w hen you're suffering from a serious disease, it's natural to seek relief wherever you can find it. However, many of the pharmaceutical solutions to illnesses that are offered on the market today come with serious side effects, and if you don't read the fine print, you could be blindsided when these dangerous comorbid conditions come home to roost. While drugs made by the international pharmaceutical giant Gilead may be designed to help people who have AIDS and related conditions, this purported reduction of symptoms often comes at a great cost; whether you've already been harmed by Gilead or you're considering trying a product made by this company, you should gain as much insight as possible into the potential dangers that these drugs can pose.
What is Gilead?
g ilead, or Gilead Sciences, is an American biotechnology company that serves customers all around the world. This company was founded in 1987, and since then, they have produced a number of antiviral drugs that are designed to combat conditions such as HIV, hepatitis, and the flu. Gilead is listed on the S&P 500, and its yearly earnings are counted in the billions of dollars.
This company burst onto the scene right when HIV and AIDS were starting to become international terrors, and there's something about this timing that reeks of opportunism. Sure enough, one of the most constant criticisms leveled at Gilead is that they are exploiting their customers with the incredibly high prices that many of their drugs command. To make matters even worse, Gilead drugs are notorious for their serious side effects, which can be even more damaging than the conditions they are designed to treat. Like many competitive drug companies around the world, Gilead was started by a venture capital firm, and it's plain to see that the primary purpose of this company is to make money.
Over the years, Gilead has faced a number of lawsuits, and their drugs have made headlines again and again, and usually not for positive reasons. Nonetheless, many people who have HIV, AIDS, and other conditions look to the drugs made by Gilead as lifelines leading out of their desperate situations, and it appears that this desperation plays a critical role in this company's business model.
What Drugs Does Gilead Make?
h ere are some examples of the types of drugs that are manufactured by this company:
Viread (tenofovir disoproxil fumarate)
v iread, which is a form of tenofovir disoproxil fumarate (or "tenofovir") for short, is a common component of the drug regimen that is prescribed to treat HIV. It is an antiviral medication, and its primary purpose is to slow the multiplication of the HIV virus within the human body. This drug is not meant to be a cure for HIV or AIDS, and the most that it can do is reduce the symptoms of these diseases.
Tenofovir can also be used to treat hepatitis B, but it is not considered to be a cure for this disease. Like AIDS, the symptoms of hepatitis B are caused by a virus, and Viread is designed to slow the multiplication of the hepatitis B virus within the human body.
The FDA approved Viread for consumer sale in 2001, and this drug went through a stringent approval process before it was allowed on the market. A number of medical and pharmacological reviews were conducted into the safety of this drug, and chemistry and microbiology reviews were also performed. While the FDA was well aware of the potential dangers that this drug could pose to HIV and hepatitis B patients, it was approved anyway, and it has not come under significant scrutiny from this regulatory body in subsequent years.
Truvada (emtricitabine and tenofovir disoproxil fumarate)
t ruvada is another popular drug from Gilead, and it includes two of the components that are also used in a number of other HIV/AIDS drugs. This drug is considered to be an antiretroviral medication, which means that it is designed to combat retroviruses such as HIV. Like Viread, Truvada reduces the levels of the HIV virus present in the body, and this respite allows the immune system to return to semi-normal functionality.
Specifically, Truvada is a type of antiretroviral medication called a nucleoside reverse transcriptase inhibitor (NRTI), and it is one of only a handful of these medication types on the market. Truvada can cause serious side effects, and these effects can even end up being fatal under certain circumstances. A number of scientific reviews were undertaken to determine the safety and effectiveness of this drug in preparation for FDA approval, and Truvada was eventually approved in 2004. Since then, the FDA has not taken any action to remove Truvada from the market.
Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate)
a tripla has all of the ingredients of Truvada, but it also includes efavirenz, which is a type of antiretroviral medication that was approved shortly after the release of Truvada. Like Viread and Truvada, Atripla is designed to reduce the symptoms of HIV/AIDS, and it is not a cure for either of these conditions. Since it includes efavirenz, however, which belongs to a relatively new class of drugs called non-nucleoside reverse transcriptase inhibitors, Atripla has a mode of action that is somewhat different from its predecessors, and some consider it to be a more effective treatment for HIV and AIDS.
Stribild (elvitegravir, cobicistat, tenofovir disoproxil fumarate, and emtricitabine)
s ince Stribild contains four different drugs, it is sometimes known as the "quad pill." The FDA approved this drug in 2012, and this drug combats HIV and AIDS in a slightly different way than any of its predecessors. Cobicistat makes it harder for your liver to break down antiviral medications, which means that all of the other drugs in Stribild can be included in lesser quantities than were included in previous AIDS medications made by Gilead. Unsurprisingly, the inclusion of this ingredient means that Stribild is harder on your liver than any of its predecessors, but it was approved by the FDA anyway.
Complera (rilpivirine, tenofovir disoproxil fumarate, and emtricitabine)
c omplera was approved by the FDA in 2011, and it contains both nucleoside reverse transcriptase inhibitors (NRTI) and non-nucleoside reverse transcriptase inhibitors (NNRTI). While Complera consists of three different drugs, it is produced in a single tablet. Interestingly, Complera can only be used in patients who have never tired an HIV medicine before, and this drug can't be taken in conjunction with any other HIV drugs.
