Running out of treatment options for a disease is terrifying for any patient. For people infected with multidrug-resistant (MDR) HIV-1, a lack of treatment options often means a death sentence. But now, thanks to a clinical trial conducted by Westat, a new treatment advance is giving these patients fresh hope.

The drug is Trogarzo™, an infusible agent that blocks HIV from infecting certain immune cells while preserving normal immunological functions. Trogarzo was introduced to Westat in 2015 under its original name, ibalizumab, when our company was tapped to conduct the phase 3 registration trial of it.

Facilitating an expedited review

Because of the seriousness of MDR HIV-1 and the lack of treatment options for it, the Food and Drug Administration (FDA) had assigned “orphan drug status” and “breakthrough therapy” designation to ibalizumab. Put on a fast track, Westat prepared to work swiftly to establish the drug’s safety and effectiveness through well-controlled studies.

We worked aggressively—focusing on enrollment of eligible participants and quick qualification of new sites authorized to administer the drug to participants in dire need of it. We formed a central hub with the sites and with qualified labs. In less than 3 years, precisely following the required FDA clinical trial process, we completed the phase 3 trial. Our next steps were to integrate data from the phase 2b study into the phase 3 study and author the clinical study report for submission of the Biologics Licensing Application to the FDA.

What did the study show?

Trogarzo proved to be beneficial to MDR HIV-1 patients. It inhibited HIV cell entry and suppressed the HIV viral load below the level of detection when combined with an optimized background regimen of anti-HIV agents.

Trogarzo goes to market

On March 6, 2018, the FDA gave Trogarzo the green light to be marketed in the U.S. Today, Trogarzo is recognized as the first of a new class of antiretroviral medications to stop the progression of HIV in MDR HIV-1-infected individuals. Its novel mechanism of action has proven to be a critical new treatment advance for MDR HIV-1-infected patients seeking a last-resort therapy.