Monday, July 31, 2017

Really Rapid Review — Paris IAS 2017

HIV and ID Observations
An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.

Really Rapid Review — Paris IAS 2017
Paul E. Sax, MD

Last week, the International AIDS Society meeting returned to Paris for the first time since 2003.

Here’s a Really Rapid Review® of some of the conference highlights, roughly ordered by “cure”, prevention, treatment, and complications....

Continue reading.....

Saturday, July 29, 2017

Hepatitis C: analysis of cures versus new infections in 91 countries

Review
The road to elimination of hepatitis C: analysis of cures versus new infections in 91 countries
Andrew M Hill, Sanjay Nath, Bryony Simmons 

View Full Text Article
Published July, 2017

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PDF Provided By HenryEChang  

Abstract
Background
Hepatitis C (HCV) can only be eradicated if annual rates of cure (SVR) are consistently and significantly higher than new HCV infections, across many countries. In 2016, the WHO called for a 90% reduction in new HCV infection by 2030. Direct-acting antivirals (DAA) can cure the majority of those treated, at around 90% in most populations, at potentially very low prices. We compared the net annual change in epidemic size across 91 countries using data on SVR, new HCV infections, and deaths. In a further 109 countries, we projected this figure using regional averages of epidemic size.

Methods
Epidemiological data for 2016 were extracted from national reports, publications and the Polaris Observatory. There were 91/210 countries with data on SVR, HCV-related deaths and new infections available for analysis; 109 countries had net change in epidemic size projected from the regional prevalence of HCV, extrapolated to their population size. ‘Net cure’ was defined as the number of people with SVR, minus new HCV infections, plus HCV-related deaths in 2016.

Results
For the 91 countries analysed, there were 57.3 million people with chronic HCV infection in 2016. In the remaining 109 countries, the projected epidemic size was 12.2 million, giving a global epidemic size of 69.6 million. Across the 91 countries, there was a fall from 57.3 to 56.9 million people in 2017, a 0.7% reduction. The projected global net change was from 69.6 to 69.3 million, a 0.4% reduction. Ten countries had at least five times more people reaching SVR than new HCV infections, including Egypt and USA. In 47/91 countries, there were more HCV infections than SVR in 2016.

Conclusion
Very few countries are on target to achieve elimination of HCV as a public health problem by 2030. While the North American, North African/Middle East and Western European regions have shown small declines in prevalence, the epidemic is growing in sub-Saharan Africa and Eastern Europe. Far higher rates of DAA treatment are required for worldwide elimination of HCV.


Friday, July 28, 2017

New At Hepatitis C Online: Vosevi and Mavyret

Hepatitis C Online is a free educational, web-based service that functions as a comprehensive resource for diagnosing, monitoring and managing the Hepatitis C virus infection. The service is produced at the University of Washington, through a partnership with the International Antiviral Society-USA, and funded by a grant from the Center for Disease Control and Prevention.

Although Hepatitis C Online is aimed at clinicians, a wealth of information is provided for people living with HCV as well. This interactive site offers easy to follow modules about the natural history of HCV, staging liver fibrosis, managing cirrhosis and treating the virus, click here to browse materials.

Updates At Hepatitis C Online
Information on Gilead's newly FDA approved Vosevi and AbbVie's Mavyret  was recently added, however, make sure to check the website in the future for additional updates. The clinical trial data is not new information, but now its easier to review.

Here are a few links to get you started:

Summary

Links
View clinical trial data in either slide decks, in your browser or download PDF.

Key Drug Interactions
For complete information on sofosbuvir-velpatasvir-voxilaprevir-related drug interactions, see the Drug Interactions section in the Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi) Prescribing Information.

We can cure hepatitis C. But we’re now making the same mistake we did with AIDS

The Washington Post

We can cure hepatitis C. But we’re now making the same mistake we did with AIDS

 
Three years ago, we wrote about the wide gap in access to hepatitis C treatment, hoping that mistakes made in the world’s response to AIDS would not be repeated in another epidemic of a lethal, blood-borne disease.
Our worst fears have been realized. The World Health Organization now reports that 4 out of 5 people infected with hepatitis C aren’t even aware of it. Of those who do know, fewer than 1 in 50 have received treatment. These numbers are far worse in parts of South Asia and sub-Saharan Africa, where the majority of the global extreme poor live. In many places, such as Rwanda, infected patients remain on waiting lists for treatment, without which many succumb early to liver failure, cancer and other related complications.
Continue reading....

European Commission Grants AbbVie's MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

European Commission Grants AbbVie's MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

- MAVIRET is a new 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and who are new to treatment*
- Marketing authorization is supported by 97.5 percent cure** rate across this group of patients(1)
- MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease(1)
- AbbVie's investigational, pan-genotypic HCV treatment is also under Priority Review by the U.S. FDA

NORTH CHICAGO, Ill., July 28, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Commission has granted marketing authorization for MAVIRET® (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is a new 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who comprise the majority of the 71 million people living with HCV globally.2,3

"MAVIRET represents an innovation in HCV care as an 8-week, pan-genotypic option that combines two distinct antiviral agents and has high efficacy even against most genotypes commonly associated with resistance to treatment," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This new treatment advancement has the potential to meet the diverse needs of patients in as short as 8 weeks across Europe."

MAVIRET is also indicated for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 (GT3) chronic HCV infection.1 MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.1

The approval of MAVIRET is supported by data from eight registrational studies in AbbVie's clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations.

"MAVIRET is an 8-week, pan-genotypic treatment for non-cirrhotic patients new to treatment with chronic hepatitis C that met all primary efficacy endpoints in its extensive HCV clinical trial program, achieving high cure rates," said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "MAVIRET offers a new therapy for the majority of HCV patients and removes many complexities of pre-treatment patient evaluation."

