Model living with HIV

What is PIFELTRO?

PIFELTRO is a prescription HIV medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults.

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

PIFELTRO may be right for you if you have not received HIV medicines in the past or if your healthcare provider determines that you meet certain requirements to replace your current HIV medicines.

One Pill Taken With Other HIV Medicines Once a Day at About the Same Time Every Day With or Without Food

Learn about:

Side effects

Managing your
HIV

Cholesterol and 
PIFELTRO

A low rate of side effects

In a 96-week study of adults who had never been on an HIV treatment before, 364 adults received a PIFELTRO-based single-tablet regimen, while 364 adults received an Atripla once-daily tablet. In this study, fewer adults stopped taking a PIFELTRO-based single-tablet regimen than Atripla because of side effects.

97% of Participants Continued With A PIFELTRO® (doravirine)-Based Single-Tablet Regimen vs. 93% of Participants Continued With Atripla (efavirenz, emtricitabine, tenofovir disoproxil fumarate)

What are the most common side effects?

The most common side effects of PIFELTRO include:

  • nausea
  • dizziness
  • headache
  • tiredness
  • diarrhea
  • stomach (abdominal) pain
  • abnormal dreams

These are not all the possible side effects of PIFELTRO. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the Same 96-Week Study of Adults Who Had Never Been on an HIV-1 Treatment Before, the Most Common Side Effects of the PIFELTRO® (doravirine)-Based Single-Tablet Regimen Were: 7% Dizziness, 5% Nausea, 5% Abnormal Dreams

Changes in your immune system (immune reconstitution syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV medicine.

Your health and HIV

Staying undetectable is important

PIFELTRO, when taken as part of a multi-tablet regimen, can help you get your viral load to undetectable.

Undetectable means the level of HIV in your blood is so low that lab tests can’t detect it.

And when your HIV is under control, you can focus on your health and life goals beyond HIV.

Model living with HIV

In a 48-week study, adults living with HIV who were undetectable on their current treatment regimen switched to a PIFELTRO-based single-tablet regimen either at the start of the study, or at week 24 of the study.

At the start of the study:

  • 447 adults switched to a PIFELTRO-based single-tablet regimen.
  • 91% of those adults stayed undetectable at week 48.

At week 24 of the study:

  • 209 adults switched to a PIFELTRO-based single-tablet regimen.
  • 95% of those adults were undetectable at week 24 before switching to a PIFELTRO-based single-tablet regimen.

At week 48 of the study:

  • 95% of those adults who switched to PIFELTRO-based single-tablet regimen at week 24 stayed undetectable at week 48.
Infographic Showing the Percentage (more than 9 out of 10) of Adults Who Switched to a PIFELTRO-Based Single-Tablet Regimen and Stayed Undetectable

more than 9 out of 10

adults who completed the study stayed undetectable

PIFELTRO may not have these effects on all adults living with HIV.

More about this study:

Participants were undetectable (HIV-1 RNA <50 copies/mL) for at least 6 months before starting the trial and had no history of resistancea to the PIFELTRO-based single-tablet regimen. The current treatment regimens consisted of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a protease inhibitor (PI) plus either ritonavir or cobicistat, elvitegravir plus cobicistat, or a non-nucleoside reverse transcriptase inhibitor (NNRTI) before switching to a PIFELTRO-based single-tablet regimen. Participants were assigned by chance to one of the two treatment groups in the study. Participants and their healthcare providers taking part in the study knew which group they were part of.

aResistance happens when the virus changes form and your medicine stops working.

About cholesterol

HIV and/or treatments for HIV may have a negative impact on your “bad” cholesterol (LDL-C). In a 96-week study of adults who had never been on an HIV treatment before, 320 adults received PIFELTRO as part of a treatment regimen and 311 adults received another treatment regimen.b

PIFELTRO, as part of a treatment regimen, did not raise “bad” cholesterol, while the other treatment regimen did at week 48.

The benefit of these changes has not been demonstrated.

Effect on “bad” cholesterol (LDL-C) at week 48:

PIFELTRO as part of a treatment regimen:

The image depicts a teal box with a teal arrow pointing straight down with the text '-4.6 mg/dl of LDL-C' next to it. To the right of the teal box is the text 'vs.' To the right of ‘vs.' is an orange arrow pointing straight up. On top of the orange arrow is the text 'other treatment' with a footnote 'b' superscript attached to it. To the right of the orange arrow is the text '9.5 mg/dL of LDL-C'.
The image depicts a teal box with a teal arrow pointing straight down with the text '-4.6 mg/dl of LDL-C' next to it. To the right of the teal box is the text 'vs.' To the right of ‘vs.' is an orange arrow pointing straight up. On top of the orange arrow is the text 'other treatment' with a footnote 'b' superscript attached to it. To the right of the orange arrow is the text '9.5 mg/dL of LDL-C'.

bThe other treatment regimen included darunavir plus a ritonavir boost (PI + ritonavir boost), once daily.

Models living with HIV
Models living with HIV

Ready to learn more?

Learn about how to take PIFELTRO, side effects, and more.

Taking PIFELTRO
Safety information

What is PIFELTRO?

