Notes from ACHN CC: In a DDI study of Sovaprevir plus ritonavir-boosted Reyataz (the most widely used PI for HIV) with 30-something patients, three patients had grade-3 liver-enzyme elevations and two patients had grade-4 elevations.
Manifestation of liver toxicity is always a bad thing for a drug that treats liver disease, but in this case it’s even worse than usual. That’s because ACHN was hoping to position ACH-1625 as a best-in-class PI for patents with HCV/HIV co-infection.
Moreover, ACHN does not understand exactly what caused the extremely large (50-350x) increases in the plasma concentration of Sovaprevir observed in the DDI patients who had elevated liver enzymes.
Although the FDA is permitting ACHN to continue enrolling patients in the Sovaprevir + ACH-3102 combination study, the partial clinical hold is nevertheless a big setback, IMO, for the reasons cited above.
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