Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.

“As the first fixed-dose combination of two pan-genotypic, direct-acting antivirals, SOF/VEL represents an important step forward in the treatment of patients with hepatitis C,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes. SOF/VEL complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing.”

The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for SOF/VEL is supported by data from four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Those who received SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94 percent,while those who received SOF/VEL for 12 weeks and 24 weeks achieved SVR12 rates of 83 percent and 86 percent, respectively.

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Gilead Drug Combo Could Be Indicated for All Forms of Hepatitis C

Study shows drug may eliminate need for HCV genotype testing altogether

A new Gilead Sciences drug combination that targets six genotypes of the hepatitis C virus (HCV) has achieved promising results in four international phase III clinical studies.

 Gilead has announced results from ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4. The studies evaluated a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) with velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of genotype 1 to 6 chronic HCV infection.

In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 patients with genotype 1 to 6 HCV infection received 12 weeks of SOF/VEL. Among these patients, 21%% had compensated cirrhosis and 28% had failed prior treatments. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. The primary endpoint for all studies was a sustained virological response at week 12 post-treatment (SVR12)

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What We Talk About When We Talk About Hepatitis C

Since 2007, more people have died every year from hepatitis C than from HIV. Fortunately, the latest hepatitis C medications can cure nearly everyone in a relatively quick, easy fashion. So, if it is so easy to cure hepatitis C, why haven't we?

Ostensibly, it is because of the cost. At $1125 a pill for Gilead Sciences' drug Harvoni, a 12-week course of hepatitis C treatment would amount to $94,500. Trying to manage these costs, many state Medicaid programs and insurance companies have severely restricted access to treatment. You save money if you deny treatment to people, and dead people cost nothing.

This means that although we can cure hepatitis C, we aren't. Under many insurance plans, patients have to prove that they have cirrhosis. In short, treatment is approved when liver damage has progressed to its worst stage. It is like refusing to pay for diabetes drugs until the patient is blind or minus a few toes.

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Gilead Limits Enrollment in its Hep C Patient Program to Pressure Insurers

In a bid to push back against payers, Gilead Sciences GILD -0.71% is limiting enrollment to its patient assistance program for hepatitis C drugs, which helps people obtain the Sovaldi and Harvoni treatments when they lack sufficient insurance coverage or the financial wherewithal to get the medicines otherwise.

The drug maker is taking this step after finding that some payers, despite receiving discounts in recent months, have continued to restrict patient access to its hepatitis C medicines. As a result, Gilead has been picking up the cost of the medicines for more people it would like seeking patient assistance, according to a July 1 letter sent to patient groups and community health providers, among others.

A Gilead spokeswoman declined to say how many people are enrolled in its Support Path assistance program, how many may be affected by the change or provide actions taken by specific payers.

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FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

File this under ‘Show me the data.’

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.38%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Here’s what happened:

Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.

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Consumers Sue Anthem for Denying Coverage for a Gilead Hepatitis C Drug

The controversy over the new crop of hepatitis C treatments has taken yet another turn as consumers are starting to file lawsuits against insurers that deny them access to the medicines. Over the past two weeks, two different women alleged that Anthem Blue Cross refused to pay for the Harvoni treatment sold by Gilead Sciences GILD -1.74% because it was not deemed “medically necessary.”

The issue emerges after more than a year of debate over the cost of the medicines and complaints by public and private payers that the treatments have become budget busters. The new hepatitis C treatments, which are sold by Gilead Science and AbbVie, cure more than 90% of those infected and, in the U.S., cost from $63,000 to $94,500, depending upon the drug and regimen, before any discounts.

In response, drug makers have been pressured to offer discounts and some state Medicaid programs, for instance, set restrictions before providing coverage to some hepatitis C patients. By setting restrictions, payers hope to limit the number of patients for whom coverage is provided. And this is the tack that Anthem Blue Cross has pursued, according to court documents.

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U.S.A-$373.9 Billion Spent on Drugs in 2014

“Drug spending in the United States last year was one for the record books. Pharmacists filled a record 4.3 billion prescriptions in 2014 that cost nearly $374 billion, according to a new report issued by the IMS Institute for Healthcare Informatics. 

The 13.1% increase in drug spending in 2014 was mainly driven by two things: the availability of new hepatitis C [HCV] treatments and very few products losing patent protection,” said Murray Aitken, IMS Health senior vice president and the executive director of the IMS Institute for Healthcare Informatics. “Sovaldi [sofosbuvir; Gilead] was the biggest drug launch in history and accounted for about $8 million, or 2%. of the 13% increase.

