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While it has not yet been proven, it seems that Gilead Sciences, Inc. had the ability to bring safer, TAF-based versions of its HIV pills to the market up to a decade earlier than they actually did. Victims who took the more dangerous, TDF-based versions of the pills and who have suffered from their severe side effects have filed mass tort claims against Gilead for their losses.
Gilead Sciences, Inc. has manufactured numerous pills for HIV treatment. Some are based on the drug tenofovir disoproxil fumarate, or TDF, including the brand name pills:
Newer treatments, however, are based on the drug tenofovir alafenamide fumarate, or TAF, including the brand names:
Different brand names signify different drug вЂњcocktails.вЂќ For example, the TDF-based drug Stribild has a total of four drugs in it:
Newer, TAF-based versions of these pills merely replace the active ingredient TDF with the newer drug TAF. For example, Genvoya, the drug that replaces Stribild, is comprised of:
Only one drug is comprises solely of TDF, Viread, and it was replaced by Vemlidy, which is comprised solely of TAF.
Yes. Numerous medical studies and clinical trials have shown that TAF-based HIV drugs are less toxic and safer to take than HIV drugs that are based on TDF. In particular, TDF-based HIV drugs can cause:
TAF-based HIV drugs either do not present these dangers, or carry far lower risks.
For example, there are three studies conducted in 2014 and 2015 that compared bone loss in 2,068 people taking either a TDF-based drug or the TAF-based pill, Genvoya.4 After 48 weeks, these studies found bone loss in patients taking a TDF-based drug was far higher than in those people taking Genvoya in both their hip and in their spine:
|Patients Taking TDF-Based Drugs||Patients Taking TAF-Based Genvoya|
|Percentage of Bone Loss in the Hip||2.4% to 3.8%||0.6% to 0.8%|
|Percentage of Bone Loss in the Lumbar Spine||2.9% to 3.6%||1.0% to 1.6%|
Gilead was developing TAF as a safer alternative to TDF as early as April 2001. That was when scientists at Gilead published an article on TAF toxicity in dogs.5 The experiments conducted for these studies found that TAF was far more effective than TDF, meaning it could be administered at far lower doses and reduce the dangers of its toxicity.
Of course, Gilead could have been researching and developing TAF-based HIV treatments well before this point.
It is unclear when Gilead could have released its TAF line of HIV treatments because, in 2004, they stopped developing the new drug for nearly ten years.
Lawsuits filed by victims claim that Gilead put TAF development on hold вЂњbecause TDF sales were booming and Viread had begun to corner the market in antiviral treatments for HIV.вЂќ6 By withholding TAF-based drugs, it allowed Gilead to reap the profits it would make over its entire period of exclusive rights to sell TDF-based HIV treatments. By withholding the safer, TAF-based versions of these drugs, it would allow Gilead to release TAF treatments just as its TDF ones were beginning to face market competition from generics.7 Market analysts estimated that such a move would have made Gilead billions of dollars.8
Gilead, meanwhile, claims that their movement away from TAF was purely a business decision: They shifted money away from TAF research and into integrase inhibitors вЂ“ another type of HIV treatment.9
Whether Gilead withheld its safer TAF versions of its HIV treatments or not will make a huge difference in the lawsuits currently pending against the pharmaceutical company. The timeline of its development of TAF and TDF drugs paints a damning picture against the company:
A former Los Angeles prosecutor, attorney Neil Shouse graduated with honors from UC Berkeley and Harvard Law School (and completed additional graduate studies at MIT). He has been featured on CNN, Good Morning America, Dr Phil, The Today Show and Court TV. Mr Shouse has been recognized by the National Trial Lawyers as one of the Top 100 Criminal and Top 100 Civil Attorneys.