Showing posts with label Harvoni® (Ledipasvir/Sofosbuvir). Show all posts
Showing posts with label Harvoni® (Ledipasvir/Sofosbuvir). Show all posts

Thursday, September 27, 2018

Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C

Of Interest
Sep 27, 2018

Sept 26 2018
The U.S. drug pricing system is a mess. It's an absolute disaster. Just about every entity involved, from drug companies to consumers to insurers to the government, agrees that offering discounts off the list price is a convoluted way to sell a life-saving product.

Maria Carolina Marcello, Gram Slattery
A Brazilian court has stripped the patent protection of a Gilead Sciences Inc big-selling hepatitis C treatment in Brazil, paving the way for cheaper generics, a presidential candidate who pushed for the move said on Monday....

Gilead Sciences to Sell Authorized Generics of Hepatitis C Drugs
Gilead Sciences will sell authorized generics of its blockbuster hepatitis C drugs Epclusa and Harvoni, Bloomberg reported. The brand-name versions sparked widespread debate about US pharmaceutical costs when they were introduced at a price of more than $1000 per pill. The less expensive versions will cost $24,000 for a course of treatment, which compares with a list price for Harvoni of $94,500. The company’s hepatitis C drugs remain among the best-selling pharmaceutical products in history, but they've also made Gilead the subject of congressional hearings and accusations of greed.

Gilead Press Release
United States
Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C
-- List Price of Authorized Generics to Reflect Discounts in the System Today --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today plans to launch authorized generic versions of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg), Gilead's leading treatments for chronic hepatitis C virus (HCV), in the United States, through a newly created subsidiary, Asegua Therapeutics LLC. The authorized generics will launch at a list price of $24,000 for the most common course of therapy and will be available in January 2019.

Since the launch of Gilead's first HCV medication in 2013, the average price paid for each bottle of medicine in the United States has decreased by more than 60 percent off of the public list prices, across health insurers and government payers. Due to the complexity and structure of the U.S. healthcare system, however, these discounts provided by Gilead may not always translate into lower costs for patients. Further, existing contracts, together with laws associated with government pricing policies, make it challenging to quickly lower a product's list price once it is on the market.

The authorized generics are priced to more closely reflect the discounts that health insurers and government payers receive today. Insurers will have the choice of offering either the authorized generics or the branded medications for both Epclusa and Harvoni. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to our medications to beneficiaries who were previously denied coverage.

"Launching these authorized generics is the best solution available to us today to quickly introduce a lower-priced alternative to our HCV medications without significant disruption to the healthcare system and our business," said John F. Milligan, PhD, President and Chief Executive Officer, Gilead Sciences. "This launch also will hopefully help increase transparency by more closely aligning our medications' list prices with their cost. Our ultimate goal is to lower the list price of Epclusa - a medication we believe is of great importance given its clinical profile across genotypes - and Harvoni. We are committed to working with all of our partners in the healthcare system to help enable list price reductions of our HCV medications and find better solutions to reduce patients' out-of-pocket costs."

Beyond the company's efforts to reduce patient costs, Gilead is continuing to pursue innovative collaborations and long-term financing models, such as a potential subscription model, that could not only expand access, but aim to eliminate HCV in the United States and around the world.

About Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking 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 that 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 June 30, 2018, 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.

Tuesday, August 21, 2018

Hepatitis C - Adverse events from DAAs can persist for months after treatment

Of Interest
March 14, 2018
March 24, 2018
May 30, 2018

Adverse events from DAAs can persist for months after treatment, study finds
Liz Meszaros, MDLinx | August 21, 2018
Adverse events (AEs) related to treatment with direct-acting antivirals (DAAs) may persist after treatment in a significant number of patients with chronic hepatitis C, according to results from a study published in the European Journal of Gastroenterology and Hepatology. Clinicians and patients should be aware of this possibility.

Abstract: Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized study

“This real-life study is to the best of our knowledge the first to examine the rate of AEs in patients with hepatitis C virus (HCV) genotype (GT) 1 infection, randomized to one of two different DAA regimens in a real-world setting,” noted these authors, led by Christina Sølund, MD, PhD, Department of Infectious Diseases and Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark.

Recently, the development of DAA agents has revolutionized the treatment of chronic hepatitis C, which is estimated to affect more than 70 million people worldwide. Before the advent of DAAs, the standard of care for these patients consisted of treatment with pegylated-interferon and ribavirin (RBV), lasting for 24 to 48 weeks, which not only had significantly lower cure rates and tolerability, but also carried a high incidence of severe AEs.

Now in their second iteration, DAAs have changed the playing field in the treatment of chronic hepatitis C by directly targeting the proteins responsible for viral replication. Improved sustained virologic responses (SVR) of 90% or more and good tolerability and efficacy in patients who have historically been difficult to treat—such as those with liver cirrhosis, liver transplantation, or previous treatment failures—have characterized the second-generation DAAs.

Few studies, however, have compared different DAA regimens. For this reason, Dr. Sølund and colleagues conducted their investigation. They included 96 patients with chronic hepatitis C with either GT1 or GT3, who were randomized to two different treatment arms. The first was comprised of 72 patients infected with GT1, who were treated for 12 weeks with ledipasvir/sofosbuvir/RBV vs paritaprevir/ombitasvir/ritonavir/dasabuvir/RBV. The second group consisted of 24 patients infected with GT3, who were treated with daclatasvir/sofosbuvir/RBV for 12 weeks vs a 24-week course of sofosbuvir/RBV.

Unfortunately, due to a change in national treatment guidelines, the GT3 treatment arm was prematurely terminated. Therefore, efficacy data are available from both GT3 and GT1 patients, but the incidence of AEs is available only for GT1 patients.

Cure was achieved by 97% of GT1 patients and 83% of GT3 patients, with SVR at 12 months. Virologic failure occurred in only one G3 patient.