As for patent protection, the health system saves money when drugs move from branded products to generics. Typically, there has been a savings of between 15 [billion] and 30 billion a year due to patent expiries. But in 2014, that figure was only $12 billion,” he said”.

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Gilead uses Georgia as free-drug testbed for hepatitis C elimination

(Reuters) - Gilead Sciences is seeking to convince governments and multilateral agencies worldwide that hepatitis C can be eliminated with a demonstration project in Georgia offering free drugs to all those who need them.

The unprecedented program will make the Caucasian country a testbed for uprooting the liver-destroying disease, using Gilead's highly effective but costly pill Sovaldi, plus its newer product Harvoni once approved.

Georgia has the world's third highest prevalence of hepatitis C, after Egypt and Mongolia, with nearly 7 percent of adults carrying the virus. It also has a wide range of viral variations and different types of patients.

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Pharma accused of restricting access to hep C drug in poor countries

New drugs for hepatitis C are a major breakthrough but hugely expensive in rich countries. Pharma giant Gilead will allow cheap copies to be made for poor countries - but only for patients with proof of identification and citizenship and the drug supplies will be closely tracked

The battle over access to the new hepatitis C drug, Gilead’s sofosbuvir (and similar drugs coming along behind) is hotting up. There is angst even in the richest countries over the $1000 a pill price tag. It now looks as though Gilead is going to extraordinary lengths to ensure that cheaper versions, which it is permitting generic companies to make for poor countries, do not arrive in affluent world pharmacies.

Gilead has agreed to grant voluntary licences to eleven Indian generic companies, which means the drug will be sold at a reduced price in low-income countries. But Médecins Sans Frontières, the volunteer doctors who are treating hepatitis C infection in some of the poorest regions, say the company has imposed unacceptable conditions.

Gilead stipulates that patients will only get the drug if they can provide identification, proof of citizenship and residency, which MSF says will penalise refugees and marginalised communities. The drug supplies will be closely tracked through codes on the bottles. Gilead, even though it will not be the manufacturer, will have access to that information. If they need more, patients will have to return an empty bottle.

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Charity attacks Gilead over hepatitis C drug restrictions

(Reuters) - Charity Medecins Sans Frontieres has accused U.S. drugmaker Gilead Sciences Inc GILD.O of restricting access to its breakthrough hepatitis C drug Sovaldi in developing countries as it tries to protect profit margin in wealthier nations.

MSF, also known as Doctors Without Borders, said Gilead's restrictions aimed to stop discounted supplies of Sovaldi being diverted to patients from rich countries, but that the effort had resulted in "multiple restrictions and demands" on people receiving treatment in poor countries.

It said Gilead was excluding people without national identity documents, a move that hurts migrants, refugees and marginalized patients.

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Zydus, Gilead Sciences, SoviHep, Sofosbuvir, Ledipasvir, HCV, Liver Gilead Sciences And Zydus Launch SoviHep Hepatitis C Drug

American biotechnology firm Gilead Sciences and Indian pharmaceutical company Zydus launched SoviHep, a drug for treating Hepatitis C.

On Tuesday, March 17, Zydus issued a statement that confirmed it has signed a non-exclusive agreement with Gilead Sciences, which will enable the company to manufacture sofosbuvir, trade name SoviHep, as well as fixed-dose combination of sofosbuvir/ ledipasvir for circulation in more than 90 countries, which includes India. The drug will be marketed by Zydus Heptiza, which is a specialty division in the group.

Hepatitis C may affect the quality of life for patients. Pankaj Patel, Managing Director and Chairman of the Zydus Group, reveals that the launch of SoviHep will provide better treatment for the disease and improve the quality of life for millions of people.

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Hepatitis Pills Contributed to 13 Percent Spike in Drug Spending

Costly new hepatitis pills helped drove a 13 percent increase in drug spending last year among insurer-managed plans in the United States, a rate not seen in more than a decade, according to a report from the pharmacy benefit manager Express Scripts.

A course of therapy to treat the liver-damaging hepatitis C virus could cost as much as $150,000 with the approvals of medicines such as Gilead Sciences Inc.’s Sovaldi and Harvoni and Johnson & Johnson’s Olysio, Express Scripts said in the report, released Tuesday. Driven as well by higher costs of specialty and compounded medicines, the estimated drug spend in general for each person in commercial-insured plans was $980 in 2014.

