FDA Approves Sofosbuvir for Chronic Hepatitis C

Posted by The Evidence Blog on January 21, 2014

The standard of care for patients with chronic hepatitis C has been the combination of ribavir and pegylated interferon. This regimen is associated with side effects, which some patients cannot tolerate. With the recent FDA approval of sofosbuvir, patients with hepatitis C now have another treatment option. Sofosbuvir efficacy and safety were demonstrated in 4 pivotal phase III clinical trials. Hayes will continue to monitor the post-marketing surveillance results to identify any issues that may develop as sofosbuvir becomes more widely used in clinically practice.

The Food and Drug Administration (FDA) has approved sofosbuvir (Sovaldi; Gilead) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. Note that most patients in the U.S. are genotype 1 and will not necessarily be eligible for the all-oral regimen that does not include interferon.

Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval, indicating that the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases.

HCV is a viral disease that causes inflammation of the liver, which can lead to diminished liver function, liver failure, or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. According to the Centers for Disease Control and Prevention (CDC), approximately 3.2 million Americans are infected with HCV.

Most current HCV regimens in the United States utilize a combination of an oral medication plus ribavirin plus interferon, an injectable therapy that can cause undesirable side effects. Sovaldi is an oral medication that blocks a specific protein needed by HCV to replicate. It is approved for use as a component of a combination antiviral treatment regimen for chronic HCV infection that might include Sovaldi and ribavirin or Sovaldi, ribavirin and interferon, depending on the patient’s genotype. It is not designed to be used as a stand-alone treatment. The recommended treatment duration is 12 weeks for genotypes 1, 2, and 4, and 24 weeks for genotype 3. A 12-week treatment will cost $84,000.

Sovaldi’s effectiveness was evaluated in 6 clinical trials comprising 1947 treatment-naïve participants and treatment-experienced patients, including those co-infected with HCV and HIV. The trials were designed to measure whether HCV was still present in the blood at least 12 weeks after finishing treatment. The absence of any virus at this point suggests that the HCV infection has been cured.

The results from the trials showed that a treatment regimen containing Sovaldi was effective in treating multiple genotypes of HCV among various patient groups. Additionally, Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.

The most common side effects reported throughout the clinical studies with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia, and anemia.

  1. Food and Drug Administration (FDA). FDA approves Sovaldi for chronic hepatitis C [news release]. December 6, 2013. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm. Accessed December 16, 2013.

Topics: Hayes Blog

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