PIFELTRO is a prescription HIV-1 medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who
PIFELTRO is a prescription HIV-1 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).
You and your doctor can decide if PIFELTRO could be right for you.
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.
continued with a PIFELTRO-based single-tablet regimen
3% discontinued treatment due to side effects
93% continued with Atripla (EFV/FTC/TDF)
7% discontinued treatment due to side effects
Definitions
EFV, efavirenz; FTC, emtricitabine; TDF, tenofovir disoproxil fumarate.
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-based single-tablet regimen were:
DIZZINESS
NAUSEA
ABNORMAL DREAMS
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. Call your doctor for medical advice about side effects. You may report side effects to 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 any new symptoms after starting your HIV-1 medicine.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call FDA at 1-800-FDA-1088.
Please read the Patient Information for PIFELTROTM (doravirine) and discuss it with your doctor. The physician Prescribing Information also is available.