Hepatitis C New Drugs Review
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Hepatitis C New Drugs Review
FDA approved Incivek(telaprevir, Vertex) on Monday 23 May by its PDUFA deadline.A paradigm shift in the treatment of Hepatitis C virus infection. http://knol.google.com/k/krishan-maggon/boceprevir-merck-telaprevir-vertex/3fy5eowy8suq3/151#
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Specialists not Necessary for Direct-Acting Antiviral Treatments

Specialists not Necessary for Direct-Acting Antiviral Treatments | Hepatitis C New Drugs Review | Scoop.it
Nurse practitioners with three hours training were better than specialists or primary care providers at getting HCV patients to complete their DAA regimens, Washington, DC area researchers found.
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Scientists find a way to cure hepatitis C with 6 weeks of treatment

Scientists find a way to cure hepatitis C with 6 weeks of treatment | Hepatitis C New Drugs Review | Scoop.it
A pilot study presented today found that all patients with acute HCV who were treated with a direct-acting antiviral treatment over a 'short-duration' of six weeks had undetectable HCV after a 12 week follow-up. The investigator-initiated study, presented at The International Liver Congress in Barcelona, Spain, demonstrated that the combination of sofosbuvir and ledipasvir for only six weeks is sufficient to treat patients with acute HCV.
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Innovative sources of financing to help scale up prevention and treatment of viral hepatitis in low and middle-income countries – IFPMA

Innovative sources of financing to help scale up prevention and treatment of viral hepatitis in low and middle-income countries – IFPMA | Hepatitis C New Drugs Review | Scoop.it
New treatment options for #HepC & goals of #UHC call for new approaches in funding sustainable funding sources https://t.co/MQw9981CsZ

Breakthroughs in the treatment of hepatitis C pose questions on how to make innovations more available to a large number of patients. A new report looks at possible innovative funding solutions for low and middle-income countries (LMICs) to scale up treatments for viral hepatitis and support health systems to deliver them. 

The report reviews over 20 different existing funding mechanisms, but finds no one single innovative mechanism is best. Instead, a mixture of approaches that consider the national context offer considerably more promise. 

The report states that successful innovative finance mechanisms require collaboration between payers, patients and healthcare providers. Political commitment to control viral hepatitis through a comprehensive public health approach is critical to ensure interest from prospective funders.
Krishan Maggon 's insight:
About VHPB: The Viral Hepatitis Prevention Board (VHPB) is an international board of experts in viral hepatitis, offering a platform for dissemination of scientific information related to viral hepatitis. Board members meet twice a year to discuss technical and country specific issues. The Board has a permanent scientific secretariat, located at the Centre for the Evaluation of Vaccination (CEV) of the University of Antwerp. 

About IFPMA: IFPMA represents the research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry’s 1.3 million employees research, develop and provide medicines and vaccines that improve the life of patients worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.
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Scientists find a way to cure Hepatitis C with six weeks of treatment - EASL, The International Liver Congress™ 2016

Scientists find a way to cure Hepatitis C with six weeks of treatment - EASL, The International Liver Congress™ 2016 | Hepatitis C New Drugs Review | Scoop.it

Short treatment with sofosbuvir and ledipasvir over only six weeks is sufficient to cur


April 16, 2016, Barcelona, Spain: A pilot study presented today found that all patients with acute HCV who were treated with a direct-acting antiviral treatment over a ‘short-duration’ of six weeks had undetectable HCV after a 12 week follow-up. The investigator-initiated study, presented at The International Liver CongressTM in Barcelona, Spain, demonstrated that the combination of sofosbuvir and ledipasvir for only six weeks is sufficient to treat patients with acute HCV. 


 Those infected with HCV usually develop acute Hepatitis C, which spontaneously clears in 10 to 50% of infected persons. Early diagnosis of HCV infection is rare and the disease may go unnoticed until patients have already developed serious liver damage.1 Sofosbuvir and ledipasvir is one possible regimen for treatment of patients with chronic HCV. Sustained virologic response (SVR) is greater than 95% with a 12-week course of this treatment.2

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This Week in HIV Research: Antibody Being Tested for HIV Prevention, and Differing Results on HCV Treatment in Coinfection

This Week in HIV Research: Antibody Being Tested for HIV Prevention, and Differing Results on HCV Treatment in Coinfection | Hepatitis C New Drugs Review | Scoop.it
This week, two large clinical trials will test whether a broadly neutralizing antibody injected into humans can prevent HIV infection.
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Serum Levels of Hepatitis B Surface Antigen and DNA Can Predict Inactive Carriers With Low Risk of Disease Progression - Liu - 2016 - Hepatology - Wiley Online Library

