Ongoing Real World Study Reports High Sustained Viral Response Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Genotype 1 Hepatitis C Patients

- Interim results from the independent AMBER study demonstrated 98 percent (n=39/40) SVR(12) rate in patients who completed a 12- or 24-week treatment regimen and 12 weeks follow-up

- Real world interim data presented at the Viral Hepatitis Congress supports findings from previous HCV genotype 1 Phase 3 clinical trials with VIEKIRAX + EXVIERA

NORTH CHICAGO, Illinois, Sept. 11, 2015 /PRNewswire/ -- New real world interim data from the independent AMBER study were presented for AbbVie's VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) with or without ribavirin (RBV) in genotype 1 (GT1) chronic hepatitis C virus (HCV) infected patients. The primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR12). This study of Polish patients who reached post-treatment at week 12 (n=40 of 186 enrolled to date), demonstrated 98 percent (n=39/40) SVR12.1 These results further help to support the GT1 data shown in AbbVie's Phase 3 clinical trial development program. Interim data from the AMBER study were presented at the Viral Hepatitis Congress in Frankfurt, Germany.

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8 simple ways for Hispanics to stay healthy

Many of these examples could be applied to people living with hepatitis C (AF)


In May, the first national study on Hispanics and their health was released by the U.S. Centers for Disease Control and Prevention (CDC).The surprising results showed that Hispanics are generally healthier and have a longer life expectancy than non-Hispanic whites, though we do have some areas to grow in.

"Although Hispanics have lower overall drinking rates compared with white non-Hispanics, when they do drink, on average they have higher rates of binge drinking," says Dr. Ken Dominguez, a medical epidemiologist with the CDC and lead author of the report. More surprising news? The study revealed that Hispanics are affected specifically by certain conditions, with high rates of obesity and diabetes contributing to the two leading causes of death: cancer and heart disease.

That may sound alarming, but the study provides ways to target the health risks — some of them symptomless, some of them woven into the festive fabric of our culture — that we face. After all, knowledge is power. "Being Hispanic does not have to determine your quality of life," says Dominguez, who advises us to "take charge of your own health, practice healthy behaviors."

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Warning to Scots against hep C as health chiefs vow to eradicate 'silent killer'

RESIDENTS in the west of Scotland at risk of hepatitis C are being urged to get tested against the “silent killer”.

The number of new cases of the infection diagnosed in the Greater Glasgow area have risen in a year by about 5% - from 623 in 2013 to 656 last year.

It is estimated that overall 37,000 people have hep C in Scotland – 20,000 diagnosed and 17,000 undiagnosed.

About 40% of Scottish cases are in the Greater Glasgow area.

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Can Indian generic makers find gold with a blockbuster Hepatitis C drug?

For patients with Hepatitis C, Dr Parveen Malhotra prescribes a tablet that doctors say is revolutionising the treatment paradigm for the dreaded liver ailment. The hepatologist from Haryana's Rohtak town too has reported a higher cure rate since switching to the orally administered sofosbuvir from the injectable interferon five months ago.

According to World Health Organization data, hepatitis C kills half a million people a year and infects 150 million globally. Screening often includes costly multiple tests without which the ailment often goes undetected. In this backdrop, say doctors, sofosbuvir, is proving to be a magic bullet, unlike some of the alternatives that came with a host of side effects.

"This molecule (sofosbuvir) is revolutionary. Earlier we used to treat with interferon therapy, but here you have for the first time a therapy in oral form. With this molecule the ease of treatment has improved," said Dr Mandar Kubal, director of Mumbai based Infectious Diseases & Pulmonary Care.

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Canada: Psychosis, Hepatitis C linked to high death rate in Downtown Eastside: UBC

The mortality rate in the Downtown Eastside is eight times the national average, according to a new UBC study that followed 371 people for about four years. 

 

The death rate in the Downtown Eastside is eight times higher than the Canadian average, and treatable problems are linked to mortality, according to research from the University of British Columbia published last month.

