Alisporivir administered with ribavirin can be an effective treatment with or without interferon for patients with HCV genotype 2 or 3, according to results presented at the International Liver Congress in Barcelona, Spain.
In an international, multicenter trial, researchers randomly assigned 340 patients with HCV genotype 2 or 3 to receive the following treatments:
- 1,000 mg alisporivir (ALV) daily (n=83)
- 600 mg ALV with ribavirin (RBV) daily (n=84)
- 800 mg ALV with RBV daily (n=94)
- 600 ALV with peginterferon (Peg) (n=39)
- Peg/RBV (n=40)
Participants receiving alisporivir who achieved undetectable HCV RNA levels after four weeks remained on their respective treatments for 24 weeks, while patients with detectable RNA received alisporivir, peginterferon and ribavirin from weeks 6 through 24. Results presented at the meeting included end-of-treatment response (ETR) for all participants and sustained viral response (SVR) 12 for 66% of participants.
The ALV/RBV combination resulted in a higher HCV clearance at week 6 (49% among patients in the 600 mg group and 46% in the 800 mg group) than ALV administered on its own (32%). Of the 70 evaluable patients who received ALV/RBV without interferon, 95% achieved ETR and 88% achieved SVR12. Among 177 patients who received either ALV/RBV or ALV/RBV with delayed add-on interferon, 97% achieved ETR and 90% achieved SVR12, compared with 88% ETR and 72% SVR12 in patients who only received Peg/RBV.
Researchers observed reduced flu-like symptoms among ALV patients compared with Peg/RBV patients, as well as a lower discontinuation rate. Six ALV patients (2%) experienced transient hyperbilirubinemia with ALT normalization.
“Alone or with RBV, ALV maintains on-treatment HCV control, confirming ALV high barrier to resistance,” the researchers wrote. “ALV/RBV interferon-free or add-on interferon has potential to provide better efficacy and safety than Peg/RBV.”
For more information:
Pawlotsky J-M. Abstract #1405. Presented at: The International Liver Congress, April 18-22, Barcelona, Spain.