Gilead Sciences announced Friday the new FDA approval of Sofosbuvir also marketed as (Sovaldi), the newest treatment for chronic hepatitis C (CHC) infection.
Sovaldi was approved by the FDA on December 6th, 2013.
Sovaldi (Sofosbuvir) 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. The second drug approved by the FDA in the past two weeks was Simeprevir (Olysio) by Janssen to treat chronic HCV infection.
Sovaldi (Sofosbuvir) is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, among the second generation of protease inhibitors that directly attack the Hep C virus cell.
These are the highlights of Sovaldi (Sofosbuvir):
* A 400mg tablet, once-daily oral dose. *See below for recommended regimens.
*Sovaldi (Sofosbuvir) approved for use in Genotypes 1, 2, 3, or 4
*High Cure Rates with an overall response rate of 90% in most gentotypes.
*Shortened 12 Week Course of Therapy for Many Patients.
*First Ever Oral Treatment Regimen for Genotypes 2 or 3. *See below for recommended regimens.
*First Regimen for Patients Awaiting Liver Transplantation to Prevent HCV Recurrence.
Recommended regimens and treatment duration for Sovaldi (Sofosbuvir) combination therapy in HCV mono-infected or HCV/HIV-1 co-infected patients follows:
Genotype 1 or 4
Duration: 12 weeks
Treatment: Sovaldi (Sofosbuvir) + ribavirin
Duration: 12 weeks
Treatment: (Solvaldi Sofosbuvir) + ribavirin
Duration: 24 weeks
Gilead states that Sovaldi (Sofosbuvir) can be considered for (CHC) chronic hepatitis C patients with genotype 1 infection in combination with ribavirin for 24 weeks for those patients who are interferon ineligible.
Additionally, Sovaldi (Sofosbuvir) should be used in combination with ribavirin for treatment of CHC patients with hepatocelluar carcinoma (liver cancer) awaiting liver transplantation for up to 48 weeks or until liver transplant to prevent post-transplant HCV infection.
Treatment regimen, duration and response to Sovaldi (Sofosbuvir) are dependent on viral genotype and patient population, and associated baseline factors. Monotherapy is not recommended. Full Prescribing Information will be available at Gilead.com.
“I believe Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of hepatitis C,” said Ira Jacobson, MD, Chief of the Division of Gastroenterology and Hepatology, Well Cornell Medical College, New York City and a principal investigator in the Sovaldi (Sofosbuvir) clinical trials.
Chronic hepatitis C affects an estimated 4 million people in the United States, the majority whom are “baby boomers”—individuals born between 1945 and 1965. The disease is the nation’s leading cause of liver cancer and liver transplantation and in recent years has surpassed HIV/AIDS as a cause of death.
The current standard treatment for HCV can involve up to 48 weeks of therapy with a peglated interferon (peg-IFN), ribavirin (RBV)-containing regimen and in some genotypes used with one of the first class of protease inhibitors approved by the FDA in 2011, telaprevir (Incivek) and boceprevir (Victrelis).
Side effects of Sovaldi (Sofosbuvir) Most Common:
Drug Interactions with Sovaldi:
In addition to rifampin and St. John’s wort, coadministration of Sovaldi is not recommended with carbamazepine, oxcarbazepine, Phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of Sofosbuvir, reducing its therapeutic effect.
See more from Gilead on warnings and precautions.
U.S. Patient Assistance Program
Gilead is committed to ensuring that people with hepatitis C can access Sovaldi and has launched Support Path, to provide assistance to patients who are uninsured, underinsured, or who need financial assistance to pay for the medicine.
The program consists of an integrated offering of support services for patients, providers including:
–Access to dedicated case managers to help patients and their providers with insurance-related needs, including identifying alternative coverage options such as federally-insured programs (e.g., Medicaid, Medicare) and health exchanges.
–Education and support, including a 24/7 nursing support service line and the ability to schedule an onsite visit from a clinical educator.
–The Sovaldi Co-pay Coupon Program, which provides co-pay assistance for eligible patients with private insurance who need assistance paying for out of pocket medication costs. Most patients will pay no more than $5 per co-pay. Co-pay assistance can also be applied toward deductibles and co-insurance obligations.
—Gilead will provide support to the Patient Access Network (PAN) Foundation, an independent non-profit organization that provides assistance for eligible federally-insured and privately-insured patients who need help covering out of pocket medication costs.
—The Support Path Patient Assistance Programs will provide Sovaldi at no charge for eligible patients with no other insurance options.
Information about how to apply for any of these forms of assistance can be found at My Support Path.com or by calling 1-855-7MyPath (1-855-769-7284) between 9am-8pm EST.
Gilead is committed to helping ensure access to Sovaldi in resource-limited settings. The company is developing a hepatitis C treatment access program, focusing on those countries with the greatest HCV burden. Full program details will be announced in the coming months.
Resource Information from:
Have you been waiting for Sovaldi (Sofosbuvir)? Do you have a question about Hep C Treatment? What are your thoughts or concerns about this new drug?
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