Adverse events occurred in 97% of GT1 patients with the most common being anemia, fatigue, and headache.

“We found no statistically significant difference in AEs, neither between treatment groups nor in relation to anemia or cirrhosis. The overall rate of AEs was comparable to other real-world studies, but the frequency of the most common AEs, such as anemia (78%), fatigue (74%), headache (74%), pruritus/eczema (46%), and heartburn/abdominal discomfort (38%), was higher in our study,” they added.

Only 3% of GT1 patients discontinued treatment due to AEs. Notably, 45% of patients with AEs thought to be related to a DAA regimen still manifested the AEs at 4 weeks after treatment. At 12 weeks this was still the case in 11% of patients.

“We consider this an important finding that can be used when informing the patient about AEs that might be caused by the DAA regimen, despite the number of patients included in our study being relatively small,” noted the authors. “The low discontinuation rate reflects that AEs possibly induced by DAA treatment are rarely treatment limiting, even when DAA treatment is given in combination with RBV,” they concluded.

This study received support from the Faculty of Health and Medical Sciences, University of Copenhagen and from Hvidovre Hospital Research Foundation, the Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, the Capital Region of Denmark’s Research Foundation, the Innovation Fund Denmark project 060-2009-3, the Novo Nordisk Foundation, and the Danish Research Council.

Thursday, July 12, 2018

Challenges and perspectives of direct antivirals for the treatment of hepatitis C virus infection

Journal of Hepatology
Challenges and perspectives of direct antivirals for the treatment of hepatitis C virus infection
JohannesVermehren, James S. Park, Ira Jacobson, StefanZeuzem


Follow On Twitter 
The following full-text articles downloaded and shared by Henry E. Chang.

Treatment of chronic hepatitis C virus (HCV) infection has been revolutionized with the development of direct-acting antiviral agents (DAAs). Eight to twelve weeks of all-oral, once-daily treatments is now the standard of care and viral eradication can be achieved in >95% across different patient populations. Despite these advances, several unresolved issues remain, including treatment of HCV genotype 3, chronic kidney disease, and in patients in whom DAA therapy has failed. Glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) are the most recently approved DAA regimens. Given the overwhelming success of modern DAA-based therapies, GLE/PIB and SOF/VEL/VOX are also likely to represent the last DAAs to be approved. Both are pangenotypic, once-daily, all-oral DAA combinations that have the potential to close the gaps in the current DAA treatment portfolio. Here, we review the challenges associated with current DAAs and how these two regimens may be implemented in existing treatment algorithms.

Of Special Interest
Hepatitis C Management Simplification From Test to Cure:A Framework for Primary Care Providers
SOF/VEL or GLE/PIB), both highly tolerated and effective for all genotypes.

Sofosbuvir and Ledipasvir is Associated with High Sustained Virologic Response and Improvement of Health-Related Quality of Life in East Asian Patients with Hepatitis C Virus Infection
In summary, our data clearly show the superiority of IFN-free RBV-free LDV/SOF in East Asian patients with chronic HCV genotype 1 infection. The advantages of that regimen are related not only to its high efficacy and excellent tolerability but also to significantly better quality of life during treatment and after achieving SVR. These data provide evidences up porting the comprehensive benefit of LDV/SOF for eligible patients which should inform all stakeholders, including providers, payers, and policy makers in East Asian countries

Absolute denials of DAA regimens by insurers in the U.S. have remained high & increased over time, regardless of type of insurance.

Friday, April 27, 2018

Harvoni effective for HCV genotype 4, including cirrhotic cases

In The Journal
Original article Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt
gamal Shiha,1,2 gamal esmat,3 Mohamed Hassany,4 reham Soliman,2,5 Mohamed elbasiony,1,2 rabab Fouad,3 aisha elsharkawy,3 radi Hammad,4 Wael abdel-razek,6 talaat Zakareya,6 Kathryn Kersey,7 Benedetta Massetto,7 anu Osinusi,7 Sophia lu,7 Diana M Brainard,7 John g McHutchison,7 imam Waked,6 Wahid Doss4

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Significance of this study
What is already known about this subject?
► In Egypt, which has one of the highest prevalences of hepatitis C virus (HCV) infection in the world (6.3%), >90% of patients are infected with HCV genotype 4.
► At the time of study design, sofosbuvir was the only direct-acting antiviral (DAA) drug available in Egypt. As such, the only DAA treatment options were sofosbuvir plus ribavirin plus pegylated interferon for 12 weeks, or sofosbuvir plus ribavirin for 24 weeks; there were no treatment options for patients who had failed direct-acting antiviral agent therapy.
► We sought to find the optimal regimen for ledipasvir–sofosbuvir in Egypt. Shorter treatment durations and/or the removal of ribavirin and pegylated interferon and their associated toxicities would be of benefit to patients. What are the new findings?
► Treatment-naive patients without cirrhosis were effectively and safely treated with the fixeddose combination of ledipasvir/sofosbuvir for 8 weeks.
► Rates of sustained virological response 12 weeks post-treatment (SVR12) of ≥94% were observed with 12 weeks of ledipasvir/ sofosbuvir±ribavirin treatment in interferonexperienced patients with or without cirrhosis. All sofosbuvir or ledipasvir–sofosbuvirexperienced patients in this study achieved SVR12 with 12 weeks of ledipasvir–sofosbuvir plus ribavirin for 12 weeks.
► Overall, the addition of ribavirin did not appear to increase rates of SVR observed with ledipasvir–sofosbuvir, but it was associated with an increase in the incidence of adverse  events.
Continue to article:

Commentary @ Healio
Harvoni effective for HCV genotype 4, including cirrhotic cases
April 27, 2018 
Patients with hepatitis C genotype 4 had high sustained virologic response rates with Harvoni over 8 weeks in treatment-naive cases without cirrhosis and over 12 weeks with ribavirin regardless of cirrhosis or treatment experience, according to recently published data from a phase 3 study in Egypt.

