Data presented at WTC support brincidofovir's antiviral activity and safety profile in hematopoietic cell transplant (HCT) and solid organ transplant recipients who were treated for viral infections including adenovirus (AdV), cytomegalovirus (CMV), BK virus, Epstein-Barr virus (EBV) and varicella zoster virus (VZV).
Chimerix Presentations at WTC include:
Brincidofovir for the Treatment of Serious or Life-Threatening Double-Stranded DNA Virus Infections in Patients Receiving Liver Transplant as Part of Multiorgan Transplantation
Ten patients who had received multiorgan transplants (liver ± kidney/pancreas/small bowel) ages six months to 15 years were treated with brincidofovir for life-threatening DNA virus infections including AdV, CMV, BK virus, Epstein-Barr virus (EBV) and varicella zoster virus (VZV) after failing existing antiviral therapies. Brincidofovir treatment duration ranged from one to 26 weeks and antiviral activity was observed against all five DNA viruses. Overall, liver and kidney function remained stable or improved in all patients while receiving brincidofovir and during follow-up. In this small, uncontrolled, multiorgan transplant patient population with life-threatening viral infections, the only serious adverse event attributed to brincidofovir was diarrhea in one patient which resolved on treatment. These clinical data support the continued evaluation of brincidofovir for the prevention or treatment of multiple viral infections in patients who have received solid organ transplants or who have other immune dysfunction, and complement previous in vitro potency of brincidofovir against all five families of DNA viruses that cause human disease.
Switch from Existing Antivirals to Brincidofovir Leads to Improving Renal Function
The expanded access study of brincidofovir (BCV, CMX001), Study 350, enrolled immunocompromised patients with life-threatening DNA viral infection(s) and no other therapeutic options. Twenty-five percent (25%, n=66) of patients enrolled had received prior antivirals foscarnet or cidofovir, known to be nephrotoxic, providing an opportunity to evaluate the change in renal function during BCV therapy. Despite the heterogeneity and complexity of these patients, greater than 80% of patients who received cidofovir or foscarnet showed improvement in renal function during brincidofovir treatment, including patients with severe renal impairment (eGFR < 30 mL/min) when they began BCV. In patients who switched from prior cidofovir to brincidofovir (n=37) greater than 80% showed improvement in renal function measured by eGFR. In patients with severe renal impairment at baseline, 100% had measurable improvement in eGFR while on brincidofovir, with > 60% improving by a clinically significant 20 mL/min or more. These data support the lack of nephrotoxicity associated with brincidofovir, consistent with data from the Phase 2 CMV prevention trial which showed a dose-related improvement in GFR. Further study of brincidofovir is planned in kidney transplant recipients and other patient populations at high risk of renal impairment.
Brincidofovir Experience in Renal Transplant Patients for Treatment of Refractory CMV Infection
Patients who had failed previous antiviral treatment for CMV infection received brincidofovir under an expanded access protocol (Study 350). Five kidney transplant patients (ages 44-56) with refractory or resistant CMV infections received brincidofovir for 10-171 days (mean 91 days) at doses of 100-200 mg twice weekly. Three patients had a complete virologic response with undetectable CMV ( < LOD 100c/mL), and one patient had a -2.4 log10 reduction in CMV viremia from Baseline. The most common adverse events were diarrhea and nausea reported in three of five patients. One of the five patients discontinued for drug-related adverse events. In this small, uncontrolled subset of kidney transplant recipients, there were no remarkable shifts in renal function during treatment. These data support further evaluation of brincidofovir for the treatment and prevention of CMV in patients who receive a kidney transplant.
About Brincidofovir (CMX001)
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