March 17, 2014

(APASL) 24th Conference of the Asian Pacific
Association for the Study of the Liver
12-15 March, 2014
Brisbane, Australia

Reported by Jules Levin

(All links open into new windows)

Source NATAP

Sovaldi's Terrific Launch

Provided by Seeking Alpha

Peter Geschek

Mar. 17, 2014 9:34 AM ET  |  16 comments |  About: GILD by: Peter Geschek

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Summary

  • Sovaldi, Gilead’s oral Hepatitis C drug, by all accounts is having a fantastic launch.
  • The usual bickering about its high cost is louder than usual because of the large number of patients.
  • It’s time to consider the cost of not using this wonder drug.

Launch

Gilead Sciences' (GILD) Sovaldi is now projected to become the best-selling medicine of all time by several analysts.

Sovaldi is the first in a new wave of Hep C treatments that promise better cure rates and a shorter treatment course. Some even forecast it would reach $9 billion or more in sales by 2017, at which level it would surpass Pfizer's (PFE) Lipitor and take the crown as the biggest-selling drug of all time.

Analysts are trying to outdo each other with optimistic forecasts. According to ISI Group analyst Mark Schoenebaum, if prescriptions were to never grow again, that is assuming a flat line from here on, sales could be projected at $8 billion for 2014.

RBC analyst Michael Yee notes, Sovaldi's weekly total prescriptions are tracking 114 percent higher in its first full-quarter of launch than what Incivek, Vertex's (VRTX) Hep C drug did. Incivek holds the title for fastest drug launch ever, after raking in $1.56 billion in the first four quarters.

Wells Fargo analyst Brian Abrahams maintains an Outperform rating on Gilead, following IMS prescription data for Sovaldi for the week ending Feb. 28. The week's total prescriptions for Sovaldi were 6,398, up 20.9 percent vs. the previous week's 5,291. In one scenario, he forecasts sales by the end of 2014 at $10.80 billion.

Citigroup's analyst Yaron Werber believes that since Sovaldi is tracking at $943 million for the first twelve weeks of launch, it could post $8.76 billion in sales for 2014.

Pricing

There is a louder than usual bickering about the price of the drug. The reason for that probably is that the potential patient base is a lot larger than for most of the expensive drugs, and also that the company Gilead represents a favorite target for activists.

The California Technology Assessment Forum members gave a "low value" rating to Sovaldi, not because of any efficacy issues but because of its cost. The vote was non-binding, and the panel claimed that not all Hep C patients require the most expensive drugs. They said that if California treated every patient with liver damage, it would cost the state over $6 billion.

In January, the AIDS Healthcare Foundation urged state Medicaid providers to deny coverage for the drug until Gilead agrees to lower the price. The group, which provides HIV testing and prevention services, argued that Sovaldi's price "will unnecessarily drive up health care costs and limit access to potentially lifesaving care", and it noted that Sovaldi costs 1,100 percent more than Gilead's most expensive HIV drug, Stribild, which costs $80 per pill.

Express Scripts (ESRX), the giant pharmacy benefit manager, has made a statement earlier this year that it may eliminate certain new drugs from its formulary because of their high cost. The company later denied that it meant Sovaldi. For the time being, it could have a problem denying Sovaldi, since it is the only new Hep C antiviral to show effectiveness in genotypes 2 and 3, and those patients represent about 20 percent of all Hep C patients in the U.S.

Gilead itself has said that payers should be comfortable with the price of the drug, especially when considering the long-term benefits. For example, a new liver, when it is available at all, costs about $300,000 in the U.S., not counting additional expenses.

Economics

Sovaldi's treatment regimen costs $84,000 at wholesale, but the newly approved Olysio from Johnson & Johnson (JNJ) isn't much cheaper at $66,000 for one course of treatment. And the new treatments are a lot more effective than the similarly priced Incivek and Victrelis that they are replacing.

Sovaldi's benefit is not a few months of extra survival like some of the newer cancer drugs, but for most patients, it represents a cure.

Also, $84 thousand seems like a bargain when the cost of medical management of end-stage liver disease and/or liver transplantation is considered.

