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U.S. Lawmakers Question $84,000 Treatment for HCV Infection

Sovaldi (sofosbuvir) draws fire from insurers and health care advocates

U.S. House Democrats have asked Gilead Sciences, Inc. to explain how the company set its $84,000 price for the hepatitis C virus (HCV) treatment Sovaldi (sofosbuvir).

The lawmakers also asked the company’s chief executive officer to explain what is being done to make sure the medicine gets into the hands of low-income patients, especially in government-run health programs.

“Our concern is that a treatment will not cure patients if they cannot afford it,” the lawmakers wrote in a letter dated March 20. They asked Gilead to brief Congress by April 3.

Sovaldi (sofosbuvir), a nucleotide analog inhibitor of HCV NS5B polymerase, was approved in December 2013 as a “breakthrough” treatment for chronic hepatitis C (CHC) as a component of a combination antiviral treatment regimen. The drug offers higher cure rates and fewer side effects than older therapies, but its high cost has attracted scrutiny and resistance from insurers and public health advocates.

Sovaldi is administered as a 400-mg tablet taken once daily with or without food. It should be used in combination with ribavirin or in combination with pegylated interferon (pegIFN) and ribavirin for the treatment of chronic HCV infection.

The drug’s safety and efficacy were evaluated in five phase III trials in a total of 1,724 HCV mono-infected subjects with genotypes 1 through 6 CHC and in one phase III trial in 223 HCV/human immunodeficiency virus-1 (HIV-1) co-infected subjects with genotype 1, 2, or 3 CHC.

NEUTRINO was an open-label, single-arm trial that evaluated 12 weeks of treatment with sofosbuvir in combination with pegIFN alfa-2a and ribavirin in 327 treatment-naïve subjects (median age, 54 years) with genotype 1, 4, 5, or 6 HCV infection compared with a pre-specified historical control. The overall sustained virologic response (SVR) rate was 90% (295/327).

FISSION was a randomized, open-label, active-controlled trial that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared with 24 weeks of treatment with pegIFN alfa-2a and ribavirin in 499 treatment-naïve subjects (median age, 50 years) with genotype 2 and 3 HCV. The overall SVR rate was 67% for both treatment groups.

POSITRON was a randomized, double-blinded, placebo-controlled trial that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared with placebo (n = 71) in subjects who were IFN intolerant, ineligible, or unwilling. The subjects’ median age was 54 years. The overall SVR rate was 78% in the sofosbuvir + ribavirin group compared with 0% in the placebo + ribavirin group.

FUSION was a randomized, double-blinded trial that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in 201 subjects (median age, 56 years) who did not achieve SVR with prior IFN-based treatment (relapsers and nonresponders). The overall SVR rates were 50% (51/103) at 12 weeks and 71% (70/98) at 16 weeks.

The VALENCE trial evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype-2 or -3 HCV infection in a total of 419 subjects (median age, 51 years) who were treatment-naïve or who did not achieve SVR with prior IFN-based therapy. The overall SVR rates were 93% (68/73) for genotype-2 patients at 12 weeks and 84% (210/250) for genotype-3 patients at 24 weeks.

The open-label PHOTON-1 trial evaluated the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in subjects with genotype 1, 2, or 3 CHC co-infected with HIV-1. The overall SVR rates were 76% (87/114) for genotype-1 patients at 24 weeks; 88% (23/26) for genotype-2 patients at 12 weeks; and 92% (12/13) for genotype-3 patients at 24 weeks.

Sources: Bloomberg; March 21, 2014; Congressional Letter; March 20, 2014; and Sovaldi Prescribing Information; December 2013.

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