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We Cure Viral Diseases with Non-Pathogenic Viruses!

Hepatitis Therapeutic Program

Despite the spectacular success of antiviral therapy in preventing cirrhosis complications in HBV and HCV hepatitis, decompensation is still a major unresolved problem with poor outcome. Innovative new treatments are required for this patient population. The infectious bursal disease virus (IBDV) superinfection therapy (SIT) is such a treatment. Our goal is to develop the R903/78 antiviral biological drug product for the interferon-free, oral superinfection treatment of decompensated patients, who have the least time available and the most to lose.

Proof-of-principle phase IB/II clinical trial of IBDV superinfection

The idea that viral competition can be therapeutically exploited by using a non-pathogenic IBDV virus was demonstrated in a preliminary clinical trial as proof-of-principle in Hungary. Eighty-four patients of both sexes, with either a diagnosis of acute B (43 patients) or acute C (41 patients) viral hepatitis, were included in the study. There was a significant difference between the IBDV treated and control group patients that progressed into chronic disease. Prior to complete recovery significantly more control patients relapsed. Also, late remissions were recorded significantly more frequently with conventional treatment than with IBDV treatment. The duration of the first icteric phase was also shortened with the IBDV treatment. In addition, remission within one month of treatment was registered more often in the virus treated groups than in the control groups. No side effects of the IBDV treatment were noted.
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Representative treatment curves for drug treated (red line) and control patient
(blue line) are indicated. The efficiency of the therapy is measured by ALT and
bilirubin levels, respectively. Treatment not only speeded up the recovery but
prevented the elongated elevation of bilirubin level characteristic of control patient.



Successful IBDV superinfection therapy of four decompensated chronic hepatitis patients

There was a highly significant additional observation that IBDV superinfection therapy was also effective in four moribund decompensated chronic hepatitis patients (two HBV, two HCV), who went into long-lasting remission or were stabilized with significant clinical improvement. It is important to mention that before the IBDV treatment, conventional therapy failed to stabilize the patientsí conditions. One of the patients was confined to bed, unable to support herself due to a severe malaise. In the second patient, a portal hypertension developed, suggesting a very poor prognosis. In the third patient progressive jaundice, generalized oedema and hepatic encephalopathy occurred and a request for liver transplantation was refused because of the high-level viremia. The fourth decompensated chronic HCV patient had a 20-year-history of the disease. Conventional interferon, ribavirin and thymosin treatment was unsuccessful. A striking feature of the IBDV therapy was the regeneration of the cirrhotic liver over several years of follow up. Importantly, as of May 2013, three patients were still well, whereas one patient died of liver cancer.

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Cholinesterase activity levels indicating regeneration of
the liver in a chronic HCV patient treated with IBDV-SIT.