SAFETY, TOLERANCE, AND CLINICAL EFFICACY OF RPR 109413 AND GAMIMUNE-N

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In the past several years there has been increasing concern about the risk of transmitting virus infections by intravenous gammaglobulin. Initial studies focused on the risk of Hepatitis b; when the AIDS virus was identified it proved to be sensitive to the ethanol used in the processing of intravenous gammaglobulin so that there never has been a case a HIV transmitted by gammaglobulin. Unfortunately, the Hepatitis C virus is not so sensitive, and in 1994 there was an outbreak of Hepatitis C caused by one of the licensed preparations of gammaglobulin. Several strategies have been developed to decrease the risk of transmitting virus infections. Most have employed a solvent and detergent step to inactivate all known enveloped viruses. This process is not effective against other types of viruses. Armour Pharmaceuticals has developed a liquid intravenous gammaglobulin preparation that is heat pasteurized to inactivate a wide variety of known viruses. This is a multicenter, randomized double-blind, Phase II study comparing the new heat-pasteurized RPR 109413 to the licensed preparation Gamimune-N. In the first six month phase two of three patients are randomized to receive the RPR product and the other third receives Gamimune-N. In the second six months all patients receive the RPR gammaglobulin without blinding. All patients are treated at the same dose and frequency that they were treated prior to the study. Efficacy is evaluated by use of patient diaries, use of medications, and days of hospitalization or days missed from work or school. Safety is monitored by recording clinical reactions to the infusions and by measuring serum chemistries and blood counts.