TROGARZO is a drug for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults who:
- have received several anti-HIV-1 regimens in the past, and
- have HIV-1 virus that is not responding to many antiretroviral medicines, and
- who are failing their current antiretroviral therapy
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
TROGARZO is used in combination with other antiretroviral medications. TROGARZO is is given by a health care professional once every two weeks directly into the bloodstream through a needle in the vein. This is known as an intravenous, or IV infusion. It takes 15-30 minutes to receive TROGARZO infusion.
A new DRUG TRIALS SNAPSHOT is now available
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 TROGARZO 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 TROGARZO Package Insert for complete information.
TROGARZO (ibalizumab-uiyk)
(tro-gar-zo)
Thera
Approval date: March 6, 2018
(tro-gar-zo)
Thera
Approval date: March 6, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
TROGARZO is a drug for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults who:
- have received several anti-HIV-1 regimens in the past, and
- have HIV-1 virus that is not responding to many antiretroviral medicines, and
- who are failing their current antiretroviral therapy
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
How is this drug used?
TROGARZO is used in combination with other antiretroviral medications.
TROGARZO is is given by a health care professional once every two weeks directly into the bloodstream through a needle in the vein. This is known as an intravenous, or IV infusion. It takes 15-30 minutes to receive TROGARZO infusion.
What are the benefits of this drug?
In the trial, 33 of the 40 patients (83%) treated with TROGARZO experienced a significant decrease in their HIV-RNA levels one week after TROGARZO was added to their failing antiretroviral regimens.
After 24 weeks of TROGARZO treatment (in combination with other antiretroviral drugs), 43 % of the patients achieved HIV RNA suppression.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
The trial was too small to determine the differences among sex, race and age subgroups.
What are the possible side effects?
During the initial phase of treatment with TROGARZO, the immune system may get stronger and begin to fight infections that were hidden (a condition called immune reconstitution syndrome). Immune reconstitution syndrome is a serious condition.
The most common side effects of TROGARZO include diarrhea, dizziness, nausea, and rash.
Were there any differences in side effects among sex, race and age?
The trial was too small to determine differences in side effects among sex, race and age subgroups.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved TROGARZO based on evidence from one clinical trial (NCT02475629) of 40 adult patients with HIV-1 infection who did not respond to various anti-HIV treatments anymore.
The trial was conducted in the United States and Taiwan.
Figures 1, 2, and 3 summarize how many patients participated in the clinical trial 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
Race
|
Number of Patients
|
Percentage
|
|---|---|---|
White
|
22
|
55
|
Black or African American
|
13
|
32
|
Asian
|
4
|
10
|
Not reported
|
1
|
3
|
FDA review
Figure 3. Baseline Demographics by Age
FDA review
How were the trials designed?
The benefits and side effects of TROGARZO were studied in one clinical trial that enrolled patients with HIV-1 infection who did not respond to various anti-HIV treatments anymore.
The trial consisted of three periods:
The trial consisted of three periods:
- An observation period from Day 0 to Day 6, during which patients continued their old therapy
- A therapy period from Day 7 to Day 13, during which patients received TROGARZO and continued their old therapy, and
- A maintenance period from Day 14 to Week 25 during which patients received lower dose of TROGARZO plus other anti-HIV drugs
The benefit of TROGARZO was assessed by measuring the number of HIV-1 copies in the blood from Day 7 to Day 14.
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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