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New Warnings About HIV Drug Intelence

Stevens-Johnson-Syndrome-08-27-09.jpgJohnson & Johnson’s HIV drug Intelence may cause deadly allergic reactions and liver damage. It has been linked to Stevens-Johnson Syndrome (also known as toxic epidermal necrolysis), an allergic reaction that starts with flu-like symptoms and a rash, and which may develop into blisters and shedding of skin. There has been one reported death from Intelence-related Stevens-Johnson Syndrome.

The drug company has appropriately warned physicians to watch for possible reactions, and the drug’s label has been revised.

Intelence History

Intelence is a brand name for the drug Etravirine, which is an antiretroviral medication used to treat human immunodeficiency virus (HIV) infection. Intelence was developed by Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson. It was the first NNRTI to be approved in a decade and the first to be approved in the US that was shown to be effective against HIV that was resistant to other NNRTIs.

What Is a TNRTI?

TNRTI stands for “Transcription Nucleoside/Tide Reverse Transcriptase Inhibitor.” It is a type of medication used to treat HIV infection by inhibiting the action of reverse transcriptase, which is an enzyme that is necessary for HIV replication. TNRTIs are nucleoside or nucleotide analogs, which means they mimic the natural building blocks of DNA and RNA, and are incorporated into the viral DNA chain during reverse transcription. Once incorporated, they cause premature termination of the viral DNA chain, which ultimately prevents the virus from replicating and spreading throughout the body. Some examples of TNRTIs include lamivudine, emtricitabine, and tenofovir.

The following is a list of NNRTI drugs:

  1. Efavirenz  Sustiva)
  2. Rilpivirine (Edurant)
  3. Delavirdine (Rescriptor)
  4. Nevirapine (Viramune)
  5. Doravirine (Pifeltro)

When Was Intelence Approved By the FDA?

Etravirine was approved by the U.S. Food and Drug Administration (FDA) in 2008 for use in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults who have failed prior HIV therapy. It works by blocking the reverse transcriptase enzyme, which the virus uses to replicate. It was approved using the Accelerated Approval Program.  As of 2023, the FDA has yet to use this pathway for a drug that treats HIV.

Since its approval, Intelence has been used by many people living with HIV and has been shown to be effective in suppressing the virus. However, like all medications, it can cause side effects, including nausea, diarrhea, headache, and rash.

In 2013, the FDA approved a new tablet formulation of Intelence that can be taken once daily instead of twice daily, which may improve adherence to the medication.

Intelence Side Effects

Intelence (etravirine) is a medication used in combination with other antiretroviral drugs to treat HIV infection. Like all medications, it can cause side effects. Some of the common side effects of Intelence include:

  • Nausea
  • Diarrhea
  • Rash
  • Fatigue
  • Headache
  • Insomnia
  • Abdominal pain
  • Dizziness
  • Vomiting
  • Elevated liver enzymes

Some people may also experience more serious side effects, such as an allergic reaction, liver toxicity, or a severe skin reaction called Stevens-Johnson syndrome.

Is There a Generic for Intelence?

Amneal’s etravirine is a generic equivalent of Intelence and is indicated for HIV treatment in 2021.

Are There Any Intelence Lawsuits?

None that we are award of. There is a lawsuit involving Truvada, which is another HIV drug.