Dr. Christian Marsolais reports

THERATECHNOLOGIES' TROGARZO(TM) (IBALIZUMAB-UIYK) SHORTENS TIME TO HIV UNDETECTABILITY AND EXTENDS DURABILITY OF UNDETECTABILITY AND VIRAL SUPPRESSION IN A MATCHED TREATMENT COMPARISON

Theratechnologies Inc. has presented data from a landmark study in which the use of ibalizumab, a monoclonal antibody anti-retroviral therapy (ART) commercialized as Trogarzo, was associated with favourable virologic outcomes compared with non-ibalizumab regimens used in routine care in heavily treatment-experienced people with HIV. In the study, which was presented at the 17th annual American Conference for the Treatment of HIV (ACTHIV) in Phoenix, Ariz., use of ibalizumab resulted in a statistically significant doubling of the likelihood of viral undetectability, as well as a much longer duration of undetectability and viral suppression, compared with a real-world, non-ibalizumab control group from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) database.

Developed by epidemiologists at Epividian, OPERA is a large electronic health record (EHR) database containing patient-level data without identifiers and collected at the point of care for about 14 per cent of the total U.S. HIV population. The ibalizumab study is thought to be the first matching-adjusted indirect treatment comparison (MAIC) study in HIV, an approach designed to facilitate a closely matched comparison from a synthesized, real-world population, when randomization to a control arm would be impractical or unethical.

"We are proud of our collaboration with the Epividian team on this MAIC analysis, which shows superior outcomes of Trogarzo-based regimens in heavily treatment-experienced people with HIV, as compared to the real-world standard of care," said Christian Marsolais, PhD, senior vice-president and chief medical officer of Theratechnologies. "This is the largest data set and longest follow-up for Trogarzo since our phase 3 study, and reinforces its importance in a patient population that historically has had limited novel treatment options."

"The OPERA cohort has the benefit of large numbers of patients contributing rich clinical and resistance data over a long period of time," explained Michele Jonsson-Funk, PhD, member of the Epividian epidemiology and clinical advisory board and assistant professor in the department of epidemiology at the University of North Carolina, Chapel Hill. "With those details, it was possible to align the groups on inclusion criteria and key clinical factors in order to understand the impact of ibalizumab."

"Comparing the ibalizumab clinical trial experience to a well-matched real-world cohort provides us with additional validation of ibalizumab's efficacy," said Michael Wohlfeiler, MD, of the AIDS Healthcare Foundation and a co-author of the study. "The potency and durability of ibalizumab, as observed in this latest analysis, bolster the clinical rationale for its use in regimens for heavily treatment-experienced patients and could have important clinical benefits for these individuals."

The study evaluated data from 76 participants in two clinical trials (phase 2b and phase 3) who received 800 milligrams of ibalizumab every two weeks (treatment arm), and compared those data with outcomes from 65 individuals treated with non-ibalizumab-containing regimens as routine care in the OPERA cohort (control arm). Standardized mortality rate (SMR) weighting ensured balance between the treatment and control groups in terms of baseline age, CD4 cell count, viral load (VL) and susceptibility to specific ART agents.

Despite ibalizumab trial participants having more severe disease at baseline than non-ibalizumab controls, ibalizumab was associated with superior virologic outcomes. At 24 weeks, investigators observed a statistically significant doubling of the likelihood of viral undetectability (defined as VL less than 50 c/millilitre) in the treatment arm versus the control arm (SMR-weighted hazard ratio (HR): 1.98; 95-per-cent confidence interval (CI): 1.02, 3.69). Achievement of viral suppression (defined as VL less than 200 c/mL) was also more likely with ibalizumab, though this finding did not reach statistical significance (SMR-weighted HR: 1.28; 95-per-cent CI: 0.82, 2.06).

Among those who achieved undetectability on ibalizumab, 95 per cent maintained undetectability through the end of follow-up, compared with 27 per cent of those on non-ibalizumab regimens (SMR-weighted HR: 16.08; 95-per-cent CI: 3.99, 64.78). Additionally, the same significance emerged for maintaining viral suppression, which was 18 times lower for real-world non-ibalizumab regimens compared with ibalizumab. For both durability analyses, confidence intervals were wide but statistically significant (SMR-weighted HR: 18.36; 95-per-cent CI: 2.48, 135.68).

The abstract and poster can be found on Theratechnologies' website.

About Trogarzo

Trogarzo is a long-acting, CD4-directed, postattachment HIV-1 inhibitor. In the United States, Trogarzo (ibalizumab-uiyk), in combination with other anti-retroviral(s), is indicated for the treatment of human immunodeficiency virus Type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection failing their current anti-retroviral regimen.

Trogarzo is administered by intravenous (IV) infusion as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9 per cent sodium chloride injection, USP. In October ,2022, the Trogarzo maintenance dose was approved by the U.S. Food and Drug Administration (FDA) to also be administered as an undiluted intravenous push over 30 seconds.

Important safety information

Do not receive Trogarzo if you have had an allergic reaction to Trogarzo or any of the ingredients in Trogarzo. Trogarzo can cause allergic reactions, including serious reactions, during and after infusion. Tell your health care provider or nurse, or get medical help right away if you get any symptoms of an allergic reaction. Before you receive Trogarzo, tell your health care provider about all of your medical conditions, including if you are pregnant or plan to become pregnant as it is not known if Trogarzo may harm your unborn baby or if you are breastfeeding or plan to breastfeed as it is not known if Trogarzo passes into breast milk. Tell your health care provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins and herbal supplements.

Changes in your immune system (immune reconstitution inflammatory syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your health care provider right away if you start having new symptoms after starting your HIV-1 medicine. The most common side effects of Trogarzo include: diarrhea, dizziness, nausea and rash. Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trogarzo. For more information, ask your health care provider or pharmacist.

About Theratechnologies Inc.

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

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