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Researchers find SVR from Incivek-Based Regimens Improved Liver Fibrosis Scores

In a retrospective analysis, researchers found that patients with hepatitis C virus infection who achieved sustained virologic response after treatment with an Incivek-based regimen showed improvement in serum markers for liver fibrosis, according to study data.

Data of 1,208 patients with HCV was collected and evaluated from the PROVE3 phase 2 clinical study and the ADVANCE and REALIZE phase 3 clinical studies that were investigating Incivek (telaprevir, Vertex Pharmaceuticals Inc.). For the analysis, all patients were divided according to severity of fibrosis measured through their baseline Metavir score, and whether or not they reached SVR after treatment. The researchers measured the patients’ scores from four biomarker tests: FibroTest, aspartate aminotransferase (AST) to Platelet Ratio Index (APRI), Fibrosis-4 (FIB-4) and Forns' Score, before and after HCV treatment.

The analysis showed that patients who reached SVR had lasting improvements in their scores from all four noninvasive liver fibrosis tests. Also, improvements that correlated with SVR were seen among all of the liver fibrosis tests (P < .05). Any improvements in these scores in patients who failed to reach SVR were comparable with baseline scores 24 weeks post-treatment.

“These improvements remained significant even when patients were grouped according to their baseline Metavir score,” the researchers wrote. “On average, the scores from different tests exhibited differential improvements following SVR.”

The improvements in APRI from baseline to 24 weeks post-treatment for patients who attained SVR corresponded to complete fibrosis regression, the test with the largest improvement. However, improvements in scores from Forns' Score, FIB-4 and FibroTest were “more modest,” with improvements corresponding to less than one fibrosis stage, according to the research.

Among each baseline Metavir group, the corresponding Forns’ Scores were higher in patients who did not reach SVR compared with those who reached SVR.

“Overall, these results demonstrated that attaining SVR with a telaprevir-based regimen led to significant improvements in liver health as determined by four biomarker tests,” the researchers concluded. “However, not all correlations observed between noninvasive markers and fibrosis stage at baseline hold after SVR is attained.” – by Melinda Stevens

Disclosures: Haseltine and all authors report being employed by and possibly holding stock or stock options in Vertex Pharmaceuticals Inc.