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SAPPHIRE-I, II trials demonstrate minimal serious AE in HCV
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WASHINGTON, D.C. — Patients with hepatitis C virus infection genotype 1 included in the SAPPHIRE-I and II phase 3 clinical trials experienced a low rate of study drug related serious adverse events and study drug discontinuations during treatment with direct-acting antivirals and ribavirin, according to data presented at ICAAC 2014.
Researchers randomly assigned 1,025 patients in a 3:1 ratio to a three direct-acting antiviral (3D) regimen of ABT-450/ritonavir, ombitasvir and dasabuvir plus ribavirin (RBV; n=770) or matching placebos (n=255) for 12 weeks.
Overall results indicated that 89% of patients receiving AbbVie’s 3D+RBV regimen and 76.9% receiving placebo reported adverse events. In the SAPPHIRE-I trial with treatment-naive, noncirrhotic patients (n=473), 87.5% experienced any adverse event (AE), 4.2% experienced severe AE, and 2.1% had serious AE. In the SAPPHIRE-II trial with prior pegylated interferon/RBV-experienced patients (n=297), 91.2% of patients reported any AE, 2.4% had severe AE, and 2% had serious AE.
In the pooled analysis of SAPPHIRE-I and II trials with both treatment-naive and experienced patients received 3d+RBV , 89% had any AE, 3.5% had severe AE, and 2.1% had serious AE. In the combined trials, among treatment-naive and experienced patients receiving placebo , 76.9% experienced any AE, 0.4% had severe AE, and 0.4% had serious AE. The rates of drug discontinuance due to an AE were low and similar in all patient groups (0.4% in pooled group receiving placebo and 0.8% in pooled group receiving 3 D+ RBV).
“AbbVie’s 3DAA plus RBV regimen was generally well-tolerated by the selected patient population,” Tolga Baykal, MD, of AbbVie Inc., told Healio.com/Hepatology. – by Melinda Stevens
For more information:
Jensen DM. Abstract V-477. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 5-9, 2014; Washington, D.C.
Disclosure: The researchers report multiple relevant financial disclosures.