Serum Levels of Hepatitis B Surface Antigen and DNA Can Predict Inactive Carriers With Low Risk of Disease Progression - Liu - 2016 - Hepatology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Serum Levels of Hepatitis B Surface Antigen and DNA Can Predict Inactive Carriers With Low Risk... https://t.co/OjUglXlv4f
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Hepatitis

Hepatitis | Hepatitis C New Drugs Review | Scoop.it
Most types of hepatitis can be cured. According to Hepatitis Australia, worldwide, 1 in 12 people live with chronic hepatitis B or C.
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Quest Diagnostics launches test for picking hepatitis C drug

Quest Diagnostics launches test for picking hepatitis C drug | Hepatitis C New Drugs Review | Scoop.it
Top testing company Quest Diagnostics has begun offering new hepatitis C tests that can help doctors determine which of the expensive new drugs for the liver-destroying virus will work best for each patient.
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Variable radiation sensitivity among liver metastases. ecancer - News

Variable radiation sensitivity among liver metastases. ecancer - News | Hepatitis C New Drugs Review | Scoop.it
#Cancer Variable radiation sensitivity among liver metastases: Radiation is a commonly used… https://t.co/rRun9dgzUx

Moffitt Cancer Center researchers report that liver metastases have different sensitivities to radiation therapy based on the location of the primary tumour, with results published in International Journal of Radiation Oncology, Biology, and Physics.

 Previously, Moffitt researchers developed a radiosensitivity index (RSI) that predicts how well tumours respond to radiation therapy based on the expression of 10 different genes.
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Journal of Hepatology

Journal of Hepatology | Hepatitis C New Drugs Review | Scoop.it
RT @JHepatology: Our latest issue is up, #HCV screening needed, mouse model for #HEV and much more
https://t.co/cNtZAU1XSq https://t.co/z1f…
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Hepatitis C treatment for under $300 coming soon

Hepatitis C treatment for under $300 coming soon | Hepatitis C New Drugs Review | Scoop.it
Drugs for Neglected Diseases initiative says drug successfully tested in Egypt could be available within 18-24 months
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AbbVie Announces High SVR Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Regardless of the Presence of Resistance-Associated Variants Prior to Treat...

AbbVie Announces High SVR Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Regardless of the Presence of Resistance-Associated Variants Prior to Treat... | Hepatitis C New Drugs Review | Scoop.it
BARCELONA, Spain, April 14, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced data showing that patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection who received the recommended regimen of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets), with or without ribavirin (RBV), achieved high sustained virologic response rates at 48 weeks post-treatment (SVR48), regardless of the presence of baseline resistance-associated variants (RAVs).1 These late-breaking data from a post-hoc analysis of five completed Phase 3 clinical trials will be presented today at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain. 

 The study found that no matter whether certain RAVs, called NS5A, were present, 100 percent (n=148/148) of patients with genotype 1b (GT1b) chronic HCV infection, who received VIEKIRAX + EXVIERA without RBV for 12 weeks, achieved SVR48.1 Results also showed 97 percent of patients with genotype 1a (GT1a) chronic HCV infection with or without baseline NS5A RAVs (n=57/59 and n=351/361 respectively) achieved SVR48 when receiving the recommended regimen of VIEKIRAX + EXVIERA with RBV.1 These findings included both patients new to therapy and pegylated interferon/ribavirin (pegIFN/RBV) treatment-experienced, as well as those with compensated cirrhosis.1
Krishan Maggon 's insight:
About VIEKIRAX® + EXVIERA® VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection. VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV. Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
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Europe shapes new action plans on HIV/AIDS and viral hepatitis

Europe shapes new action plans on HIV/AIDS and viral hepatitis | Hepatitis C New Drugs Review | Scoop.it
Two advisory committees met in Copenhagen, Denmark, on 4–5 April 2016 to guide new action plans on HIV/AIDS and viral hepatitis for the WHO European Region 2016–2021.
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New cures for hepatitis C — but are they affordable? - Harvard Health Blog

New cures for hepatitis C — but are they affordable? - Harvard Health Blog | Hepatitis C New Drugs Review | Scoop.it
Several new drugs have been developed to treat hepatitis C and are very effective but also prohibitively expensive for many.
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Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies

Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies | Hepatitis C New Drugs Review | Scoop.it
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from several Phase 2 and Phase 3 studies evaluating its two investigational, pangenotypic, fixed-dose combination therapies for the treatment of chronic hepatitis C virus (HCV) infection, as well as new data highlighting the potential use of Harvoni® (ledipasvir/sofosbuvir) in adolescents aged 12 to 17. Data were presented this week at The International Liver CongressTM 2016 in Barcelona, Spain. “
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Phase 2 data show treatment efficacy in ‘difficult-to-cure’ Hepatitis C patients - EASL, The International Liver Congress™ 2016

Phase 2 data show treatment efficacy in ‘difficult-to-cure’ Hepatitis C patients - EASL, The International Liver Congress™ 2016 | Hepatitis C New Drugs Review | Scoop.it

AbbVie 


April 16, 2016, Barcelona, Spain: A Hepatitis C (HCV) drug currently under investigation, ABT-493 and ABT-530, which is an all-oral once-daily antiviral treatment, helped HCV genotype 3 patients with heavily scarred livers and no previous treatment history to achieve a 100% sustained virologic response after receiving the treatment for 12 weeks (SVR12). Additional data from this study, also presented at The International Liver CongressTM today in Barcelona, Spain, show that 97% of patients with the same HCV genotype, but without scarred livers, achieved SVR12 after eight weeks on the same treatment without ribavirin (RBV). 


 As treatments for HCV have evolved, genotype 3 patients have become the most difficult subgroup of patients to cure.1 Although there have been recent advances in direct-acting antiviral therapies for HCV genotype 1, genotype 3 remains a challenge and is a highly prevalent strain of the infection globally, with a particularly high concentration of cases in Asia.1

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WHO highlights Hepatitis testing innovations at The International Liver Congress - EASL, The International Liver Congress™ 2016

WHO highlights Hepatitis testing innovations at The International Liver Congress - EASL, The International Liver Congress™ 2016 | Hepatitis C New Drugs Review | Scoop.it
15 April 2016, Barcelona, Spain: Innovative Hepatitis testing projects from 5 countries will b
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RASSF1A and DOK1 Promoter Methylation Levels in Hepatocellular Carcinoma, Cirrhotic and Non-Cirrhotic Liver, and Correlation with Liver Cancer in Brazilian Patients

RASSF1A and DOK1 Promoter Methylation Levels in Hepatocellular Carcinoma, Cirrhotic and Non-Cirrhotic Liver, and Correlation with Liver Cancer in Brazilian Patients | Hepatitis C New Drugs Review | Scoop.it
Hepatocellular carcinoma (HCC) is the second most common cause of cancer mortality worldwide. Most cases of HCC are associated with cirrhosis related to chronic hepatitis B virus or hepatitis C virus infections. Hypermethylation of promoter regions is the main epigenetic mechanism of gene silencing and has been involved in HCC development. The aim of this study was to determine whether aberrant methylation of RASSF1A and DOK1 gene promoters is associated with the progression of liver disease in Brazilian patients. Methylation levels were measured by pyrosequencing in 41 (20 HCC, 9 cirrhotic, and 12 non-cirrhotic) liver tissue samples. Mean rates of methylation in RASSF1A and DOK1 were 16.2% and 12.0% in non-cirrhotic, 26.1% and 19.6% in cirrhotic, and 59.1% and 56.0% in HCC tissues, respectively, showing a gradual increase according to the progression of the disease, with significantly higher levels in tumor tissues. In addition, hypermethylation of RASSF1A and DOK1 was found in the vast majority (88%) of the HCC cases. Interestingly, DOK1 methylation levels in HCC samples were significantly higher in the group of younger (<40 years) patients, and higher in moderately differentiated than in poorly differentiated tumors ( p < 0.05). Our results reinforce the hypothesis that hypermethylation of RASSF1A and DOK1 contributes to hepatocarcinogenesis and is associated to clinicopathological characteristics. RASSF1A and DOK1 promoter hypermethylation may be a valuable biomarker for early diagnosis of HCC and a potential molecular target for epigenetic-based therapy.
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New Tests for Choosing Right Hep C Drug Could Save Money

New Tests for Choosing Right Hep C Drug Could Save Money | Hepatitis C New Drugs Review | Scoop.it
New tests designed to help doctors pick the right hepatitis C medicine for patients could mean faster cures and lower costs.Read more about New Tests for Choosing Right Hep C Drug Could Save MoneyComments
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New triple drug combination shows promise in hepatitis C infected patients