In 2011, a study was made about the economic cost of advanced liver disease by the Henry Ford Foundation, financed by Genentech, now a subsidiary of Roche (OTCQX:RHHBY).

The study compared the economic burden for U.S. patients based on data from a large private health insurance claims database from 2003 to 2010. The database included claims for all prescription medications and all medical services submitted for payment.

Researchers looked at 53,796 patients with chronic hepatitis C. Out of that total, 41,858 (78%) were without cirrhosis, 3,718 (7%) with compensated cirrhosis, and 8,220 (15%) with end-stage liver disease. Mean age was 49 years, 51 years, and 52 years respectively.

The study estimated the annual healthcare costs to be $24,176 for patients with chronic hepatitis C infection.

When looked at by disease stage, average annual costs were estimated to be $17,277 among patients with no cirrhosis, $22,752 among patients with compensated cirrhosis, and $59,995 annually among patients with end-stage liver disease.

The main cause of higher healthcare expenses were the inpatient costs for patients with end-stage liver disease and pharmacy costs for patients with compensated cirrhosis.

The key, therefore, is to treat and cure the infection early to prevent the consequences of more advanced disease and the associated economic burden.

These numbers are three years old, and so the cost should be adjusted for medical inflation. Remember also that these are annual figures that will occur year after year for the rest of the person's life. They never go away, but can rise when the disease enters into a more serious phase. The cure, of course, does not eliminate the costs entirely, but drastically reduces them as far as hepatitis is concerned.

The bottom line in the price dispute is that it is not realistic to single out a company or a single drug. If you want price reduction, it has to be industry-wide, including hospital costs, the cost of the process of getting a new drug approved, the price of the competing products. Otherwise, you may kill the exact product and its maker that works best for the patients.

As to Gilead, in its many years in the HIV drug business, it has been constantly attacked for high prices and rarely, if ever, budged.

Huge market

Hepatitis kills more people than HIV in most countries.

HIV/AIDS is the world's best-known virus, the subject of marches, concerts, publicity and billions of dollars of aid, and with good reason: it killed 1.47 million people in 2010.

Viral hepatitis is not as famous, but it killed 1.44 million worldwide, almost as many as HIV.

And viral hepatitis killed more people in 117 of the 187 countries tracked by the Institute of Health Metrics and Evaluation at the University of Washington, including in India, China, Britain and Japan.

Five different viruses can cause an inflammation of the liver, and accordingly, there are five types of hepatitis: Hepatitis A, B, C, D and E.

Types A and E are transmitted through contaminated water and food. Types B, C and D are delivered through infected blood, like dirty syringes, or in the case of B, through intercourse or the mother giving it to her child during birth.

Hepatitis B and C, in particular, can be the cause of liver cirrhosis and cancer.

The CDC estimates that in the U.S., about 3.2 million persons are chronically infected with HCV. Approximately 75-85 percent of people infected with the HCV virus will develop chronic infection.

Successful treatment is measured by an SVR (sustained virologic response), which signifies an undetectable viral load after the designated period of treatment. Any drug that gets rid of the hepatitis C virus, and there's no virus six months after therapy, is considered a cure.

Gilead said at an earnings conference earlier this year that at this point, only about 20 percent of the specialist physicians have prescribed Sovaldi, indicating that the launch still has some way to go to penetrate the market.

In an effort to spread the word faster, the company started direct-to-consumers television advertising, which aims to increase awareness of the drug and helps maintain strong patient in-flow throughout the year.

Competition

Behind Gilead, AbbVie's drugs are the nearest to FDA approval.

Barclays analyst Ying Huang believes that Gilead has an advantage over AbbVie: the convenience of fewer pills and the shorter therapy duration for untreated patients. These two advantages are underappreciated, but they both are critical when it comes to patient compliance.

Also, in Phase III trials, Gilead's regimen was associated with fewer relapses than AbbVie's.

Gilead's fixed dose combination does not contain ritonavir, which is known for drug-on-drug interactions and shows comparable efficacy with or without ribavirin. AbbVie's regimen requires ritonavir, and in some cases, ribavirin.

Investors' view

Gilead's earnings-per-share increase in 2013 was 4.6 percent from 2012, but it is projected to rise 84 percent from 2013 for 2014 and 51 percent for the following year.