“Given the high prevalence of HCV in Egypt and the heterogeneity of the HCV-infected population with respect to age, comorbidities and prior HCV therapy, there is a need in Egypt for a highly efficacious, well-tolerated, single-tablet regimen with simple monitoring,” Gamal Shiha, MD, PhD, from the Liver Research Institute and Hospital in Egypt, and colleagues wrote. “With the widespread use of sofosbuvir, an efficacious treatment for those who have failed treatment with a sofosbuvir-based regimen would also be highly desirable.”

Full Article:

Thursday, April 26, 2018

A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6‐ to 12‐ year old children

A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6‐ to 12‐ year old children
M. H. F. El‐Shabrawi N. M. Kamal H. R. El‐Khayat E. M. Kamal M. M. A. H. AbdElgawad M. Yakoot

First published: 25 April 2018

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No available data on the use of sofosbuvir/ledipasvir combination in treatment of hepatitis C virus (HCV) infection in children 6‐ to 12‐ year old.

To assess the safety and efficacy of sofosbuvir plus ledipasvir in children 6‐ to 12‐ year old with chronic HCV genotype 4 infection.

This is a pilot prospective single arm observational open‐label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6‐ to 12‐ years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half the adult dose (200/45 mg) once daily for 12 weeks. Laboratory tests including virological markers were measured at baseline, 2, 4, 8 and 12 weeks (end of treatment [EOT]), and 12 weeks after end of treatment for sustained virological response 12 (SVR12).

The intention‐to‐treat (ITT) SVR12 rate was 19/20 (95%; 95% CI: 76.4%‐99.1%). SVR12 was not assessed in one patient who was lost to follow‐up after showing viral negativity at the EOT12. All the remaining 19 patients (100%, 95% CI: 83.18%‐100%) who completed the full protocol and follow‐up visits achieved SVR12 with normal liver, haematological, and renal function tests and no side effects or fatalities.

This pilot study demonstrated that the fixed dose sofosbuvir/ledipasvir combination could be safe and effective treatment in children 6‐ to 12‐ years with chronic hepatitis C genotype 4 infection. Our pilot results might encourage larger and multicentre studies in this age group.

Thursday, April 12, 2018

Liver Congress 2018 - ‘what you need to know in 5-minutes’ video clips each day from the conference

 ‘what you need to know in 5-minutes’

Hi folks, if you need help navigating the International Liver Congress, begin here: For Patients: The International Liver Congress 2018 . This page is a collection of links with conference updates and a list of websites you may be interested in visiting. As once a patient myself, exploring Practice Point was an easy way to review key data presented at the meeting.  Each day of the conference Practice Point uploads 5-minute video clips summarizing that day's hepatitis C presentations. However, you need to register, its free, check out the process below with highlights of today's clip. 

Link: Practice Point
Independent Conference Coverage from the 53rd Annual Congress of the European Association for the Study of the Liver (EASL)*
In this video series, Dr. Brown will present ‘what you need to know in 5‐minutes’ regarding today's presentations from The International Liver Congress EASL 2018 in Paris, France. These educational Clinical Clips will spotlight the latest advances in the prevention and treatment of hepatitis C through a series of daily, ‘what you need to know in 5-minutes’ videos each day from the conference. 

Clinical Clips Day One - April 12, 2018
Highlights: Harvoni® (Ledipasvir/Sofosbuvir) 8wks treatment vs 12wks in black treatment-naïve genotype 1 patients.

HCV genotype 3 using 8wks of Epclusa® (Sofosbuvir/Velpatasvir) for patients on Opioid Substitution therapy.

Epclusa® (Sofosbuvir/Velpatasvir) plus ribavirin for HCV genotype 3 patients with cirrhosis, and finally HCV treatment for patients with decompensated cirrhosis.
Start here.....

Check Practice Point each day of the conference, April-12 - April 15.

For patients, navigating registration
Link - Click here to register
The good news, only areas marked with * are required. The process is self-explanatory, it goes like this.

Email *
Confirm Email *
Password * Confirm Password *
First Name *
Last Name *
Degree * If you do not have a medical degree type in "Other" when the next box appears, type in "Patient"
Select the category that best represents your specialty * Pick one, anyone.
Areas of Interest (Check all that apply) * Pick one, anyone.

Good luck

Tuesday, April 10, 2018

Sweden-Introduction of second-generation direct-acting antivirals in HCV:Register-based Study

Introduction of the second-generation direct-acting antivirals (DAAs) in chronic hepatitis C: a register-based study in Sweden
P. Frisk, K. Aggefors T. Cars N. Feltelius S. A. LoovB. Wettermark O. Weiland

First Online: 09 April 2018

The conditions for introducing the first six of the second-generation direct-acting antivirals for chronic hepatitis C infection in Sweden were outlined in a national introduction protocol. The overall cure rate was estimated to 96%, with some variation between genotypes. Despite regional variation in other cost containment strategies, the high level of adherence to recommendations among prescribers and similar introduction rates in the regions indicate that the protocol contributed considerably to a rapid uptake and equal distribution of DAAs in Sweden.


Purpose Introduction of the direct-acting antivirals (DAAs) for treatment of chronic hepatitis C (CHC) infection has been challenging in all health systems. In Sweden, a national protocol for managed introduction was developed. It was optional, but all county councils agreed to implement and follow it. The purpose of this study was to study (a) cure rates among all patients initiated on treatment in 2014–2015, (b) prescribers’ adherence to the drug recommendations and treatment eligibility criteria in the protocol, and (c) introduction rate in the six Swedish healthcare regions.

A cross-sectional study where national data from the Prescribed Drug Register and the quality register InfCare Hepatitis defined the study population, and clinical data from the Patient Register and InfCare Hepatitis were used to monitor outcomes. Descriptive statistics were used.

