Patient B had acute pancreatitis and hyperlipasemia
(lipase 1,697 UI/L; reference range 73-393 UI/L).
Nonspecific hyperamylasemia and hyperlipasemia
in diabetic ketoacidosis: incidence and correlation with biochemical abnormalities.
Importantly, in patients who were not also receiving didanosine (ddI), asymptomatic hyperlipasemia
was reported in 2 patients (5%) receiving 200 mg Reverset and in one placebo-treated subject (3%).
Other reports concerning undetermined hyperlipasemia could not demonstrate an association (18-20).
Several studies in the literature have reported persistent hyperlipasemia (19,20,27,28), but were not able to demonstrate any macrolipase or could not identify the association (18).
In contrast to immunoglobulin-bound macroenzymes, the hyperlipasemia was present for only ~3 months.
The decision to discontinue development of our lead HIV compound, DFC (dexelvucitabine, formerly Reverset) because of an unacceptably high increase in the frequency of grade 4 hyperlipasemia
in patients receiving 200 mg DFC without 3TC or FTC.
Incyte Corporation (Nasdaq: INCY) announced today its decision to discontinue the development of DFC (formerly Reverset), due to a recently observed increase in the frequency of grade 4 hyperlipasemia in patients receiving 200 mg DFC without 3TC or FTC.
As this component of the patient safety database has expanded, it has now become apparent that the frequency of grade 4 hyperlipasemia in patients taking 200 mg DFC without 3TC or FTC is, in Incyte's view, unacceptably high.
A higher than expected incidence of asymptomatic hyperlipasemia
, a marker of pancreatic inflammation, in patients who are also receiving the drug didanosine (ddI or Videx(R)) was the only adverse event of note.
The only adverse effect of note to date has been a higher than anticipated incidence of asymptomatic hyperlipasemia
in patients who are also receiving didanosine.