October 18, 2013

Primary Care

Affixing a reminder sticker that lists risk factors for hepatitis C virus (HCV) infection onto patients’ medical charts can be effective in increasing the number of patients sent for HCV testing by their primary care physicians. It also boosts the number of patients found HCV-positive, according to a new study. 

HCV is the leading cause of liver failure in the United States, accounting for 15,000 deaths in 2007 and 3.2 million Americans with chronic HCV infection. Although new antiviral treatments promise to greatly reduce the burden of HCV-related disease, a majority of HCV-positive patients (45–85 percent) are unaware that they are infected.

To increase screening, the researchers developed a 2-ply (carbon copy) sticker with a list of 12 HCV infection-related risk factors (with yes and no check boxes) and 2 items about HCV testing (Was patient tested recently? Was an HCV test ordered?). The stickers, affixed to each patient’s chart, reminded the physician to ask about HCV risk factors. The top sheet could be detached for later data analysis, while the bottom sheet remained in the patient’s chart. The physicians saw 8,891 patients over the 15-week study period who had not undergone a recent anti-HCV antibody test. Screener pages were completed for 3,250 (36.2 percent of patients), with significant racial and gender-related differences in screening rates.

Overall, 27.8 percent of those screened had at least one risk factor. More than half (55.4 percent) of patients with any risk factors—and 13.7 percent of those with no identified risk—underwent HCV testing, yielding infection rates of 6.8 percent and 2.2 percent, respectively. Seven of the risk factors, including ever use of injected or snorted drugs, accounted for 82.9 percent of the 41 HCV-positive patients, but another 7 HCV-positive patients had no risk factors when screened. The researchers collected data from three urban clinics that instituted the use of the stickers with all adult patients and HCV testing based primarily on the presence of HCV risk factors as part of the Hepatitis C Assessment and Testing project.

The study was funded by AHRQ (Contract No. 290-06-0012). More details are in "Effectiveness of a risk screener in identifying hepatitis C virus in a primary care setting," by Mari-Lynn Drainoni, Ph.D., Alain H. Litwin, M.D., Bryce D. Smith, Ph.D., and others in the November 2012 American Journal of Public Health 102(11), pp. e115-e121.

DIL

Current as of June 2013

Internet Citation: Reminder stickers can boost screening for hepatitis C virus in primary care clinics: Primary Care. June 2013. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/newsletters/research-activities/13jun/0613RA23.html

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Provided by Healio

October 18, 2013

BRUSSELS — Peter Reiss, MD, PhD, professor of medicine at the University of Amsterdam, discusses the ongoing development of direct-acting antivirals, which is expected by many physicians to revolutionize the treatment of HIV and hepatitis C virus co-infections.

During a plenary session at EACS 2013, presenter Heinrich Wedemeyer, MD, from the Hannover Medical School, described the advent of direct-acting antiviral agents as a revolution in treatment for chronic HCV, but also cited several remaining challenges, namely drug interactions and cost.

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Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced preliminary data from two phase III studies conducted by Janssen R&D Ireland evaluating simeprevir in genotype 4 chronic hepatitis C in adult patients with compensated liver disease, and in genotype 1 hepatitis C and HIV-1 co-infected adult patients. The data were presented today at the ongoing European AIDS Conference (EACS), October 16-19 in Brussels.

“Based on these encouraging data with the high cure rates seen in patients co-infected with HCV genotype 1 and HIV-1 we believe that simeprevir could provide a new treatment option in this specific patient group” says Charlotte Edenius, EVP Development, Medivir AB. “We are also delighted to see the positive interim results from patients infected with HCV genotype 4, a strain of virus which currently have limited treatment options.”

HCV/HIV co-infected patients - Study Design
This phase III, open-label trial evaluated the safety and efficacy of simeprevir (150 mg QD) with peginterferon and ribavirin (PR) for 12 weeks in patients co-infected with HCV genotype-1 and HIV-1 (N=106). Treatment-naïve patients (N=53) and prior relapsers (N=15) (without cirrhosis) received response-guided therapy (RGT) with PR up to 24 or 48 weeks. All other patients (prior null responders [N=28], partial responders [N=10] and all patients with cirrhosis) received PR up to 48 weeks. The primary endpoint was sustained virologic response (SVR) rate 12 weeks after end of treatment. In the study 93 patients were receiving antiretroviral therapy (ART), 12% of patients had cirrhosis, 82% had genotype 1a subtype and 73% had an IL28B CT or TT genotype.

