Table 3. Boceprevir labels (US and Europe).
Patients | HCV RNA | Treatment | |
---|---|---|---|
Week 4 | Week 12 | ||
Boceprevir is administered after 4 weeks of “lead-in” with pegylated IFN-α and ribavirin alone at the dose of 800 mg every 7-9 hours with food, in combination with either pegylated IFN-α2b (1.5 μg/kg/week subcutaneously) or pegylated IFN-α2a (180 μg/week subcutaneously), and ribavirin (0.8 to 1.4 g/day according to body weight). Futility rule: stop therapy if HCV RNA >100 IU/mL at week 12 or detectable at week 24. Abbreviations: IFN, interferon. | |||
Treatment-naïve without cirrhosis | Undetectable | Undetectable | Treat with 3 drugs until week 28 |
Detectable | Undetectable | Treat with 3 drugs until week 36 Continue with pegylated IFN-α and ribavirin until week 48 |
|
Responder-relapsers and partial responders without cirrhosis | Undetectable | Undetectable | US: Treat with 3 drugs until week 36 Europe: Treat with 3 drugs until week 36 Continue with pegylated IFN-α and ribavirin until week 48 |
Detectable | Undetectable | Treat with 3 drugs until week 36 Continue with pegylated IFN-α and ribavirin until week 48 |
|
Null responders and all cirrhotics | All patients | Treat with 3 drugs until week 48 |