Authorization is supported by 97.5 percent (n=779/799)† cure** rate with just 8 weeks of treatment in GT1-6 patients without cirrhosis and who were new to treatment.1 This high cure rate was achieved in patients with varied patient and viral characteristics and including those with CKD.1 For compensated cirrhotic patients, a 98 percent (n=201/205)‡ cure rate was achieved with 12 weeks of treatment.1 For GT3 treatment-experienced patients with or without compensated cirrhosis, a 96 percent (n=66/69) cure rate was achieved with 16 weeks of treatment.1 In registrational studies for MAVIRET, less than 0.1 percent of patients discontinued treatment due to adverse reactions.1 The most commonly reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.1

MAVIRET combines two new, potent§ direct-acting antivirals that target and inhibit proteins essential for the replication of the hepatitis C virus. The presence of most genotypes or baseline mutations that are commonly associated with resistance have been shown to have minimal impact on efficacy of MAVIRET.

Approval of MAVIRET follows a review under accelerated assessment by the European Medicines Agency, which is granted to new medicines of major public health interest. MAVIRET is now licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. AbbVie's investigational, pan-genotypic treatment has also been granted accelerated review designations by other regulatory authorities including the U.S. Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare and is not yet approved in those countries.

*Patients without cirrhosis and new to treatment [either treatment-naive or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
†Data were pooled from 8-week arms of the ENDURANCE-1 and 3, and SURVEYOR-2 studies.
‡Data were pooled from 12-week GT3 treatment-naive, compensated cirrhotic arm of the SURVEYOR-2 and EXPEDITION-1 studies.
§Based on EC50 values of glecaprevir and pibrentasvir against full-length or chimeric replicons encoding NS3 or NS5A from laboratory strains and chimeric replicons from clinical isolates.1

About MAVIRET® (glecaprevir/pibrentasvir)
MAVIRET® is approved in the European Union for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

MAVIRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment,* who comprise the majority of people living with HCV. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV infection. MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

EU Indication
MAVIRET is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Important EU Safety Information
Contraindications:
MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers, such as rifampicin, carbamazepine, St. John's wort, phenobarbital, phenytoin, and primidone.

Special warnings and precautions for use:
Hepatitis B virus reactivation
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment.

Hepatic impairment
MAVIRET is not recommended in patients with moderate hepatic impairment (Child-Pugh B).

Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor
MAVIRET is not recommended for the re-treatment of patients with prior exposure to NS3A/4A and/or NS5A-inhibitors.

Adverse Reactions
Most common (≥10%) adverse reactions for MAVIRET were headache and fatigue.

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

For more information, please visit www.abbvie.com/HCV.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Nature - Eliminating viral hepatitis, articles and interviews

Nature - Eliminating viral hepatitis, articles and interviews

Article series: Eliminating viral hepatitis
Viral hepatitis is a global public health problem, and the burden of disease is increasing. In 2016, spurred by development of effective new treatments for hepatitis C and expanding access to hepatitis B vaccination, the 194 Member States of the WHO committed to eliminating viral hepatitis as a public health threat by 2030. Here, Nature Reviews Gastroenterology & Hepatology explores areas vital to meeting this ambitious target, from basic viral research to public policy.

2017
August 2017 Volume 14 Number 8
Eliminating viral hepatitis — momentum must keep building
doi:10.1038/nrgastro.2017.107
Abstract
Full text
PDF (235 KB)

August 2017 Volume 14 Number 8
Many European countries 'flying blind' in their efforts to eliminate viral hepatitis
doi:10.1038/nrgastro.2017.98
Abstract
Full text
PDF (255 KB)

August 2017 Volume 14 Number 8
HCV elimination — lessons learned from a small Eurasian country, Georgia
doi:10.1038/nrgastro.2017.100
Abstract
Full text
PDF (179 KB)

Begin here.........

For World Hepatitis Day Nature Releases Viral Hepatitis Articles and Interviews

Hugh Thomas writes an introduction to World Hepatitis Day 2017, including a mini-collection of research on viral hepatitis, in addition read an array of interviews about viral hepatitis research.

Raquel Peck CEO of the World Hepatitis Alliance explains the importance of World Hepatitis Day , Jeffrey V Lazarus and Kelly Safreed-Harmon discuss  WHO's strategy towards the elimination of viral hepatitis.

Begin here.....

Gilead's Vosevi® European Commission Grants Marketing Authorization

European Commission Grants Marketing Authorization for Gilead's Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C

Date(s): 28-Jul-2017 5:46 AM

-- Vosevi is the First and Only Single Tablet Regimen for Patients Who Have Previously Failed Therapy with Direct-Acting Antivirals --
-- European Commission Also Extends Marketing Authorization for Harvoni® (sofosbuvir/ledipasvir), Enabling First Direct-Acting Antiviral Regimen for Adolescent Hepatitis C Patients --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 28, 2017-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

Vosevi was authorized as a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis or with compensated cirrhosis, who have previously failed therapy with a direct-acting antiviral (DAA)-containing regimen. A 12-week regimen was also authorized for use in DAA-naïve patients with compensated cirrhosis infected with any HCV genotype, with an option to shorten therapy to 8 weeks for those infected with genotype 3. For DAA-naïve patients without cirrhosis, the recommended treatment duration is 8 weeks.
"DAA-based therapies have transformed our ability to treat hepatitis C. However, until now we have had limited options for patients who have failed to achieve cure with these regimens," said Professor Michael Manns, Director of the Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. "Vosevi has demonstrated high cure rates across a range of DAA-experienced patients, with a simple 12-week single tablet regimen. Availability of Vosevi will have a significant impact for this group of patients, offering them the opportunity to be cured of this disease."

Gilead also today announced an extension of the marketing authorization for Harvoni® (ledipasvir 90mg/sofosbuvir 400mg). Previously authorized for the treatment of adults with chronic HCV genotype 1, 3, 4, 5 or 6 infection, the indication for Harvoni has been extended to include the treatment of chronic HCV genotype 1, 3, 4, 5 and 6 infection in adolescents aged 12 to < 18 years. Harvoni is the first direct-acting antiviral regimen to receive marketing authorization in the European Union extended for use in the adolescent population.