The new hepatitis C medicines are particularly challenging for government health plans and programs.

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Gilead Sciences (NASDAQ:GILD) and AbbVie (NYSE:ABBV) Trying to Make the Most from Market Share

Gilead Sciences (NASDAQ:GILD) share prices are dropping as a result of the FDA giving the approval to AbbVie (NYSE:ABBV) of its hepatitis C drug, Viekira Pak. Through drastic price cuts, Gilead Sciences (NASDAQ:GILD) is facing a tough time trying to become market leader. Both companies have confirmed that the price reductions are so that they can attract more customers yet investors may not consider this a positive sign.

After Gilead Sciences (NASDAQ: GILD) launched Sovaldi, its drug for oral hepatitis C, it revolutionized the treatment. Before this, patients of hepatitis C had to be treatment with cures that had significant side effects like ribavirin and peg interferon that lasted nearly 48 weeks and had only 50%-80% cure rates.

However, Sovaldi’s treatment doesn’t eliminate ribavirin from the core, but it does put aside peg interferon and gives cure rates of 90%. This is why doctors embraced the drug with open arms and turned it into the quickest drug to achieve such successful levels of treatment. It made nearly $10.3 billion sales in the previous year. However, Gilead Sciences (NASDAQ: GILD) strengthened its drug back in October, when it won the approval by the FDA for its drug Harvoni.

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Nursing Times-NHS-NICE gives backing to hepatitis C drug in latest draft guidance

“The marketing authorisation for ledipasvir-sofosbuvir recommends treatment for hepatitis C genotypes 1, 3 – in combination with ribavirin – and 4”.

“Genotypes 1 and 3 hepatitis C account for the majority of chronic hepatitis C cases in England (46% and 43%, respectively). Genotype 4 hepatitis C accounts for around 4% of cases”.

“Ledipasvir-sofosbuvir, manufactured by Gilead, is administered orally as a single tablet – with or without ribavirin – and works by inhibiting the replication of the hepatitis C virus. It prevents hepatitis C virus replication by inhibiting the NS5A and NS5B proteins”.

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New Cigna, Catamaran Hep C Pacts Put Gilead Drugs to the Test

"Since the December 2014 approval of AbbVie Inc.’s hepatitis C treatment Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets), at least 10 companies have disclosed exclusive or semi-exclusive deals with Gilead Sciences, Inc. that feature the manufacturer’s hepatitis C agents, Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir). But Catamaran Corp. and Cigna Corp. this month unveiled the first outcomes-based arrangements with Gilead that industry observers say could open the door for more value-based deals around hepatitis C and other specialty agents".

"Catamaran on Feb. 3 said it would offer a new hepatitis C patient management program through its specialty pharmacy, BriovaRx, that features Gilead’s Harvoni and Sovaldi as exclusive hepatitis C treatment options (DBN 2/6/15, p. 1). Similarly, Cigna Corp., a long-term Catamaran customer, on Feb. 4 said it would offer Harvoni as the only preferred brand drug treatment for customers with hepatitis C genotype 1 infection as well as develop an outcomes-based incentive program".

"While both companies declined to provide specifics on how the deals are structured, other outcomes-based pharmaceutical arrangements between manufacturers and insurers or PBMs have tied rebate payments to agreed-upon outcomes achieved by the payers’ members. Cigna, for instance, in 2010 embarked on an outcomes-based partnership with Merck & Co. in which the drugmaker provided rebates to Cigna when its members with type 2 diabetes met goals for adherence to prescribed medications and low blood sugar levels (DBN 12/17/10, p. 1). And Prime Therapeutics LLC in 2012 signed an outcomes-based contract with EMD Serono, Inc. for its multiple sclerosis drug Rebif (interferon beta-1a) through which the drugmaker promised to pay rebates to the PBM if its members taking Rebif had a higher total cost of care than people on other MS medications. Adherence levels were also considered. Cigna inked a similar deal with EMD Serono in 2011".

