MedicalResearch.com Interview with:
Brinda Emu MD
Assistant Professor of Medicine (Infectious Diseases
New Haven, CT
MedicalResearch.com: What is the background for this study?
Response: Ibalizumab is a fully humanized monoclonal antibody that targets the CD4 receptor. This Phase III registrational study enrolled individuals with HIV infection that harbor high levels of multi-drug resistance, with limited treatment options. At IDWeek in October, 2016, data was presented that demonstrated patients experienced a significant decrease in viral load after receiving a single loading dose of ibalizumab 2,000 mg intravenously (IV) in addition to their failing antiretroviral therapies (ART) (or no therapy). Seven days after this loading dose, 83% of patients achieved a ≥ 0.5 log10 decrease from baseline compared with 3% during the seven-day control period .These results were statistically significant (p<0.0001).
At CROI, additional data on the Week 24 results from this study are now presented.
MedicalResearch.com: What are the main findings?
Response: The new data presented yesterday at CROI show that patients with multidrug resistant (MDR) HIV-1 infection experienced a mean increase in CD4+ T cell of 48 cells/µL after 24 weeks of treatment with ibalizumab plus an optimized background regimen (OBR).
- Patients also experienced a significant decrease in viral load after receiving a single loading dose of ibalizumab 2,000 mg followed by biweekly doses of 800 mg, in addition to their failing ART (or no therapy)
- Viral load decreases were maintained during the 24-week trial
- At the end of the treatment period, the proportion of study participants with undetectable viral load (HIV-1 <50 copies/mL) was 43% (mean viral load reduction of 3.1 log10) and 50% of patients had a viral load lower than 200 copies/mL
- The mean reduction in viral load was 1.6 log10over the 24 week treatment period with more than 48% of patients experiencing a viral load reduction of more than 2.0 log10.
MedicalResearch.com: What should readers take away from your report?
Response: As HIV providers, we now have access to a large number of effective, well-tolerated antiretrovirals across multiple classes. Unfortunately, for a small group of individuals with highly drug resistant virus, the need for new classes of drugs remains essential. This Phase III study of ibalizumab represents the first potential new class of antiretrovirals in a decade. It is exciting to see that, in this study of MDR-HIV, a significant proportion of patients had both meaningful viral load suppression as well as an increase in CD4+ T cell counts. The meaningful increase in CD4+ T cell counts is particularly important for patients with multi-drug resistant virus, as they often have the most advanced disease.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: As stated above, the studies for ibalizumab have focused on a great unmet need, which is the treatment of MDR-HIV with limited approved treatment options. Given that we have seen both antiviral activity as well as immunologic response, I hope that we will see additional studies that investigate the role of this novel agent earlier in the course of treatment.
MedicalResearch.com: Is there anything else you would like to add?
Response: There is an urgent need for a drug with a new mechanism of action for patients infected with multidrug resistant HIV-1. In addition, ibalizumab is unique for other reasons. As an intravenous injection given every two weeks, it is the first long-acting antiretroviral medication that has reached this phase of development. As a monoclonal antibody, it is also the first non-small molecule for the treatment of HIV to reach this phase of development. These unique properties mark an important era in antiretroviral drug development, and it will be critical for us going forward to discuss the potential for these novel approaches to fight HIV.
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CROI 2017 abstract:
LONG-ACTING IBALIZUMAB IN PATIENTS WITH MULTI-DRUG RESISTANT HIV-1: A 24-WEEK STUDY
Stanley Lewis1, Jeffry Fessel2, Brinda Emu3, Shannon Schrader4, Princy Kumar5, Gary J. Richmond6, Steven Weinheimer1, Christian Marsolais7
February 13–16, 2017 | Seattle, Washington
Abstract Number: 449LB
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