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  5. Drug Trials Snapshots: GENVOYA
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Drug Trials Snapshots: GENVOYA

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.

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 GENVOYA Prescribing Information for complete information.

GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets
jen-VOY-uh
Gilead Sciences
Approval date: November 5, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

GENVOYA is a drug for the treatment of HIV-1 infection in adults and children 12 years of age and older. It is a fixed-dose combination tablet, which means GENVOYA includes more than one drug combined in a single tablet.

How is this drug used?

GENVOYA is a tablet that is taken by mouth with food once a day.

GENVOYA should not be given with other antiretroviral products and may have drug interactions with a number of other commonly used medications.

What are the benefits of this drug?

GENVOYA reduced viral load and is comparable to other treatments.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

Subgroup analyses were conducted for sex, race and age.

  • Sex: GENVOYA worked similarly in men and women.
  • Race: GENVOYA worked similarly in Whites, Blacks, and Asians.
  • Age: The majority of patients in the trials were below 65 years of age. Differences in how well GENVOYA worked between those below and above 65 years of age could not be determined.

What are the possible side effects?

The most common side effect associated with GENVOYA is nausea. Serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system (immune reconstitution syndrome).

GENVOYA can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal.

Patients receiving GENVOYA experienced significantly higher increases in serum cholesterol (both total and LDL, or “bad”, cholesterol) compared to patients receiving another HIV medication in the clinical trials.

GENVOYA is not approved to treat chronic hepatitis B virus infection.

Were there any differences in side effects among sex, race and age?

Subgroup analyses were conducted for sex, race and age.

  • Sex: The risk of side effects was similar in men and women.
  • Race: The risk of side effects was similar in black and non-black patients.
  • Age: The majority of patients in the trials were below 65 years of age. Differences in the risk of side effects between those below and above 65 years of age could not be determined.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved GENVOYA based on evidence from 4 clinical trials of 3,171 adults and one trial of 23 children with HIV.

Figure 1 summarizes how many men and women were enrolled in the clinical trials in adults.

Figure 1. Baseline Demographics by Sex--Adults

Pie chart summarizing how many men and women were enrolled in the clinical trial used to evaluate efficacy of the drug GENVOYA.  In total, 2746 men (87%) and 425 women (13%) participated in the clinical trial used to evaluate efficacy of the drug GENVOYA.

Clinical Trial Data

Figure 2 summarizes how many boys and girls were enrolled in the clinical trial in children.

Figure 2. Baseline Demographics by Sex for Children

Pie chart summarizing how many boys and girls were enrolled in the clinical trial used to evaluate efficacy of the drug GENVOYA.  In total, 12 boys (52%) and 11 girls (48%) participated in the clinical trial used to evaluate efficacy of the drug GENVOYA.

Clinical Trial Data

Figure 3 and Table 1 summarize the percentage of adults by race enrolled in the clinical trials.

Figure 3. Baseline Demographics by Race--Adults

Pie chart summarizing the percentage of patients by race enrolled in the GENVOYA clinical trial. In total, 21 American Indian or Alaskan Natives (<1%), 275 Asians (9%), 732 Black or African Americans (23%), 18 Native Hawaiian or Pacific Islanders (<1%), 1933 Whites (61%), and 2 not permitted (<1%) participated in the clinical trial.

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Not permitted=collection of race data not permitted in all countries
Clinical Trial Data

Table 1. Demographics of Efficacy Trials by Race--Adults

Race Number of Patients Percentage
American Indian or Alaska Native 21 <1%
Asian 275 9%
Black or African American 732 23%
Native Hawaiian or Pacific Islander 18 <1%
White 1933 61%
Not Permitted 2 <1%

<1%=less than="">
Not permitted=collection of race data not permitted in all countries
Clinical Trial Data

Figure 4 and Table 2 summarize the percentage of children by race enrolled in the clinical trial.

Figure 4. Baseline Demographics by Race—Children

Pie chart summarizing the percentage of children by race enrolled in the GENVOYA clinical trial. In total, 4 Asians (17%) and 19 Black or African Americans (83%) participated in the clinical trial.

Clinical Trial Data

Table 2. Baseline Demographics by Race—Children

Race Number of Patients Percentage
Asian 4 17%
Black or African American 19 83%

Clinical Trial Data

Figure 5 summarizes how many patients adults by age were enrolled in the clinical trials.

Figure 5. Baseline Demographics by Age—Adults

Pie chart summarizing how many individuals of certain age groups were enrolled in the GENVOYA clinical trial.  In total, 3,080 participants were below 65 years old (97%) and 91 participants were 65 and older (3%).

Clinical Trial Data

How were the trials designed?

GENVOYA was evaluated in four clinical trials in adults and one clinical trial in adolescents. In the adult trials, patients were randomly assigned to receive GENVOYA or another FDA approved HIV treatment.  In the adolescent trial, all patients received GENVOYA.

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.

PRESCRIBING INFORMATION

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