"The authorization of Vosevi and the extended indication for Harvoni demonstrate our ongoing commitment to bring therapies with high cure rates to all HCV-infected patients," said John Milligan, PhD, Gilead's President and Chief Executive Officer. "We look forward to working with healthcare providers and governments to ensure Vosevi is made available to patients who would benefit the most from it, while continuing to expand the benefits of our other approved medicines for patients with chronic HCV infection across Europe."

Sofosbuvir-based regimens are recommended by global guidelines across HCV genotypes and disease severities and have been used to treat more than 1.5 million patients worldwide. Vosevi is Gilead's fourth sofosbuvir-based treatment to be granted marketing authorization by the European Commission for the treatment of chronic HCV infection. The marketing authorization of Vosevi follows an accelerated review procedure by the European Medicines Agency, reserved for medicinal products expected to be of major public health interest. It allows for the marketing of Vosevi in all 28 countries of the European Union. Gilead will now work diligently with national pricing and reimbursement agencies across Europe to make Vosevi available to patients.

The approval of Vosevi is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4) evaluated 12 weeks of the single tablet regimen in patients with hepatitis C genotypes 1-6 previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of Vosevi in DAA-naïve patients with hepatitis C genotypes 1-6. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with Vosevi (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with hepatitis C genotypes 1-6 with and without cirrhosis treated with Vosevi (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and compensated cirrhosis treated with Vosevi (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse drug reactions among patients who received Vosevi in the POLARIS studies were headache, diarrhea and nausea.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®, for use in combination with other agents for the treatment of adults with chronic HCV infection. The single tablet regimen, Harvoni, received marketing authorization in the European Union on November 18, 2014. The single tablet regimen of sofosbuvir (400mg) and velpatasvir (100mg) received marketing authorization in the European Union on July 8, 2016, under the trade name Epclusa® for the treatment of adults with chronic HCV infection.
Vosevi was approved by the U.S. Food and Drug Administration on July 18, 2017 for the re-treatment of adults with genotype 1-6 chronic HCV infection.

Important Safety Information for Vosevi
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) are contraindicated. Co-administration with strong OATP1B inhibitors (e.g. ciclosporin), rosuvastatin, dabigatran etexilate and ethinylestradiol-containing medicinal products is also contraindicated.

Patients co-infected with hepatitis C and hepatitis B are at risk of hepatitis B virus reactivation and should therefore be monitored and managed according to current clinical guidelines.
Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral treatments (e.g. tenofovir disoproxil fumarate- and efavirenz-containing regimens). Safety has not been established in patients with severe renal impairment (glomerular filtration rate <30ml/min).

Monitoring of digoxin and amiodarone is recommended when used with sofosbuvir/velpatasvir/voxilaprevir.

The "interaction with other medicinal products and other forms of interaction" section of the Vosevi EU Summary of Product Characteristics (SmPC) should be consulted before starting therapy with sofosbuvir/velpatasvir/voxilaprevir.

Sofosbuvir/velpatasvir/voxilaprevir should not be administered concomitantly with other medicinal products containing sofosbuvir.

In clinical studies, headache, diarrhoea and nausea were the most commonly reported adverse drug reactions.

Important Safety Information for Harvoni
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with rosuvastatin or St. John's wort (Hypericum perforatum) is contraindicated. Co-administration with certain P-glycoprotein (P-gp) inducers (e.g. rifampicin, carbamazepine and phenytoin) is not recommended. For patients on statins dose reduction should be considered and careful monitoring for statin adverse events (myopathy and rhabdomyolysis) should be undertaken.
Patients co-infected with hepatitis C and hepatitis B are at risk of hepatitis B virus reactivation and should therefore be monitored and managed according to current clinical guidelines.
Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral regimens. Safety has not been established in patients with severe renal impairment.
Monitoring of digoxin and dabigatran is recommended when used with ledipasvir/sofosbuvir.
Ledipasvir/sofosbuvir should not be administered concomitantly with other medicinal products containing sofosbuvir.
In clinical studies headache, fatigue and nausea were more common in patients treated with ledipasvir/sofosbuvir compared to placebo.

About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward­Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing Vosevi for the treatment of adults with chronic HCV infection or Harvoni for the treatment of adolescents with chronic HCV infection. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Full European Summary of Product Characteristics for Vosevi, Sovaldi, Harvoni and Epclusa are available from the EMA website at www.ema.europa.eu.

Vosevi, Sovaldi, Harvoni and Epclusa are trademarks or registered trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Thursday, July 27, 2017

Australia - 'We have been waiting for so long': hep C patients get access to new cure

'We have been waiting for this moment for so long': hepatitis C patients have access to cure with Epclusa PBS listing
Kate Aubusson
More than 200,000 Australians with hepatitis C will soon be able to afford a new, highly effective treatment for the chronic, highly stigmatised infection.
From August 1, the Turnbull government will subsidise the drug Epclusa, a bumper medication combining the two antivirals sofosbuvir and velpatasvir, Health Minister Greg Hunt is set to announce on Friday.
Continue reading....

Prioritize Injection Drug Users for Hepatitis C Treatment

Coverage from the
International AIDS Society (IAS) 2017 Conference 

Prioritize Injection Drug Users for Hepatitis C Treatment
Ingrid Hein
July 27, 2017 
"Average drug users with HCV are likely to infect two to six people before they move away from drug use," he reported. "A focus on treating people who are HCV-positive and injecting is the only way to slow and prevent spread of the virus."
Targeting treatment to patients with advanced liver fibrosis "as a result of the virus has been shown to be a less-effective model for eliminating HCV," Dr Dillon told Medscape Medical News. By selecting patients most likely to spread the disease, the impact will be greater, he added.
In Scotland, more than 85% of the people with a diagnosis of hepatitis C inject drugs, Dr Dillon reported. To date, they have been considered by most treatment services to be "too chaotic to treat" because they are associated with poor adherence to therapy and rapid reinfection, he explained.
Continuer reading....

