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PSI-7977 Plus Pegylated Interferon/Ribavirin for Genotype 1

http://www.hepctrust.org.uk/Treatment/Potential+New+Drugs/Drugs+that+target+the+virus/Pharmasset+PSI+7977

"PSI-7977 Plus Pegylated Interferon/Ribavirin for Genotype 1

The genotype 1 analysis included 121 treatment-naive patients. Approximately half were men, the median age was about 50 years, about 75% were white, 20% were black, and 10% were Hispanic. About 75% had HCV subtype 1a and about 40% had the favorable IL28B CC gene pattern; people with liver cirrhosis were excluded.

Participants were randomly assigned to receive 200 mg or 400 mg once-daily PSI-7977 plus pegylated interferon/ribavirin for 12 weeks, continuing on pegylated interferon/ribavirin alone for another 12 weeks. At that point, those with extended rapid virological response (eRVR) stopped treatment, while non-eRVR patients continued on a pegylated interferon/ribavirin "tail" through week 48. A control arm received pegylated interferon/ribavirin standard therapy for 48 weeks.

Results

All participants receiving either dose of PSI-7977 experienced rapid HCV viral load suppression.
Rapid virological response (RVR), undetectable HCV RNA at week 4:
98% of patients receiving 200 mg PSI-7977 + pegylated interferon/ribavirin;
98% of patients receiving 400 mg PSI-7977 + pegylated interferon/ribavirin;
19% of patients receiving pegylated interferon/ribavirin alone.
End-of-treatment response at week 12:

91% of patients receiving 200 mg PSI-7977 + pegylated interferon/ribavirin;
91% of patients receiving 400 mg PSI-7977 + pegylated interferon/ribavirin;
50% of patients receiving pegylated interferon/ribavirin alone.
SVR12:

88% of patients receiving 200 mg PSI-7977 + pegylated interferon/ribavirin;
91% of patients receiving 400 mg PSI-7977 + pegylated interferon/ribavirin;
Patients receiving pegylated interferon/ribavirin standard therapy are still undergoing follow-up for SVR.
The SVR12 rate reached 98% among patients who received at least 8 weeks of 400 mg PSI-7977.
All but 1 patient in the 2 PSI-7977 arms qualified for 24 total weeks of treatment according to response-guided therapy.
No PSI-7977 recipients experienced viral breakthrough while on PSI-7977, but 3 people in the 200 mg group did so while on the pegylated interferon/ribavirin tail.
1 person each in the 200 mg and 400 mg groups experienced post-treatment relapse, none of whom showed evidence of the S282T resistance mutation.
PSI-7977 was generally well-tolerated with an adverse events profile similar to that of pegylated interferon/ribavirin standard therapy.
Insomnia was more common in the 400 mg PSI-7977 arm (15% vs 8% in control arm and 4% in 200 mg PSI-7977 arm).
There were no treatment discontinuations due to adverse events related to PSI-7977
The researchers noted that the high SVR rate among HCV genotype 1 patients was independent of predictors of poor interferon response.
Lawitz elaborated that among the 13 PROTON participants with the unfavorable IL28B TT pattern, all had a "brisk response" and all achieved SVR12."
1 Responses
Avatar universal
When was this done Dave?  I don't think they are doing the 200mg dosing anymore in current trials.  
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