HIV and Hep C drug trial underway

An Australian drug company has begun phase two human trials of an antiviral drug that will treat patients infected with both HIV and Hepatitis C (HCV). Drug company Biotron has begun trials of the drug, called BIT225, in 12 patients with the two diseases.

The patients will receive 28 days treatment with BIT225 in combination with interferon and ribavirin (IFN/RBV), which is the standard approved treatment for HCV. At the conclusion of the treatment with BIT225 they will continue to receive IFN/RBV for up to 48 weeks in total.

The patients will not have previously received IFN/RBV (i.e. treatment-näive), but at the time of inclusion into the trial will be on antiretroviral drugs (ART), with HIV levels below the level of detection.

Biotron’s managing director Michelle Miller said the trial was specifically targeting Hepatitis C.

“While BIT225 appears to target both HIV and HCV, in this particular study we are focusing on the HCV aspect of the disease in these dual-infected patients”, she said.

“The pharmaceutical industry and international regulatory authorities are focused on new treatments in this difficult-to-treat population.

“Even though HIV will be below the level of detection, the virus will be present in the underlying reservoirs. BIT225 is being assessed for its ability to target HIV in these reservoir cells in a separate Phase 1b/2a clinical trial that is currently in progress.”

The proportion of people infected with both HIV and HCV is significant with the co-infected group offering particular challenges to treatment with current therapies, according to the company.

HCV is a more serious disease in those with HIV, and is a leading cause of death.  It has been estimated that between 25 percent and 40 percent of HIV-positive people in the USA are co-infected with HCV.

The trial, which is underway at the Siriraj Hospital in Bangkok, Thailand, is currently recruiting patients.  It is expected to be completed in the first half of 2013.