A total of 3447 patients were initiated on treatment during 2014–2015. The overall cure rate, based on data from 85% of the cohort, was 96%, with variation between genotypes. Adherence to drug recommendations increased over time and varied between 43.2 and 94.2%. Adherence to the treatment eligibility criteria was initially 80% and increased to 87% when treatment restrictions were widened. The introduction rate differed initially between the regions and reached stable levels 15–18 months after the launch of the first DAA.

The estimated overall cure rate was 96%, with some variations between genotypes. A high level of adherence to the introduction protocol as well as similar introduction rates in the health care regions indicate that the introduction protocol, alongside with other measures taken, contributed considerably to a rapid uptake and equal distribution of DAAs in Sweden.

Continuer reading online:

Wednesday, February 28, 2018

Ontario Expands Patient Access to Chronic Hepatitis C Therapies On Public Drug Plan

Ontario Expands Patient Access to Chronic Hepatitis C Therapies On Public Drug Plan

  • Gilead applauds Ontario's Ministry of Health for expanding access to curative hepatitis C therapies to all diagnosed patients, regardless of severity of illness
  • Ontario's expanded access includes EPCLUSA®, a 12 week treatment for patients with chronic hepatitis C across all six genotypes
  • Gilead's new product, VOSEVI™ is now available under the Ontario Drug Benefit Program
  • The removal of the fibrosis level criterion for access furthers Canada's commitment to the World Health Organization's Global Hepatitis C elimination efforts
MISSISSAUGA, ON, Feb. 28, 2018 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today recognizes the Ontario Ministry of Health and Long-Term Care for its leadership in the expansion of access to therapies that treat chronic hepatitis C virus infection under the Ontario Drug Benefit (ODB) Program. Today, all eligible ODB recipients will have greater access to treatment, regardless of the severity of disease (fibrosis level), to achieve a cure and improve their quality of life. Patients with chronic hepatitis C will no longer have to wait for their disease to progress before starting treatment.

"Expanded access is an important milestone to achieve Canada's commitment to eliminating hepatitis C by 2030," said Kennet Brysting, General Manager of Gilead Canada. "Increasing hepatitis C treatment rates among patients and high-risk populations will help to reduce the burden of illness, the risk of transmission and the significant associated costs to the healthcare system."

Today's announcement will allow more patients to access a broad selection of therapies, including all those developed by Gilead Canada – EPCLUSA (velpatasvir/sofosbuvir), VOSEVI (voxilaprevir/velpatasvir/sofosbuvir), HARVONI® (ledipasvir/sofosbuvir) and SOVALDI® (sofosbuvir). EPCLUSA is a publicly accessible treatment that can be used for patients with hepatitis C infection across all six genotypes, and VOSEVI is approved for use in patients who have failed on a previous direct-acting antiviral (DAA) treatment regimen.

"Canada has committed to eliminating hepatitis C by 2030, and to accomplish this goal we need to significantly increase treatment rates," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and hepatologist at Toronto General Hospital. "Treatment regimens are getting shorter, simpler and more widely effective across genotypes meaning that treatment is now easier for both patients and physicians to manage.

"Currently, an estimated 44 per cent still remain undiagnosed, so increasing treatment rates also requires improving screening and diagnosis, which is why the Canadian Liver Foundation recommends that everyone in Canada born between 1945 and 1975 receive a one-time test for hepatitis C," added Dr. Sherman. "Treatment should be an option for everyone, regardless of disease severity, where they live in the province or their ability to pay. We're glad to see that the Ontario government is taking steps to make treatments accessible for more Ontarians with chronic hepatitis C."

For more information on the expanded access for hepatitis C therapies and VOSEVI listing:

Tuesday, January 23, 2018

The Effect of Shorter Treatment Regimens for Hepatitis C on Population Health and Under Fixed Budgets.

In case you missed it

The Effect of Shorter Treatment Regimens for Hepatitis C on Population Health and Under Fixed Budgets.
Morgan JR, et al. Open Forum Infect Dis. 2018.

Full Text
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Background: Direct acting antiviral hepatitis C virus (HCV) therapies are highly effective but costly. Wider adoption of an 8-week ledipasvir/sofosbuvir treatment regimen could result in significant savings, but may be less efficacious compared with a 12-week regimen. We evaluated outcomes under a constrained budget and cost-effectiveness of 8 vs 12 weeks of therapy in treatment-naïve, noncirrhotic, genotype 1 HCV-infected black and nonblack individuals and considered scenarios of IL28B and NS5A resistance testing to determine treatment duration in sensitivity analyses.

Methods: We developed a decision tree to use in conjunction with Monte Carlo simulation to investigate the cost-effectiveness of recommended treatment durations and the population health effect of these strategies given a constrained budget. Outcomes included the total number of individuals treated and attaining sustained virologic response (SVR) given a constrained budget and incremental cost-effectiveness ratios.

Results: We found that treating eligible (treatment-naïve, noncirrhotic, HCV-RNA <6 million copies) individuals with 8 weeks rather than 12 weeks of therapy was cost-effective and allowed for 50% more individuals to attain SVR given a constrained budget among both black and nonblack individuals, and our results suggested that NS5A resistance testing is cost-effective.

Conclusions: Eight-week therapy provides good value, and wider adoption of shorter treatment could allow more individuals to attain SVR on the population level given a constrained budget. This analysis provides an evidence base to justify movement of the 8-week regimen to the preferred regimen list for appropriate patients in the HCV treatment guidelines and suggests expanding that recommendation to black patients in settings where cost and relapse trade-offs are considered.

Risks for Hepatitis B Reactivation with Newer Hep C Treatments Detailed

Medical News |

January 22, 2018
Risks for Hepatitis B Reactivation with Newer Hep C Treatments Detailed
By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

About a quarter of patients with chronic hepatitis B infection experience reactivation of the virus when they receive direct-acting antivirals (DAAs) for hepatitis C infection, according to a meta-analysis in the Lancet Gastroenterology and Hepatology.

