Stribild is a combination drug that is prescribed to treat HIV infections, so they don't escalate and become acquired immune deficiency syndrome (AIDS). This medicine has four active substances: Tenofovir Disoproxil, Elvitegravir, Cobicistat, and Emtricitabine.
European scientists in the 1980s discovered this drug and then a small biotech firm – Gilead Sciences – acquired the rights to trade this medicine. Tons of research followed, and in 1997, the company made a groundbreaking revelation that Stribild could treat HIV patients. Scientists modified the chemical make-up of this drug so it could be taken orally rather than intravenously.
The Federal Drug Administration (FDA) approved this drug in 2001, and the modification made this medicine (sold under the name Viread) more marketable and sales skyrocketed. Incorporating this medicine into the treatment regimen of HIV patients meant they could lead healthier lives and increase their chances of living longer.
A caveat, Stribild does not cure HIV-1 infection or AIDS. This medicine works by staving off the virus to control damage to the immune system and stop the patient from acquiring diseases and ailments linked to AIDS. Consumer Alert Now is keen to educate patients in California on the dangers of taking Stribild, as explained in this article. We also delve into mass torts and how you can join one against Gilead Sciences Inc.
How Stribild Works
When a person is infected with HIV, the virus attacks cells and takes control, forcing the cell to create excess copies of the virus. Developing the additional copies requires enzymes which are forms of proteins acting like biological catalysts to speed up chemical reactions.
The anti-HIV medications in Stribild obstruct the functioning of these proteins, so the HIV-infected cells fail to produce more viruses. Reducing the activity of these enzymes, therefore, slows the growth and spread of HIV in the body so the patient can avoid getting sicker. Stribild inhibits the activity of enzymes, so the affected cells create new copies of HIV at a slower rate.
Who Can Take Stribild?
Adults and children who are at least 12 years and have a minimum body mass of 77 lbs (35 kg) qualify to use this drug to manage HIV symptoms and accompanying ailments. These patients may not have taken other HIV medications, or they wish to replace the medicines they are taking. Apart from the age and weight criteria, patients who are replacing other HIV meds with Stribild must satisfy the following specific requirements:
- Be taking the same HIV medication for a minimum of 6 months
- Never had unsuccessful HIV treatments in the past
- Have a viral load below 50 copies/mL
- Not have drug resistance mutations linked to any HIV medicines in Stribild.
What are the Components of Stribild?
As mentioned before, Stribild is a full combination drug regimen for managing HIV infection, and it should, therefore, not be used with other chemical treatments for HIV. This prescription has four different medicines formulated to develop one robust pill; Elvitegravir, Tenofovir Disoproxil Fumarate, Emtricitabine, and Cobicistat. We shall now discuss these components in greater detail to understand their role in fighting HIV.
- Elvitegravir (EVG)
This HIV medicine functioned as an integrase inhibitor and was manufactured in 2008 by Gilead Sciences, a pharmaceutical company. The FDA green-lighted Elvitegravir in 2012 primarily to be administered to adult patients who were commencing HIV treatment. This drug was part of the fixed-dose combination, otherwise known as Stribild.
In 2014, the FDA approved this medicine as a single pill formulation that was marketed as Vitekta and the following year; Elvitegravir was approved for use among HIV-1 patients. Doctors could then prescribe the drug as a second fixed-dose combination pill (Genvoya). These patients must have received antiretroviral therapy before. In this scenario, EVG is taken along with ritonavir and other antiretroviral drugs.
Phase II of the clinical trial noted that patients who took EVG daily registered higher reductions in viral load after six months as compared to those who randomized. Nonetheless, studies deduced that patients who received EVG suffered from side effects like diarrhea (7%), headaches, rashes, fatigue, and vomiting among roughly 1% of patients.
- Tenofovir Disoproxil Fumarate
Tenofovir is used alongside other HIV medicines to control the rate of infection, thus reducing the levels of this virus in your body. When taken correctly, this NRTI effectively helps patients' immune systems function better, so they don't succumb to opportunistic infections.
