AbbVie’s investigatory “3D” hepatitis C virus (HCV) treatment regimen rapidly improves indicators of liver health among those with cirrhosis, Medscape reports. Researchers conducted a new analysis of the TURQUOISE-II Phase III trial of the 3D regimen and presented their findings at the American College of Gastroenterology 2014 Annual Scientific Meeting in Philadelphia.
The 3D regimen comprises a fixed-dose combination of the protease inhibitor ABT-450 and ritonavir coformulated with the NS5A inhibitor ombitasvir (ABT-267), as well the non-nucleoside polymerase inhibitor dasabuvir (ABT-333). In the TURQUOISE-II trial, 3D was given with ribavirin for 12 or 24 weeks.
A decision on the 3D regimen is expected from the U.S. Food and Drug Administration in mid-December.
Levels of liver enzyme tests improved across the board between the study’s outset and the end of treatment. In the 12-week group, the average alanine aminotransferase decreased from 99 to 32 units per liter, aspartate aminotransferase decreased from 88 to 33 U/L and gamma-glutamyl transferase decreased from 94 to 33 U/L. In the 24-week group, alanine aminotransferase decreased from 100 to 28 U/L, aspartate aminotransferase decreased from 92 to 29 U/L and gamma-glutamyl transferase decreased from 100 to 31 U/L.
Measures of liver function also improved. In the 12-week group, conjugated bilirubin decreased from 0.3 to 0.19 milligrams per deciliter, albumin decreased from 3.9 to 4.1 grams per dL and prothrombin time decreased from 11.5 to 11.3 seconds. In the 24-week group, conjugated bilirubin decreased from 0.31 to 0.17 mg/dL, albumin decreased from 3.9 to 4.2 g/dL and prothrombin time decreased from 11.3 to 11.2 seconds (though this last decrease was not statistically significant).
In order to test how 3D affected portal hypertension, the researchers looked at platelet count, seeing an upward trend in the 12-week group. This increase may indicate an improvement in portal hypertension, but more research is necessary.
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