Drug maker Gilead Sciences, Inc., the leading manufacturer of HIV drugs worldwide, has come under fire for its HIV drug tenofovir disoproxil fumarate (TDF), which plaintiffs across the country allege Gilead knew had the potential to cause kidney disease and bone damage in users yet continued to promote without warnings. Additionally, Gilead is accused of deliberately withholding from the market an HIV drug the company knew was safer and more effective than TDF, in order to boost its profits from TDF before the drug patent expired. The lawsuits pending against Gilead allege that patients taking one of five Gilead HIV drugs containing TDF, marketed under the brand names Truvada, Viread, Atripla, Complera or Stribild, were needlessly exposed to debilitating kidney and bone damage as a result of the treatment.
Tenofovir disoproxil fumarate is an antiretroviral medication prescribed as a treatment for HIV and AIDS that has been linked to serious and potentially life-threatening kidney and bone damage. Gilead’s top-selling TDF medication is Truvada (emtricitabine and tenofovir disoproxil fumarate), which was granted accelerated approved by the FDA in 2004. Other similar TDF drugs include Atripla (Efavirenz), Complera (Rilpivirine) and Stribild (Elvitegravir, Cobicistat and Emtricitabine), all of which are used to treat HIV, and Viread (Tenofovir DF), which is used to treat HIV and hepatitis B. TDF is not a cure for HIV or AIDS. Rather, the drug is meant to be taken long-term to manage the symptoms associated with the illness and to improve patients’ quality of life. Unfortunately, research shows that prolonged exposure to TDF can result in devastating and irreversible damage to the bones and kidneys.
Before Truvada was even approved by the FDA, Gilead was already investigating a safer version of TDF that posed fewer risks, called tenofovir alafenamide (TAF), yet continued to promote Truvada and TDF as safe treatments. At that time, TDF and Truvada had just recently been patented and still had years of protection against generic brands, which Gilead planned to take advantage of. TDF was also considered the leading treatment for HIV, which allowed Gilead to charge extremely high prices for the drug. So, rather than go public with research that showed TAF was a safer and more effective treatment than TDF, Gilead covered the studies up to protect its bottom line. It wasn’t until 2010, when the patent on TDF and Truvada was running out, that Gilead announced the discovery of TAF, a drug that would revolutionize the treatment of HIV.
As an alternative to TDF for the treatment of HIV and AIDS, TAF is considered far less toxic and is also more easily absorbed by the body, which makes the drug more effective, even at significantly lower doses. Because the concentrations of the main ingredient, tenofovir, are smaller, the drug doesn’t accumulate in the blood and kidneys as much as TDF, which means TAF poses fewer risks for users. Unfortunately, rather than offering HIV patients taking TDF-based drugs this new-and-improved treatment option that posed fewer risks to their bones and kidneys, Gilead is accused of putting profits before people and deliberately delaying the introduction of TAF for business reasons, at the expense of patients who were put at severe risk of debilitating side effects.
Patients taking TDF-based medications while Gilead allegedly withheld a safer alternative from the market were exposed to devastating bone and kidney damage possibly leading to the following side effects:
There are a number of lawsuits pending against Gilead for injuries allegedly associated with Truvada and other TDF drugs, including a class action lawsuit representing plaintiffs in the state of California. The lawsuits all involve similar allegations that Gilead knew about the potential for serious side effects to occur because of TDF treatment, yet failed to properly warn patients or healthcare providers, and intentionally delayed the release of a safer version of the HIV drug in order to protect its bottom line. If you or someone you know took a TDF-based medication like Truvada, Viread, Atripla, Complera or Stribild, you may have grounds to file a lawsuit against Gilead for the costs of medical treatment, pain and suffering, lost income, loss of consortium and other damages.