Adults and children aged two years and above qualify for Tenofovir. Patients must always take this drug in combination with other anti-HIV medicines. The FDA has green-lighted this drug to manage chronic HBV infection in adults.
While Tenofovir does not cure HIV, it assists the prescribed regimen to work better so patients can enjoy improved health and thus lead quality lives. Tenofovir is also used to manage chronic hepatitis B by decreasing the levels of this virus in your body.
Cobicistat or Tybost is a module of two four-drug, fixed-dose HIV prescriptions approved by the FDA for adults. This drug is a form of pharmacokinetic enhancer which is used to boost the effectiveness of HIV drugs. Cobicistat is administered together with darunavir or atazanavir. In this way, Cobicistat does not treat HIV, so patients must adhere to the prescribed dosage given by their health care providers.
Patients with existing kidney ailments are not allowed to take this drug as it can exacerbate the symptoms and escalate to kidney failure. Breastfeeding mothers, pregnant women, or those planning to conceive must stay away from this drug. You must have a candid discussion with your physician to determine if you are eligible for Tybost or otherwise.
This drug, also known as FTC, is a prescription medicine used to treat HIV infections in adults, infants, and older children. Emtricitabine belongs to a group of HIV medicines known as nucleoside reverse transcriptase inhibitors (NRTIs). As explained previously in this text, these drugs work by blocking HIV enzymes. Blocking reverse transcriptase negates the infection from colonizing, thereby controlling the levels of HIV in the body. FTC is always co-administered with other HIV drugs medicines.
Emtricitabine can trigger a host of side effects such as nausea or occasional dizziness, but these are manageable with certain medications. Serious side effects like excess lactic acid in the blood (lactic acidosis) or liver problems are not atypical, and it is advisable to see a physician when this happens. Patients who suffer from HBV infections, kidney ailments, are pregnant or planning a pregnancy must refrain from taking FTC.
What is the Normal Dosage for Stribild?
This compound drug comes in the form of tablets as follows: 150 mg (EGV), 150 mg (Cobicistat), 200 mg (Emtricitabine), and 300 mg (Tenofovir Disoproxil Fumarate). Doctors recommend a dose of one Stribild tablet taken per daily before or after meals.
If you forget to take a dose at your usual time, take a pill right away but if it is close to the next dosage, wait for the next round. Shun the temptation to take medicine only to take another tablet just a few hours later, and never swallow two doses at once.
Stribild interacts with other chemicals, and therefore, patients are advised to declare whatever active prescriptions they may have. The doctor will determine if administering this drug could pose a problem, and if so, they will prescribe a befitting alternative.
FDA Endorsement and Clinical Trials
The FDA approved this prescription drug, and it also goes by the names EVG / COBI / FTC / TDF, or QUAD. Despite this approval, Stribild is proven to cause a plethora of side effects that can vary from mild to extreme, thus making the treatment regime difficult.
Before we delve into what the specific side effects are, let us appreciate the role of clinical trials in determining the efficacy and impact of drugs. Clinical trials seek to find out if certain medications, therapeutic strategies, or devices are safe and adequate for personal usage or consumption. These trials usually have a robust team comprising of doctors, health care professionals, nurses, scientists, clinical trial coordinators, and data managers.
While they are primarily helpful, clinical trials are often performed under diverse conditions which make their findings incomparable to the results of other experiments. Drawing comparison from one clinical trial to another becomes difficult, and this situation gives an inkling into why drugs like Stribild are considered so essential and yet breed adverse side effects.
What are the Side Effects of Stribild?
While Stribild has proven useful in treating HIV cases, this compound drug is associated with a myriad of side effects that make the treatment journey difficult. The foremost side effect is lactic acidosis, which is an accumulation of lactic acid in the bloodstream, and then problems with the liver.