Hepatitis drugs more affordable but disease still deadly: WHO

Hepatitis drugs more affordable but disease still deadly: WHO
GENEVA (Reuters) - Prices of drugs to cure hepatitis C and to treat hepatitis B are dropping dramatically, offering affordability and hope to 325 million people living with the viral liver disease that can be fatal, the World Health Organisation (WHO) said on Thursday. A generic antiviral drug for hepatitis C, which can be cured in three months, was placed this week on WHO's list of pre-qualified medicines.
Continue reading....

Related On This Blog
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

State Medicaid Programs Should Not Deny Hepatitis C Drugs

Morning Consult
State Medicaid Programs Should Not Deny Hepatitis C Drugs
Michael Ruppal   |  
...

Gilead's campaign boosted HCV diagnosis rates for baby boomers

Healio -  Industry News
Gilead announces continued focus on HBV, HCV, NASH
July 26, 2017
During an earnings conference call today, executives from Gilead Sciences disclosed second quarter earnings and projected pipeline goals with a focus on the company’s hepatitis B, hepatitis C and nonalcoholic steatohepatitis treatments.
Continue reading...

Medical Marketing & Media
Gilead's educational campaign boosted HCV diagnosis rates for baby boomers

Executives at Gilead Sciences told investors Wednesday that an unbranded campaign encouraging baby boomers to get tested for hepatitis C helped boost screening and diagnosis numbers, which in turn upped sales of its HCV therapies.

Gilead reported that its HCV franchise generated sales of $1.9 billion in the second quarter of 2017, down 17% from the same quarter in 2016. But sales increased over  the first quarter of the year, driven partly by patient starts (the initiation of an HCV therapy regimen), according to Mizuho Securities analyst Salim Syed.
Continue reading...

Wednesday, July 26, 2017

Review - HCC Risk and Direct-Acting Antivirals

Medscape Coverage from
Digestive Disease Week (DDW) 2017 

COMMENTARY
With Hepatitis C Virus on the Run, Meet the New Challenge: Hepatocellular Carcinoma
William F. Balistreri
July 26, 2017
Significant advances in the clinical practice of hepatology were addressed during this year's Digestive Disease Week. This review focuses on the concerns related to the apparent increase in the incidence of hepatocellular carcinoma (HCC).

HCC Risk and Direct-Acting Antivirals
The advent of direct-acting antivirals (DAAs) has clearly brought good news, as it may now be possible to achieve a sustained virologic response (SVR)—a "virologic cure"—in the majority of patients with chronic hepatitis C virus (HCV). However, emerging data suggest that the risk for HCC may persist or even be increased by DAA administration. This concern was addressed by two studies
Continue reading....

Free registration may be required

On This Blog
Liver Cancer After Treatment For Hepatitis C
Sift through a collection of current articles investigating the possible risk of developing liver cancer (hepatocellular carcinoma, or HCC) during and after direct-acting antiviral therapy in patients with hepatitis C.

Hepatitis C - Mylan Receives WHO Prequalification for Generic Sovaldi®

Mylan Receives WHO Prequalification for Generic Sovaldi®

First Generic Prequalification for Sofosbuvir Tablets

HERTFORDSHIRE, England and PITTSBURGH, July 26, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of approval from the World Health Organization Prequalification of Medicines Program (WHO PQ) of its application for Sofosbuvir Tablets, 400 mg, a generic version of Gilead Sciences' Sovaldi®. Sofosbuvir, a directly acting antiretroviral, will be available in developing countries to treat hepatitis C.

Mylan's Sofosbuvir Tablets, 400 mg, which are produced under license from Gilead Sciences, are the first generic version to be approved under the WHO PQ Program. With WHO PQ approval, international donors and purchasers, such as UNITAID and U.N. agencies, will able to fund and procure the product, and other buyers can be assured of the product's quality, safety and efficacy.

"This marks another important step in Mylan's leadership to help fight infectious diseases around the world," commented Mylan President Rajiv Malik. "It also furthers our mission of increasing access to high quality, affordable medicines to patients, healthcare practitioners, governments and other stakeholders to help treat hepatitis C."

Worldwide, there are more than 70 million people living with chronic hepatitis C, which results in nearly 400,000 related deaths every year. (1) The WHO estimates that antiviral medication can cure more than 95% of chronic hepatitis C cases. (2)

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.

(1, 2) http://www.who.int/mediacentre/factsheets/fs164/en/

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Modelling cost-effectiveness/health gains of a "universal" vs. "prioritized" HCV treatment policy in a real-life cohort

Modelling cost-effectiveness and health gains of a "universal" vs. "prioritized" HCV treatment policy in a real-life cohort.
Kondili LA, et al. Hepatology. 2017.

View Article
Accepted manuscript online:
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PDF Provided By @HenryEChang  

Abstract
We evaluated the cost-effectiveness of two alternative DAA treatment policies in a real-life cohort of HCV-infected patients: Policy 1 - "universal": treat all patients, regardless of the fibrosis stage; Policy 2 - treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and healthcare system perspective, was applied to the PITER cohort (representative of Italian HCV-infected patients in care). Specifically, 8,125 patients naïve to DAA treatment, without clinical, sociodemographic or insurance restrictions was used to evaluate the policies' cost-effectiveness. The patients' age, fibrosis stage, assumed DAA treatment cost of €15,000/patient and the Italian liver disease costs were used to evaluate Quality-Adjusted Life-Years (QALY) This article is protected by copyright. All rights reserved.