Earnings estimate for 2014 is $3.76 per share (an increase from the reported $2.04 for 2013) based on Bloomberg's averaging of 28 analysts' forecasts, and $5.70 for 2015 based on 27 analysts' opinion.

Analysts at Cowen believe that even these numbers are too low considering that the uptake of Sovaldi has been faster than expected. Further acceleration of sales is expected after the combination of Sovaldi and ledipasvir is approved, and in 2015, treatment volumes could be two to three times more than this year.

Cowen has a $95 price target for the stock. The Deutsche Bank price target is $132, and the consensus estimate among analysts for the 1-year price target is $100.17.

By all accounts, unless something drastically negative happens, Gilead's share price is destined to go up.

Source

By Sharon Begley

NEW YORK Fri Mar 14, 2014 6:15pm EDT

(Reuters) - The lead agency for President Barack Obama's healthcare reform announced on Friday that it would require, rather than merely encourage, insurers that sell Obamacare policies to accept funds from a federal program that helps people with HIV-AIDS pay health insurance premiums.

Earlier this year, BlueCross BlueShield of Louisiana, the state's largest carrier, said it would begin rejecting checks from the Ryan White HIV/AIDS Program for Obamacare policies it sells. For decades the Ryan White program had helped low-income people with HIV and AIDS pay for both AIDS drugs and insurance premiums, but Louisiana Blue said such "third party payments" invited fraud.

The chief federal agency administering Obamacare, the Centers for Medicare and Medicaid Services, said on Friday it was requiring insurers to accept the funds, after saying last month that it "encouraged" carriers to accept the Ryan White payments and did not see any potential for fraud.

"Given the importance of access to care for people with HIV/AIDS, today CMS amended its rules to require health insurance issuers to accept Ryan White HIV/AIDS Program funds on behalf of eligible enrollees in individual Marketplace plans," said a CMS spokeswoman. "We will work directly with issuers to ensure they are in compliance with this policy."

Although the controversy over the Ryan White payments attracted the most attention, the CMS rule also requires insurers to accept premium payments on behalf of Obamacare customers from Indian tribes, tribal organizations, urban Indian organizations, and state and federal government programs.

After CMS had encouraged acceptance of the funds, Louisiana Blue had said it would not take the Ryan White payments after this month, threatening hundreds of customers with loss of coverage due to inability to pay. Lambda Legal, a civil rights group that works on behalf of gay men and lesbians, filed a lawsuit against the company, asking a court to require Louisiana Blue to accept the payments.

On Monday the company said it would do so, but only through November 15, 2014, when the next open enrollment period for Obamacare begins. The current enrollment period, for coverage in 2014, ends on March 31.

Friday's CMS announcement means that Louisiana Blue and all other carriers will have to accept the Ryan White payments for premiums.

If an insurer refuses to comply with the interim final rule, CMS said, the organization that submitted the payment or the affected individual should contact CMS. If a company continues to refuse, CMS might levy a penalty, it said, without specifying its size.

(Reporting by Sharon Begley; Editing by Leslie Adler)

Source

New hepatitis C drugs must be affordable worldwide, say campaigners

Provided by The Guardian

Posted by Sarah Boseley Monday 17 March 2014 12.45 EDT

We must learn from the HIV epidemic and ensure that affordable prices are in place so that the millions with hepatitis C infection can get new drugs that appear to be a cure

MDG-hepatitis-leaflets-be-011

Though the cure rate of the new breakthrough, sofosbuvir, seems close to 90%, the drug is very expensive. Photograph: Graham Turner for the Guardian

There are 185 million people in the world chronically infected with hepatitis C virus, which attacks the liver and can cause liver cancer and cirrhosis. Around 350,000 people die as a result every year. Hepatitis C is blood-borne, may show no symptoms for years and, until recently, its treatment has been far from ideal. Even if you can get interferon and ribavirin, which are not available everywhere, the combination does not work in everybody. Those who are infected have felt stigmatised and neglected.

