Monoclonal antibody speeds time to HIV viral suppression, study finds
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Key takeaways:
- Ibalizumab, marketed as Trogarzo, doubled the likelihood that people with HIV will reach viral suppression.
- The finding was based on a comparison with a real-world cohort of patients on other regimens.
A monoclonal antibody was shown to speed the time to viral suppression in heavily treatment-experienced people with HIV compared with ART regimens that did not contain it, according to a study.
The study, presented at the American Conference for the Treatment of HIV (ACTHIV), evaluated the use of ibalizumab, marketed by Theratechnologies as Trogarzo, in comparison with other ART regimens.
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The FDA approved ibalizumab in 2018 for the treatment of multidrug-resistant HIV in adults with a failing ART regimen. Patients receive an 800 mg dose intravenously every 2 weeks after an initial loading dose of 2,000 mg.
The approval was based on the phase 3 TMB-301 study that showed after 24 weeks of treatment, 43% of patients had undetectable viral loads and 50% had a viral load of less than 200 copies/mL. After 48 weeks of treatment, 59% of participants were virally suppressed.
The new analysis of data presented at ACTHIV showed a doubling of the likelihood of viral undetectability and a “much longer” duration of viral suppression, Theratechnologies said in a press release.
“The potency and durability of ibalizumab, as observed in this latest analysis, bolster the clinical rationale for its use in regimens in heavily treatment-experienced patients and could have important clinical benefits for these individuals,” Michael B. Wohlfeiler, MD, chief medical officer for the AIDS Healthcare Foundation, said in the release.
The researchers compared data from 76 participants in phase 3 and 2b trials who received 800 mg of ibalizumab every 2 weeks with data from 65 people treated with nonibalizumab-containing regimens from OPERA, a large electronic health record database with deidentified patient data encompassing around 14% of the total U.S. population, according to Theratechnologies.
At 24 weeks, there was a doubling of the likelihood of viral undetectability in the ibalizumab group compared with the nonibalizumab group (SMR-weighted HR = 1.98; 95% CI, 1.02-3.69). According to the study, among participants who achieved viral undetectability on ibalizumab, 95% maintained undetectability through the end of the study compared with 27% of people who achieved undetectability without ibalizumab. Additionally, the likelihood of losing viral undetectability was 16 to 18 times higher for patients treated with nonibalizumab regimens.
According to the researchers, it was the first study comparing ibalizumab with nonibalizumab ART regimens. They said the findings suggest the therapy could have “important clinical and public health” implications for people with treatment-resistant HIV.
“Comparing the ibalizumab clinical trial experience to a well-matched real-world cohort provides us with additional validation of ibalizumab’s efficacy,” Wohlfeiler said.
References:
- Theratechnologies’ Trogarzo (ibalizumab-uiyk) shortens time to HIV undetectability and extends durability of undetectability and viral suppression in matched treatment comparison. https://www.theratech.com/news-releases/news-release-details/theratechnologies-trogarzor-ibalizumab-uiyk-shortens-time-hiv. Published May 4, 2023. Accessed May 11, 2023.
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Brunet L, et al. Virologic effectiveness of ibalizumab clinical trial experience compared to real-world clinical care without ibalizumab in the OPERA cohort. Presented at: American Conference for the Treatment of HIV; May 4-6, 2023; Phoenix.
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