Tenofovir disoproxil fumarate (TDF) is an antiretroviral drug originally developed by Gilead Sciences and sold under the brand name Viread. Other TDF drug brand names include Atripla, Complera, Stribild, and Truvada. Since first coming on the market back in 2001, TDF drugs have become widely used for the long term treatment HIV and AIDS. Hundreds of thousands of people with HIV take these drugs every day and they have generated billions in revenues for Gilead.
Gilead is now facing a growing number of lawsuits alleging that the company failed to adequately warn about very serious adverse health effects caused by TDF drugs. Even more concerning are allegations that Gilead developed an alternative type of drug that was much safer, but intentionally delayed its release for years in order to maximize profits before the patent ran out on the TDF drugs.About Viread and TDF Drugs
Viread is the brand name for prescription medication known as TDF (tenofovir disoproxil fumarate). TDF is a member of a very unique group of pharmaceutical drugs known as NRTIs (nucleoside reverse transcriptase inhibitors). Inside the body NRTI drugs like TDF work by blocking a specific enzyme called reverse transcriptase (RT). The RT enzyme basically helps certain types of cells copy their DNA and replicate themselves through a process called reverse transcription.
Retroviruses such as HIV (human immunodeficiency virus) utilize the RT enzyme to duplicate and fuel progression and expansion of the virus inside the body. TDF doesn't kill the virus so it cannot cure HIV/AIDS. However, by blocking the RT enzyme Viread and other TDF drugs effectively prevent the HIV virus cells from multiplying. When used in combination with other drugs, TDF can not only stop HIV from growing but actually reduce the amount of HIV in the system.
TDF was developed and patented by Gilead Sciences Inc., a biopharmaceutical company based in Foster City, California. In 2001 the Food and Drug Administration approved TDF for use in the treatment of HIV infection and Gilead released the drug under the brand name Viread. Viread was a groundbreaking drug and soon after its release in the U.S. hundreds of thousands of people living with HIV-1 were using it to manage their condition. If left untreated, HIV (which eventually develops into AIDS) can literally destroy the body's immune system and be fatal. Viread drastically changed the outlook and prognosis for countless HIV patients.
Unfortunately, the amazing benefits of Viread came with a fairly heavy price tag. TDF is not easily absorbed into the body. As a result, users must take very high doses of the drug in order for it to have any effect. This meant that Viread had a long list of potential side effects including problems with the kidneys and loss of bone density. As use of Viread continued to expand it eventually became apparent that these adverse health effects were more prevalent and much more serious than originally disclosed. A number of studies have now confirmed that continued use of Viread can cause acute kidney failure, cancer, and osteoporosis and the incidence rate of these side effects is alarmingly high.Gilead Intentionally Delayed Release of a Safer, Alternative Drug to Maximize Profit
Gilead is not being sued simply because Viread can cause kidney failure and bone damage. After all, Viread was literally saving lives so unless these would be acceptable risks assuming there was no alternative drug that didn't damage the kidneys or bones. Gilead is now being sued because there was a safer alternative drug.
By the time Viread was initially released on the market in 2001, researchers at Gilead were already aware that the drug was flawed and could destroy the kidneys and bones. In fact, just as Viread was being marketed as a new "wonder drug" the research & development team at Gilead was working on a different version of TDF that would be less harmful. The new drug was called tenofovir alafenamide fumarate (TAF).
TAF was basically a new and improved version of TDF. The main advantage of TAF was the way it was metabolized inside the body. The inherent problem with Viread and TDF was that only some of the drug was metabolized by the HIV cells, while the remainder ended up as a toxin in the gastrointestinal tract. By contrast, TAF is only metabolized by the HIV cells so no toxic leftovers ended up in the G.I. tract. This made TAF a much safer, much more effective alternative to TDF.
As early as 2001 or 2002 Gilead was fully aware that its new TAF drug was much safer than TAF. TAF was not only safer, but Gilead's clinical studies suggested that it was also better at suppressing HIV than TDF. The problem was that this new discovery presented a business dilemma for Gilead. The company was already making billions on Viread. Plus Viread was under patent protection for 11 years (meaning no other companies could make generic versions of Viread). If Gilead announced in 2002 that the new TAF drug was not only better but much safer than Viread, it would immediately killed the market for Viread. Gilead would have lost a decade of patent protected sales of Viread worth billions in revenues.
Rather than cut off the Viread profits prematurely, Gilead made a very deliberate business decision to delay the release of the safer TAF drug until the patent protection on Viread was almost over. Gilead probably could have released the safer TAF drug as early as 2004. Instead Gilead suppressed study results indicating TAF was safer and waited until 2015 (just before expiration of the Viread patent) to release this much safer HIV drug.Gilead Intentionally Hiked Viread Prices to Boost Sales of its New TAF Drugs
Gilead not only deliberately delayed the release of its safer drug to maximize profits, but it also manipulated prices in an effort to prompt Viread patient's to switch to the new TAF drugs. When Gilead finally released its newer, safer TAF drugs on the market in 2015, there were already hundreds of thousands of HIV patients on Viread prescriptions. The patent on Viread was expiring, so Gilead wanted doctors and patients to stop taking Viread and start taking the new TAF drugs instead (which would be patent protected for another decade).
In order to "motivate" patients and doctors to switch from Viread to the newly released TAF drugs, Gilead very deliberately jacked up the prices on Viread soon after the release of its new drugs. The older TDF drugs like Viread suddenly became much more expensive than Gilead's newly released TAF drugs.Gilead's Decision to Put Profits Over Safety Put Patients at Increase Health Risk
In April 2019, a product liability lawsuit was filed against Gilead in California alleging that over 50 individual plaintiffs were exposed to major safety risks from use Viread and Gilead's other TDF drugs. The lawsuit alleges that Gilead had a legal duty to immediately release the TAF drugs once it became aware that they were safer alternatives to the existing TDF drugs. Gilead had a choice between maximizing profits or maximizing patient health and safety. The clearly chose to prioritize profits.
By intentionally delaying release of the safer alternative TAF drugs, Gilead exposed patients to 10 additional years of toxins known to damage the bones and kidneys.Do You Have a Lawsuit Against Gilead?
The lawsuits filed against Gilead in April are just the first of what are likely to be thousands of additional cases around the country. Our firm is currently seeking clients who may have claims against Gilead involving its HIV drugs. Potential plaintiffs against Gilead would include anyone who was taking a prescription TDF drug from 2001 to 2015. Brand names for Gilead's TDF drugs include:
Anyone who took one of these drugs for treatment of HIV or hepatitis and has experienced health problems involving their kidneys or bones may be entitled to financial compensation.Miller & Zois is Currently Accepting New HIV Drug Cases
If you took any of the HIV drugs mentioned above and think you may have a lawsuit against Gilead, please contact the product liability lawyers at Miller & Zois for a free consultation. You can reach us by phone at 800-553-8082 or contact us online.