PIFELTRO is a prescription HIV medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Important Safety Information

Do not take PIFELTRO if you are currently taking any of the following medicines:

  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • enzalutamide
  • rifampin
  • rifapentine
  • mitotane
  • St. John’s wort

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. If you have taken any of the medicines in the past 4 weeks, talk to your healthcare provider or pharmacist before starting PIFELTRO.

 

PIFELTRO can cause serious side effects, including:

Severe skin reactions have happened in people treated with PIFELTRO. Call your healthcare provider right away if you develop a rash during treatment with PIFELTRO. Stop taking PIFELTRO and get medical help right away if you develop a painful rash with any of the following symptoms: fever, blisters or sores in the mouth, blisters or peeling of the skin, or redness or swelling of the eyes (conjunctivitis).

 

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.

 

The most common side effects of PIFELTRO include: nausea, dizziness, headache, tiredness, diarrhea, stomach (abdominal) pain, and abnormal dreams.

 

These are not all the possible side effects of PIFELTRO. For more information, ask your healthcare provider or pharmacist.

 

Before starting PIFELTRO, tell your healthcare provider about all your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if PIFELTRO can harm your unborn baby. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. PIFELTRO may pass to your baby in your breast milk. HIV may pass to your baby through your breast milk if your baby does not have HIV.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PIFELTRO. Keep a list of your medicines to show your healthcare provider and pharmacist. Tell your healthcare provider if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PIFELTRO with those other medicines.

 

Take PIFELTRO every day exactly as your healthcare provider tells you to take it. Take PIFELTRO 1 time each day, at about the same time every day.

 

Tell your healthcare provider if you have taken rifabutin in the past 4 weeks.

 

If you take the medicine rifabutin during treatment with PIFELTRO, take PIFELTRO 2 times each day, about 12 hours apart, as prescribed by your healthcare provider. You may not have enough doravirine in your blood if you take rifabutin during treatment with PIFELTRO.

 

Do not change your dose or stop taking PIFELTRO without talking to your healthcare provider. Stay under a healthcare provider’s care when taking PIFELTRO.

 

Take PIFELTRO on a regular dosing schedule as instructed by your healthcare provider. Do not miss doses.

 

If you miss a dose of PIFELTRO, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of PIFELTRO at the same time.

 

Get your PIFELTRO refilled from your healthcare provider or pharmacy before you run out.

 

When your PIFELTRO supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to PIFELTRO and become harder to treat.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch, or call 1-800-FDA-1088.

 

Please read the accompanying Patient Information for PIFELTRO and discuss it with your healthcare provider. The physician Prescribing Information also is available.

What is PIFELTRO® (doravirine)?
Important Safety Information for PIFELTRO® (doravirine)

PIFELTRO is a prescription HIV medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Important Safety Information for PIFELTRO® (doravirine)

Do not take PIFELTRO if you are currently taking any of the following medicines:

  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • enzalutamide
  • rifampin
  • rifapentine
  • mitotane
  • St. John’s wort

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. If you have taken any of the medicines in the past 4 weeks, talk to your healthcare provider or pharmacist before starting PIFELTRO.

 

PIFELTRO can cause serious side effects, including:

Severe skin reactions have happened in people treated with PIFELTRO. Call your healthcare provider right away if you develop a rash during treatment with PIFELTRO. Stop taking PIFELTRO and get medical help right away if you develop a painful rash with any of the following symptoms: fever, blisters or sores in the mouth, blisters or peeling of the skin, or redness or swelling of the eyes (conjunctivitis).

 

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.

 

The most common side effects of PIFELTRO include: nausea, dizziness, headache, tiredness, diarrhea, stomach (abdominal) pain, and abnormal dreams.

 

These are not all the possible side effects of PIFELTRO. For more information, ask your healthcare provider or pharmacist.

 

Before starting PIFELTRO, tell your healthcare provider about all your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if PIFELTRO can harm your unborn baby. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. PIFELTRO may pass to your baby in your breast milk. HIV may pass to your baby through your breast milk if your baby does not have HIV.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PIFELTRO. Keep a list of your medicines to show your healthcare provider and pharmacist. Tell your healthcare provider if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PIFELTRO with those other medicines.

 

Take PIFELTRO every day exactly as your healthcare provider tells you to take it. Take PIFELTRO 1 time each day, at about the same time every day.

 

Tell your healthcare provider if you have taken rifabutin in the past 4 weeks.

 

If you take the medicine rifabutin during treatment with PIFELTRO, take PIFELTRO 2 times each day, about 12 hours apart, as prescribed by your healthcare provider. You may not have enough doravirine in your blood if you take rifabutin during treatment with PIFELTRO.

 

Do not change your dose or stop taking PIFELTRO without talking to your healthcare provider. Stay under a healthcare provider’s care when taking PIFELTRO.

 

Take PIFELTRO on a regular dosing schedule as instructed by your healthcare provider. Do not miss doses.

 

If you miss a dose of PIFELTRO, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of PIFELTRO at the same time.

 

Get your PIFELTRO refilled from your healthcare provider or pharmacy before you run out.

 

When your PIFELTRO supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to PIFELTRO and become harder to treat.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch, or call 1-800-FDA-1088.

 

Please read the accompanying Patient Information for PIFELTRO and discuss it with your healthcare provider. The physician Prescribing Information also is available.