Two California residents have filed a tenofovir lawsuit against Gilead Sciences, the maker of several nucleoside reverse transcriptase inhibitors (NRTIs) used to treat HIV. The tenofovir lawsuit alleges that the company knew from the start that HIV medications it made containing tenofovir put undue strain on the kidneys and skeletal system.

NRTIs are a class of drugs that help to prevent the HIV virus from systemically replicating itself in persons who are infected. Stopping the replication process limits the ability of the HIV positive person from transmitting the disease. NRTIs also generally boost the immune system of the HIV positive patient.

The tenofovir lawsuit claims, however, that Gilead purposely hid information from the medical community and the public regarding the side effects of these drugs.

The tenofovir lawsuit filed in the late Spring specifically targeted the HIV drug Viread because this is the medication with which the plaintiffs are familiar. Viread was approved by the U.S. Food and Drug Administration in October 2001. Its generic name is tenofovir disoproxil fumarate (TDF), and this chemical composition was later combined with other HIV drugs to create medications called Atripla, Truvada, Stribild, and Complera.

The tenofovir lawsuit concerning Viread indicates that NRTIs that include TDF are not easily absorbed by the body. To achieve the desired clinical effect, these drugs have to be prescribed in higher doses.

The problem with the high dose protocol is that HIV patients have systems that are excessively taxed by the virus already.

According to the tenofovir lawsuit, this chronically weakened state makes it difficult for the body to figure out what to do with the dosage excess. It has a tendency under these circumstances to deposit itself in the kidneys for removal through the urine and in the bones. The constant overworking of the kidneys can cause kidney damage over time. The bone deposits can compromise bone density.

Another Tenofovir Lawsuit

Another tenofovir lawsuit was filed in July 2018 and specifically targets Truvada. Both cases make the argument that Gilead Sciences knew of less harmful HIV medication ingredients which could have been an alternative to TDF. The development of combining alternative ingredients into a formulation with less risks was purportedly put on permanent hold while the company milked the older formulations for their maximum profitability.

According to a Los Angeles Times article, six months prior to the approval of TDF, scientists at Gilead published research on an alternative medication known as tenofovir alafenamide fumarate (TAF). Studies with animals had indicated that TAF was far more effective and had less toxicity, the researchers reported.

Small clinical trials started across the U.S. at Gilead’s urging, but all the positive data generated from these trials became highly secretive and remained unpublished.

Gilead, according to the Los Angeles Times, made an announcement three years after TDF’s approval that it would no longer pursue TAF research while it continued to quietly apply for its patent. Meanwhile, funds were being thrown at the older formulation.

It wasn’t until the former patent was nearing the end of its life cycle in 2010 that Gilead reopened conversation with its investors concerning TAF and the need for more research. Data generated from the previous research suddenly became public at this time as well.

The FDA approved TAF in November 2015 when allegedly the drug could have been available and saved strain on the bodies of HIV patients many years previously. The first TAF drug was named Genvoya.