ECDC estimate: Around 9 million Europeans are affected by chronic hepatitis B or C

And large numbers of them are not even aware of their infection as they have not yet been tested

European Centre for Disease Prevention and Control (ECDC)

An estimated 4.7 million Europeans are living with chronic hepatitis B and almost 4 million (3.9) with chronic hepatitis C infection. However, large numbers of them are not even aware of their infection as they have not yet been tested and diagnosed. On the occasion of World Hepatitis Day on 28 July, ECDC Director Andrea Ammon highlights the need for Europe to scale-up coverage of testing, prevention interventions and linkage to suitable treatment services in order to achieve the target of eliminating viral hepatitis as a public health issue by 2030.

According to ECDC estimates, the prevalence of hepatitis B (HBV) across the European Union and European Economic Area (EU/EEA) is around 0.9% and about 1.1% for hepatitis C (HCV) - and these figures are likely to be an underestimation of the true burden as hepatitis infection often shows no symptoms.

European Commissioner for Health and Food Safety Vytenis Andriukaitis underlined the importance of increasing testing that leads to higher detection rates: ''Greater efforts are needed to reduce both the suffering and the costs that hepatitis inflicts across Europe. The Commission is fully committed to helping Member States achieve the Sustainable Development goal of ending HIV/AIDS and tuberculosis and reducing viral hepatitis by 2030. Together, we will scale up our prevention and testing programmes and reach out to the most vulnerable to reduce health inequalities. In order to tackle the underlying causes of the hepatitis epidemic we need to combine health instruments with social instruments and work together across health, social, and education policies.''

In 2015, the countries of the EU/EEA reported almost 60 000 newly diagnosed cases of these two infections - with 24 573 cases of hepatitis B and 34 651 of hepatitis C. For hepatitis C, this constitutes an increase of 4% compared to 2014 and follows the overall trend in Europe which saw a 26% rise of diagnosed and reported cases between 2006 and 2015. While the overall rise in diagnosed hepatitis cases indicates a general increase in testing practices across Europe, this does not apply to all of the European countries. A recent ECDC survey showed great variations across the countries and the proportion of undiagnosed infections ranges between 45-85% for HBV and between 20-89% for HCV, highlighting gaps in national testing programmes.

"There are highly effective drugs available to treat people infected with hepatitis B and C but the main bottleneck we see in Europe is the actual case detection: too many infections with viral hepatitis remain undiagnosed", says ECDC Director Andrea Ammon. "An ECDC study showed that less than half of the responding EU/EEA countries have dedicated hepatitis B or C testing guidance in place and even fewer countries could provide estimates on their undiagnosed infected population", Ammon continued. "There is also a clear need for countries to improve the quality and completeness of surveillance data, especially on the route of transmission. ECDC is currently working on an evidence-based testing guidance to support EU countries in their attempt to achieve the elimination target by 2030".

More testing allows treatment of those infected and reduces transmission

Across Europe, there has been a downward trend in the rate of acute HBV notifications especially among young people - most likely reflecting the positive impact of national vaccination programmes on incidence. Trends in the notifications of acute HCV provide a less reliable proxy for incidence as the disease is largely asymptomatic and cases of acute infection are difficult to diagnose.

In order to achieve elimination of hepatitis by 2030, prevention and control practices need to be scaled up to interrupt existing transmission chains. Those who might be unknowingly infected with viral hepatitis need to be identified through more testing both for their own benefit but also to be able to reduce further transmission in the community.

Source - https://ecdc.europa.eu/en/news-events/ecdc-around-9-million-europeans-are-affected-chronic-hepatitis-b-or-c

ECDC World Hepatitis Day 2017 page

Resources:
ECDC report: Hepatitis B and C testing activities, needs, and priorities in the EU/EEA
Hepatitis B - Annual Epidemiological Report for 2015
Hepatitis C - Annual Epidemiological Report for 2015
Systematic review on hepatitis B and C prevalence in the EU/EEA
ECDC Guidance: Antenatal screening for HIV, hepatitis B, syphilis and rubella susceptibility in the EU/EEA

Diplomat Now Dispensing VOSEVI™ to Treat Chronic Hepatitis C Virus

The nation's largest independent specialty pharmacy is now dispensing VOSEVI™ (sofosbuvir, velpatasvir, and voxilaprevir)

FLINT, Mich., July 26, 2017 /PRNewswire/ -- Diplomat Pharmacy, Inc. is now dispensing newly approved VOSEVI™ (sofosbuvir/velpatasvir/voxilaprevir) to treat hepatitis C virus infection

VOSEVI is used to treat all genotypes of chronic hepatitis C virus infection. It is indicated for adults without cirrhosis (liver disease) or with compensated cirrhosis who have previously been treated with a regimen containing an NS5A inhibitor such as EPCLUSA® (sofosbuvir/velpatasvir); HARVONI® (ledipasvir/sofosbuvir); VIEKIRA PAK™ or VIEKIRA XR™ (dasabuvir/ombitasvir/paritaprevir/ritonavir); TECHNIVIE™ (ombitasvir/paritaprevir/ritonavir); ZEPATIER® (elbasvir/grazoprevir); or DAKLINZA™ (daclatasvir).

VOSEVI is also indicated for chronic hepatitis C infection with genotype 1a or 3 and previous treatment with a regimen containing SOVALDI® (sofosbuvir) without an NS5A inhibitor.

To learn more about Diplomat's hepatitis program, visit diplomat.is/areas-of-excellence/hepatitis.

VOSEVI is a fixed-dose, combination tablet administered once-daily with food for 12 weeks. It contains sofosbuvir and velpatasvir­, as well as the newly approved voxilaprevir.

"Diplomat is proud to expand its therapy offerings to patients who have been diagnosed with chronic hepatitis C," said Paul Urick, president of Diplomat. "Providing an opportunity to treat patients who have failed current treatment options, this combination tablet is a valuable addition to our product offering."

