The new study is an open-label, dose escalation study designed to assess the safety and pharmacokinetics of bavituximab in approximately 24 patients chronically infected with HCV and HIV. Patient cohorts will receive ascending dose levels of bavituximab weekly for up to 8 weeks. HCV and HIV viral titers and other biomarkers will be tracked, although they are not formal study endpoints.
Dr Stephen Smith, director of the study, said: “Chronic co-infection with the hepatitis C virus affects a significant proportion of our HIV patients, yet current HCV therapies are often ineffective or poorly tolerated.”
In the US alone, an estimated 300,000 individuals are co-infected with HIV and HCV, representing up to 30% of all HIV-infected patients. Co-infected patients have been shown to have a lower response to interferon/ribavirin HCV regimens and the adverse effects of these regimens can be especially problematic for some HIV patients.
Bavituximab helps stimulate the body’s immune defenses to destroy both the virus particles and the infected cells. Bavituximab has successfully completed phase la and lb clinical trials as monotherapy in patients with chronic HCV infection, which showed that the drug is well tolerated and demonstrated encouraging signs of anti-viral activity.