Sofosbuvir/ledipasvir expected to gain market share

Forty percent of specialists surveyed intend to prescribe the investigational combination treatment sofosbuvir/ledipasvir in the next 6 months to patients with hepatitis C virus genotype 1, according to a new report.

The polymerase inhibitor sofosbuvir (Sovaldi, Gilead) was approved in December 2013 as part of an antiviral regimen for the treatment of HCV patients with genotypes 1, 2, 3 or 4.

The report, which was compiled by the Decision Resource Group, included data from surveys of 100 gastroenterologists, hepatologists and infectious disease specialists who shared information on their awareness of and interest in sofosbuvir and the second-generation protease inhibitor simeprevir (Olysio, Janssen Therapeutics). Each specialist managed at least 50 patients with chronic HCV and was not a member of a national advisory board for either product or company.

An analysis of the specialists’ near-term prescribing intentions suggests that almost one in four genotype 1 patients receiving active treatment will be prescribed the sofosbuvir/ledipasvir regimen in the next 6 months. Regimens containing sofosbuvir will account for 70% of the patient share, according to the report. Although simeprevir trails sofosbuvir in the treatment of genotype 1 infections, almost 25% of patients will receive a combination treatment containing both drugs, and patient shares of the simeprevir/sofosbuvir regimen are expected to remain stable over the next 6 months.

The specialists also reported discontinuation rates and proportions of patients treated with the drugs who achieved SVR. Reimbursement issues and out-of-pocket expenses were among the most common reasons cited by specialists for their patients choosing to discontinue treatment with simeprevir or sofosbuvir.

Specialists also are more likely to be aware of the US regulatory filing for the sofosbuvir/ledipasvir combination treatment than the filings for Bristol-Myers Squibb’s daclatasvir and asunaprevir and AbbVie’s experimental combination therapy, which consists of a protease inhibitor called ABT-450, along with ritonavir, ombitasvir and dasabuvir. Many specialists remain unaware of new therapies currently in the pipeline, according to the report.

“Our findings suggest that in the next 6 months, HCV treatment will once again undergo a significant transformation, with Gilead’s sofosbuvir/ledipasvir regimen expected to rapidly gain market share,” Brenda Perez-Cheeks, PhD, director of the Decision Resource Group, said in a press release. “However, near-term competitors that offer favorable pricing and cost sensitivity of payers will likely be a constraint on the uptake of this regimen.”

Perez-Cheeks added that the high costs associated with new HCV therapies and cost-control practices of insurance payers will not only affect simeprevir and sofosbuvir prescribing, but also treatment adherence among HCV patients.

“Indeed, interviewed specialists noted the cumbersome nature of the managed care approval process that impedes patient access and strains resources and staff,” she said.