ribavirin or peginterferon and SVR rates in studies
are well over 90%.10 Side effects are generally
mild and include headache, nausea, and fatigue.10
A new drug application was filed with the FDA in
February 2014 and an FDA decision is expected
around October 10, 2014.1 The next regimen that
we expect to be approved is the combination of
ABT-450/r/ABT-267 with ABT-333 and ribavirin for
the treatment of genotype 1 chronic HCV.1 ABT450/r/ABT-267 is three drugs co-formulated into
one tablet.1 The co-formulated tablet will be taken
once daily and ABT-333 and ribavirin will be taken
twice daily.1 The duration of therapy is expected to
be 12 or 24 weeks.11 Side effects and SVR rates are
generally similar to those seen with the ledipasvir
and sofosbuvir regimen.11 A new drug application
is expected to be filed in the second quarter of
2014 and we hope to see an FDA decision by
December 31, 2014.1 The third regimen expected
to be approved is the combination of daclatasvir
and asunaprevir for genotype 1b with anticipated
treatment duration of 24 weeks.12 SVR rates in the
studies ranged from 82% in previous non-responders
to 91% in treatment naïve patients.12 The most
common side effects reported in clinical trials were
headache, fatigue, diarrhea, nausea and asthenia.12
FDA decision is expected by February 28, 2015.1
This allows the clinician to assess the anticipated
treatment and then ͕