The recent breakthrough in treatment is, therefore, really good news. Drugs called direct-acting antivirals are going through the approvals process after excellent trials results. The leader of the pack is Gilead's sofosbuvir, licensed in Europe in November and the following month in the US. Janssen and Bristol Myers-Squibb are hard on their heels.

The cure rate seems close to 90%, which is incredibly good news for people infected with hepatitis C. But with most of the sufferers in middle-income countries and prices being set at very high levels for these new drugs, those who watched the delay in getting HIV treatment to poor countries think it is time to start agitating for access to these medicines in countries that will not find them easily affordable.

Médecins du Monde, in a new report, says we must learn the lessons from HIV. "New Treatments for Hepatitis C virus: Strategies for Achieving Universal Access" looks at the need and what companies like Gilead say they will do about it. The authors are not, as yet, impressed.

Françoise Barré-Sinoussi, virologist, winner of the Nobel prize for her early work on the HIV virus and president of the International Aids Society, specifically makes the link with HIV in a quote in the report:

“We are witnessing a revolution in the treatment of hepatitis C virus with powerful molecules capable of curing the infection. There is no question that these treatments that can save millions of lives must be made universally available at an affordable price.”

Most of the companies, says the report, want to offer high prices in high-income countries and tiered pricing for middle-income countries. They are inclined to sign voluntary licences to allow generic manufacturers to supply the drugs to lower-income populations. This is a very expensive drug. Gilead's price in the US is over $80,000 (£48,000) for a 12-week course. That will cause problems for people with inadequate health insurance, even there.

In middle-income countries, Médecins du Monde says Gilead is planning to charge $2,000 for a course. It's a lot less, but far more unaffordable. To treat all those with hepatitis C in Egypt would cost 3,154 times the country's total health spending in 2011, says the report. In Indonesia, treatment for all would cost three-quarters of the total public and private spending on healthcare in 2011. This is clearly not possible without international help.

Gilead is negotiating voluntary licences. These would allow generic companies to make versions of its drug. But Médecins du Monde is concerned that signing those as planned in India, home of most of the generic companies that supplied Africa with HIV drugs at rock-bottom prices, will deter them from offering very cheap versions of hepatitis C medicines. "The generic companies that have a voluntary licence with Gilead will probably not be able to supply countries excluded from voluntary licences," says Pauline Londeix, author of the report.

Médecins du Monde says countries should begin thinking now about using the Trips (Trade-related aspects of intellectual property) flexibilities – agreed in the World Trade Organisation at the height of the debate over HIV drug prices – to bypass patents on these drugs in order to ensure access for those in need. Certainly, it is clear that the discussion over access to these important new medicines needs to start now.

Source

Mobile Unit Links Hepatitis C Patients to Care

Medscape Medical News

Fran Lowry
March 17, 2014

NEW YORK CITY — An innovative program that goes into at-risk neighborhoods to identify people infected with HIV and hepatitis C virus is proving to be very successful at finding and linking these people to care.

"We recognize that there are a multitude of barriers to care for individuals living with hepatitis C and HIV, and we know that 50% to 75% of people who have hepatitis C are unaware of their infection," said lead investigator Stacey Trooskin, MD, from the Drexel University College of Medicine in Philadelphia.

"Most at risk are people with a history of injection drug use, those who received a drug transfusion before 1992, and those who have had multiple sexual partners. Our concern is that many of these at-risk individuals may not have access to medical care or see their doctor regularly," Dr. Trooskin explained.

She described the campaign to test and link patients to care — called Do One Thing, Change Everything — here at the International Conference on Viral Hepatitis 2014.

Dr. Trooskin and her team went into a Philadelphia neighborhood known to have one of the highest prevalences of HIV and hepatitis C and the lowest number of medical resources.

"It's a guerrilla-based street and door-to-door campaign," she explained. We invite people who are walking on the street or who answer their doors to "come out to our van to be tested for hepatitis C and HIV."

Dr. Trooskin presented results from 1001 individuals who were tested for HIV and hepatitis C from December 2012 to October 2013.

It's a guerrilla-based street and door-to-door campaign.

The OraQuick rapid antibody test was used to identify hepatitis C infection. Immediately after a reactive test result, reflexive confirmatory testing with the hepatitis C nucleic acid test was done with a blood draw.

