|This article is part of Infectious Disease Advisor’s coverage of IDWeek 2017™, which took place in San Diego, CA. Our staff will be reporting on the latest breaking research and clinical advances in infectious diseases. Check back regularly for highlights from IDWeek 2017.|
People with multidrug-resistant (MDR) HIV experienced positive safety and efficacy outcomes, including continued virologic suppression, with ibalizumab plus optimized background regimen therapy, according to research presented at IDWeek 2017, held October 4-8 in San Diego, California.
Brinda Emu, MD, of the Yale University School of Medicine in New Haven, Connecticut, and colleagues reported data from 2 phase 3 studies of ibalizumab therapy in patients with multidrug resistant HIV (Ibalizumab Plus Optimized Background Regimen in Patients With Multi-Drug Resistant HIV [TMB-301]; ClinicalTrials.gov Identifier NCT02475629 and Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1 [TMB-311]; ClinicalTrials.gov Identifier NCT02707861).
The first study — TMB-301 — was a 24-week open-label phase 3 study. Researchers examined the efficacy of and safety of ibalizumab plus an optimized background regimen in patients with MDR HIV. Participants received a 2000 mg loading dose followed by 800 mg ibalizumab every 2 weeks for 24 weeks; 7 days following the loading dose an optimized background regimen including at least 1 additional sensitive agent was added.
At 24 weeks, 24 participants in TMB-311 continued to receive 800 mg ibalizumab every 2 weeks for up to 48 weeks.
Participants in TMB-311 were considered highly resistant; 59% and 33% had “exhausted ≥3 and ≥4 [antiretroviral] classes, respectively, and 7% of patients had HIV-1 resistant to all approved [antiretrovirals].”
Nearly 90% of patients continued treatment through week 48; 3 patients discontinued treatment prior to the end of the study due to non-drug related reasons.
“Potent suppression” of viremia observed at week 24 was sustained through week 48, with a median viral load reduction of 2.5log10 at weeks 24 and 48. Of the participants, 63% experienced a viral load <200 copies/mL, while 59% experienced a viral load <50 copies/mL; these patients maintained viral suppression to week 48.
“[Ibalizumab] plus [optimized background regimen] continued to achieve higher rates of virologic suppression through week 48,” concluded Dr Emu and colleagues. “The results support the durable efficacy and long-term safety of [ibalizumab] in highly treatment-experienced [multidrug resistant] patients and offer a valuable treatment option for patients.”
Disclosures: Drs Emu, Kumar, Richmond, Weinheimer, Marsolais, and Lewis report various relationships with TaiMed Biologics Inc.
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Emu B, Fessel WJ, Schrader S, et al. 48-week safety and efficacy on-treatment analysis of ibalizumab in patients with multi-drug resistant HIV-1. Presented at: IDWeek 2017; October 4-8, 2017; San Diego, CA. Abstract 1686.