The side effects of Stribild—like other Human Immunodeficiency Virus (HIV) medications containing tenofovir disoproxil fumarate (TDF)—center around skeletal, gastrointestinal, and renal system dysfunction. Stribild, Atripla, Complera, Truvada, and Viread are all HIV drugs using TDF singularly or in combination with other ingredients.

According to www.poz.com, Stribild is a compound medication which contains elvitegravir, cobicistat, emtricitabine, and TDF. It was designed with the primary goal—not unlike the other medications of its class—of controlling internal replication of the HIV virus within an individual. By controlling viral replication, it allegedly helps to prevent transmission of the disease and keeps the patient overall healthier longer.

Like most medication regimens, there can be an initial reaction to treatment which goes away over time. Reactions such as nausea and diarrhea have been reported. Even though this can be temporary, ongoing problems—particularly if severe—should not be ignored. They can be a sign of overburdened kidneys.

According to the National Institutes for Health, renal impairment, acute renal failure, and renal tubular injury are among reported side effects of Stribild and other HIV drugs containing TDF. A physician’s evaluation of creatinine—an indicator of kidney health and function—is critical prior to starting treatment with this medication.

Other reported side effects of Stribild include a potential softening of the bones—a condition known as osteomalacia. This situation can lead to significant bone and extremity pain and often to fractures. It has been related to the use of TDF and may be related to renal tubular injury.

Stribild Manufacturer Faces Lawsuits

According to an article posted last May in the Los Angeles Times, a class action lawsuit against Gilead Sciences claims Gilead, who purchased the rights to the TDF formulation in the 80s, was well aware of the huge potential for side effects of TDF-based HIV drugs early on. The two California plaintiffs claim that a less toxic version of the main ingredient was in the works, but shelved until maximum profit could be attained by the first patent.

Purportedly, when the patent was initially purchased by Gilead, TDF was strictly an intravenous drug. Intravenous medications tend to be 100%  bioavailable, but Gilead questioned its marketability and converted it to a pill form. In order to be bioavailable in this form, the dosage had to be ramped up considerably. This meant that the excess amount had to be absorbed by the bones and kidneys, but no warnings were allegedly provided on the label.

HIV Drug Trials

A separate 2016 Los Angeles Times article indicates that private clinical trials paid for by Gilead were underway from 2001-2004 on a less toxic formula that would be less harmful to the kidneys and bones. All positive data generated was never published and research was stopped in 2004 as the original patent soared in popularity and was on its way to earning $11 billion dollars in annual sales.

Purportedly, for six years trials remained tabled. Resuming in 2010, they eventually led to the approval of a new drug in November 2016 known as Genvoya. The plaintiffs in the California class action lawsuit allege that this delayed action allowed many to suffer unnecessary bone and kidney damage.

How Widespread is the Usage for These Drugs?

A news report by P&T Community shows that the market size for anti-infective agents at the global level is expected to expand in the next several years. Infectious diseases, which include not just HIV but also conditions such as H1N1 and the Ebola virus, are driving the growth of pharmaceutical companies investing in medications. The market size for these drugs is expected for be over $100 billion by 2026.

For some patients, this leads to a strong argument that companies should be investing in the best possible solutions for those with infectious diseases rather than the ones that bring in the most potential for profit with a quick move to market. Some HIV patients say that makers of drugs like Stribild haven’t done enough to minimize the potential side effects and truly help patients.

Some of the patients in this group accusing the company of improper behavior say that the manufacturers were able to benefit from their monopoly on these drugs. When a less toxic version was allegedly developed as far back as 2000, Gilead, the maker, did not rush to share that information with the public. Stribild is one of several different kinds of medicines that poses risk of injury to bone and kidneys.

Some consumers claim that the fact that a safer version was in development and then finished shows that the company knew about the possibility of serious side effects but instead made the conscious decision not to put that newer, safer drug on the market so that the profits could continue to build from drugs like Stribild and Viread. Those drugs became the standard for prescriptions for HIV patients around the world despite the bone and kidney risks.