Recommended Doses for Gilead Drugs
- Viread: One 300 mg tablet should be taken daily, and this drug can be taken with or without food. This drug also comes in a diluted powder form for people who cannot swallow pills, and the 7.5 scoops of the oral powder should be taken daily as a substitute for the daily pill. This drug is also used to treat hepatitis B, but the suggested duration of application of Viread for this disease is unspecified
- Truvada: One 500 mg tablet of Truvada should be taken daily with or without food. If your kidney function is impaired, it may be recommended that Truvada be taken every 48 hours instead of every day.
- Atripla: Atripla contains 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir. One tablet of Atripla should be taken each day on an empty stomach, and it is recommended that this drug be taken before bed to reduce the intensity of its neurological side effects.
- Stribild: Stribild is available in two forms; as a film-coated tablet and as a normal tablet. The filmed tablet only comes in one strength, but the normal tablet comes in two different strengths. In either case, it is recommended that one Stribild tablet be taken per day with food.
- Complera: Complera comes in both a film-coated tablet and a normal tablet. In either case, one tablet of this drug should be taken per day with food.
Intended Effects of Gilead Drugs
w hile the AIDS drugs made by this company differ in some relatively significant ways, they are all designed to make it harder for the HIV virus to replicate in your body. This function in no way removes HIV from your body, it just makes your system a more inhospitable place for this virus. The cure for AIDS has yet to be announced, which means that the reduction in symptoms caused by drugs like Viread and Stribild is all that HIV and AIDS patients can hope for.
Most people who have HIV will eventually develop AIDS whether or not they take drugs made by Gilead, and most people who already have AIDS will still experience the steady, slow decline of their health that is associated with this immune disease. However, if you take the drugs made by this company, it will take longer for you to contract AIDS, and it will also take longer for you to die from this disease after you acquire it. For many people with these terrifying conditions, that consolation is worth the heavy price tag with which Gilead saddles their anti-AIDS medications.
Gilead Drug Interactions
e ach type of drug created by Gilead interacts negatively with hundreds of other drugs, so it would be unreasonable to list each interaction. While hundreds of these reactions are mild, hundreds of others can be severe or life-threatening. Always consult with your doctor before you start using one of the drugs made by this company, and make sure that you have a full list of all of the drugs that you are currently using.
It's also important to point out that none of these drugs should be used with each other under any circumstances. While many of the types of HIV drugs that were developed by Gilead early in its history as a company have since been combined into single pills, these combinations have been done with extreme accuracy and care, and many of the drugs that are contained in these multi-drug pills would interact with each other if multiple Gilead HIV medications were taken simultaneously. In some cases, these interactions are so severe that your doctor may forbid you from trying a newer Gilead concoction if you've already tried one of their pills in the past.
Gilead Drug Contraindications
a contraindication is a reason why you shouldn't use a certain drug. Here are the contraindications for each type of drug created by Gilead:
- Viread: Viread is listed as having no contraindications, which means that no preexisting conditions or other drug usages should interfere with the process of prescribing this medication. However, it should be pointed out that this contraindication information is from 2001, when Viread was approved by the FDA, and has since been countermanded by evidence that this drug shouldn't be used under certain circumstances.
- Truvada: Truvada is listed as being contraindicated in individuals who want to take this drug for HIV-1 PrEP if said individuals have an unknown or positive HIV-1 status. HIV-1 PrEP stands for pre-exposure prophylaxis, and people follow this procedure if they are concerned that they will be exposed to HIV. This practice decreases the likelihood of developing HIV through sex by 90 percent, and it decreases the likelihood of developing HIV through intravenous drug use by 70 percent.
- Atripla: Patients who have previously demonstrated hypersensitivity to efavirenz shouldn't use Atripla, and it also shouldn't be coadministered with voriconazole or elbasvir.
- Stribild: Stribild shouldn't be used with any drugs that use Cytochrome P4503A (CYP3A), which is the most important enzyme in many types of digestion. This treatment also shouldn't be coadministered with drugs that can create elevated plasma levels.
- Complera: There are a variety of drugs with which Complera is contraindicated. Consult with your doctor to learn more.
Gilead Drug Warnings
The FDA has included warnings for each Gilead drug. More information on the potentially deleterious effects of these drugs is covered in the side effects section.
- Viread: When patients using Viread for hepatitis B stop using this drug, their hepatitis B symptoms can become more intense. It's important to submit to appropriate monitoring after discontinuing the use of this drug for hepatitis B.
- Truvada: The FDA reiterates their warnings for Viread for Truvada. In addition, however, the FDA points out that Truvada should only be used for HIV PrEP immediately after it is prescribed, and it must be re-prescribed every three months. Some individuals who used Truvada for HIV PrEP developed drug-resistant strains of this disease while they were using the drug. Furthermore, Truvada should not be used for HIV prep unless an HIV test comes back as negative.