More than 2.7 million Americans have hepatitis C, according to the Centers for Disease Control and Prevention. Hepatitis C infection becomes chronic in approximately 75–85 percent of cases. Unlike many serious diseases, hepatitis C can be cured with treatment.

Hepatitis C causes liver inflammation. Some people with chronic hepatitis C infection develop cirrhosis, in which liver tissue is replaced by scar tissue, eventually preventing the liver from functioning properly.

VOSEVI is manufactured by Gilead Sciences, Inc. For full prescribing information, click here.

Hepatitis C Virus in Children: The Global Picture Archives of Disease in Childhood, July 26, 2017

Hepatitis C Virus in Children: The Global Picture

Tuesday, July 25, 2017

July Hepatitis Updates: Research and News From Around The Web

Hepatitis Updates: Research and News From Around The Web
Welcome to a mix of research, blog updates and news about hepatitis C you may have missed over the last week. Click here for previous updates. 

New Online
IDSA, AASLD critical of Cochrane review of HCV drugs
July 26, 2017
The IDSA and AASLD wrote a joint response, which was published in Clinical Infectious Diseases, to the Cochrane review that concluded that direct-acting antiviral (DAA) drugs have not been shown to reduce risks for HCV-related morbidity or all-cause mortality. The review also claimed that prior trials have underestimated DAA adverse effects.
Continue reading....

On This Blog
In July Newsletters - Rebuttal over Cochrane Review of DAAs
View each rebuttal and all ongoing media coverage. In June the HCV community was blindsided when an article with a somewhat "clickbait" headline was released by The Guardian. The Guardian reported on a systematic review published by the Cochrane Collaboration that suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits.

Modelling cost-effectiveness and health gains of a "universal" vs. "prioritized" HCV treatment policy in a real-life cohort.
Kondili LA, et al. Hepatology. 2017.
View Article
Accepted manuscript online:
PDF Download
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PDF Provided By @HenryEChang
Abstract
We evaluated the cost-effectiveness of two alternative DAA treatment policies in a real-life cohort of HCV-infected patients: Policy 1 - "universal": treat all patients, regardless of the fibrosis stage; Policy 2 - treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and healthcare system perspective, was applied to the PITER cohort (representative of Italian HCV-infected patients in care). Specifically, 8,125 patients naïve to DAA treatment, without clinical, sociodemographic or insurance restrictions was used to evaluate the policies' cost-effectiveness. The patients' age, fibrosis stage, assumed DAA treatment cost of €15,000/patient and the Italian liver disease costs were used to evaluate Quality-Adjusted Life-Years (QALY) This article is protected by copyright. All rights reserved.

New Zealand steamrolls Australia on the pharmaceutical paddock too
MENAFN Press - 25/07/2017
The Pharmaceutical Benefits Scheme (PBS), once a reasonably efficient beast which cost taxpayers 6.5 billion a year, is likely to surpass 11 billion this year. Most of it goes to Big Pharma, but just how much is hard to tell.
Continue reading...

Male hepatitis B patients suffer worse liver ailments, regardless of lifestyle
Why men with hepatitis B remain more than twice as likely to develop severe liver disease than women remains a mystery, even after a study led by a recent Drexel University graduate took lifestyle choices and environments into account.
Continue reading...

Hepatitis C Treatment Is Safe, Effective in Some CHC Patients
July 25, 2017
Treatment of hepatitis C virus (HCV) infection is safe and effective in patients with chronic HCV with or without human immunodeficiency virus (HIV) across sub-Saharan Africa, according to a recent study.
Continue reading...

Association between complicated liver cirrhosis and the risk of hepatocellular carcinoma in Taiwan
plos.org
Published: July 24, 2017
https://doi.org/10.1371/journal.pone.0181858
Hepatocellular carcinoma (HCC) represents 70%-85% of primary liver malignancies [1,2]. With abdominal sonography, we can screen for HCC and perform surveillance to detect and treat tumors in the early stages. It is well known that most cases of HCC are associated with cirrhosis regardless of the etiology [38]. The 5-year cumulative risk of developing HCC for patients with cirrhosis ranges between 5% and 30% [3, 4]. The mortality of patients with cirrhosis with cirrhosis-related complications is high and many of them die before they develop HCC [911]. However, it has not been reported whether the complications of cirrhosis are associated with the development of HCC. It is interesting and noteworthy to better understand the association between the two by using competing risk analysis model appropriately. It is well known that male patients have a higher risk of HCC than female patients do, and the risk of cirrhosis is also higher in male patients [1215]. Since cirrhosis is the most important risk factor of HCC, it will be interesting to know the difference in the incidence of HCC between the sexes in patients with cirrhosis, especially in those with complications.

This population-based cohort study aimed to explore the association between complicated cirrhosis and HCC, and identify the risk factors of HCC in patients with complicated cirrhosis.
View full text article....

Mediterranean diet linked to lower risk for gallbladder removal surgery

July 25, 2017
New data has revealed a link between high adherence to a Mediterranean diet, rich in fruits, vegetables, legumes and olive oil, and a lower risk for…
Continue reading....

Of Interest Thursday, June 29, 2017
Liver cirrhosis: a risk factor for gallstone disease in chronic hepatitis C patients in China

Changing trends in complications of chronic hepatitis C
Mei Lu, Jia Li, Loralee B. Rupp, Yueren Zhou, Scott D. Holmberg, Anne C. Moorman, Philip R. Spradling, Eyasu H. Teshale, Joseph A. Boscarino, Yihe G. Daida, Mark A. Schmidt, Sheri Trudeau and Stuart C. Gordon
Although cirrhosis and mortality among HCV-infected patients in the US have increased over the past decade, all-cause mortality has decreased in recent years
Version of Record online: 21 JUL 2017 | DOI: 10.1111/liv.13501
Continue reading....