Psychosis and liver problems related to hepatitis C were the highest risk factors for mortality, according to the study of 371 people over about four years.

Researchers recruited the participants from single-room occupancy hotels and the Downtown Community Court. Thirty-one of them died.

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Modeling the helicase to understand hepatitis C

NS3 behaves like a 'caterpillar' and helps the virus to replicate

NS3 is an enzyme specific to the hepatitis C virus. If developed, a drug capable of recognizing and selectively attacking it could fight the disease without side effects for the body. However, to be able to develop one we need to know more about the behavior of this important protein in the virus replication process. Some SISSA scientists have provided a detailed and comprehensive view of the behavior of NS3. The study has been published in the journal Nucleic Acids Research.

According to the WHO, a good 140 million people are affected by hepatitis C (3/4 million new cases per year). This is still a subtle disease which, in the event of chronic infection, heavily affects the patients' quality of life and whose complications can lead to death. One of the molecules involved in the reproduction mechanism of the virus in the body is a helicase, NS3, an enzyme that interacts with the RNA (the viral genome, which is not like our DNA) by climbing onto it and helping the pathogen's replication process.

"By knowing in detail how this helicase works, in the future we could try to block the viral replication, and thus stop the disease from proliferating in the body" explains Giovanni Bussi, SISSA professor and among the study authors. NS3 facilitates the work of the polymerases, the molecules that build a replica of the RNA strand, by "opening" and preparing the RNA to the action of the second enzyme. "NS3 crawls along the RNA strand contracting and extending like a caterpillar and, as it does so, it releases the part of the virus to which the polymerase then attaches" explains Andrea Pérez-Villa, SISSA student and first author of the paper. "We decided to analyze this protein because, unlike others, it is only present in the hepatitis C virus. This way, any drug capable of targeting its interaction with the RNA would not damage other proteins, for example, those belonging to the body being attacked by the virus. This means that, theoretically, the drug would have no side effects".

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FDA Issues Pediatric Warning for Copegus

Copegus (ribavirin) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

August 2015

WARNINGS AND PRECAUTIONS

Impact on Growth in Pediatric Patients

• During combination therapy for up to 48 weeks with PEGASYS plus ribavirin, growth inhibition was observed in pediatric subjects 5 to 17 years of age. Decreases in weight for age z-score and height for age z-score up to 48 weeks of therapy compared with baseline were observed. At 2 years post-treatment, 16% of pediatric subjects were more than 15 percentiles below their baseline weight curve and 11% were more than 15 percentiles below their baseline height curve. The available longer term data on subjects who were followed up to 6 years post-treatment are too limited to determine the risk of reduced adult height in some patients

ADVERSE REACTIONS

Growth Inhibition in Pediatric Subjects

• Pediatric subjects treated with PEGASYS plus ribavirin combination therapy showed a delay in weight and height increases with up to 48 weeks of therapy compared with baseline. Both weight for age and height for age z-scores as well as the percentiles of the normative population for subject weight and height decreased during treatment. At the end of 2 years follow-up after treatment, most subjects had returned to baseline normative curve percentiles for weight (64th mean percentile at baseline, 60th mean percentile at 2 years post-treatment) and height (54th mean percentile at baseline, 56th mean percentile at 2 years post-treatment). At the end of treatment, 43% (23 of 53) of subjects experienced a weight percentile decrease of more than 15 percentiles, and 25% (13 of 53) experienced a height percentile decrease of more than 15 percentiles on the normative growth curves. At 2 years post-treatment, 16% (6 of 38) of subjects were more than 15 percentiles below their baseline weight curve and 11% (4 of 38) were more than 15 percentiles below their baseline height curve. Thirty-eight of the 114 subjects enrolled in the long-term follow-up study, extending up to 6 years posttreatment. For most subjects, post-treatment recovery in growth at 2 years post-treatment was maintained to 6 years post-treatment.

Source:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm218877.htm