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U.S.A; Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV

SEATTLE--(BUSINESS WIRE)--Feb. 26, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced results from a Phase 3 study, ION-4, evaluating the once-daily single tablet regimen Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV. In the trial, 96 percent (n=321/335) of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. These data were presented in a late-breaker oral session (Session 152LB) at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

“This trial provides strong evidence that people who are co-infected with HIV can achieve very high rates of hepatitis C cure with a combination direct-acting antiviral regimen,” said Susanna Naggie, MD, MHS, Director of Infectious Diseases Research at Duke Clinical Research Institute and Principal Investigator for the ION-4 study. “These high cure rates were observed in most of the historically difficult-to-treat sub-populations, including those who failed previous treatment and those with cirrhosis. We are greatly encouraged by these findings.”

ION-4 is a Phase 3, multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni treatment for 12 weeks in 335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2 percent) and HIV-1 co-infection. The study included HCV treatment-naïve (45 percent) and treatment-experienced (55 percent) patients, including patients with compensated cirrhosis (20 percent), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: tenofovir and emtricitabine with efavirenz (Atripla®), raltegravir or rilpivirine (Complera®).

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India: Natco Pharma ties up with Gilead on hepatitis C drugs

(Reuters) - Natco Pharma Ltd said on Monday it has agreed a deal with Gilead Sciences Inc to supply generic copies of the U.S. drugmaker's chronic hepatitis C medicines, including $1,000-a-pill drug Sovaldi, in 91 developing nations.

Natco, a mid-sized player in India's crowded pharmaceutical industry, is the latest generic drugmaker to team up with Gilead on Sovaldi, having previously attempted to block the U.S. firm from getting a patent for the breakthrough drug in India in the hope of producing a cheaper version on its own. In September, Gilead announced similar licensing deals with seven other generic drugmakers.

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India: Mylan to distribute both Sovaldi and Harvoni for HCV

"Mylan Pharmaceuticals Private Limited, a subsidiary of Mylan Inc., has entered into an agreement with Gilead Sciences to be an exclusive distributor of Sovaldi and Harvoni in India for the treatment of hepatitis C virus infection, according to a press release.

Under the agreement, Mylan will distribute Sovaldi (sofosbuvir, Gilead) and Harvoni, a combination of ledipasvir (Gilead) and sofosbuvir, and also have the rights to manufacture and distribute generic versions of both regimens. In addition, Mylan will also retain manufacturing and distribution rights for the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 upon approval, according to the release.

“Hepatitis C is a growing public health concern, particularly in developing countries such as India where access to high quality, effective and affordable treatment remains a challenge,” Rajiv Malik, president of Mylan, said in the release. “Mylan is proud to partner with Gilead to expand access to Sovaldi and Harvoni, life-saving medications that offer an improvement in the standard of care for the 12 million hepatitis C patients in India.”

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SVR rates up with new regimens for HCV and HIV coinfection

For patients with hepatitis C virus genotype 1 and HIV coinfection, new regimens are effective and correlate with high rates of sustained virologic response after treatment, according to two studies published online Feb. 23 in the Journal of the American Medical Association.

(HealthDay)—For patients with hepatitis C virus (HCV) genotype 1 and HIV coinfection, new regimens are effective and correlate with high rates of sustained virologic response (SVR) after treatment, according to two studies published online Feb. 23 in the Journal of the American Medical Association.

Mark S. Sulkowski, M.D., from Johns Hopkins University in Baltimore, and colleagues conducted an open-label trial at 17 sites in the United States and Puerto Rico. Sixty-three patients with HCV genotype 1 and HIV-1 coinfection received the all-oral 3 direct-acting antiviral (3D) regimen of ombitasvir, paritaprevir (co-dosed with ritonavir), dasabuvir, and ribavirin for 12 or 24 weeks. The researchers found that 94 and 91 percent, respectively, of those receiving 12 or 24 weeks of 3D and ribavirin achieved SVR at post-treatment week 12 (SVR12). Fatigue, insomnia, nausea, and headache were the most common treatment-emergent adverse events (48, 19, 18, and 16 percent, respectively).

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Could This Be The Biggest Advance in Hepatitis C since Gilead Sciences' Sovaldi?

Tiny biotech stock Achillion Pharmaceuticals (NASDAQ: ACHN ) reported what could be pretty big news for hepatitis C patients this week. The clinical stage biotechnology company released data showing that combining its ACH-3102 with Gilead Sciences' (NASDAQ: GILD ) Sovaldi achieved 100% cure rates in as little as six weeks of treatment. The success of that combination is prompting Achillion to launch a study of the two drugs over an even shorter 4-week dosing period. If that study pans out, it could be the biggest advance in hepatitis C treatment since Sovaldi won approval in 2013.

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