Ibalizumab Decreased Viral Load In Patients With Resistant HIV

MedicalResearch.com Interview with:

Jacob Lalezari, MD Quest Clinical Research San Francisco, CA

Dr. Jacob Lalezari

Jacob Lalezari, MD
Quest Clinical Research
San Francisco, CA 

MedicalResearch.com: What is the background for this study? What are the main findings?

  • Tremendous strides have been made since HIV-1 was first discovered 35 years ago. However, while many HIV patients can control the infection with currently-approved therapies, there is an urgent need for new treatments that can address viruses that are resistant to multiple antiretroviral treatment classes. With people starting treatments earlier and staying on them longer, some patients also face long-term safety and tolerability issues associated with current therapies.
  • Thousands of people are infected with HIV-1 with resistance to three classes of antiretroviral therapy (ART), and are in dire need of treatment. There are limited or no treatment options available for these patients.
  • As multi-drug resistant (MDR) HIV can be transmitted, it is imperative that it be controlled in order to prevent it from becoming a larger problem. It is important to not only focus on the patient being treated but also consider those they could infect.
  • Ibalizumab is the first biologic long-acting investigational ART to show efficacy in patients in just seven days. The Phase III TMB-301 results showed that patients with MDR HIV-1 and with limited treatment options experienced a significant decrease in viral load after receiving a loading dose of ibalizumab (2,000 mg intravenously) in addition to their failing ART therapies.
    •  A total of 40 patients were enrolled in the study.
    • Seven days after the 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). Moreover, during that same period, 60% achieved a decrease of ≥1.0 log10.
    • The average viral load decrease for the total population was 1.1 log10
    • There were no treatment-related serious adverse events or discontinuations reported during the initial seven-day treatment period. 

MedicalResearch.com: What should readers take away from your report?

  • The HIV virus is a complex pathogen that finds ways to elude treatment by mutating to become resistant. Patients who have a MDR virus have limited or no remaining options to treat their infection. Therefore, it is important to add drugs with new mechanism of actions to treat MDR HIV-1.
  • Based on the clinical trial results obtained so far, ibalizumab may help to reduce the viral load in patients whose virus cannot be controlled with currently-available treatments.  Ibalizumab would be an important new treatment option for these patients when combined with other agents, and could change the way multi-drug resistant HIV is managed in the future.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

  • The Phase III study was completed on October 24, 2016. We will continue to analyze topline results of safety and secondary efficacy endpoints for the 24-week treatment period, which will be announced in the coming weeks. This is the last pivotal clinical trial required for the submission of the BLA, and based on the data, we plan to request priority review status with the FDA at the time of BLA submission.

MedicalResearch.com: Is there anything else you would like to add?

  • It’s exciting that ibalizumab has shown a statistically significant viral load reduction in some of the most seriously compromised patients — in seven days after the first dose, which is not only important for patients with HIV but is also important in reducing the risk of transmission. This trial has shown promise for the most serious patients suffering from MDR HIV-1.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation: IDWeek 2016 Abstract

 Primary Efficacy Endpoint and Safety Results of Ibalizumab (IBA) in a Phase 3 Study of Heavily Treatment-Experienced Patients with Multi-Drug Resistant (MDR) HIV-1 Infection

Session: Oral Abstract Session: Late Breaker Oral Abstracts
Saturday, October 29, 2016: 11:20 AM

Disclosure: J. Lalezari, TaiMed Biologics USA: Investigator , Research support

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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