HCV/HIV co-infected patients - Summary Primary Results
High SVR12 rates were observed regardless of prior HCV treatment response with 79% in HCV treatment-naive patients, 87% in prior relapsers, 70% in partial responders and 57% in null responders. Most patients eligible for shorter duration of treatment met the RGT criteria (89%; 54/61), of whom 87% (47/54) achieved SVR12.

The SVR12 rate in genotype 1b was 89% (16/18) and in genotype 1a 70% (62/88) where genotype 1a patients with Q80K polymorphism at baseline achieved SVR12 rates of 67% (20/30). SVR12 rates were high irrespective of baseline METAVIR fibrosis score (80% and 64% for patients with of F0–F2 and F3–F4 respectively).

Simeprevir once daily with PR was well tolerated with a safety profile similar to that observed in studies of mono-infected patients.

Primary efficacy endpoint with 150 mg simeprevir for 12 weeks with peginterferon and ribavirin (PR) for up to 24 or 48 weeks). Intent-to-treat (ITT) population.

Patients co-infected with HCV genotype-1 and HIV-1:
% (n/N) Overall
(N=106)
Treatment naive
(N=53)
Prior relapsers
(N=15)
Prior partial responders
(N=10)
Prior null responders
(N=28)
SVR12 74
(78/106)
79*
(42/53)
87
(13/15)
70
(7/10)
57*
(16/28)

* p < 0.001 vs historical PR-only controls: SVR12 for PR controls was assumed to be 29% in treatment naive (from PEGASYS® USPI, co-infected patients) and 5% in prior null responders (from INCIVEK™ USPI, mono-infected patients).

HCV Genotype 4 Patients - Interim Results
In this phase III study, 107 patients with chronic HCV genotype 4 received simeprevir once daily with peginterferon and ribavirin (PR) for 12 weeks. Treatment-naïve patients and prior relapsers received response-guided therapy (RGT) with PR up to 24 or 48 weeks. Prior partial responders and prior null responders received PR up to 48 weeks.

At the time for this interim analysis only data from patients eligible to shorten therapy and who had reached study visit W28 (SVR4) and W36 (SVR12) were included. In these patients SVR4 rates of 89-91% (N=20) and SVR12 of 67-100% (N=9) were achieved. Overall simeprevir was well tolerated and most AEs were grade 1 or 2.

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

About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, for the treatment of genotype 1 and genotype 4 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.

Janssen R&D Ireland, and its affiliated companies, are responsible for the global clinical development of simeprevir and have acquired exclusive, worldwide marketing rights, except for the Nordic countries where Medivir AB have retained the marketing rights under the marketing authorization held by Janssen-Cilag International NV.

Simeprevir was approved in Japan in September 2013 for the treatment of genotype 1 hepatitis C. In the U.S., the New Drug Application (NDA) filed by Janssen Research & Development, LLC (Janssen) for simeprevir administered once daily in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients was granted Priority Review designation by the Food and Drug Administration (FDA) in May. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April by Janssen- Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C.

To date, more than 3,700 patients have been treated with simeprevir in clinical trials

For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide – including approximately 3.2 million people in the United States – and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

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

Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people’s health and quality of life.

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Provided by Healio

October 17, 2013

SAN DIEGO — Kris Kowdley, MD, director of the Liver Center of Excellence at the Digestive Disease Institute of Virginia Mason Medical Center in Seattle, discusses the results of the AVIATOR trial, which he presented at the American College of Gastroenterology Annual Scientific Meeting.

In a phase 2b study, researchers administered an all-oral regimen of two or three direct-acting antivirals, including protease inhibitor ABT-450 with ritonavir, NS5A inhibitor ABT-267 and non-nucleoside NS5B inhibitor ABT-333, with or without ribavirin, to a cohort of patients with HCV genotype 1 for 8, 12 or 24 weeks.

All treatment arms had sustained virologic response rates of over 80% 24 weeks after treatment completion. Among 247 patients who received all three DAAs with ribavirin for 12 or 24 weeks, SVR24 occurred at a similar rate (more than 90%) in both treatment-naïve and prior null-responders to interferon-based therapy.

SVR24 rates were also high in this population regardless of age, sex, race, BMI, IL28B or HCV genotype, baseline HCV RNA levels and fibrosis severity. Incidences of breakthrough and relapse were rare, and adverse events occurred at similar rates in the 12- and 24-week groups.

Disclosure: The researchers report numerous financial disclosures.

For more information:

Kowdley K. #39: Safety and Efficacy of Interferon-free Regimens of ABT-450/r, ABT-267, ABT-333 +/- Ribavirin in Patients with Chronic HCV GTI Infection: Results from the Aviator Study. Presented at: The American College of Gastroenterology Annual Scientific Meeting; Oct. 11-16, San Diego.

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