"Our hepatitis C testing uses a very unique algorithm," Dr. Trooskin said.

"We know that 15% to 25% of individuals who are exposed to hepatitis C clear it on their own, so they will have antibodies but do not have the virus. If they only get the antibody tested, it doesn't really tell them the true nature of their status," she explained. With our protocol, "not only are we out on the street pulling people into the van to get tested, when somebody has a reactive rapid antibody test for hepatitis C, we immediately draw their blood and automatically run a second test."

The program has been very successful, Dr. Trooskin said.

She reported that 42 individuals (4.2%) had a seroprevalence of anti-hepatitis C antibodies.

Of these 42 people, 37 (88%) underwent confirmatory testing and 31 (84%) turned out to be chronically infected. For 13 (42%) of these chronically infected people, the hepatitis C diagnosis was new.

None of the people who tested positive for hepatitis C were receiving subspecialty care at the time they were tested. In addition, 9 (29%) of the people who were chronically infected had no medical insurance.

Three uninsured patients were lost to care, but the other 6 were able to get insurance.

High Rates of Care

With aggressive case management, 18 (58%) of those chronically infected with hepatitis C were linked to subspecialty care, and all of the others are now actively engaged in the linkage process, Dr. Trooskin reported. However, 10 (35%) people said they had difficulty obtaining a referral for subspecialty care from their primary care physician.

"Many of these individuals we find have not been to a primary care provider in many years. We have had great success linking individuals to care who wouldn't otherwise have had access," she said.

"The bottom line here is that testing for hepatitis C in a nonclinical setting is a necessary and effective means of identifying new hepatitis C infections. It also re-engages individuals who sort of knew they had something wrong with them and might have been told along the way that they might have hepatitis C, but didn't know they needed to do anything about it," Dr. Trooskin said.

Such testing "facilitates linkage to myriad clinical and behavioral services," said José Zuniga, PhD, president of the International Association of Physicians in AIDS Care.

"If successful, this can mean a diagnosis and cure for countless undiagnosed individuals, as well as reduced risk behaviors and reduced transmission rates," he told Medscape Medical News.

"Going to where hepatitis C is establishing a foothold is an important means by which to use the epidemiology of an evolving epidemic to ensure that recent progress in hepatitis C clinical management benefits patients in rural and urban settings alike," Dr. Zuniga explained.

This study was funded by Gilead Sciences. Dr. Trooskin is on the Gilead Sciences board for hepatitis C. Dr. Zuniga has disclosed no relevant financial relationships.

International Conference on Viral Hepatitis (ICVH) 2014: Abstract 61. Presented March 17, 2014.

Source

News Release

March 17, 2014

Patients with HIV and Hepatitis C Had 80 Percent Higher Rates of Serious Liver Disease than Hepatitis C Patients

PHILADELPHIA — A new study led by researchers at the Perelman School of Medicine at the University of Pennsylvania has found that the risk of hepatitis C-associated serious liver disease persists in HIV patients otherwise benefitting from antiretroviral therapy (ART) to treat HIV.

It has been suggested that ART slows hepatitis C-associated liver fibrosis; however, whether rates of severe liver complications in patients co-infected with HIV and hepatitis C receiving ART were similar to those with just hepatitis C remained unclear.

The study, published in the March 18 issue of Annals of Internal Medicine, examinedelectronic medical record dataof 4,280 patients infected with both HIV and chronic hepatitis C virus who were receiving ART, and 6,079 hepatitis C-only patients receiving care between 1997 and 2010.

It found that the HIV/hepatitis C-co-infected patients had an 80 percent higher rate of decompensated cirrhosis than hepatitis C-only patients. Even when co-infected patients had controlled HIV virus in response to ART, they still had a 60 percent higher rate of serious liver disease compared to those with hepatitis C alone.

“Our results suggest that serious consideration should be given to initiating hepatitis C treatment in patients co-infected with HIV and hepatitis C—particularly among those with advanced liver fibrosis or cirrhosis—in order to try to reduce the risk of serious, potentially life-threatening liver complications,” said the study’s lead author, Vincent Lo Re III, MD, MSCE, assistant professor of Medicine and Epidemiology in the division of Infectious Diseases and department of Biostatistics and Epidemiology at Penn, and an investigator in the Penn Center for AIDS Research. “By taking action sooner, we may be able to reduce the risk of advanced liver disease in co-infected patients.”