The ethics, cost, & evidence surrounding current pharmacological treatment of HCV infection.
Patients and their caregivers are wedged between big ‘‘pharma’’ and government with regard to drug pricing and access. When will the taxpayer contributions that helped fund research for lifesaving therapies be quantified and acknowledged and used as a basis for decision making regarding drug access? How much profit is enough? How much of rationing is an excuse to distribute therapy based on merit of life?
Download PDF

The above link is provided by Henry E. Chang via Twitter.
If you are interested in reading full text articles about the treatment and management of hepatitis C I highly suggest you follow Henry E. Chang.

The New York Times
The Tasmanian Hep C Buyers’ Club
Sophie Cousins
An innovative Australian takes a cue from early AIDS fighters to distribute generic new drugs that treat another potential killer, hepatitis C.
Continue Reading .......

Vosevi - Frequently Asked Questions & Gilead's My Support Path® VOSEVI Program
These frequently asked questions will help you understand what Vosevi is, how it works, and help you decide if it is the right medication for you.
Continue reading....

The Financial Case for Action on Liver Disease
The Lancet Commission into Liver Disease in the UK
In this paper the Foundation for Liver Research seeks to make the financial case for concerted preventative action through public health measures to tackle the 3 main causes of liver disease: alcohol misuse, obesity and viral hepatitis. The paper summarises the escalating financial costs to the health and care system as well as the wider societal costs related to the 3 lifestyle-related factors.

Download Report

Most Individuals With Advanced Cirrhosis Have Sleep Disturbances, Which Are Associated With Poor Quality of Life
Marwan Ghabril , Mollie Jackson, Raghavender Gotur, Regina Weber, Eric Orman, Raj Vuppalanchi, Naga ChalasaniIn summary, we describe a high prevalence of disturbed sleep in patients with cirrhosis at a large transplant center. Disturbed sleep was predicted by muscle cramps, which is an important although poorly understood complication of end-stage liver disease. Disturbed sleep in this population appears to be multifactorial in etiology and may be associated with neurocognitive dysfunction. Disturbed sleep is strongly associated with decreased quality of life, and its severity may be meaningfully categorized on the basis of PSQI. Further studies to elucidate the pathogenesis and therapies for disturbed sleep in patients with cirrhosis are needed in the face of this significant and unmet need.
Full Text Article
Download PDF
View Article Online

Blog Updates Around The Web

World Hepatitis Alliance
http://www.worldhepatitisalliance.org/
We are an ambitious patient-led and patient-driven not-for-profit organisation who work with governments, national members and other key partners to raise awareness of viral hepatitis and influence global change – transforming the lives of the 325 million people living with viral hepatitis and the future we share.

World Hepatitis Day: an annual day with the power to change millions of lives
Raquel Peck
CEO at World Hepatitis Alliance
28 July 2017 marks the 10th World Hepatitis Day: a day that remains the single most important date in the year to give people living with viral hepatitis a voice, raise awareness and advocate for the elimination of the disease.
Continue reading....
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Médecins Sans Frontières/ Doctors Without Borders (MSF)
Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation. We offer assistance to people based on need, irrespective of race, religion, gender or political affiliation. Our actions are guided by medical ethics and the principles of neutrality and impartiality.

Fighting Hepatitis in Cambodia: Hep C 101
Medical Doctor  - Theresa Chan in Cambodia
20 July 2017
A lot of our patients have known they were infected with chronic hepatitis C for a long time, sometimes for decades. For all of these years, they have assumed there would be no chance of cure, and have wondered how many years of their lives would be cut short by the disease. This is why it’s a happy job to work at MSF’s hepatitis C clinic. We give out a lot of good news and we deliver hope.
Continue reading....
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Weekly Bull
HepCBC is a non-profit organization run by and for people infected and affected by hepatitis C. Our mission is to provide education, prevention and support to those living with HCV.

Latest Issue: Weekly Bull
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HEP - Blog Updates
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

World Hepatitis Day and Vosevi
July 24, 2017
By Lucinda K. Porter, RN
I want to write about two topics this week—the newest approved hepatitis C drug (Vosevi) and World Hepatitis Day.

Hepatitis C and Supplements
Lucinda K. Porter, RN
Hepatitis C and supplements might not be a good mix, as supplements can injure the liver.

Of Interest 
Study Finds 275,000 Calls to Poison Control Centers for Dietary Supplement Exposures from 2000 through 2012

To view a list of all bloggers please click here.
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HEPATITISC.NET
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals

Truth and Consequences
By Daryl Luster - July 25, 2017
Having spoken about truth in an earlier piece, I dug into how it is a subjective thing with differing versions of truth that we believe, what I personally believe may vary dramatically...

Life’s Got A Rhythm, May As Well Dance To It 
By Rick Nash - July 24, 2017
In May of 2016 I was slotted to start Epclusa pending a blood test. While I had pushed my doctor to do an off-label Harvoni then Zepatier, Epclusa was about to be...

Messy Mouth with Hepatitis C
By Karen Hoyt -
July 20, 2017
This may sound disgusting, but when I was on treatment, there were times when my mouth was a mess. Not only were my teeth causing decay that required dental work, my mouth...

View all blog updates, here.
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The National Viral Hepatitis Roundtable NVHR
The National Viral Hepatitis Roundtable is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance.

What Are Hepatitis C Patients Experiencing in 2017?
This webinar is now archived.
Click here for the slides. Click here for the recording. (Click the link and then enter name and email address to view the webinar)
Please join us for a webinar on July 20, 2017 about what hepatitis C patients are experiencing in 2017. The webinar will feature three individuals who work with hepatitis C patients every day. They will share their perspective and knowledge of what patients are really grappling with currently. Presentations will be followed by question and answer and discussion.
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HIV and ID Observations
NEJM Journal Watch - An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.

