Side effects of Atripla have raised concerns as lawsuits allege that a drug company withheld a safer alternative to the HIV drug. Plaintiffs claim that the manufacturer of tenofovir, which can cause a number of serious and life-threatening side effects, had come up with a safer formulation years ago, but sat on it while continuing to market the older, more dangerous medication in order to preserve its monopoly and profits.

What is Atripla?

Atripla is the brand name for a combination drug used in the treatment of HIV and AIDS.

Atripla is meant to help control HIV infection by helping to decrease the amount of HIV in the body, allowing the immune system to function better. This lowers the risk of certain HIV-related complications, like further infection or cancer, as well as improves quality of life.

Atripla contains three different medications:

• Efavirenz: sold by itself under the brand name Sustiva, this is an anti-retroviral drug used to prevent HIV infections in at-risk patients
• Emtricitabine: another anti-retroviral, also known as Emtriva, that works by disabling a DNA mechanism involved in virus replication
• Tenofovir Disoproxil: a “prodrug” that is inactive until it is metabolized within the body that works with the other ingredients to inhibit viral replication on the DNA level

The latter is responsible for the side effects that have been the cause of action in recent litigation.

Who Sells Atripla?

Atripla was the result of a collaboration between Gilead Sciences and Bristol-Meyer Squibb. Approved as a treatment for HIV in 2006, it was the first time that two pharmaceutical companies had worked together to combine their respective patented HIV treatments into a single medication.

While Atripla is available in developing countries through Merck Pharmaceuticals for around $12.50 a month, the monthly cost to U.S. patients and their insurers is over $2300 (approximately $77 per dose).

What Are Some Atripla Side Effects?

Some of the more common and milder side effects of Atripla are headaches, insomnia, narcolepsy and impaired balance and coordination. There are however more serious Atripla side effects that include:

• Lactic acidosis: dangerously low pH levels in the blood
• Hepatomegaly: a non-specific (multiple causes) enlargement of the liver
• Damage to bone tissue
• Kidney damage and failure
• Arrhythmia (irregular heartbeat)
• Respiratory distress

What Are the Legal Issues Surrounding Atripla?

Plaintiffs in current and pending lawsuits claim that Gilead Sciences downplayed the risk of serious and life-threatening Atripla side effects while they delayed the development and release of a safer alternative.

According to these complaints, executives at Gilead were aware almost 20 years ago that their own scientists had developed a less toxic form of the active ingredient, tenofovir. As a result, these plaintiffs say they were subject to unnecessary pain and suffering due to bone and kidney disease for years while Gilead shelved the safer version.

A pair of Los Angeles plaintiffs are currently seeking class-action status for any HIV patients in California who suffered Atripla side effects as a result of taking the medication. If certified, the class will cover all Calif. claimants who took Atripla after Oct. 26, 2001.

In addition, the AIDS Healthcare Foundation has sued Gilead in an attempt to invalidate its patents. That case is currently working through the appeals process.

In 2015, Gilead switched to selling medications based on tenofovir alafenamide fumarate (TAF) on the grounds that TAF is safer than TDF due to the risk of kidney and bone problems associated with TDF.

What Is the Class Action Antitrust Lawsuit?

Advocates for people with HIV and several patients living with HIV filed an antitrust lawsuit against Gilead Sciences, Bristol-Myers Squibb, Johnson & Johnson subsidiary Janssen Pharmaceuticals, and Japan Tobacco back last year.

A trial date was recently set for Feb. 28, 2022.

The class action lawsuit alleges the drug companies joined forces by signing anticompetitive agreements that as long as any single drug among Gilead’s HIV combination pills was still under a patent that none of them would formulate and sell a competitive combination pill that contain those same ingredients, nor would they create generic versions or let anyone else create a generic.

Plaintiffs allege the drug companies illegally squelched any generic competition. By agreeing to keep a monopoly on the HIV combination pills and preventing a less expensive generic version to enter the market, the pricing of the brand name pills remained artificially inflated, alleges the lawsuit.

POZ reports that at a recent hearing, the pharmaceutical companies tried to convince the judge that the anticompetitive agreements were just a regular course of business to stop any one of them from striking out on their own with a multi-prong drug that would compete with the brand names already on the market.

In a tweet posted May 14, 2019 by AIDS and gay rights activist and named plaintiff Peter Staleywrote, “We allege that Gilead and the other defendants engaged in a wide range of anticompetitive conduct, allowing them to monopolize the U.S. market for HIV treatment.”

Staley goes on to say that 89% of Americans take a Gilead drug once they begin a regimen to control HIV.

What Other Drugs Are Involved?

There are a number of HIV medications containing the active ingredient tenofovir disoproxil fumarate (TDF). These include:

• Atripla
• Complera
• Stribild
• Truvada
• Viread

Can I File an Atripla Lawsuit?

If you or someone you love has taken Atripla or another of these HIV medications and has since developed serious complications, like kidney disease or bone density problems, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by such health complications, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.