The analysis included 17 observational studies among over 1600 patients with chronic or resolved HBV infection who were treated with interferon-free DAA regimens (e.g., ledipasvir plus sofosbuvir) for chronic HCV. Some 24% of those with chronic HBV infection — versus 1.4% of those with resolved infection — had HBV reactivation during treatment. Additionally, 9% of those with chronic HBV experienced hepatitis related to HBV reactivation, versus none of those with resolved HBV.

The authors say their findings "support the use of antiviral prophylaxis in patients with chronic HBV and HCV coinfection" being treated with DAAs. They add, "By contrast, patients with resolved HBV infection might only require close [alanine aminotransferase] or HBV DNA monitoring, or both."

LINK(S): Lancet Gastroenterology and Hepatology article (Free abstract)

Background: Recent NEJM Journal Watch Infectious Diseases coverage of HBV reactivation during HCV treatment (Free)

Wednesday, January 3, 2018

From Retirement To The Front Lines Of Hepatitis C Treatment

From Retirement To The Front Lines Of Hepatitis C Treatment  
Julio Ochoa Transcript January 2, 20184:13 PM ET

When a hepatitis C treatment called Harvoni was released in 2014, Dr. Ronald Cirillo knew it was big.

"It's the reason that dragged me out of retirement!" he says.

Cirillo specialized in treating hepatitis C for more than 30 years in Stamford, Conn., before retiring to Bradenton, Fla. During his time in Connecticut, the only available treatment for hepatitis C had terrible side effects and it didn't work very well. It cured the viral infection less than half the time. But the newer drugs Harvoni and Solvaldi cure almost everybody, with few adverse reactions.

Read full article: Heard on All Things Considered

Tuesday, January 2, 2018

Eight-Week Outcomes of Ledipasvir/Sofosbuvir in Noncirrhotic Treatment-Naive Patients with Hepatitis C: Analysis of Pharmacy-Based Data

Eight-Week Outcomes of Ledipasvir/Sofosbuvir in Noncirrhotic Treatment-Naive Patients with Hepatitis C: Analysis of Pharmacy-Based Data
Jennifer Andres , PharmD, BCPS1*, Stephen Lott , PharmD, MS, CSP3, Kamran Qureshi , MD2

J Manag Care Spec Pharm, 2018 Jan;24(1):23-28.

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BACKGROUND: Clinical trials have demonstrated that 8 weeks of ledipasvir and sofosbuvir (LDV/SOF) achieved high rates of sustained virologic response at 12 weeks (SVR12) in patients with hepatitis C viral (HCV) genotype 1 infection. The effectiveness of this combination was noted to be robust in treatment-naive noncirrhotic patients and in patients with an HCV viral load of < 6 million IU/mL before treatment. Generalizability of these results to community clinical practice, however, was advised with caution due to the variability of staging methods, fluctuating nature of viral loads, lack of prospective trials, and real-life confirmation.

OBJECTIVE: To evaluate the efficacy, defined as SVR12, of LDV/SOF in a real-world setting.

METHODS: Patients met inclusion criteria if given 8 weeks of LDV/SOF by a specialty pharmacy from October 2014 to October 2015 and if SVR12 was assessed after therapy completion. Clinical outcomes data were obtained from the pharmacy database.

RESULTS: Of the 6,391 prescriptions of LDV/SOF received by the pharmacy, 3,648 (57%) were covered by insurance, and among them, only 511 (14%) were for an 8-week regimen. SVR12 data were available for 380 (74%) patients who completed an 8-week regimen. 230 different prescribers wrote prescriptions, and 57 different insurance plans approved the 8-week regimen. The majority (74%) of patients were followed by gastroenterology clinics. The 380 patients included in the analysis were all treatment-naive HCV genotype 1 patients. Overall, SVR12 was achieved in 97% of patients, while 10 patients relapsed. The SVR12 rates were lower (93%) in patients with stage 3 fibrosis, particularly in African Americans (29 of 35: 83%).

CONCLUSIONS: Outcomes were favorable for the 8-week use of LDV/SOF in a noncontrolled real-world setting in treatment-naive noncirrhotic patients with a baseline viral load < 6 million IU/mL. Use of this approach in African Americans with evidence of advanced fibrosis should be avoided.

This work was presented in part as a poster at the 2016 International Liver Conference; Barcelona, Spain; April 13-17, 2016.

What is already known about this subject
  • Initial evidence for an 8-week treatment duration of ledipasvir/sofosbuvir comes from a post hoc analysis of a clinical trial.
  • Real-world analyses have agreed with the hepatitis C viral (HCV) RNA threshold of < 6 million IU/mL to qualify for 8 weeks of treatment.
  • Current guidelines recommend that patients with HCV RNA < 6 million IU/mL can use ledipasvir/sofosbuvir for 8 weeks if they are not African American or HIV coinfected.
What this study adds
  • This study provided results that were consistent with current guideline recommendations.
  • Sustained virologic response at 12 weeks was high in the African American patient population, except in patients with stage 3 fibrosis, and also high in the HIV-coinfected patient population.

Monday, January 1, 2018

HCV in Southeast Asia - Ledipasvir and Sofosbuvir for HCV Genotype 6

Kenneth Bender

The successful treatment of hepatitis C virus genotype 6 (HCV-GT6) with a non-interferon-based fixed dose oral regimen of ledipasvir and sofosbuvir (LDV/SOF) bodes well for treating HCV in Southeast Asia, where newer pangenotypic agents are not available to treat this region's most prevalent genotype.

Continue reading......

On This Blog
2018 HCV Genotypes and Treatment
Offered on this page is research updates with a focus on treating HCV according to genotype using FDA approved medicines. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities. 

