WOONSOCKET, R.I., Sept. 17, 2014 /PRNewswire/ — An analysis done by the CVS Health Research Institute
provides insights regarding patients taking Sovaldi® (sofosbuvir), a
new and expensive treatment for Hepatitis C introduced in December. The
data shows that over the last several months (May through August 2014)
there has been a plateau and actual downward trend in Sovaldi
utilization. This suggests another surge of patients will begin therapy
when a number of new therapeutic regimens of similar efficacy and
shorter duration are introduced in the Fall.
In clinical trials for Sovaldi, more than 95 percent of patients
achieved cure rates and almost all patients completed therapy, with only
about two percent discontinuing treatment. However, clinical trials
rarely capture the real-life challenges faced by patients taking a new
drug. The new CVS Health
data also provides a first look at the drug’s use outside of the
clinical trial setting and shows therapy discontinuation rates of 8.1
percent, approximately four times higher than in trials. Furthermore,
patients who were completely new to Hepatitis C treatment were more
likely to discontinue therapy, a finding which has substantial
implications for clinicians and their patients.
Adverse events reported included anemia, which developed in 85% of
patients, and rash in 24%. In patients treated with telaprevir, 23%
developed rash, while 0% of patients treated with boceprevir developed
SAN DIEGO — Premature treatment discontinuation because of the high
rate of adverse events is a significant issue with direct-acting
antivirals among hepatitis C patients in clinical practice, a speaker said here.
“Our SVR [sustained virologic response] rates have improved with the advent of direct-acting antivirals [DAA], but there’s still a lot of room to go,” Phillip K. Henderson, DO, clinical instructor of medicine with the University of South Alabama, said at the American College of Gastroenterology Annual Scientific Meeting.
rates with boceprevir (Victrelis, Merck & Co.) and telaprevir
(Incivek, Vertex Pharmaceuticals) are much higher in the real-world
setting than in the clinical trials that led to the drugs’ approvals.
This news comes from two studies presented at The Liver Meeting, the
annual meeting of the American Association for the Study of Liver
Researchers say that treatment rates are low because of the
complexity of treatment with the direct-acting antivirals (DAA) and
concerns about side effects, even at experienced centers. The FDA
approved boceprevir and telaprevir for the treatment of patients with
hepatitis C virus (HCV) genotype 1 infection in combination with
pegylated interferon and ribavirin in 2011.