Background/aims: To test the safety and efficacy of the Aethlon Hemopurifier, a lectin affinity cartridge, in clearing hepatitis C virus (HCV) from the blood of HCV-positive end-stage renal disease patients undergoing dialysis. Viral RNA was measured using real-time quantitative reverse transcriptase polymerase chain reaction.
Results: HCV clearance from plasma or blood was measured using either direct capture on immobilized Galanthus nivalis agglutinin (GNA) or using miniature plasmapheresis cartridges containing immobilized GNA. HCV in plasma samples was rapidly cleared by direct affinity capture (t(1/2) = approx. 20 min) and HCV in human blood was cleared using the Hemopurifier (t(1/2) = 2-3 h). Institutional-review-board-sanctioned clinical safety studies were conducted at the Apollo and Fortis Hospitals in India. At Apollo, 4 patients were treated 3 times/week for 2 weeks. HCV captured on the Hemopurifier averaged 8.9 x 10(8) viral copies/cartridge (n = 5), representing approximately 30% of the initial viral body burden. At Fortis, 3 patients treated 3 times/week for 1 week completed the viral load studies. Two patients showed measurable viral load reduction, while the third showed both increases and decreases in viral load. After Hemopurifier treatment, average HCV viral load was reduced by 57%. Surprisingly, average viral load was also 82% lower 7 days after treatment. Control samples also showed a marked transient reduction in HCV viral load as previously reported.
Conclusion: The Hemopurifier rapidly cleared HCV from blood treated in vitro. In patients, the combination of the Hemopurifier plus dialysis decreased HCV viral load by 57% in 1 week. Moreover, viral load reduction continued up to 7 days after treatment.