Sunday, December 31, 2017

Hepatitis C - Treatment failures in a real-world cohort with SOF & (DCV or LDV)

Alimentary Pharmacology & Therapeutics
Version of Record online: 22 DEC 2017

Viral kinetics analysis & virological characterization of treatment failures in a real-world cohort with chronic HCV treated with SOF & an NS5A inhibitor (DCV or LDV)
S. Fourati1,2 | J. Guedj3,4 | S. Chevaliez1,2 | T. H. T. Nguyen3 | F. Roudot-Thoraval5 | I. Ruiz2,6 | A. Soulier1,2 | G. Scoazec6 | A. Varaut6 | L. Poiteau1,2 | M. Francois6 | A. Mallat6 | C. H ezode6 | J.-M. Pawlotsky1,2

Full Text

Summary Background: The combination of sofosbuvir (SOF) plus an NS5A inhibitor for 12 weeks is highly efficacious in patients with chronic hepatitis C. As the costs of generic production of sofosbuvir and NS5A inhibitor are rapidly decreasing, the combination of these DAAs will be the standard treatment in most low- to middle income countries in the future.

Aim: To identify key predictors of response that can be used to tailor treatment decisions.

Methods: A cohort of 216 consecutive patients infected with HCV genotype 1 (1a: n = 57; 1b: n = 77), 2 (n = 4), 3 (n = 33) or 4 (n = 44) were treated with sofosbuvir (SOF) + daclatasvir (n = 176) or SOF + ledipasvir (n = 40) for 12 weeks. The viral kinetics was analysed using the biphasic model and the cure boundary was used to predict time to clear HCV. Results: The overall SVR rate was high (94.4%; n = 204), regardless of the time to viral suppression or low-level viraemia at the end of treatment. The model-based predicted HCV RNA levels at the end of treatment could not differentiate patients who did from those who did not achieve SVR. The presence of NS5A resistance associated substitutions [position 28 (OR = 70.3, P<.001) and/or 31 (OR = 61.6, P = .002)] at baseline was predictive of virological failure in cirrhotic patients but was not associated with on-treatment viral kinetics.

Conclusion: This real-world study confirms the excellent results of clinical trials with therapies based on a combination of SOF plus an NS5A inhibitor. It suggests that a personalized approach including baseline NS5A inhibitor resistance testing may inform treatment decisions in cirrhotic patients.

Full-text article shared by @HenryEChang via Twitter

Friday, December 29, 2017

Efficacy and safety of Harvoni in Japanese patients aged 75 years or over with hepatitis C genotype 1

World J Hepatol. Dec 28, 2017; 9(36): 1340-1345
Published online Dec 28, 2017. doi: 10.4254/wjh.v9.i36.1340
Retrospective Cohort Study

Efficacy and safety of sofosbuvir and ledipasvir in Japanese patients aged 75 years or over with hepatitis C genotype 1
Yoshinori Ozono, Kenji Nagata, Satoru Hasuike, Hisayoshi Iwakiri, Kenichi Nakamura, Mai Tsuchimochi, Yuri Yamada, Yuka Takaishi, Mitsue Sueta, Tadashi Miike, Yoshihiro Tahara, Shojiro Yamamoto, Kotaro Shide, Tomonori Hidaka, Yoko Kubuki, Kazunori Kusumoto, Toshimasa Ochiai, Junya Kato, Naoto Komada, Shuichi Hirono, Kazuo Kuroki, Masafumi Shigehira, Kazuya Shimoda

To evaluate the efficacy and safety of a regimen containing sofosbuvir (SOF) and ledipasvir (LDV) in Japanese patients aged ≥ 75 years with hepatitis C genotype 1.

This multicenter, retrospective study consisted of 246 Japanese patients with HCV genotype 1 at nine centers in Miyazaki prefecture in Japan. Demographic, clinical, virological, and adverse effects (AE)-related data obtained during and after SOF/LDV therapy were collected from medical records. These patients were divided into two groups, younger (aged < 75 years) and elderly (aged ≥ 75 years). Virological data and AEs were analyzed by age group.

The sustained virological response (SVR) rates at 12 wk after treatment were 99.2%, 99.4%, and 98.7% in the overall population and in patients aged < 75 and ≥ 75 years, respectively. Common AEs during therapy were headache, pruritus, constipation, and insomnia. These occurred in fewer than 10% of patients, and their incidence was not significantly different between the younger and elderly groups. Two patients discontinued treatment, one due to a skin eruption and the other due to cerebral bleeding.

Compared with younger patients, elderly patients had a similar virological response and tolerance to SOF/LDV therapy.

Core tip: Most Japanese patients with hepatitis C are elderly, and those aged ≥ 75 years account for more than 50%. However there are few reports regarding sofosbuvir (SOF) and ledipasvir (LDV) therapy in patients aged ≥ 75 years in the real-world. The present study demonstrated that patients aged ≥ 75 years had a similar virological response and tolerance to SOF/LDV therapy compared with patients aged < 75 years in the real-world cohorts. Therefore, SOF/LDV therapy might be effective and safe in elderly patients.

Case Report: Severe Steroid-responsive Skin Disorders Related to Harvon for HCV.

Intern Med. 2017 Dec 27. doi: 10.2169/internalmedicine.9744-17. [Epub ahead of print]

Severe Steroid-responsive Skin Disorders Related to Ledipasvir and Sofosbuvir for HCV.
Tadokoro T1, Morishita A1, Fujita K1, Oura K1, Sakamoto T1, Nomura T1, Tani J1, Yoneyama H1, Masaki T

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Combination therapy with ledipasvir and sofosbuvir (LDV/SOF), direct-acting antiviral agents, is highly effective against hepatitis C virus genotype 1 infection. Although LDV/SOF is safer than conventional treatment, reports have indicated that LDV/SOF was discontinued in certain cases due to severe skin disorders. A 68-year-old woman presented with a rash after starting LDV/SOF treatment. We interrupted LDV/SOF and began the oral administration of prednisolone (PSL). After the rash improved, we re-started LDV/SOF with PSL. After treatment, the rash clearly improved; we checked for a sustained virologic response 12 weeks after treatment. Steroids may therefore be an effective treatment option for controlling the side effects of LDV/SOF.

