
What is PIFELTRO?
PIFELTRO is a prescription HIV-1 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-1 medicines in the past or if your healthcare provider determines that you meet certain requirements to replace your current HIV-1 medicines.
Learn about:
A low rate of side effects
In a 96-week study of adults who had never been on an HIV-1 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.

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 doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 doctor right away if you start having new symptoms after starting your HIV-1 medicine.
Your health and HIV-1
Staying undetectable
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-1 in your blood is so low that lab tests can’t detect it.
And when your HIV-1 is under control, you can focus on your health and life goals beyond HIV-1.

HIV-positive model
In a 48-week study, adults living with HIV-1 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 stayed undetectable at week 48.

PIFELTRO may not have these effects on all adults living with HIV-1.
More about this study:
Patients were undetectable (HIV-1 RNA <50 copies/mL) for at least 6 months before starting the trial and had no history of resistance* 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, or elvitegravir plus cobicistat, or an non-nucleoside reverse transcriptase inhibitor (NNRTI) before switching to a PIFELTRO-based single-tablet regimen. Patients were assigned by chance to 1 of the 2 treatment groups in the study. Patients and their healthcare providers taking part in the study knew which group they were part of.
*Resistance happens when the virus mutates and your medicine stops working.
About cholesterol
HIV-1 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-1 treatment before, 320 adults received PIFELTRO as part of a treatment regimen and 311 adults received another treatment regimen*.
PIFELTRO, as part of a treatment regimen, did not raise bad cholesterol, while the other treatment regimen did.
The benefit of these changes has not been demonstrated.
Effect on bad cholesterol (LDL-C) at week 48:

*The other treatment regimen included darunavir plus a ritonavir boost (PI + ritonavir boost), once daily.
An additional treatment consideration
Keeping a healthy weight is an important part of taking care of your health. Talk to your doctor about how PIFELTRO may affect your weight.