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Drug Trials Snapshot: BIKTARVY
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the BIKTARVY Package Insert for complete information.
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the BIKTARVY Package Insert for complete information.
BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide)
(bik-TAR-vee)
Gilead Sciences
Approval date: February 7, 2018
(bik-TAR-vee)
Gilead Sciences
Approval date: February 7, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
BIKTARVY is a drug for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. BIKTARVY is a combination of three antiviral drugs in a single tablet: bictegravir (new drug for HIV-1 treatment), emtricitabine, and tenofovir alafenamide (previously approved for HIV-1 treatment).
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
How is this drug used?
BIKTARVY is a tablet that is taken once daily with or without food.
What are the benefits of this drug?
In patients with HIV-1 infection, BIKTARVY decreases viral load (number of HIV-1 copies in the blood) and increases the number of immune cells in the blood (CD4 count).
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: BIKTARVY worked similarly in men and women.
- Race: BIKTARVY worked similarly in White and Black or African American patients. The number of patients in other races was small; therefore, differences in how the drug worked in other races could not be determined.
- Age: BIKTARVY worked similarly in patients below or above 50 years of age. The number of patients older than 65 years of age was small. Therefore, differences in how well the drug worked in patients above 65 years of age could not be determined.
What are the possible side effects?
BIKTRAVY may cause serious side effects:
- Worsening of hepatitis B infection may occur after discontinuation of BIKTARVY treatment in patients infected with HIV-1 and hepatitis B.
- During the initial phase of treatment with BIKTARVY, the immune system may get stronger and begin to fight infections that were hidden (a condition called immune reconstitution syndrome).
- New or worsening kidney problems.
- Build-up of lactic acid in the blood with enlargement of the liver, which may be fatal.
The most common side effects of BIKTARVY include diarrhea, nausea, and headache.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in men and women.
- Race: The occurrence of side effects was similar in White and Black or African American patients. The number of patients in other races was small; therefore, differences in side effects among other races could not be determined.
- Age: The occurrence of side effects was similar in patients younger or older than 50 years of age. The number of patients 65 years of age or older was small; therefore, differences in side effects among patients older than 65 years of age could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved BIKTARVY based on evidence from four clinical trials of 2,414 adult patients with HIV-1 infection. Two trials (Trial 1489-NCT 02607930, and Trial 1490- NCT 02607956) studied patients who had not received antiretroviral therapy in the past, and two trials (Trial 1844-NCT 0260312, and Trial 1878-NCT 02603107) studied patients who were treated with antiretroviral drugs that had resulted in suppression of HIV viral load for at least 3 months and who were switched to BIKTARVY.
The trials were conducted at 465 centers in 34 countries including the United States.
Figures 1, 2, and 3 summarize how many patients participated in the clinical trials by sex, race and age.
Figure 1. Baseline Demographics by Sex
FDA review
Figure 2. Baseline Demographics by Race
FDA review
Table 1. Baseline Demographics by Race
| Number of Patients | Percentage | |
|---|---|---|
| Race | ||
| White | 1523 | 63 |
| Black or African American | 695 | 29 |
| Asian | 67 | 3 |
| American Indian or Alaska Native | 18 | less than 1 |
| Native Hawaiian or Pacific Islander | 7 | less than 1 |
| Other/Unknown | 104 | 4 |
FDA review
Figure 3. Baseline Demographics by Age
FDA review
How were the trials designed?
The benefits and side effects of BIKTARVY were studied in four clinical trials. Two trials were in adults who had not received HIV-1 treatment in the past. In these two trials, patients were randomly assigned to receive either BIKTARVY or another HIV-1 treatment, and neither the patient or the healthcare provider knew which treatment was being given until after the trials were completed.
The other two trials were in patients who were receiving HIV-1 treatment that had resulted in suppression of HIV-1 viral load. These patients were randomly assigned to continue their treatment or switch to BIKTARVY. In one trial (Trial 1844), neither the patients or the healthcare providers knew which medication was being given until after the trial was completed. In the other trial (Trial 1878), both, patients and healthcare providers knew which medication was being given.
The benefit of BICTRAVY in all four trials was assessed by measuring the number of HIV-1 copies in the blood after 48 weeks of treatment.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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