There are several combination human immunodeficiency virus (HIV) drugs on the market today that have, with long-standing use, been associated with damage to the human skeletal and renal system. Complera side effects have spurred recent litigation against Gilead Co., its manufacturers.

Complera is a combination HIV medicine that has two ingredients considered to be nucleoside reverse transcriptase inhibitors (NRTIs) and one non-nucleoside reverse transcriptase inhibitor (NNRTI).

NRTIs and NNRTIs inactivate an enzyme that initiates or speeds up chemical reactions which allow for the multiplication of the HIV virus in the body. Drugs of this class helped to prevent this replication in patients infected with the virus according to the manufacturer, Gilead.

Long range Complera side effects that have been identified stem from a controversial NRTI ingredient known as tenofovir disoproxil fumarate (TDF). TDF is also present in other combination and non-combination drugs sold under the brand names of Atripla, Truvada, Stribild and Viread.

The Complera side effects seen as a result of the TDF ingredient that affects the bones include osteopenia and osteoporosis. Osteopenia is a generalized weakening of the skeletal system because the body ceases to make new bone at a rate equal to the speed at which it is absorbing old bone tissue.

Osteopenia is a midway point between the strong bones of youth and the extremely weakened condition called osteoporosis where bones break easily and often without provocation.

Complera side effects aside, both osteopenia and osteoporosis typically do not develop until after age 50 if they develop at all. It disproportionately affects women and genetics can play a part. Diet and exercise make a difference in whether these conditions ever develop.

The Complera side effects that affect the renal system can range from acute to chronic kidney disease, kidney failure and even more rare disorders such as Fanconi syndrome.

In one of two lawsuits filed against Gilead, plaintiff Jonathan G. said he was diagnosed with Fanconi syndrome. He was also allegedly diagnosed with osteopenia and osteoporosis after taking a TDF-based formulation for nine years. He is approximately 60 years old.

The Shelving of a Less Toxic Formulation

The other plaintiff involved in the twin actions is Michael L. who is approximately 37 years old. Michael L. said he suffers from osteopenia and osteoporosis after taking a TDF-based Gilead HIV drug for 11 years.

Both of the men sought damages for being exposed to the high toxicity level of TDF which purportedly led the development of Complera side effects.

The central controversy of this legal action was the purported shelving of scientific research and development of a less toxic formulation known as tenofovir alafenamide fumarate (TAF). In 2015, TAF was approved by the U.S. Food and Drug Administration (FDA).

According to the LA Times, Gilead referred to TAF as an “interesting new molecule” with which their scientists were working.

This announcement was allegedly timed perfectly with the expiration of Gilead’s patent on TDF. Plaintiffs point out Gilead’s record of publishing research on TAF in 2001 as well as running animal studies and paying physicians to do small human clinical trials. The animal studies and human clinical trials reportedly revealed a greater effectiveness with less potential damage.

The two California men insisted that Gilead betrayed their trust by failing to warn of potential side effects of original formulation and by shelving work on more effective and less toxic version for nearly 20 years. These actions purportedly subjected these men and other HIV patients to unnecessary risks and suffering.