APASL - New Phase III Data from Once-Daily Simeprevir

New Phase III Data from Once-Daily Simeprevir Presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL)

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. 

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

APASL 2014 – “ Hepatology: The New Era Begins”

APASL 2014 – “ Hepatology: The New Era Begins”

APASL 2014 held in Brisbane, Australia from 12 to 15 March 2014, is one of the world’s foremost gatherings of the leaders in in the world of hepatology.

The Asian Pacific Association for the Study of the Liver (APASL) began in August 1978 in Singapore. APASL covers the region from China, Mongolia and Kazakhstan in the North, to Australia and New Zealand in the South, the Pacific Islands in the East and Egypt and Iran in the West. 


Click on the image below to read the APASL Daily News, March 15-12, click here for additional updates.

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Sponsored Content: Interview with President of the World Hepatitis Alliance
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In this interview, Mr Charles Gore, President of the World Hepatitis Alliance, discusses the group’s strategic goals for the next few years and their desire to raise the international profile of…

APASL: a new era begins
18 Mar 2014
A revolution is underway in the treatment of hepatitis C, as Gastroenterology Update reports from the meeting of the Asian Pacific Association for the Study of the Liver held in Brisbane last week.

HIV patients set to benefit from new hep C drugs
18 Mar 2014
Hepatitis C could soon be eradicated in the Australian HIV community, a Sydney expert says.

Show regional leadership, hepatitis expert urges
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Australia must improve its poor hep C treatment rates and do much more in the region to manage the disease, says a leading international hepatitis advocate.

Vertical transmission of hep B on the way out
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Tenofovir in pregnant women with hepatitis B is extremely effective in preventing in utero infection and in combination with vaccination could eradicate the disease altogether, a New Zealand expert…

Patients increasingly dying waiting for transplants
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Patients listed for liver transplant are more likely than ever to die before a donor liver becomes available, says a New Zealand expert.

Schizophrenia linked to liver cancer
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People diagnosed with schizophrenia have double the risk of developing hepatocellular cancer, an intriguing Taiwanese study has found.

Acupuncture soothes in liver cancer
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APASL - Rapid rise in liver cancer requires regional response

Rapid rise in liver cancer requires regional response

Asia-Pacific’s medical professionals are warning that without major changes to screening and treatment for chronic liver disease, the region risks losing its battle to contain a rapidly increasing cancer which is already the second leading cause of cancer deaths globally.

Liver cancer in Australia has increased almost 50% in the previous decade and the number of deaths has nearly doubled (778 in 2001 to 1,423 in 2011).*

Speaking at the 2014 meeting of the Asian Pacific Association for the Study of Liver (APASL) in Brisbane this week, Associate Professor Amany Zekry explained that liver cancer is the end stage of chronic liver disease, which includes diseases such as hepatitis B and C as well as non-alcoholic fatty liver disease (NAFLD).

“In the Asia Pacific region it is estimated that 340 million people are affected by viral hepatitis alone and NAFLD, due to obesity, is becoming a key cause of chronic liver disease,” she added.

NAFLD affects about 5.5 million Australians and is increasingly affecting younger people with a West Australian study finding NAFLD affects about 13% of 17 year olds.

Professor Zekry, chair of the Australian Liver Association, said NAFLD was also increasing across the Asia Pacific region as many countries adopt a more westernised diet and lifestyle.

In China, the prevalence of fatty liver increased from about 14% in 1996 to 23% in 2004; it affects about 22% of people in Malaysia, 30% in Japan and 30% in Sri Lanka.

“Strategies to increase screening and treatment programs in high-risk populations are urgently needed across the region, including Australia,” said Prof Zekry.

"Policy makers are starting to take action against obesity, but there is no emphasis as yet on the importance of screening for liver disease, such as doctors following up on abnormal liver tests in people with obesity and diabetes.”

Prof Zekry added that without these protocols, measures to prevent the progression of liver disease and risk of liver cancer could not be implemented.

“For viral hepatitis, effective vaccination programs are vital to prevent hepatitis B and its complications such as cirrhosis and liver cancer. For instance, in Taiwan a nationwide hepatitis B vaccination program that has proven very successful in reducing the risk of liver cancer,“ said Prof Zekry.

“With hepatitis B and C infections, new treatments are offering exceptionally high rates of cure which will also help reduce the rates of liver scarring and hopefully, the burden of liver cancer.”

“Better treatment prevents transmission of the virus, but people with hepatitis need to be diagnosed and referred to engage with treatment. That’s an issue in Australia, across the region and globally.”

