Pifeltro (doravirine)

What is Pifeltro (doravirine) for?

Pifeltro (doravirine) is a prescription medicine indicated to treat adults with human immunodeficiency virus type 1 (HIV-1) infection. It is used in combination with other antiretroviral medicines.^[1]

Pifeltro is not suitable for HIV-infected patients who are resistant to medicines in the same class (non-nucleoside reverse transcriptase inhibitors or NNRTIs).^[1]

It is available in tablet form each containing 100 mg doravine.^[1]

How does Pifeltro (doravirine) work?

The active ingredient in Pifeltro, doravine, is a so-called non-nucleoside reverse-transcriptase inhibitor (NNRTI). It is a type of molecule that can block the enzyme reverse transcriptase (RT), which is produced by the virus to make new copies of itself. By blocking RT), rilpivirine can lower the number of HIV particles in the blood and keep the levels low.^[2]

The medicine cannot cure HIV infection or AIDS, but it can allow the immune system to repair itself and prevent further damage.^[2]

Where has Pifeltro (doravirine) been approved?

Pifeltro (doravirine) was approved for the treatment of people with HIV-1 infection by:

• Food and Drug Administration (FDA), USA on August 30, 2018.^[3]
• European Medicines Agency (EMA) on November 22, 2018.^[4]
• Therapeutic Goods Administration (TGA), Australia on January 18, 2019.^[5]
• Health Canada on November 18, 2019.^[6]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Pifeltro (doravirine) taken?

The standard dosage is:^[1]

• One 100-mg tablet taken daily with or without food.
• When taken together with rifabutin, you should take one tablet twice daily (approximately 12 hours apart).

Warning: Pifeltro (doravirine) should not be used with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers, because these medicines may reduce the effectiveness of Pifeltro.1

Complete information about Pifeltro (doravirine) dosage and administration can be found in the official prescribing information listed in our references section.1

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Pifeltro (doravirine)?

Common adverse reactions

The most common side effects (≥5% of patients) listed in the prescribing information include:^[1]

• Nausea
• Dizziness
• Headache
• Tiredness
• Diarrhea
• Stomach (abdominal) pain
• Abnormal dreams

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Changes in your immune system (Immune Reconstitution Syndrome)

Use in a specific population

It is not known if Pifeltro (doravirine) can harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.^[1]

Mothers with a HIV-1 infection should not breastfeed, because the virus can pass to the baby via the breast milk. It is not known if the medicine can pass on to the baby via breast milk and harm your unborn baby.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDAA]: Pifeltro (doravirine) [PDF]
ViiV Healthcare, Aug 2018

2. European product information Pifeltro
EMA, Nov 2018

3. FDA Approves Merck’s Pifeltro (doravirine) for the Treatment of HIV-1 in Appropriate Patients
Drugs.com, Aug 2018

4. Australian product information Pifeltro
TGA, Jan 2019

5. Ontario and Quebec provide reimbursement for HIV therapies PIFELTRO® (doravirine) and DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate)
Newswire.ca, Nov 2019