title: Patient Characteristics and Prescribing Patterns Associated with Sofosbuvir Treatment for Chronic HCV Infection in a Commercially Insured Population.
abstract: BACKGROUND
  In December 2013, the US Food and Drug Administration (FDA) approved sofosbuvir (Sovaldi) for the treatment of patients with chronic hepatitis C virus (HCV) infection. Given the potential "warehousing" of patients before the launch of sofosbuvir and the possibility that some patients and providers may have elected to continue deferring treatment in anticipation of more promising, interferon-free therapies in the pipeline, the early landscape for sofosbuvir treatment is difficult to ascertain.
  
  
  OBJECTIVE
  To describe the demographics, clinical characteristics, and prescribing patterns associated with members requesting treatment with sofosbuvir in a commercially insured population in the United States.
  
  
  METHODS
  A descriptive analysis was conducted using a randomly selected sample of commercially insured members who were identified as having a prior authorization request for sofosbuvir between March and June 2014. Member and provider characteristics, as well as treatment information, were collected using a prior authorization database from OptumRx, a national pharmacy care services company. The results were analyzed using descriptive statistics.
  
  
  RESULTS
  A total of 338 members were selected for inclusion in the analysis. Chronic HCV genotype 1 infection was present in 74.3% of the members. Chronic HCV genotype 2, 3, or 4 was identified in 13.9%, 9.5%, and 1.2% of the members, respectively. Gastroenterologists and hepatologists accounted for 90% of providers. Among the 251 members with chronic HCV genotype 1, an interferon-free regimen was requested for 59.4% (N = 149) of them; the most frequently requested (51.4%) regimen for members with chronic HCV genotype 1 was the off-label combination of sofosbuvir plus simeprevir. Of the members with chronic HCV genotype 1, 19.1% had liver fibrosis equivalent to METAVIR stage F0 to F2 fibrosis, and 24.7% had liver fibrosis equivalent to METAVIR stage F3 to F4 fibrosis. For the remaining 56.2%, the degree of liver fibrosis was not known or could not be determined. Of the members with documented liver fibrosis, 49.6% were determined by liver biopsy.
  
  
  CONCLUSIONS
  The results show that the initial prescribing of sofosbuvir often included the off-label interferon-free regimen of sofosbuvir plus simeprevir during the study period (of note, this combination regimen was approved by the FDA in November 2014, after the completion of the study period). The off-label prescribing pattern may be attributable to "warehousing" of patients who were awaiting more tolerable therapies. Furthermore, the limited utilization of noninvasive tests to assess liver fibrosis suggests that providers may benefit from additional education on these methods. Although this analysis provides insight into the treatment of patients with chronic HCV immediately after the launch of sofosbuvir in the United States, future research should reevaluate the treatment patterns of chronic HCV infection to capture recent advances in the treatment of this disease.
authors.affiliation: Clinical Pharmacists, OptumRx, Irvine, CA.
authors.forename: Brent M
authors.initials: BM
authors.lastname: Tambourine
authors.affiliation: Clinical Pharmacists, OptumRx, Irvine, CA.
authors.forename: Arash
authors.initials: A
authors.lastname: Sadeghi
authors.affiliation: Senior Biostatistician, Optum, Irvine, CA.
authors.forename: Jianing
authors.initials: J
authors.lastname: Yang
authors.affiliation: Director, Health Economics and Outcomes Research, Optum, Irvine, CA.
authors.forename: Karen M
authors.initials: KM
authors.lastname: Stockl
authors.affiliation: Vice President, Clinical Programs, OptumRx, Irvine, CA.
authors.forename: Heidi C
authors.initials: HC
authors.lastname: Lew
authors.affiliation: Chief Medical Officer, Optum Life Sciences, Irvine, CA.
authors.forename: Brian K
authors.initials: BK
authors.lastname: Solow
authors.affiliation: Associate Director, Health Economics and Outcomes Research, Optum, Cypress, CA.
authors.forename: Josephine N
authors.initials: JN
authors.lastname: Tran
keywords: chronic hepatitis C virus infection; direct-acting antivirals; interferon-free treatment; off-label use; prescribing patterns; prior authorization; ribavirin; simeprevir; sofosbuvir