POSSIBLE BIKTARVY SIDE EFFECTS

The most common side effects of BIKTARVY in clinical studies through 2 years were each experienced in at least 5% of people.

In clinical studies of 634 adults new to HIV-1 treatment, the most common side effects were diarrhea (6%), nausea (6%), or headache (5%).

These are not the only side effects of BIKTARVY. Tell your healthcare provider if you have any side effects that bother you or do not go away.

  • Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking BIKTARVY.
  • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking BIKTARVY.
  • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
  • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call ‍1‑800‑FDA‑10881‑800‑FDA‑1088.

Studied in a Diverse Group of Adults

BIKTARVY was evaluated in 4 clinical trials, involving more than 2,400 adults living with HIV.

  • Two studies involved more than 1,200 adults new to HIV-1 treatment (634 new to BIKTARVY and 640 new to other treatments*) over a 2-year period.
  • Two additional studies involved more than 1,100 adults who replaced or continued their current treatment (572 replaced treatment with BIKTARVY and 568 continued their current treatment**) over a 1-year period.

Results showed that BIKTARVY works in a diverse group of adults, regardless of age, sex, race, viral load, or CD4 T-cell count.

THE 2-YEAR STUDIES REVEALED

Only 1%

of adults new to treatment stopped taking BIKTARVY because of side effects

vs 2% of adults who stopped taking either one of the other treatments due to side effects.*

*The other treatments were TRIUMEQ® (abacavir, dolutegravir, lamivudine) or DESCOVY® (emtricitabine, tenofovir alafenamide) + TIVICAY® (dolutegravir).

**The continued treatments were TRIUMEQ (abacavir, dolutegravir, lamivudine), or a combination of either EPZICOM® (abacavir, lamivudine) or TRUVADA® (emtricitabine, tenofovir disoproxil fumarate) + atazanavir or darunavir (with cobicistat or ritonavir).

Please see Important Facts about BIKTARVY® and DESCOVY®, including important warnings.

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