Tenofovir manufacturer Gilead Sciences is facing pressure to lower the cost of Descovy, a form of tenofovir alafenamide (TAF), after the U.S. Food and Drug Administration (FDA) recently approved the drug as a pre-exposure HIV prophylaxis for homosexual men and transgender women.

On Oct. 4, 2019, AIDS Healthcare Foundation’s (AHF) President Michael Weinstein said, “Gilead should really do the right thing now and significantly cut the price of Descovy.”

Months earlier, the AHF asked Gilead to reduce Descovy to $1 per pill. The medication currently is available for approximately $60 per pill.

The AHF also pointed to what it perceives as “Gilead’s greed” in the past. The drug maker faces a TDF class action lawsuit and several personal injury lawsuits over allegations it held back the release of Genvoya, Odefsey and Descovy, which are believed to be safer tenofovir medications. These three newer HIV medications are made of tenofovir alafenamide (TAF), which has a better safety profile than tenofovir disoproxil fumarate (TDF), which is the active ingredient in Gilead’s Viread, Truvada, Atripla, Complera and Stribild drugs, which were hit the U.S. market between 2001 and 2012.

Genvoya became available in 2015. Odefsey and Descovy entered the market in 2016. Gilead reported a net profit of more than $18 billion in 2015.

Allegations Against Tenofovir Manufacturer

According to the Washington Blade, at least two personal injury lawsuits allege Gilead knew the older TDF medications could cause kidney injury and bone issues, but continued to market the drugs to milk the most money out of them before the patent on TDF expired in 2015.

Gilead allegedly withheld the safer TAF-based drugs from market during that period of time even though it had research that showed the TAF drugs were less harmful.

Before TAF-based Descovy was approved for the prevention of HIV, Gilead’s Truvada was approved for that use in people who had not yet tested positive for HIV. Several patients who took Truvada as a prophylactic have filed suit against Gilead because the patients now face brittle bones or kidney disease that they would not have developed otherwise.

In a press release, Weinstein said that “Gilead must atone for its deliberate suppression of TAF from patients over the past decade or more simply in order to maximize its profits and extend sales of its more harmful TDF-based medications.”

The tenofovir manufacturer has argued that it included warnings that people with a history of bone problems or kidney ailments could suffer harmful side effects. Patients who have filed suit allege they had no history of either type of physical limitations until they started taking Gilead’s TDF-based drugs.

One lawsuit filed last summer alleges that TDF drugs have low bioavailability, which means the drug’s active ingredients don’t absorb well in the human body. As a result, an abundance of the drug must be taken in order for it to reach therapeutic levels. The alleged side effect is the excess amounts of TDF make their way to the bones and kidneys.

Patients allege they have suffered myriad side effects, including bone death, bone density loss, bone fractures, osteopenia, osteoporosis, kidney damage, kidney failure, chronic kidney disease and kidney toxicity.