Case reports; drug eruption; hepatitis C; ledipasvir and sofosbuvir; steroid
PMID: 29279506 DOI: 10.2169/internalmedicine.9744-17 

Friday, December 15, 2017

8-week Harvoni cost-effective alternative to 12-week regimen

December 14, 2017
An 8-week course of Harvoni for hepatitis C virus infection in both black and nonblack patients was a cost-effective alternative to a 12-week course, according to researchers.

Shorter course therapy may be a viable option under a constrained budget and can benefit patients who are treatment-naive and noncirrhotic, they wrote in Open Forum Infectious Diseases.
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SVR after HCV treatment improves liver stiffness in progressive fibrosis
December 14, 2017
Sustained virologic response after direct-acting antiviral treatment for hepatitis C significantly improved liver stiffness from baseline to end of treatment, and…
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Friday, October 27, 2017

Safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in hepatitis C virus/human immunodeficiency virus co-infected patients

World J Hepatol. Oct 28, 2017; 9(30): 1190-1196
Published online Oct 28, 2017. doi: 10.4254/wjh.v9.i30.1190

Safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in hepatitis C virus/human immunodeficiency virus co-infected patients
Xiaoping He, Lynne Hopkins, George Everett, Willie M Carter, Cynthia SchroppDyce, Khalid Abusaada, Vincent Hsu

Core tip: This is a retrospective study to evaluate the safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in patients with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) co-infection in an urban HIV clinic. It demonstrated the high rates of SVR12 of ledipasvir/sofosbuvir on HCV eradication in patients co-infected with HCV and HIV, regardless of HCV baseline levels, HCV treatment history or cirrhosis condition. The oral combination of ledipasvir/sofosbuvir represents a safe and well tolerated HCV treatment option that does not require modification for many of the common HIV antiretroviral therapy (ART). Occasional HIV virologic rebound occurred but later resolved without the need to change ART.


To evaluate the safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in patients with hepatitis C virus (HCV)/human immunodeficiency virus (HIV) co-infection in an urban HIV clinic.

A retrospective cohort study of 40 subjects co-infected with HIV-1 and HCV treated with the fixed-dose combination of ledipasvir and sofosbuvir for 12 wk from 2014 to 2016. All patients included were receiving antiretroviral therapy (ART) with HIV RNA values of 100 copies/mL or fewer regardless of baseline HCV RNA level. The primary end point was a sustained virologic response of HCV at 12 wk (SVR12) after the end of therapy.

Of the 40 patients enrolled, 55% were black, 22.5% had been previously treated for HCV, and 25% had cirrhosis. The patients were on a wide range of ART. Overall, 39 patients (97.5%) had a SVR 12 after the end of therapy, including rates of 97.1% in patients with HCV genotype 1a and 100% in those with HCV genotype 1b. One patient with HCV genotype 3a was included and achieved SVR12. Rates of SVR12 were similar regardless of previous treatment or the presence of compensated cirrhosis. Only 1 patient experienced relapse at week 12 following treatment and deep sequencing didn’t reveal any resistance associated mutation in the NS5A or NS5B region. Interestingly, 7 (17.5%) patients who were adherent to ART experienced HIV viral breakthrough which resolved after continuing the same ART regimen. Two (5%) patients experienced HIV-1 virologic rebound due to noncompliance with HIV therapy, which resolved after resuming the same ART regimen. No severe adverse events were observed and no patient discontinued treatment because of adverse events. The most common adverse events included headache (12.5%), fatigue (10%), and diarrhea (2.5%).

This retrospective study demonstrated the high rates of SVR12 of ledipasvir/sofosbuvir on HCV eradication in patients co-infected with HCV and HIV, regardless of HCV baseline levels, HCV treatment history or cirrhosis condition. The oral combination of ledipasvir/sofosbuvir represents a safe and well tolerated HCV treatment option that does not require modification for many of the common HIV ART. Occasional HIV virologic rebound occurred but later resolved without the need to change ART.

Wednesday, October 11, 2017

Hepatitis C Treatment With Direct-Acting Antivirals Confers Survival Benefit

In Case You Missed It

Today over at Infectious Disease Advisor, media coverage on the study; Effect of Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir and Ledipasvir/Sofosbuvir Regimens on Survival Compared With Untreated Hepatitis C Virus–Infected Persons: Results From ERCHIVES, is highlighted, the full-text article shared by @HenryEChang via Twitter, can be reviewed here.

Hepatitis C Treatment With Direct-Acting Antivirals Confers Survival Benefit
October 11, 2017
Among patients with hepatitis C, direct-acting antiviral regimens paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) and ledipasvir/sofosbuvir (LDV/SOF) were shown to be associated with a significant improvement in survival, according to the results of a study published in Clinical Infectious Diseases ...

Full-Text Article

Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir and Ledipasvir/Sofosbuvir Regimens on Survival Compared With Untreated Hepatitis C Virus–Infected Persons: Results From ERCHIVES

Tuesday, September 19, 2017

Blog Updates on Hepatitis - Inactivated Zoster Vaccine, Harvoni Cures Hep C patient & Opioids

Thanks for stopping by, here's your blog updates from around the web.

Harvoni Cures Hep C patient Brenda in Clinical Trial part 1
September 19, 2017
This week on Life Beyond Hep C we’re hearing Hep C patient Brenda’s courageous Hep C treatment fight and experience.
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All Swiss hepatitis C sufferers can access costly drugs like Harvoni
All patients suffering from hepatitis C can be treated with the drugs Harvoni and Epclusa from next month, after the Federal Office of Public Health lifted ...

