Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4)].
12.4 Microbiology
Persistence of Resistance-Associated Substitutions
Persistence of telaprevir-resistant NS3 amino acid substitutions has been observed following treatment failure. Of a combined 255 treatment-naïve and previously treated subjects from Trials 108, 111, and C216 in whom telaprevir-resistant variants had emerged during treatment, 103 (40%) had detectable resistant variants by population sequencing at end of trial (follow-up range 2-70 weeks, median 45 weeks) and results for loss of variants were similar across the three trials. In the combined trials, 46% of the telaprevir-resistant substitutions in subtype 1a and 16% of the substitutions in subtype 1b were still detected by the end of trial: 29% of V36, 16% of T54, 38% of R155, 14% of A156, and 44% of V36M+R155K variants were detected at the end of trial.
In a 3-year follow-up trial of 56 treatment-naïve and prior treatment-failure subjects who did not achieve SVR with a telaprevir regimen in a Phase 2 trial and had telaprevir-resistant variants after treatment failure, variants were detected by population sequencing in 11% (6/56) of subjects (median follow-up of 25 months). Telaprevir-resistant variants V36L/M, T54S, and R155K were detectable (present at greater than 25% of the viral population) in some subjects at 24 months. By 36 months, V36M, T54A/S, and A156N/S/T variants had fallen below the level of detection by population sequencing in all subjects. At 36 months, 3% of the subject isolates that had the R155K variant still had detectable R155K variants by population sequencing.
The lack of detection of a substitution based on a population-based assay does not necessarily indicate the substitution has declined to the pre-treatment level. The long-term clinical impact of the emergence or persistence of detectable INCIVEK resistance-associated substitutions is unknown. No data are available regarding INCIVEK efficacy among patients who were previously exposed to INCIVEK, or who previously failed treatment with an INCIVEK-containing regimen.
Perhaps reading what info years of research has proven would be helpful
Mike as far as new drugs available in the future, things look very promising, here is link to advocates journals, she has posted lots of INFO on the new drugs as they were presented at the 2012 ESLD meeting
http://www.medhelp.org/user_journals/index/1739543?personal_page_id=2242526