- Atripla: The FDA reiterates their hepatitis B warnings for Atripla but also points out that acute exacerbations of hepatitis B following treatment are much more common in patients who are coinfected with HIV.
- Stribild: The same warnings are given for Stribild as were given for Atripla.
- Complera: The FDA warns that Complera is not approved for the treatment of hepatitis B, and then this regulatory body goes on to reiterates the warnings it gave for Stribild and Atripla.
Side Effects of Gilead Drugs
h ere is a list of some of the incredibly serious side effects that have been associated with these drugs. In most cases, these side effects are associated with each HIV drug that Gilead has produced.
Bone Effects: Drugs that contain Viread can decrease bone mineral density (BMD) and increase bone cell turnover rates, which leads to dangerously compromised bone structure. In essence, Viread can increase bone pain and make people more susceptible to fractures.
- Immune Reconstitution Syndrome: Some people who have used drugs containing Viread have developed serious inflammatory reactions to infections that previously hadn't caused any issues.
- Lactic Acidosis: Some patients who have used Viread drugs have developed lactic acidosis, which causes the pH in your bloodstream to drop to dangerous levels.
- Renal Impairment: Use of drugs containing Viread has caused kidney damage or even complete kidney failure in some patients.
- Early Failure: In some of the earlier Gilead HIV drugs, such as Viread and Truvada, early treatment failure was noted. In reaction to these failures, non-nucleoside reverse transcriptase inhibitors (NNRTIs) were included to complement the nucleoside reverse transcriptase inhibitors (NRTIs) that are contained in these drugs. Early virological failure is when an anti-HIV drug stops working prematurely and drug-resistant virus mutations set in almost immediately, which can also impact the effect of subsequent anti-HIV treatments.
- Skin Reactions: Severe skin rashes have been noted in patients who used Atripla and Complera.
- Hepatoxicity: Some people who used Atripla and Complera developed hepatitis while they formerly had perfectly functioning livers.
- Psychiatric Issues: Many people who used Complera and Atripla have complained of psychological issues associated with these drugs.
The Gilead Controversy
w ith all of the side effects that have been noted in relation to Gilead formulations, it's no wonder that this company has been caught in the center of a swirling controversy for decades. As if it weren't enough that Gilead's drugs were disturbingly unsafe, however, this company's business practices have also been called into question on numerous occasions.
In 2015, for instance, a Senate Finance Committee investigation uncovered that Gilead purposefully set an exorbitantly high price for a hepatitis C treatment despite knowing that the public would react negatively. The cost of this treatment, known as Sovaldi, was set at $84,000 largely to please shareholders. To add injury to insult, the exorbitant prices commanded by Sovaldi come with side effects such as liver failure. It was revealed that the company had a potential price range of $50,000 to $115,000 to work with, and they chose their final price arbitrarily.
Gilead justified this action by stating that drug prices must remain high to pay for "innovation." In 2017, this company also bought a company responsible for creating a promising cancer drug, and it's expected that they will set treatment prices at around $750,000.
It's also worth pointing out that Gilead developed another drug at the same time they developed Viread, which was their first blockbuster HIV medication. This drug is called tenofovir alefanemide (TAF), but it wasn't released until the company developed Odefsy and Descovy in 2014 and 2016 respectively. While TAF is relatively safe, the active ingredient in Viread, TDF, has a low absorption rate, and it has proven to be incredibly harmful. It's a mystery why Gilead didn't release their safer drug at the same time as Viread or alter Viread to be more similar to TAF since they already had the R&D infrastructure in place.
Since Gilead was given its original funding by a venture capital firm, it's unsurprising that this company would put profits before people. However, those who prey on the weak are hated by society, and those who exploit the sick to increase quarterly earnings are doubly hated.
Legal Action Against Gilead
g ilead has been the target of many legal attacks ever since Viread was released. Many of these cases have been brought about by whistleblowers who used to be employees, and the majority of them have been settled. Companies like Gilead are used to paying out billions of dollars to continue making profits off of people's distress, and fending off legal attacks is just a day in the life for executives at this company.
However, a previously dismissed whistleblower case was revived in 2017 by the Ninth Circuit Court of Appeals. The plaintiffs in this case assert that Gilead lied to the FDA during the approval process for Viread about the ingredients contained in this drug, and if true, this would be a violation of the False Claims Act. However, that's not the only potential horror on Gilead's shareholders' horizon.
A suit by two California men who developed kidney and bone problems after using Truvada has become a class-action lawsuit. The men caught on to the fact that Gilead perplexingly withheld the release of a much safer HIV drug and marketed Viread instead, which is a component of Truvada. They allege that Gilead purposefully misconstrued the effects of Viread while keeping a much safer alternative off the market and on the shelf.
Find a Gilead Lawsuit Expert Near Me
t hings don't look good for Gilead, but things are looking up for the people that this company has hurt. If you've been hurt by a drug made by Gilead, there's still hope. Consumer Alert Now serves people all around the country, and this company standing by to help you get the justice you need for your drug injury through a Gilead lawsuit. To get started, reach out to the legal experts at Consumer Alert Now by calling (800) 511-0747 today.