The liver is the biggest internal organ, and it has many vital functions in the human body from making proteins to synthesizing glycogen and producing bile. Understandably, a side effect of medications that affects this organ and undermines its normal function cannot be taken lightly. If you have been taking Stribild and have suffered the following symptoms, please contact your physician as soon as possible:
- Stomach pains accompanied by nausea
- Labored breathing
- Frequent lightheadedness
- General body weakness
- Pain in the muscles
- An abnormal heartbeat
The above symptoms are indicative of lactic acidosis, but you can only get diagnosed upon getting a thorough exam by a doctor. Stribild users can also suffer signs of liver problems as listed below:
- Yellowing of the skin or jaundice
- Little to no appetite for days on end
- Mild to extreme nausea
- Dark-colored urine
- Abdominal pain
- Bowel movements with a light color
Apart from the specific symptoms above, HIV patients consuming Stribild can experience a change in their immune system that influences how their bodies respond to infections. This condition is known as immune reconstitution inflammatory syndrome (IRIS), and it is common when a patient is undergoing HIV treatment. As the immune system regains strength, it may start responding quicker to infections that were previously undetected.
Osteopenia is yet another side effect of taking Stribild where the bones start to soften and start aching. Extreme pain makes normal functioning difficult even when the bones are not brittle, and this condition can pave the way for osteoporosis. People with strong bones are not susceptible to osteopenia, unlike their counterparts whose bones are less dense.
Emotional issues like anxiety and depression are also common among patients who have been on these drugs containing TDF. They may be fearful, experience hopelessness, have trouble sleeping, or wake up swiftly. Patients also get unexpected feelings of sadness and deal with other psychological symptoms.
Experiencing any of these symptoms while undergoing treatment for HIV and related illnesses is a call for concern, and patients are advised to contact their health care provider immediately.
Gilead Sciences Inc. and Legal Woes
One of the primary goals of clinical trials is identifying if a drug causes unforeseen harm, but the research so far has misled HIV patients on the effects of taking Stribild. In spite of FDA approval, this drug and its manufacturer (Gilead Sciences Inc.) has been the focus of many lawsuits.
One particular lawsuit was filed on May 2018 by Jonathan Gary and Michael Lujano who claimed Gilead deliberately withheld safer HIV medicines. They say the company did so with the explicit intention of profiting from the monopoly. The lawsuit says executives knew of a less toxic drug that had fewer harmful effects on patients undergoing HIV treatment. More specifically, the new drug did not damage the bones and kidneys of patients as Tenofovir was known to do.
This revelation was apparently made at the turn of the millennium, but Gilead remained quiet and subsequently betraying millions of patients who were taking Tenofovir. The lawsuit described a profit-chasing game aimed at keeping the most prescribed drug reigning in the market at the expense of patients.
Michael Lujano, a co-petitioner in the suit claimed patients who took Gilead's flagship brand suffered from built-up toxicity in the bones and kidneys, the latter being vital organs. The pharmaceutical company misrepresented the side effects of taking Stribild, and so patients went on taking it. Attorneys for the AIDS Healthcare Foundation are seeking to elevate this suit to a class action. It will feature all patients taking this drug since October 2001 (FDA's approval date) to this day.
By the time Viread was approved, the company had become aware of the adverse effects of this phenomenal drug and its scientists were hard at work addressing this. Nonetheless, the drug went on to harm patients, and this triggered a series of lawsuits over the years. Also, the AIDS Healthcare Foundation called Gilead Sciences’ patents into question, and the case is still in the U.S. Circuit Court of Appeals in Washington.
The lawsuit also claimed the company failed to publish the results of the 2004 clinical trials done on patients who had active prescriptions for Tenofovir Alafenamide Fumarate (TAF). Refusing to report that a less toxic drug was available and had shown better outcomes for patients was cited as "an act of malice." At the time, Gilead Sciences claimed it had suspended the clinical trial pending additional business review. However, the discovery shows the manufacturer covered-up information so they could keep selling the more profitable version.
To make things worse, the pharmaceutical giant continued applying for more patents for the older version of the medicine despite having pledged to stop development. Gilead delayed the development of TAF, the safer drug, to extend the existing patents as they prevented competition. With this monopoly, the company could preserve its exorbitant prices and rack in billions of dollars in annual profits.
In March this year, a set of 25 plaintiffs from different parts of the country filed a lawsuit against Gilead Sciences Inc. due to the adverse side effects of Stribild. These petitioners claim they have taken this HIV drug or other TDF-centric formulations and experienced many unwanted side effects.
