New data from its phase III clinical trial programme, STARTVerso, which is evaluating Faldaprevir in combination with Pegylated Interferon and Ribavirin ( PegIFN/RBV ) were presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases ( AASLD ).
In STARTVerso 1&2, 84% of treatment-naïve patients receiving Faldaprevir were able to shorten the total time on treatment from 48 to 24 weeks; 83% of these patients achieved viral cure ( SVR12 ). Overall, 73% and 72% of patients achieved SVR12 with Faldaprevir 120 mg and 240 mg regimens, respectively.
Interim results from STARTVerso4 showed that 74% of patients with HCV/HIV co-infection treated with Faldaprevir had undetectable HCV 4 weeks after the conclusion of treatment ( SVR4 ), a response rate similar to that seen with HCV mono-infection.
Additionally, treatment of difficult-to-cure patients who have relapsed on previous HCV treatment ( STARTVerso 3 ) demonstrated viral cure rates of 70% with Faldaprevir.
In the same study, patients who partially responded and those who showed no response to previous treatment achieved viral cure rates of up to 58% and 33%, respectively.
More than 2,200 patients have been studied in the STARTVerso trial programme, including patients with difficult-to-cure types of HCV.
Over 300 patients in the programme have HCV/HIV co-infection; these patients have higher levels of HCV in their blood and can be more difficult to cure.
A total of 677 patients were treatment-experienced, meaning they had attempted previous HCV treatment but did not achieve viral cure.
The 40% of patients in STARTVerso 3 had advanced liver disease ( greater than or equal to F3 fibrosis ).
The 59% of patients in STARTVerso 1&2 had a non-CC IL28B genotype;1 in previous studies, these patients were less likely to achieve viral cure.
The STARTVerso trial results are particularly promising given the inclusion of a broad range of patients and the similar success rates seen in both HCV mono and HCV/HIV co-infected patients.
Faldaprevir as part of this Interferon-based regimen is likely to offer advantages over first generation protease inhibitors with fewer skin reactions, gastrointestinal events and no additional anaemia. In the STARTVerso clinical trial programme, adverse events were generally mild and well manageable. Most common adverse reactions included jaundice due to transient bilirubin elevation ( unconjugated hyperbilirubinemia ), nausea, fatigue, diarrhoea, headache, anaemia and rash.
The 95% of patients completed Faldaprevir treatment. ( Xagena )
Source: Boehringer-Ingelheim, 2013