” said Michael Weinstein, President of AIDS Healthcare Foundation, which has criticized and cautioned against the widespread deployment of PrEP as a community wide public health strategy, such as the CDC’s recommendation that 1.2 million Americans be put on PrEP, but supports its use on a case-by-case basis decided upon between a medical provider and his or her patient. “Now, on the heels of this drug resistant infection found in one individual who appeared to be adherent with the drug portion of his PrEP regimen, a larger concern is about the potential for a more drug resistant strain of HIV entering the community-at-large.”

In November 2015, the CDC recommended that 1.2 million high-risk Americans go on PrEP. At the time, USA Today reported that the Centers for Disease Control (CDC) confirmed that three years after the FDA first approved the use of Gilead Sciences’ successful HIV/AIDS treatment medication, Truvada, for pre-exposure prophylaxis to prevent HIV transmission in uninfected individuals, just 21,000 people were on PrEP today in the U.S.

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