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March 1, 2011

Low-Dose Ritonavir Does Not Affect PK of Investigational HCV Protease Inhibitor

As the incidence of HCV infection increases in HIV infected MSM newer oral agents to treat HCV are being investigated for use with standard HIV therapies. Telaprevir (TVR) is an investigational protease inhibitor being studied in combination with peginterferon alfa-2a and ribavirin. The pharmacokinetics of this HCV protease inhibitor when used in combination with low-dose ritonavir (RTV) were not well established, but data was presented at the 18th Conference on Retroviruses and Opportunistic infections which studied this combination.

Varun Garg of Vertex Pharmaceuticals in Beerse, Belgium present a study in which 3 groups of healthy volunteers were given TVR at doses of 250mg twice daily combined with RTV 100mg twice daily, 750mg twice daily combined with 100mg RV twice daily or 750mg three times a day alone. Subjects were treated for 14 days with either combination.

When compared to TVR 750mg every 8 hours given alone, TVR PK parameters on day 14 were 59% to 74% lower when TVR 250mg every 12 hours was co-administered with RTV 100mg every 12 hours, and 15% to 32% lower when TVR 750mg every 12 hours was co-administered with RTV 100mg every 12 hours.

This data showed that following multiple doses of TVR and RTV, no significant boosting of TVR occurred with exposure to RTV. Additional studies regarding the clinical implications of co-administration of TVR and RTV need to be completed, but it would appear that PK data are favorable for co-administration of TVR with a commonly used HIV protease inhibitor.

Reference: Garg V, Luo X, McNair L, et al. et al. Low-dose RTV and the Pharmacokinetics of the Investigational HCV Protease Inhibitor TVR in Healthy Volunteers. Presented February28, 2011, at the 18th Conference on Retroviruses and Opportunistic Infections, Boston, MA: Poster Abstract 629.

Source: Reporting from Boston, MA for PRN News: A.C. Demidont, DO