TROGARZO® (ibalizumab-uiyk) offers powerful, durable virological response for HIV-1 patients with second-line regimen failure, and beyond.1, 2
AT 7 DAYS POST-LOADING DOSE
(TROGARZO® functional monotherapy):1
83% of patients achieved a virologic response (95% CI: 67%, 93%) vs. 3% of patients pre-loading dose (p<0.0001).
Patients who achieved HIV RNA <50 copies/mL at week 24 maintained viral suppression up to week 48
Note: 48-week data is not included in the TROGARZO® Prescribing Information nor has it been reviewed by the FDA.
ITT-MEF = Intent To Treat - Missing Equals Failure.
A single arm, multicenter study of 40 heavily treatment-experienced patients with multidrug resistant HIV-1. Patients were required to have viral load >1,000 copies/mL, documented resistance to at least 1 antiretroviral from each of 3 classes of antiretrovirals, been treated for at least 6 months and be failing or had recently failed therapy. Days 0-6 (Control period): Patients were monitored on their current failing regimens (or no therapy). Days 7-13 (Functional monotherapy period): Patients continued on background failing regimens and received 2,000 mg of TROGARZO® (loading dose). Day 14: Background regimen was optimized to include at least one active agent. Day 21-Week 25 (Maintenance period): Patients received 800 mg of TROGARZO® every 2 weeks (maintenance dose). The primary efficacy endpoint was the proportion of patients achieving a –0.5 log10 decrease in viral load during the Functional monotherapy period, as compared to the proportion of patients achieving a –0.5 log10 decrease during the Control period.
THE 1st MONOCLONAL ANTIBODY FOR HIV-1, ACTIVE AGAINST HIV-1
STRAINS RESISTANT TO ALL APPROVED ANTIRETROVIRALS
TROGARZO® (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor.1
TROGARZO® is a humanized monoclonal antibody that binds to domain 2 of CD4 on the surface of immune cells.
The HIV-1 envelope glycoprotein (gp120) binds to domain 1 of CD4. Through steric hindrance, TROGARZO® blocks the steps required for viral entry without interfering in normal CD4-mediated immune functions.
TROGARZO® is active against HIV-1 strains resistant to all approved antiretrovirals.
There is no evidence of cross-resistance between TROGARZO® and any of the approved classes of antiretrovirals (NRTI, NNRTI, PI, INSTI, CCR5 antagonist, fusion inhibitor).
TROGARZO® activity is independent of co-receptor tropism (CXCR4 vs. CCR5).
CCR5 = C-C chemokine receptor type 5; CXCR4 = C-X-C chemokine receptor type 4; INSTI = Integrase Strand Transfer Inhibitor; NNRTI = Non-Nucleoside Reverse Transcriptase Inhibitor; NRTI = Nucleoside Reverse Transcriptase Inhibitor; PI = Protease Inhibitor
TROGARZO® IS INCLUDED IN THE DHHS GUIDELINES FOR MANAGING TREAMENT EXPERIENCED HIV-1 PATIENTS
WHAT THE DHHS GUIDELINES RECOMMEND FOR TREAMENT EXPERIENCED HIV PATIENTS
DEFINE FAILURE: HIV RNA ≥200 copies/mL
Persistent HIV RNA ≥200 copies/mL is considered virologic failure, and is associated with accumulation of drug-resistance mutations.
BE PROACTIVE: MODIFY AS SOON AS POSSIBLE
When resistance mutations compromise a regimen, it should be modified as soon as possible to avoid progressive accumulation of resistance mutations.
Virologic responses to new regimens are greater in patients with lower HIV RNA levels and/or higher CD4 cell counts.
Thus, a change is best done before viremia worsens or CD4 count declines
CHOOSE A FULLY ACTIVE REGIMEN
A new regimen should include at least two, and preferably three, fully active agents. A fully active agent is one that is expected to have uncompromised activity on the basis of the patient’s ART history and his or her current and past drug-resistance test results
CONSIDER A NEWER MOA
The availability of newer ART, including those with new mechanisms of action, makes it possible to suppress HIV RNA to <50 copies/mL in most patients.
Adapted from DHHS Guidelines: Management of the Treatment-Experienced Patient, H2-H6.
TROGARZO® is generally well tolerated, with a low incidence of adverse reactions.
Overall, most (90%) adverse reactions reported were mild or moderate in severity.
Only 2 patients experienced severe adverse reactions (1 case of severe rash, 1 case of IRIS).
TROGARZO® is administered every 2 weeks by intravenous infusion.
TROGARZO® is used in combination with other antiretroviral(s). Every TROGARZO® vial contains 200 mg.
TROGARZO® IS THE ONLY ANTIRETROVIRAL WITH NO EXPECTED DRUG-DRUG INTERACTIONS
*dependant on insurance coverage
The THERA patient support® program provides patients with access to TROGARZO® and ongoing support throughout their treatment.
Reimbursement Navigation and Financial Assistance
Infusion Coordination and Support
To enroll new patients or find more information, visit THERApatientsupport.com
For information about coverage contact THERA patient support® at 1-833-238-4372. A Patient Care Coordinator will assess on the patient’s private or government insurance coverage, including AIDS Drug Assistance Program (ADAP) and will also assist in applying any eligible co‑pay assistance
For your practice:
TROGARZO® DOSING AND ADMINISTRATION GUIDE
Download the TROGARZO® Dosing & Administration Guide, which provides an overview on IV infusion.
Download the full Prescribing Information for TROGARZO®, which includes complete product information.
FOR YOUR PATIENTS:
YOUR GUIDE TO TROGARZO®
Download the TROGARZO® patient brochure, which provides patients with useful information on TROGARZO®, what to expect with their infusions, and how the THERA patient support® program can help.
FOR MORE INFORMATION
Talk to your Theratechnologies Representative
Call the THERA patient support® program at 1-833-238-4372
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References: 1. TROGARZO® Prescribing Information. Theratechnologies Inc. March 6, 2018. TROGARZO® Prescribing Information. Theratechnologies Inc. May 2018. 2. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV, October 2018.
Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported following infusion of TROGARZO® during post-approval use. Symptoms may include dyspnea, angioedema, wheezing, chest pain, chest tightness, cough, hot flush, nausea, and vomiting. If signs and symptoms of an anaphylactic or other clinically significant hypersensitivity reaction occur, immediately discontinue administration of TROGARZO® and initiate appropriate treatment. The use of TROGARZO® is contraindicated in patients with known hypersensitivity with TROGARZO®.
Immune Reconstitution Inflammatory Syndrome
Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in one patient treated with TROGARZO® in combination with other antiretrovirals. During the initial phase of combination antiretroviral therapies, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections, which may necessitate further evaluation and treatment.
The most common adverse reactions (all Grades) seen in clinical trial experience, reported in at least 5% of subjects receiving TROGARZO® were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%).
Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: one subject had a severe rash and one subject developed IRIS manifested as an exacerbation of progressive multifocal leukoencephalopathy.
Use in Specific Populations
Pregnancy: No adequate human data are available to establish whether or not TROGARZO® poses a risk to pregnancy outcomes. Monoclonal antibodies, such as ibalizumab-uiyk, are transported across the placenta as pregnancy progresses; therefore, ibalizumab-uiyk has the potential to be transmitted from the mother to the developing fetus.
Lactation: No data are available regarding the presence of TROGARZO® in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for HIV-1 transmission, instruct mothers not to breastfeed if they are receiving TROGARZO®.
TROGARZO® (ibalizumab-uiyk), in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.