New triple drug combination shows promise in hepatitis C infected patients | Hepatitis C New Drugs Review | Scoop.it
New data presented today at The International Liver Congress™ 2016 in Barcelona, Spain, demonstrates a high sustained virologic response (SVR) at 12 weeks from the all-oral combination of sofosbuvir/velpatasvir and experimental compound GS-9857 in patients with the Hepatitis C virus (HCV). This triple combination treatment was generally safe and effective, even in patients who had […]
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Merck’s Commitment to Hepatits C

Merck’s Commitment to Hepatits C | Hepatitis C New Drugs Review | Scoop.it
For nearly 30 years, Merck has been at the forefront of the response to chronic HCV and our team continues to work tirelessly to advance scientific knowledge of this significant global public health issue.
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British Journal of Cancer - Acute changes in liver tumour perfusion measured non-invasively with arterial spin labelling

British Journal of Cancer - Acute changes in liver tumour perfusion measured non-invasively with arterial spin labelling | Hepatitis C New Drugs Review | Scoop.it
The BJC is owned by Cancer Research UK, a charity dedicated to understanding the causes, prevention and treatment of cancer and to making sure that the best new treatments reach patients in the clinic as quickly as possible. 

conclusions: Hepatic ASL-MRI can detect acute response to targeted tumour vascular disruption entirely non-invasively. Hepatic ASL of liver tumours has potential for use in a clinical setting. 

Keywords: perfusion; MRI; liver; cancer; metastasis; vascular disrupting agents
Krishan Maggon 's insight:
British Journal of Cancer (2016) 114, 897–904. doi:10.1038/bjc.2016.51 www.bjcancer.com Published online 31 March 2016
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HLA-C/KIR genotype linked to HBeAg-positive HBV interferon response

HLA-C/KIR genotype linked to HBeAg-positive HBV interferon response | Hepatitis C New Drugs Review | Scoop.it
The human leucocyte antigen-C and killer immunoglobin-like receptor genotypes are associated with response to interferon-based therapy in patients with chronic hepatitis B virus infection positive for hepatitis B e antigen, say researchers.
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On-the-go diagnosis of HIV and HCV co-infections

On-the-go diagnosis of HIV and HCV co-infections | Hepatitis C New Drugs Review | Scoop.it
HIV and hepatitis C virus (HCV) infections are among the leading causes of death worldwide, and an estimated one-third of people with HIV/AIDS are co-infected with HCV.
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Merck’s ZEPATIER™ (Elbasvir and Grazoprevir) Showed Superiority on Efficacy and Safety Endpoints Compared to Sofosbuvir Plus Peginterferon and Ribavirin Treatment Regimen in Phase 3 Trial | Merck N...

Merck’s ZEPATIER™ (Elbasvir and Grazoprevir) Showed Superiority on Efficacy and Safety Endpoints Compared to Sofosbuvir Plus Peginterferon and Ribavirin Treatment Regimen in Phase 3 Trial | Merck N... | Hepatitis C New Drugs Review | Scoop.it

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from C-EDGE Head-to-Head, the company’s comparative, Phase 3, open-label clinical trial evaluating the efficacy and safety of ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg tablets versus a regimen of sofosbuvir 400mg tablets plus peginterferon and ribavirin (pegIFN/RBV) in treatment-naïve and pegIFN/RBV treatment-experienced patients with chronic hepatitis C (HCV) genotype (GT) 1 or GT4 infection (abstract #PS002). In this study, ZEPATIER demonstrated superiority on efficacy and safety endpoints compared to sofosbuvir plus pegIFN/RBV, based on pre-specified analyses. In the full analysis set (FAS) (n=255), the efficacy endpoint of sustained virologic response (SVR) 12 weeks after the completion of therapy (SVR12, considered virologic cure) was achieved in 99 percent (128/129) of patients receiving ZEPATIER for 12 weeks versus 90 percent (114/126) of patients receiving sofosbuvir plus pegIFN/RBV for 12 weeks. The study’s safety endpoint was the frequency of pre-specified (Tier 1) safety events focusing on tolerability, hematologic side effects, and liver-related laboratory abnormalities.1 ZEPATIER – Merck’s once-daily, fixed-dose combination tablet indicated with or without RBV for the treatment of chronic HCV GT1 or GT4 infection in adults – was approved by the U.S. Food and Drug Administration (FDA) on Jan. 28, 2016, based in part on prior studies from the Phase 3 program. The results of C-EDGE Head-to-Head will be featured today in the official press program at The International Liver Congress™ 2016.

Krishan Maggon 's insight:
About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets 

 ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin (RBV) for treatment of chronic HCV genotype (GT) 1 or GT4 infection in adults.
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