What Is the Generic for Complera?

Tenofovir disoproxil fumarate (TDF) is generic for Complera and several other medications that are used in the treatment of HIV. Other names include Atripla, Truvada, Stribild and Viread.

Complera is not meant to be mixed with other drugs; it is used to treat HIV in patients who have never taken HIV medicines before. Currently, there is no generic equivalent for Complera on the market.

What Is TDF?

Complera is a prodrug, which means that it is inactive until it the patient’s system metabolizes it, at which point it becomes a medication. Originally, it was synthesized by the late Dr. Antonín Holý, a prominent Czech chemist who helped to develop several antiretroviral drugs used to treat HIV and hepatitis B as well as drugs for other viral diseases as well as cancer. 

Why Is TDF Prescribed?

The medication that is generic for Complera is indicated primarily for HIV/AIDS and chronic hepatitis B. Additionally, it may be administered prophylactically to those who are at risk for HIV and have potentially been exposed to the disease. However, it is not a cure.

TDF may be prescribed as monotherapy, or in combination with other medications, such as emtricitabine (Truvada), efavirenz, or both (Atripla). It is usually administered orally.

In addition to being used to treat HIV positive patients, TDF drugs are used in a type of therapy called pre-exposure prophylaxis, or PrEP. In this treatment, people without HIV are prescribed a TDF medication in order to reduce their risk of contracting the virus.

PrEP is recommended for people who are at a high risk of HIV infection based on their lifestyle. Taken daily, TDF PrEP treatment is reportedly highly effective.

According to the CDC, PrEP can reduce the risk of getting HIV through sex by 99 percent when TDF is taken daily. PrEP can reduce the risk of getting HIV by 74 percent among people who are at risk from injecting drugs.

How Does TDF Work?

In simple terms, TDF prevents viruses from replicating themselves. When activated by the patient’s metabolism, the active ingredient prevents the action of an enzyme known as reverse transcriptase, which is necessary for a virus to reproduce. By binding to the virus’ DNA, it stops the transcription process, preventing replication. 

Why Is the Drugmaker Being Sued?

Plaintiffs claim that TDF causes kidney and bone damage. There are also allegations that Gilead Sciences had developed a safer, more effective version of the medication, known as tenofovir alafenamide fumarate (TAF), several years ago, but withheld it from the market in order to wring as much profit as possible from the older, more dangerous version. 

Although studies have shown that TDF and TAF drugs have similar efficacies, TAF can reportedly be prescribed at much lower doses. For example, one study from 2015 found that 300 mg of TDF had similar outcomes as 10 mg of TAF when used with other HIV drugs – a common treatment regimen.

In addition, the research patients who were treated with TAF reportedly showed fewer signs of kidney injury and more mild decreases in bone mineral density when compared with TDF patients.

“A regimen based on TAF or TDF seems to be roughly equivalent in effectiveness,” the researchers concluded. “A TAF-based regimen has a reduced potential for causing kidney injury and thinning bones than a TDF-based regimen.”

Although Gilead will be transitioning to TAF drugs, plaintiffs in TDF lawsuits claim that the company should have used the safer alternative when they first discovered it instead of waiting for their TDF patent to expire. Had TAF been available, patients might have not suffered the serious side effects, plaintiffs say.

What Kind of Kidney Damage Has Been Reported?

When TDF is taken for an extended period, the result can be Fanconi Syndrome, a generalized condition in which the kidneys are unable to reabsorb many necessary biochemical substances, such as glucose, phosphorus, potassium and some amino acids. Instead, these substances are excreted through urination.

Fortunately, this damage can sometimes be reversed by discontinuing the medication.

Are There Other Side Effects of TDF?

Frequently reported side effects of TDF include diarrhea, dizziness and nausea. Other adverse effects that patients may suffer from TDF include:

• depression
• fever
• headaches
• insomnia
• itching and skin rash

According to the label warning, some patients may suffer lactic acidosis or liver injuries.

Is There a Substitute Generic for Complera?

There is no generic substitute for Complera – but TAF is the latest, safest and most effective successor to TDF. It does not appear to cause kidney damage. Another alternative is Abacavir (ABC). In a recent clinical study, patients who were switched to TAF or ABC after suffering kidney damage from long-term treatment with TDF recovered 75 percent of their normal kidney function within less than a year.