This Penn-led study is the largest comparison to date of liver-related complications between antiretroviral-treated HIV/hepatitis C- co-infected patients and those with hepatitis C-alone.

Hepatitis C is a treacherous infection of the liver that can remain clinically dormant for years. The U.S. Centers for Disease Control and Prevention has reported that hepatitis C is the leading cause of cirrhosis, liver cancer, and the need for liver transplants in the nation. It is spread through contact with infected blood. Health experts estimate that more Americans die from it each year than HIV. Co-infection with hepatitis C occurs in 20-30 percent of patients with HIV infection, likely due to a shared route of infection.

Liver disease usually occurs in two stages: compensated and decompensated. In the earlier, less severe stage, the liver still can function normally by compensating for the damage. When extensive damage occurs and the liver can no longer function normally, decompensation occurs. The higher rates of serious liver disease found in co-infected patients in the Penn-led study were classified as liver decompensation. 

The authors also found that rates of decompensation were higher for co-infected patients with advanced liver fibrosis, severe anemia, diabetes, and non-black race.

In addition to Dr. Lo Re, other Penn co-authors include Michael J. Kallan, MS; A. Russell Localio, PhD; K. Rajender Reddy, MD; and Jay R. Kostman, MD. Brian L. Strom MD, MPH, formerly Executive Vice Dean for Institutional Affairs at Penn and now Chancellor of Rutgers Biomedical and Health Sciences, also participated in the investigation.

The study was funded primarily by the National Institute of Allergy and Infectious Diseases (research grant K01 AI070001 to Dr. Lo Re].

###

Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $4.3 billion enterprise.

The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 17 years, according to U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $392 million awarded in the 2013 fiscal year.

The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania -- recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report; Penn Presbyterian Medical Center; Chester County Hospital; Penn Wissahickon Hospice; and Pennsylvania Hospital -- the nation's first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Chestnut Hill Hospital and Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine.

Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2013, Penn Medicine provided $814 million to benefit our community.

Source

logga-top-enkel-se

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that new phase III data for the once-daily protease inhibitor simeprevir have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia.

  • The phase III ATTAIN study in treatment-experienced adult patients with chronic hepatitis C virus (HCV) and compensated liver disease achieved its primary efficacy endpoint by demonstrating non-inferiority of simeprevir compared to telaprevir when both are given in combination with PegIFN/RBV. Simeprevir demonstrated superior safety profile including fewer adverse events (AEs), fewer serious adverse events (SAEs) and less anemia versus telaprevir.
  • Pooled analysis of data from the phase III QUEST-1 and QUEST-2 studies confirmed efficacy in treatment-naïve genotype 1b HCV patients, with 85 percent (ITT analysis) of treatment-naïve patients achieving SVR12 when treated with simeprevir in combination with PegIFN/RBV, compared to 53 percent when treated with placebo in combination with PegIFN/RBV.
  • In the PROMISE phase III trial of prior relapse patients, a subgroup analysis of genotype 1b patients demonstrated that 86 percent (ITT analysis) of these patients achieved SVR12 when treated with simeprevir in combination with PegIFN/RBV, compared to 43 percent when treated with placebo in combination with PegIFN/RBV.

“We are very pleased to report on the successfully completed phase III ATTAIN study demonstrating non-inferiority of simeprevir compared with telaprevir, and a superior safety profile in this difficult to treat patient group. Moreover, the further analysis of the genotype 1b HCV patients of the phase III studies QUEST-1, QUEST-2 and PROMISE demonstrated very high SVR12 rates supporting the strength of simeprevir as a treatment option for this large patient population” says Charlotte Edenius, EVP Development, Medivir AB.

