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Infectivology Xagena

Hepatitis C genotype 1: phase III Program of an all-oral Interferon-free therapy


AbbVie has announced the completion of its phase III clinical program and released results of four additional studies designed to assess investigational all-oral, interferon-free therapy with and without Ribavirin in patients with chronic genotype 1 ( GT1 ) hepatitis C virus ( HCV ) infection.

The investigational regimen consists of the fixed-dose combination of ABT-450 /Ritonavir ( 150/100mg ) co-formulated with ABT-267 ( 25mg ), dosed once daily, and ABT-333 ( 250mg ) with or without Ribavirin ( weight-based ), dosed twice daily.
The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing sustained virologic response ( SVR ) rates across different patient populations.

Study M13-389 ( PEARL-II )

PEARL-II is a global, multicenter, randomized, open-label, controlled study to evaluate the efficacy and safety of 12 weeks of treatment with regimen with and without Ribavirin in non-cirrhotic, GT1b HCV-infected, treatment-experienced adult patients.
The study population consisted of 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis: 91 patients randomized to the regimen without Ribavirin for 12 weeks, and 88 patients randomized to the regimen with Ribavirin for 12 weeks.
In the Ribavirin-free arm, 100% ( n=91/91 ) of patients achieved SVR12, while 97% ( n=85/88 ) achieved SVR12 in the Ribavirin-containing arm.
The most commonly reported adverse events were fatigue and headache.
Discontinuations due to adverse events were reported in none of the patients in the Ribavirin-free arm and two ( 2% ) patients in the Ribavirin-containing arm. There were no patients in either arm of the study that experienced virologic relapse or breakthrough.

Study M13-961 ( PEARL-III )

PEARL-III is a global, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with  regimen with and without Ribavirin in non-cirrhotic, GT1b HCV-infected, treatment-naive adult patients.
The study population consisted of 419 GT1b treatment-naive patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without Ribavirin for 12 weeks, and 210 patients randomized to the regimen with Ribavirin for 12 weeks.
Following 12 weeks of treatment, 99% receiving the regimen without Ribavirin ( n=207/209 ) and 99% receiving the regimen with Ribavirin ( n=209/210 ) achieved SVR12.
The most commonly reported adverse events were headache and fatigue.
No patient discontinued study drug due to adverse events. Virologic relapse or breakthrough was noted in none of the patients receiving the regimen without Ribavirin and 0.5% of patients receiving the regimen with Ribavirin.

Study M14-002 ( PEARL-IV )

PEARL-IV is a global, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with regimen with and without Ribavirin in non-cirrhotic, GT1a HCV-infected, treatment-naive adult patients.
The study population consisted of 305 GT1a treatment-naive patients with no evidence of liver cirrhosis: 205 patients randomized to the regimen without Ribavirin for 12 weeks, and 100 patients randomized to the regimen with Ribavirin for 12 weeks.
Following 12 weeks of treatment, 90% of patients receiving the regimen without Ribavirin ( n=185/205 ) and 97% receiving the regimen with Ribavirin ( n=97/100 ) achieved SVR12.
The most commonly reported adverse events were fatigue, headache and nausea.
Discontinuations due to adverse events were reported in two ( 1% ) patients receiving the regimen without Ribavirin and no patients in the Ribavirin-containing arm.
Virologic relapse or breakthrough was noted in 8% of patients receiving the regimen without Ribavirin and 2% of patients receiving the regimen with Ribavirin.

Study M13-099 ( TURQUOISE-II )

TURQUOISE-II is the first phase III study completed exclusively in GT1 cirrhotic patients investigating an all-oral, Interferon-free regimen. It is a global, multicenter, randomized, open-label study evaluating the efficacy and safety of 12 or 24 weeks of treatment with regimen with Ribavirin in cirrhotic, GT1a and GT1b HCV-infected, treatment-naive and treatment-experienced adult patients.
The study population consisted of 380 GT1a and GT1b, treatment-naive and treatment-experienced patients with compensated cirrhosis: 208 patients randomized to the regimen with Ribavirin for 12 weeks, and 172 patients randomized to the regimen with Ribavirin for 24 weeks.
Following 12 weeks of treatment, 92% of patients ( n=191/208 ) achieved SVR12. Following 24 weeks of treatment, 96% of patients ( n=165/172 ) achieved SVR12.
The most commonly reported adverse events were fatigue, headache and nausea.
Discontinuations due to adverse events were reported in four ( 2% ) patients receiving the regimen with Ribavirin for 12 weeks and four ( 2% ) patients in the 24-week arm.
Virologic relapse or breakthrough was noted in 6% of patients in the 12-week arm and 2% in the 24-week arm. ( Xagena )

Source: Abbvie, 2014

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