These HIV medications have limited bioavailability, which is the extent and rate at which the circulatory system can absorb the medicine. Bioavailability is vital for non-intravenous drugs as it establishes the correct amounts patients should take for each dose to avoid harming the body any shape or form.
Drugs that are administered intravenously are fully absorbable, but this method was not popular in the market. The company sought to develop a formulation that came in the form of tablets to woo clients, but as oral delivery of TDF has proven less effective. Patients are only absorbing limited amounts in the bloodstream, and the plaintiffs are claiming Gilead was acutely aware of this low bioavailability from the onset but kept selling the drug anyway.
At the start of the millennium, the market showed no healthy signs of an intravenous HIV drug excelling and so, the Foster City pharmaceutical manufacturer settled for an oral format of TDF instead. Low absorption means large doses of the active ingredient were added to the formulation. These excessive dosages are said to be responsible for the harmful side effects patients are experiencing.
The excess TDF dosage is deposited to the kidneys damaging the renal system over time, even reaching the final stages of renal ailments, which are fatal. The patient's skeletal system is not spared either; patients have reported suffering from osteopenia. In extreme scenarios, patients are diagnosed with osteoporosis.
Patients with bone-related ailments are unable to remain upright for long, do chores and other routine activities like walking, and those who are badly off now use wheelchairs. HIV patients battling kidney diseases from these side effects rely on daily dialysis treatments. These procedures are expensive, not to mention time-consuming.
Gilead may have weathered the storm over the past years, but lawsuits involving its HIV medications containing Tenofovir are bound to keep coming. The company requires that physicians prescribing Stribild are well informed about the drug and are furnished with essential educational materials.
These package leaflets and summary of drug characteristics usually cover the risk of kidney ailments in adolescents and adults. They also suggest measures to curb this risk and protocols for screening and monitoring patients. Nevertheless, these safety guidelines have failed to guarantee patients' well-being. After all, patients are ingesting drugs laden with active substances that harm the renal and skeletal system.
What is a Mass Tort?
Mass torts are civil actions bearing several plaintiffs who are suing one or more corporations. Depending on the prevailing circumstances, these legal processes can either be litigated in state or federal courts. Mass torts are different from personal injury lawsuits in three significant ways:
- They involve huge volumes of claims concerning one product or device
- The facts and issues under scrutiny have similar elements or are uniform for all plaintiffs
- These civil actions are interdependent in value across the various claims
The overarching goal of this litigation is to have the collective grievances of injured persons heard and tried together. This way, they leverage the economies of scale and level of efficiency. Proceedings can carry on for years before a settlement is reached, and therefore, this practice requires massive financial investments to cover the upfront and subsequent expenses.
Expenses can be in the form of expert witness fees, document preparation, evidence discovery, and travel expenses, etc. The sheer scale of mass torts calls for enlisting many support staff of paralegals, junior associates, and legal assistants to keep track of everything as the suit unfolds.
How Can I Join a Mass Tort?
Victims who wish to join a mass tort must get class certification. This document links a specific plaintiff with the lawsuit by comparing similar elements of their damages to the main trial. No class action case can proceed without certifying a class plus a host of other problems that can undermine the case.
Consumer Alert Now advises that mass torts come with a higher standard of evidence and proof that the corporation is liable for the damage inflicted on the plaintiffs, and this burden of proof stays with the legal team. Victim statements and testimony of their injuries are vital, followed by drawing direct links between these damages and the defendant.
Find a Qualified Mass Tort Attorney Near Me
If you or your loved one has been affected by the adverse side effects of Stribild, you are entitled to sue Gilead Sciences Inc. As you can see in this article, the pharmaceutical company is being accused of withholding crucial information from patients. They chose to pursue profits over the health of millions of patients who trusted them to treat their HIV symptoms and related illnesses.
Please note, not every attorney can handle mass torts. These complex litigations must be prosecuted by qualified attorneys who are endowed with vast resources to sustain the case for years if needed. For further expert advice; contact Consumer Alert Now at 800-511-0747.