You are here

U.S. Hepatitis Trial Put on Hold

Potential liver problems cited (July 25)

The FDA has placed a partial clinical hold on an ongoing phase II U.S. study of VX-135, a nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor, because of possible liver problems.

The partial hold follows the observation of reversible elevated liver enzymes in patients receiving 400 mg of VX-135 in combination with ribavirin in a phase II study in Europe.

The hold prevents evaluation of a 200-mg dose of VX-135 in the U.S. study. Evaluation of a 100-mg dose of VX-135 in combination with ribavirin as part of the 12-week phase II study in the U.S. is continuing as planned.

The compound’s developer (Vertex Pharmaceuticals) currently markets the leading hepatitis C drug, Incivek (telaprevir). To provide high cure rates, however, that treatment must be taken with injected interferon, which is difficult to tolerate.

Sources: Vertex Pharmaceuticals; July 25, 2013; and Reuters; July 25, 2013.

Recent Headlines

Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs