China Rejects Gilead Patent Bid On $1,000-A-Day Hepatitis C Drug Sovaldi (Sofobuvir)

In response to news that the Chinese government patent office has denied a request by Gilead Sciences for a key patent on the hepatitis C drug sofosbuvir (trade name Sovaldi) Médecins Sans Frontières/Doctors Without Borders (MSF) observed in a statement Friday (June 19) that this drug, along with other antivirals, is the backbone of several newer, more effective and even curative hepatitis C treatments, yet it is exorbitantly priced in many countries (roughly $1,000 per day for one pill daily in the U.S.) , restricting access for people who need it.

An Analyst Blog by financial analysis firm Zacks.com notes that Gilead has been a target of criticism for the high price tags associated with its HCV drugs Sovaldi (approximately $84,000 for a typical 12-week course) and Harvoni (approximately $94,500 for a typical 12-week course). The blog says Gilead has been under pressure to reduce HCV drug prices, and reports that the company has entered into agreements with several pharmacy benefit managers and health care service companies and is in the process of undertaking several pricing measures including a discount increase, charge back and rebates.

Gilead says it is committed to ensuring that people with hepatitis C can access Sovaldi and has launched Support Path (http://www.MySupportPath.com), a program to provide assistance to patients who are uninsured, underinsured or who need financial assistance to pay for the medicine. The MySupportPath program consists of an integrated offering of support services for patients and 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. Gilead says most patients will pay no more than $5 per co-pay. Co-pay assistance can also be applied toward deductibles and co-insurance obligations.

Additionally, Gilead promises to 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 Program 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 http://www.MySupportPath.com or by calling 1-855-7MyPath (1-855-769-7284) between 9 a.m. – 8 p.m. EST.

From a global perspective, Gilead says it is “committed to helping ensure access to Sovaldi in resource-limited settings,” and that the company is developing a hepatitis C treatment access program that will focus on countries with the greatest HCV burden, with program details to be announced.

Chronic hepatitis C (CHC) is a global public health crisis, with at least 150 million people living with the disease globally, including an estimated 4 million in the United States, and 350,000-500,000 people die annually from Hep C complications. The majority of American Hep C patients 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 of care for HCV involves up to 48 weeks of therapy with a pegylated interferon (peg-IFN)/ribavirin (RBV)-containing regimen, which may not suitable for certain types of patients.

Sovaldi is a breakthrough medicine that directly targets the Hep C virus — described as an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. Sovaldi is a direct-acting agent, meaning that it interferes directly with the HCV life cycle by suppressing viral replication. Treatment regimen and duration for Sovaldi are dependent on both viral genotype and patient population. Treatment response varies based on baseline host and viral factors. Monotherapy is not recommended for treatment of CHC.

In a study of 327 patients who had no prior Hep C treatments and who all received Sovaldi once daily for 12 weeks along with another oral medicine (ribavirin) and a weekly injection (peginterferon alfa), 89% of those with the most common type of Hep C (genotype 1) were cured. Cure in this context means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.

The U.S. Food and Drug Administration (FDA) approved Sovaldi 400 mg tablets in December, 2013 as a once-daily oral nucleotide analog polymerase inhibitor for treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Sovaldi’s efficacy has been established in subjects with hepatitis C virus (HCV) genotypes 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milancriteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection. The FDA also granted Sovaldi Priority Review and Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. However, the the Wholesaler Acquisition Cost (WAC) of a 28-tablet bottle of Sovaldi in the United States is $28,000.

Sovaldi’s curative efficacy has been established in subjects with hepatitis C virus (HCV) genotypes 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milancriteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
Sovaldi’s FDA approval was supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, which evaluated 12 or 16 weeks of treatment with Sovaldi combined with either RBV or RBV plus peg-IFN. Three of these studies evaluated Sovaldi plus RBV in genotype 2 or 3 patients who were either treatment-nave (FISSION), treatment-experienced (FUSION) or peg-IFN intolerant, ineligible or unwilling (POSITRON). NEUTRINO evaluated Sovaldi in combination with Peg-IFN/RBV in treatment nave patients with genotypes 1, 4, 5 or 6. In these studies, Sovaldi-based therapy was found to be superior to historical controls (NEUTRINO and FUSION) or to placebo (POSITRON), or non-inferior to currently available treatment options (FISSION) based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. Trial participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90 percent.

In Sovaldi clinical trials led by principal investigator Ira Jacobson, MD of the Division of Gastroenterology and Hepatology at Weill Cornell Medical College, in New York City, Sovaldi in combination with other agents achieved very high cure rates while shortening duration of treatment to as little as 12 weeks and reducing or completely eliminating the need for interferon injections, depending on the viral genotype.

A Sovaldi FAQ can be found here:
http://sovaldi.com/faq

However, the MSF release notes that Gilead’s patent application was rejected following a pre-grant challenge filed by the Initiative for Medicines, Access & Knowledge (I-MAK), and that a number of additional challenges have been filed on patent applications for sofosbuvir, including in India, Argentina, Ukraine, Russia, Brazil and at the European Patent Office by different parties. MSF further observes that patents on sofosbuvir have already been rejected in both Egypt and India.

China with its vast population is of course a lucrative market for pharmaceuticals and is also the world’s single largest source of “raw” active pharmaceutical ingredients for all sorts of medicines. MSF observes that there have been limitations on use of the raw material for sofosbuvir because of patent barriers, noting that China is increasing its capacity to produce finished products for drugs and vaccines, and suggests that with the decision to reject the secondary patent on sofosbuvir, there is greater potential for generic sofosbuvir to enter the Chinese market earlier.

Médecins Sans Frontières/Doctors Without Borders is in the process of starting to scale-up treatment of hepatitis C, currently treating people with sofosbuvir in Pakistan, and plans to expand treatment in nine countries.

MSF’s response to the China patent office rebuff of Gilead’s application says that”Chinas rejection of a key patent on sofosbuvir goes to show that there are serious questions about whether this drug merits patenting, and sends a strong signal to other countries that are currently reviewing patent applications for the drug. China could prove to be an important supplier for the raw materials as well as the finished product of sofosbuvir. Increased competition from manufacturers in China could help push the price of sofosbuvir down, so that more people can access it. We hope that other countries where Gilead is seeking patents for sofosbuvir are watching closely.
Rohit Malpani, Director of Policy & Analysis, MSF Access Campaign.”

Dr. Jennifer Cohn, Medical Director of the MSF Access Campaign is cited noting that “This is good news for people with hepatitis C, and will hopefully lead to more people in developing countries being able to access low-cost versions of sofosbuvir. Gilead’s exorbitant pricing is preventing people from getting the treatment they need in both rich and poor countries. A cure for hepatitis C does nobody any good if nobody can afford it.”

Sources:
Médecins Sans Frontières/Doctors Without Borders (MSF)
Gilead Sciences
Zacks.com blog

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