The hepatitis C virus (HCV) treated patients were among end-stage renal disease patients enrolled in human safety studies being conducted at the Fortis Hospital, in Delhi, India.
In the studies, robust viral load reductions were observed in tested patients completing a three-treatment Hemopurifier protocol. The resulting data documented that two of three HCV patients tested responded with measurable viral load reductions during the course of three four-hour Hemopurifier treatments. The three treatments were administered during scheduled dialysis therapy every other day over the span of five days.
The third patient showed both increases and decreases in viral load during the course of treatment, but demonstrated an overall reduction in follow-on viral load tests. Given the small sample size, viral load data was averaged for all three patients. Average initial HCV viral load was 3.13 x 108 viral units per ml of blood. After completion of three Hemopurifier treatments, viral load was reduced an average 57% (final 4.1x107IU/ml).
The stepwise drop in HCV viral load averaged 36% per treatment. Follow-on testing indicated that HCV viral load was 60% lower than initial viral load values when measured three days after final Hemopurifier treatment, and at seven days post treatment, viral load declined to 82% below starting viral load values. Additionally, none of the patients were being treated with antiviral drug therapy.
Viral load measurements were performed with real-time quantitative polymerase chain reaction (RT-PCR). Control samples were measured in duplicate while treatment samples were generally measured in triplicate. In conclusion, the Hemopurifier treatment of HCV infected patients undergoing dialysis resulted in a net viral load reduction of 60 to 80% with the effects of treatment progressing at least seven days beyond Hemopurifier treatment.