Yes, Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) can increase cholesterol levels but this does not appear to be a frequent or serious side effect. Elevated LDL cholesterol (greater than 190 mg/dL) has been reported in 2% to 3% of patients (2 to 3 out of every 100 patients) taking Biktarvy in a clinical trial conducted by the manufacturer.

LDL (low density lipoprotein), sometimes called “bad” cholesterol, can increase your risk for heart disease, heart attack or stroke if left unchecked. Results can differ between patients, and cholesterol levels can increase due to age or other factors. It is important that you discuss your overall health with your doctor and determine if regular blood tests are needed to check your cholesterol levels.

Tenofovir alafenamide (TAF), as a component of Biktarvy, has been linked with slight increases in LDL cholesterol. However, research suggests the risk may be modest. Tenofovir disoproxil fumarate (TDF) has been linked with a lowering of lipids, but the clinical significance of this finding is not known.

• In a randomized, clinical study of TAF in patients new to antiretroviral treatment, levels of LDL ("bad") cholesterol, HDL (“good”) cholesterol, and triglycerides were elevated compared to tenofovir disoproxil fumarate (TDF). However, the total cholesterol to high-density lipoprotein ratio was unchanged for both, so the overall clinical impact is unknown, but there may be little difference.
• Low-density lipoprotein (LDL) cholesterol elevations were more common in the group that received TAF compared to those receiving TDF (9% vs. 3%); however the absolute increase in LDL cholesterol (17 mg/dL vs. 11 mg/dL) was not significant (P=0.11).
• At week 48, no differences in total cholesterol (P=0.54) or LDL cholesterol (P=0.37) were seen when patients were analyzed using the National Cholesterol Education Program (NCEP ATPIII) Adult Treatment Panel classification system, and no differences were seen in triglyceride changes.

Biktarvy has also been reported to elevated LDL cholesterol in other randomized, controlled studies from 2% to 5% of participants. TAF is also found in other combination medications used for HIV treatment or prevention.

What other side effects occur with Biktarvy?

Overall, Biktarvy is well-tolerated by most patients. In three-year studies completed by the manufacturer, only 1% of adults who received Biktavry as their first HIV treatment stopped the medicine due to side effects.

The most common side effects with Biktary include: diarrhea (in 6% of patients), nausea (6%), and headache (5%).

Biktarvy may also worsen hepatitis B (HBV) infection. If you have both HIV-1 and HBV and stop taking this treatment, your HBV may suddenly worsen. Do not stop taking Biktarvy without first talking to your health care provider, as they will need to monitor your health.

Other serious side effects for Biktarvy include:

• immune system changes
• kidney problems, including kidney failure
• liver problems, which may rarely lead to death
• too much lactic acid in your blood (lactic acidosis)

These are not all the side effects reported with Biktary. Tell your doctor immediately if any new or worsening side effects occur during treatment. You can review a full list of side effects here.

How is Biktarvy used in HIV treatment?

Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide, often abbreviated BIC/FTC/TAF), was first approved in 2018 to treat HIV. Biktarvy is for use in adults and children who weigh at least 31 pounds (14 kilograms). The manufacturer is Gilead Sciences.

Biktarvy is not a cure for HIV or AIDS, but can help many people achieve and maintain undetectable viral loads.

Biktarvy is taken as once-daily, single tablet regimen for the treatment of two HIV groups:

• those who have no antiretroviral treatment history
• those who are already virologically suppressed on another stable HIV regimen with no history of treatment failure or known resistance.

Bottom Line

• Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) can increase cholesterol levels due to the tenofovir alafenamide (TAF) component, but this does not appear to be a frequent or significant side effect.
• Elevated LDL ("bad") cholesterol (greater than 190 mg/dL) has been reported in 2% to 3% of patients (2 to 3 out of every 100 patients) taking Biktarvy in one clinical trial.
• Biktarvy is well-tolerated by most patients. The most common side effects with Biktary may include diarrhea (in 6% of patients), nausea (6%) and headache (5%).

This is not all the information you need to know about Biktarvy for safe and effective use. Review the full Biktarvy product information here, and review this information with your health care provider.