Opioid overdoses shorten US life expectancy by 2½ months
Opioid drugs -- including both legally prescribed painkillers such as oxycodone and hydrocodone, as well as illegal drugs such as heroin or illicit fentanyl -- are not only killing Americans, they are shortening their overall life spans. Opioids take about 2½ months off our lives, according to a new analysis published in the medical journal JAMA.

States expand investigation of opioid makers, distributors
Geoff Mulvihill, Associated Press - Houston Chronicle
Attorneys general from most states are broadening their investigation into the opioid industry as a nationwide overdose crisis continues to claim thousands of lives. They announced Tuesday that they had served subpoenas requesting information from five companies that make powerful prescription painkillers and demanded information from three distributors. Forty-one attorneys general are involved in various parts of the civil investigation.
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Addiction clinics need physician education, lifted restrictions to treat HCV
HCV Next - HEALIO - Meeting News
Opioid agonist therapy clinics represent an important conduit for people who inject drugs to receive information, screening and treatment for hepatitis C. Within these clinics, however, physicians and addiction specialists self-reported low competence regarding current HCV treatments. Additionally, policies that restrict treatment for current and recent drug users present an ongoing barrier.
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My 2 cents: College friend doing good work
Tom Blackwell - National Post 
Faced with a widow's legal challenge, Ontario will transplant livers into almost 100 alcoholic-liver-disease patients, as evidence suggests they do as well as others.

What parents should know about tattoos
Posted September 19, 2017,
Claire McCarthy, MD, Faculty Editor, Harvard Health Publications
These days, tattoos are increasingly common. According to a 2015 Harris poll, three in 10 American adults have a tattoo — up from two in 10 in 2012. They are particularly popular in young people; among Millennials, nearly half have a tattoo. To help parents make this tough decision, the American Academy of Pediatrics (AAP) released a clinical report entitled “Adolescent and Young Adult Tattooing, Piercing, and Scarification.” Here are some highlights — and some points parents and teens really need to talk about.
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Fighting Hepatitis in Cambodia: Beginnings and Endings
Theresa Chan - Theresa is an MSF doctor, currently working at a hepatitis C clinic in Cambodia.
Beginnings and endings have been leaking into my to-do list as well. Right now I’m working on writing the MSF guidelines for treating hepatitis C, which will be the basis for the Cambodian national guidelines one day when our clinic is turned over to the Ministry of Health, so even as we are recovering from the busy beginning of this clinic, we are contemplating its end.
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Inactivated Zoster Vaccine Soon to Be Approved — Should Patients Wait for It?
Paul E. Sax, MD - Contributing Editor NEJM Journal Watch 
For the last year or so, conversations with patients about getting the zoster vaccine have gone something like this:
Patient: So should I get the shingles vaccine? I saw an ad for it on TV.
Me:  Well, yes … and no.
Patient (confused — he/she has never heard me say anything but an enthusiastic “Yes!” to vaccines):  What does that mean?
Me:  There’s a better shingles vaccine coming soon, likely within a year. So I’d wait.
Now it looks like that wait is almost over.
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Can Restricting Fructose Intake Reduce Fatty Liver Disease in Children?
Kristine Novak - Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology.
Reducing dietary fructose for as little as 9 days decreases liver fat, visceral fat, and de novo lipogenesis and increases insulin sensitivity, secretion, and clearance in children with obesity and metabolic syndrome, researchers report in the September issue of Gastroenterology. These findings support efforts to reduce sugar consumption.
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Only One-Quarter of Hepatitis C Patients Got Treatment Before Widespread DAA Use
SEPTEMBER 19, 2017
Gail Connor Roche - MD Magazine
Only one-quarter of patients worldwide with the chronic hepatitis C virus (HCV) received antiviral treatment before the widespread use of direct-acting antiviral (DAA) drugs, a review that considered almost 500,000 people has found.
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Adolescents With HCV Achieve 98% Cure Rate in Direct-Acting Antiviral Study
Gail Connor Roche - MD Magazine
Adolescents treated for hepatitis C achieved a 98% cure rate with a direct-acting antiviral drug (DAA) therapy, a study has found.
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HCV Drug Resistance: Infrequent, and Frequently Overcome
Kenneth Bender - MD Magazine
Hepatitis C virus (HCV) mutations that can resist drug treatment are infrequent, and are unlikely to withstand longer treatment durations or the addition of a synergistic drug, according to new analysis of resistance testing, treatment response and re-treatment interventions. Resistance testing does appear to Wyles and Luetkemeyer to be indicated, however, in patients with genotype 1a before treatment with elbasvir/grazoprevir (Zepatier, Merck), and should be considered prior to treatment with ledipasvir/sofosbuvir (Harvoni) for those with genotype 1a and cirrhosis or with prior NS5A treatment failure...
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Hepatitis A: frequently asked questions
Paul Sisson Contact Reporter The San Diego Union-Tribune
In an effort to combat a deadly hepatitis A outbreak, San Diego will begin washing streets in ...
Q: If I've had hepatitis B or hepatitis C am I immune to hepatitis A?
Continuer reading.....

Cannabis in Gastroenterology: Physicians Lack Answers as Patient Interest Peaks
Healio Gastroenterology, September 2017
Despite a lack of high quality evidence due to federal regulations on research, many state medical marijuana programs have designated GI conditions like severe nausea, inflammatory bowel disease (IBD) and hepatitis C as qualifying conditions, and studies show that many patients are self-medicating with marijuana. Experts agreed physicians should equip themselves to explain the known risks and benefits to inquiring patients, and understand the legal frameworks of their state medical marijuana programs.
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On Twitter
Tweeted By Don Crocock, Follow here--->  @dcrocock   
Rationale for cannabis-based interventions in the opioid overdose crisis
Harm Reduction Journal
The growing body of research supporting the medical use of cannabis as an adjunct or substitute for opioids creates an evidence-based rationale for governments, health care providers, and academic researchers to consider the implementation and assessment of cannabis-based interventions in the opioid crisis.
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