Two HIV drugs made by Gilead Sciences, Atripla and Viread (tenofovir disoproxil fumarate), are at the heart of a recent lawsuit filed by a patient with HIV who claims the medications caused kidney damage. Plaintiff Philip E. is seeking unspecified monetary damages over allegations that the defendant sold medication it knew was capable of harming kidneys and bones.

Case Background

According to his lawsuit, in 2007 Philip was diagnosed with HIV, the virus that causes AIDS. He was prescribed Atripla, a form of tenofovir,  to manage the virus. Six months later, the suit states, Philip’s physicians switched him to Viread, a different form of the same medication (tenofovir disoproxil). He continued to take this medication until August 2010, when his treatment team switched Philip to a non-tenofovir drug.

Philip claims to have been unaware that the tenofovir dosage required for the drug to be effective caused significant kidney and bone injury over the three years he was taking it. Allegedly, he was exposed to far more of the active ingredient than was needed to prevent his HIV from turning into AIDS. He claims that Gilead Sciences was aware that its products posed a serious risk of renal and osteotoxicity based on studies carried out prior to 2001, when the company introduced its first tenofovir-based medication.

Philip further alleges that Gilead had developed a similar, but safer, version of tenofovir medication (tenofovir alafenamide fumarate, or TAF) that was effective at lower dosages, thus reducing the risk of bone and kidney damage – but deliberately kept it off the market in order to maximize its revenues from Atripla and Viread. This claim is reinforced by a deposition from a company representative who confirmed that the real reason for abandoning TAF was fear of acknowledging the dangers of TDF and thus harming sales.

Atripla, Viread and TAF

TDF is highly effective for both managing HIV and preventing AIDS, and is normally prescribed in combination with other retroviral medications. It can be used prophylactically for people who suffer needlestick injuries or are otherwise at risk for contracting HIV. However, in order to obtain the benefit of the drug, the patient must take a high dosage (300 milligrams per day), although a patient’s body can only absorb and use a small amount. The remainder stays in the kidneys and bones, according to drugs.com.

TAF is absorbed into the cells targeted by HIV with greater efficiency. This allows the patient to take a much lower dose to get the therapeutic effect, resulting in significantly lower toxic exposure to kidneys and bones.

Allegedly, Gilead Sciences kept TAF off the market, falsely claiming that it was too similar to TDF to justify further development. The real reason, according to the suit, was to avoid hurting sales of TDF medications by admitting there was a safer alternative, going so far as to promoting it to doctors as a “miracle drug.”

Philip E.’s Atripla and Viread Lawsuit is Case 9:19-cv-81474-RLR in the Fifteenth Circuit Court for Palm Beach County, Fla.