ATTAIN
About the ATTAIN study

The multicenter phase III clinical study of treatment-experienced genotype 1 HCV patients partial- and null-responder patients to at least one previous course of PegIFN/RBV therapy called the ATTAIN study is a randomized, double-blind, two-arm study. In the trial, 771 patients were randomized (1:1) to treatment with either 150 mg of simeprevir once daily plus PegIFN/RBV or 750 mg of telaprevir three times per day plus PegIFN/RBV for 12 weeks, followed by 36 weeks of PegIFN/RBV alone.

Results from the ATTAIN study
Results from ATTAIN show that simeprevir achieved its primary endpoint of non-inferiority to telaprevir in treatment-experienced HCV patients and demonstrated a superior safety profile. In the study, 54 percent of chronic HCV genotype 1 prior partial- and null-responder patients treated with simeprevir administered once daily in combination with pegylated interferon and ribavirin achieved the primary endpoint of sustained virologic response 12 weeks after end of treatment (SVR12) compared to 55 percent of patients treated with telaprevir administered three-times daily plus pegylated interferon and ribavirin.

Among prior null-responder patients, 44 percent of patients in the simeprevir arm achieved SVR12 versus 46 percent of patients in the telaprevir arm. Among prior partial-responder patients, 70 percent of patients in the simeprevir arm achieved SVR12 versus 69 percent of patients in the telaprevir arm.

SVR12 rates across patient subgroups were generally similar between the simeprevir and telaprevir arms, including among patients with the HCV genotype 1a Q80K mutation. Twenty-seven percent of patients with the HCV Q80K mutation achieved SVR12 in the simeprevir arm versus 26 percent in the telaprevir arm. The study also found that 60 percent of patients with the IL28B CC genotype, 55 percent of CT patients and 48 percent of TT patients in the simeprevir arm achieved SVR12, versus 67, 57 and 50 percent of patients in the telaprevir arm, respectively.

The most common adverse events during the first 12 weeks of treatment occurred at a consistently lower frequency in the simeprevir treatment arm compared to the telaprevir treatment arm, including pruritus (31 percent versus 43 percent), fatigue (32 percent versus 38 percent), headache (25 percent versus 29 percent), anemia (13 percent versus 37 percent), and nausea (17 percent versus 28 percent). Thirty-four percent and 18 percent of simeprevir-treated patients experienced on-treatment failure and relapse, respectively, compared to 32 percent and 17 percent of telaprevir-treated patients, respectively. Two percent of patients in the simeprevir arm and eight percent of patients in the telaprevir arm discontinued treatment early due to an adverse event. Serious adverse events were reported in two percent of patients in the simeprevir arm and nine percent of patients in the telaprevir arm.

QUEST-1, QUEST-2 and PROMISE
Pooled analyses of the QUEST-1, QUEST-2 and PROMISE studies of simeprevir combination therapy in genotype 1b HCV patients

In a pooled analysis of the QUEST-1 and QUEST-2 studies, 89 percent of treatment-naïve genotype 1b HCV patients treated with simeprevir in combination with pegylated interferon and ribavirin and met the criteria for response guided therapy (94 percent) achieved SVR12 compared to 53 percent of patients treated with placebo in combination with pegylated interferon and ribavirin (ITT-analysis 85 and 53 percent, respectively). In patients typically considered difficult to treat, 71 percent of patients with the IL28B TT genotype and 78 percent with METAVIR F3-F4 scores achieved SVR12 in the simeprevir arm. Two percent of patients in each treatment arm discontinued treatment with simeprevir or placebo early due to an adverse event.

An analysis of the PROMISE study found that 89 percent of prior-relapser genotype 1b HCV patients treated with simeprevir in combination with pegylated interferon and ribavirin and met the criteria for response guided therapy (95 percent) achieved SVR12 compared to 43 percent of patients treated with placebo in combination with pegylated interferon and ribavirin (ITT-analysis 86 and 43 percent, respectively). In patients typically considered difficult to treat, 68 percent of patients with the IL28B TT genotype and 84 percent with METAVIR F3-F4 scores achieved SVR12 in the simeprevir arm. No patients discontinued treatment with either simeprevir or placebo due to adverse events during the entire treatment phase in this analysis of PROMISE.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08.30 CET on 17 March 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 infected patients with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and USA. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. This application is under review by the EMA.

Simeprevir is also being studied in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website: www.medivir.com

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