In Australia, less than 2% of people with hepatitis C come forward for treatment for various reasons including perceived stigma, poor understanding of how the disease progresses, fear of side effects from treatment and other existing conditions.

“Our optimism surrounding significant treatment advances is tempered by the scale of the problem and the low profile of liver disease. Controlling the epidemic of liver cancer requires much greater public awareness of the problem and its preventable risk factors," said Prof Zekry.

“Chronic liver disease is one of the biggest health issues in the Asia Pacific region. APASL 2014 is an opportunity to come together to encourage a more effective public policy response in prevention and access to services across the region.”

*Ref: Australian Institute of Health and Welfare (AIHW) 2014. Australian Cancer Incidence and Mortality (ACIM) books.

Source - APASL

APASL - New treatments promise a future free from hep C

Sofosbuvir and simeprevir are currently under review in Australia and New Zealand. They received FDA approval in the US in December 2013, European Medicines Agency (EMA) approval in January 2014 and were recognised as the treatments of choice for hepatitis C in new US guidelines for the management of hepatitis C published last month [February].


New treatments promise a future free from hep C

A new era in hepatitis C is on our doorstep with treatments boosting cure rates to over 90% and the very real prospect of eradicating the condition within the next 20 years.

The new anti-viral medications also offer a much shorter duration of treatment and fewer side effects, significantly improving the outlook for people with the disease and reducing the risk of virus transmission in the community.

Almost two-thirds of the 180 million individuals with hepatitis C live in the Asia-Pacific region, including about 300,000 Australians and 50,000 New Zealanders.

According to Professor Ed Gane, University of Auckland and Deputy Director of the New Zealand Liver Transplant Unit, identifying people with hepatitis C is now of the utmost importance along with assessing their liver disease and preparing them for antiviral treatment.

“Based on some preliminary modeling, we believe if we can increase the number of patients receiving antiviral treatment three-fold and increase the success of treatment to more than 90%, it may be possible to eradicate hepatitis C in both Australia and New Zealand within the next 20 years.”

Speaking at the 2014 meeting of the Asian Pacific Association for the Study of Liver (APASL) in Brisbane this week, Professor Gane said direct acting anti-virals such as sofosbuvir and simeprevir had improved the safety and efficacy of antiviral therapy in patients infected with the most common hepatitis C genotype 1.

By adding simprevir to the current treatment of pegylated interferon plus ribavirin and halving treatment time from 48 week to 24 weeks, cure rates have doubled from 40% to 80%. Similarly, the addition of sofosbuvir has reduced the duration of treatment to just 12 weeks and improved cure rates to 90%.

“For the most prevalent form of the hepatitis C virus (genotype 1) in the world and the hardest to treat, this is a huge leap forward,” Professor Gane said.

Sofosbuvir and simeprevir are currently under review in Australia and New Zealand. They received FDA approval in the US in December 2013, European Medicines Agency (EMA) approval in January 2014 and were recognised as the treatments of choice for hepatitis C in new US guidelines for the management of hepatitis C published last month [February].

Professor Gane said the next imminent advance for patients infected with HCV genotype 1 was an all-oral, interferon-free treatment regimen such as the combination of sofosbuvir and ledipasvir, which achieved 90-99% cure rates in phase 3 trials.

“The beauty of sofosbuvir-based treatments is that they are safe for everyone including those co-infected with HIV, those who have had a liver transplant and patients whose livers are deteriorating badly.”

“The new medications enable people to get better quickly and recover without the need for a transplant. So it is more important than ever for people with hepatitis C to be identified so they can benefit from the new wave of medications.”

“Australia has one of the highest diagnosis rates of hepatitis C in the world because they have been very successful in raising awareness, advocating and testing for hepatitis C. Japan has always been a leader in surveillance and treatment and China is doing much better now. Poorer countries in Asia-Pacific though are struggling.”

He said compared to Australia’s diagnosis rate of 90%, New Zealand was lagging behind at 40%. However a government-funded, community-based pilot project to improve uptake of hepatitis C testing, assessment and treatment was currently underway.

Professor Gane said less common forms of the hepatitis C virus (genotype 2 and 3) were also responding to the new medications.

“Twelve weeks of sofosbuvir and ribavirin has a cure rate of 98% in people infected with genotype 2 and 24 weeks of sofosbuvir and ribavirin has a cure rate of 94% in those infected with genotype 3.”

“The remaining issue will be the cost of these medications. In some countries with limited resources, it may be that they are initially rationed to people with the most severe disease. However, widespread access to affordable all-oral therapy in all countries will be needed if we want to achieve global eradication of HCV,” Professor Gane added.

Source - APASL