Mystifying Cochrane Library Review on HCV Therapy Elicits Strong Response from IDSA
Paul E. Sax, MD
July 19th, 2017
Last month, The Cochrane Review published a controversial paper on HCV therapy that left many ID doctors and hepatologists rather perplexed.
After reviewing 138 randomized clinical trials using directly acting, non-interferon based therapies, they came to the following conclusions:
  • The use of sustained virologic response (“SVR”) — or “cure”, if you want to use plain English — as a valid endpoint for clinical outcomes is questionable.
  • There is insufficient evidence that treatment with DAA-based regimens improves clinical outcome.
  • The studies reviewed were at high risk of bias, so tended to overestimate benefits and minimize harm.
  • More randomized clinical trials are needed.
Anyone — clinician, researcher, or patient — who has experienced the miraculous advances in HCV therapy that started in 2014 could easily be scratching their heads at these conclusions.
The FDA might be surprised as well, since they have allowed permanent clearance of HCV RNA as an appropriate surrogate marker of the effectiveness of HCV therapy.
Fortunately, we now have a focused, persuasive response by the IDSA, just published in Clinical Infectious Diseases; Download PDF here....
Continue reading.......

Of Interest

REFILE-Treating HCV may improve glycemic control in diabetics
Last Updated: 2017-07-20
(Corrects affiliation in paragraph 2 to University of Washington, Seattle)

By Marilynn Larkin
NEW YORK (Reuters Health) - Treating hepatitis C virus (HCV) infection with direct-acting antiviral (DAA) agents is associated with improved glycemic control in patients with type 2 diabetes, researchers suggest.

HCV infection increases the risk of diabetes in individuals with metabolic syndrome, and may worsen glycemic control in those with diabetes, according to Dr. George Ioannou of the University of Washington, Seattle, and colleagues. To see whether clearing the virus with DAAs has an impact, the team reviewed data from 2,435 patients with diabetes (97% men, mean age 62, about 40% white/40% black) who underwent DAA-based antiviral treatment (no interferon or ribavirin) for HCV in the U.S. Veterans Affairs health care system in 2014 and 2015.

The team compared changes in average hemoglobin A1c (HbA1c) levels and use of antidiabetic medications the year before and after antiviral treatment between patients who achieved a sustained virologic response (SVR) - defined as a viral load below the lower limit of quantification 12 weeks or more after the end of treatment - and those who did not.

Almost all (99%) participants had genotype 1 HCV, and were treated with LDV/SOF (ledipasvir/sofosbuvir; 56.2%) or SMV (simeprevir) plus SOF (38.3%).

As reported online June 28 in Diabetes Care, 2,180 patients achieved an SVR and 255 did not.

Compared with those whose HCV treatment failed, patients who achieved an SVR were less likely at baseline to have cirrhosis (35.3% versus 54.5%) and decompensated cirrhosis (9.3% versus 20%).

They were also less likely to be taking antidiabetic medications (74.8% versus 78.0%) or insulin (41.3% versus 49.8%).

Among those with elevated baseline HbA1c, DAA treatment was associated with a greater HbA1c reduction in patients who achieved SVR (0.98%) than in those who did not (0.65%; adjusted mean difference 0.34, P = 0.02).

Use of antidiabetic medications decreased more in patients who achieved SVR than in those who did not, especially insulin use, which dropped significantly to 38% in patients achieving SVR compared with a slight increase to 51% in those who sustained treatment failure.

Comparing the pre- and post-treatment periods, weight increased slightly more in patients with an SVR than in those whose treatment failed. Hemoglobin concentrations decreased significantly more in patients whose treatment failed than in those who achieved an SVR.

Serum creatinine levels increased slightly and similarly in patients who did and did not achieve an SVR.

After adjusting for changes in weight, hemoglobin concentrations, and creatinine, the associations between SVR and an HbA1c drop or antidiabetic medication use remained essentially unchanged.

Summing up, Dr. Ioannou told Reuters Health by email, "After treatment of HCV with DAAs in diabetic patients, there appeared to be an improvement in glycemic control as demonstrated by decreased HbA1c levels and decreased number of insulin prescriptions. I believe our study does suggest an endocrine benefit to viral eradication and thus could be an additional compelling reason to treat chronic hepatitis C in diabetic patients."

Dr. Valentina Rodriguez, an endocrinologist at NYU Langone Medical Center in New York City, told Reuters Health, "It is exciting to have new data which not only confirms the previously studied association between type 2 diabetes and HCV, but also demonstrates beneficial effects of newer DAAs on improvement in A1C and reduction in insulin requirements."

The researchers did "a good job" of controlling for confounders such as weight loss, which might have accounted for the glycemic control benefits seen with interferon, she noted by email.

"Importantly," she added, "the study also accounted for other variables that could have falsely lowered/raised hemoglobin A1C testing in patients with treated/untreated HCV, including anemia and chronic kidney disease. This makes the interpretation of improved glycemic control more reliable."

"Some caveats we should keep in mind are the follow-up time for this study; though it is encouraging that insulin requirements and A1C decreased in the first 15 months post-therapy, longer term data with regards to micro/macrovascular complications (are) unavailable," Dr. Rodriguez continued.

"Also, not all HCV genotypes were studied; patients with HCV genotypes 2 and 3 were not included, possibly because they have been shown to be notably less cost-effective to treat with DAA therapy than the genotype 1 patients," she observed.

"The practical implementation of newer, more expensive drugs such as DAAs can be challenging," she acknowledged. "However, when considering that the price of insulin has increased by over 200% over the last four years, we must readdress the cost effectiveness of these drugs for patients with both type-2 diabetes and HCV."

Dr. Rodriguez concluded, "Future studies with longer follow up times will be helpful in establishing whether treatment of HCV with DAAs will also lead to decreased cardiovascular events and other diabetes-related deaths, which would impact healthcare spending even more significantly."

SOURCE: http://bit.ly/2tHimJ4

Diabetes Care 2017.

Thanks for stopping by!
Tina