Patients, and family members of late patients, have filed a TDF lawsuit against Gilead Sciences, claiming that a number of HIV drugs made by the company cause serious side effects like bone density and kidney problems. Allegedly, the drug company sold these drugs, despite the fact that they had the ability to release a safer HIV drug.

The patients who filed the HIV drugs lawsuit say that they experienced injuries from taking the prescription drugs Viread, Truvada, Atripla, Complera, and Stribild. Allegedly, all of these drugs are manufactured and marketed by Gilead for the treatment of Human Immunodeficiency Virus-I infection (HIV).

The patients and families say that all of these drugs are made from a compound, tenofovir, which is a nucleotide analogue reverse transcriptase inhibitor. It treats HIV by working to block the enzyme that HIV needs to replicate.

According to the lawsuit, Gilead was responsible for developing a version of tenofovir that could be taken orally. Before this development, the drug had to be taken intravenously. Allegedly, the oral dose of tenofovir was advertised as attractive to patients because it was more convenient than the intravenous version.

However, the patients and families argue that to be administered orally, tenofovir has to be delivered at a much higher dose to be effective. Allegedly, this high dose, given in oral form, poses a safety risk to patients’ kidneys and bones.

In its oral form present in drugs like Viread, Truvada, Atripla, Complera, and Stribild, tenofovir is called tenofovir disoproxil fumarate (TDF).

The TDF lawsuit argues that Gilead knew that the oral form of the HIV drug posed a safety risk to kidneys and bones. Cidofovir and adefovir dipivoxil, two of Gilead’s other antiviral drugs that have molecular structures similar to tenofovir, had allegedly been shown to be toxic to kidneys.

To further support their argument that Gilead knew that TDF posed a danger to kidney and bone health, the patients in the lawsuit say that Gilead was aware of preclinical data that showed a high dose of the drug posed a greater risk of toxic effect. Additionally, patients also claim that the data also showed that bone and kidney damage was more likely the longer the patient took TDF.

The Gilead HIV drug side effect lawsuit goes on to assert that Gilead had a less dangerous and more effective HIV drug available before it began marketing TDF, but did not put it on the market in order to preserve TDF sales by admitting that the TDF drugs were less safe than the alternative drug.

This alternative drug is tenofovir alafenamide fumarate (TAF), which is absorbed into the cells HIV targets at a much higher rate and can be administered at a radically lower dose than TDF, which reportedly reduces the risk of kidney and bone damage.

The patients in the Gilead TDF lawsuit say that the drug company knowingly put the health of HIV patients at risk in the interest of their own profits.

However, Poz says that TAF HIV drugs may not offer so many more advantages over TDF as many people had hoped. 

Gilead made headlines recently for reportedly offering to donate enough of Truvada, one of the drugs in question in the HIV drugs lawsuit, to supply 200,000 HIV patients for up to eleven years. The New York Times notes that some experts worry that this donation is may be part of Gilead and other drug company’s efforts to keep HIV drug prices high for most patients.  

The Gilead HIV Drug Kidney and Bone Side Effects Class Action Lawsuit is Case No. 3:19-cv-02538, in the U.S. District Court for the Northern District of California.