Massive PrEP Pill Study Underway

An international study on a temporary HIV prevention pill is underway. The concept is known as pre-exposure prophylaxis or PrEP.

In a massive medical trial on three continents, doctors are testing a controversial pill that could temporarily boost immunity against HIV before a person is even exposed to the virus. If the pill works safely, doctors must then address whether such a drug, if made widely available, could actually worsen the AIDS epidemic. The pre-exposure pill undergoing testing seems promising, since HIV drugs taken within days after exposure to the virus have been shown to reduce the risk of infection by 80 percent. But public health officials debate whether people at high risk for the virus, such as men who have sex with men, would be more likely to set aside the use of condoms to instead rely on a drug regimen that doesn't provide full protection against the disease, which is spread by contact with the blood or semen of an infected person.

The drug being tested is tenofovir, which is sold in the U.S. as Viread. For years there have been anecdotal reports of gay men taking Viread as a preventive, despite its enormous cost.

Good News/Bad News For Gilead

It's a complicated turn of events for Gilead, the maker of HIV drug Viread. The 9th Circuit Court has reinstated a securities class action suit against the drug maker which claims that Gilead had misled investors about the demand for Viread.

The suit charges that Gilead fostered demand for Viread by using improper marketing such as "aggressively promoting off-label uses." Among the off-label uses were "marketing to patients co-infected with Hepatitis B." The suit (PDF) claims that 75% - 95% of Viread sales came from such off-label sales.

Little Viread is sold as a stand-alone drug today as it is most commonly prescribed as part of the combination pills Atripla and Truvada. However, the drug has been studied in recent years as a possible daily HIV preventive, with one AIDS activist even calling for it to be "coformulated with Viagra."

However, on the same day that the above lawsuit was green-lighted, comes word that the FDA actually HAS just approved Viread as a treatment for chronic Hepatitis B in the United States. The drug is already approved for such use in Europe. So Gilead wins by having one of the few drugs approved to treat Hep B, but loses for how they got to that approval. I think. Insiders?