Saturday, November 7, 2015

Hepatitis C Still Focus of Liver Meeting - For the difficult-to-treat patients with genotype 3 and advanced fibrosis

Medscape Medical News > Conference News

Hepatitis C Still Focus of Liver Meeting
Laird Harrison
November 06, 2015

SAN FRANCISCO — The latest trials of combination hepatitis C drugs aimed at specific genotypes will get top billing at this year's Liver Meeting.

"We have seen phenomenal change in hepatitis C treatment over the last 2 years, and this has not slowed down one bit," said Gary Davis, MD, from MedLogician Consulting in Simpsonville, South Carolina, who is cochair of the American Association for the Study of Liver Diseases scientific program committee.

For the difficult-to-treat patients with genotype 3 and advanced fibrosis, a couple of the new drug combinations are providing "much improved" results, Dr Davis told Medscape Medical News.

Friday, November 6, 2015

The Medicines Patent Pool Expands Mandate to Hepatitis C and Tuberculosis Treatment

The Medicines Patent Pool Expands Mandate to Hepatitis C and Tuberculosis Treatment

MPP’s voluntary licensing work could benefit millions of patients in low- and middle-income countries

Geneva, 6 November 2015 – The Medicines Patent Pool (MPP), the world’s only voluntary licensing mechanism in public health, announced an expansion of its mandate today to hepatitis C and tuberculosis medicines. The UNITAID Executive Board, meeting November 4-5 in Geneva, approved the MPP’s proposals to improve access to both life-saving direct acting antivirals (DAAs) to treat hepatitis C and new and re-purposed medicines for tuberculosis. UNITAID created the MPP in 2010 to provide better health options for people living with HIV. To date, MPP has signed agreements for twelve antiretrovirals (ARVs) for countries home to 87-93% of people living with HIV in the developing world.

“I greatly welcome the broadening of the Medicines Patent Pool’s mandate to encompass hepatitis C and tuberculosis, giving MPP a vital opportunity to help secure lower prices for medicines to fight these two lethal diseases,” said Philippe Douste-Blazy, Chair of the Executive Board at UNITAID.

“The MPP is a cornerstone of UNITAID’s efforts to transform the HIV medicines market and rapidly scale up HIV treatment in low- and middle-income countries,” said Lelio Marmora, UNITAID’s Executive Director. “The MPP now joins us in helping to meet international targets to make curative hepatitis C and TB medicines accessible to those who need them.”

The World Health Organization estimates that hepatitis C (HCV) affects between 130 and 150 million people worldwide. The vast majority lives in low- and middle-income countries. New direct acting antivirals that are effective across all major HCV strains could cure millions. Building on its HIV model, the MPP will seek to license for generic manufacture new and pipeline hepatitis C medicines that can eliminate the virus in a short course of oral therapy.

“The recent approval of new treatments with greater efficacy and low side effects represents an incredible opportunity to move closer to eradication, but only if these drugs are affordable and accessible,” said Raquel Peck, CEO for the World Hepatitis Alliance, an umbrella organisation representing 400 million patients. “We have urged for the Medicines Patent Pool’s participation in the HCV response and are thrilled with the UNITAID board decision.”

Tuberculosis is the leading cause of death for people living with HIV and killed 1.5 million people globally in 2014 alone. TB treatment has become more complex, particularly with the emergence of multidrug-resistant (MDR) strains of Mycobacterium tuberculosis. The MPP will work to ensure access to new treatments for multi-resistant and drug-susceptible TB.

“The TB Alliance welcomes the MPP’s entry into the TB field,” said Mel Spigelman, President & CEO of the Global Alliance for TB Drug Development, the world’s leading product development partnership (PDP) for the development of TB medicines. “We are looking forward to working with the MPP on a range of projects, from access-oriented licensing for new drugs and regimens, to the development of appropriate formulations for children.”

“We thank UNITAID for its confidence in the MPP,” said Greg Perry, MPP’s Executive Director. “MPP believes that its unique approach to negotiating licences for HIV is working and we look forward to applying our model to tackling access and innovation challenges in HCV and TB.”

New numbers released today confirm that the MPP has saved the international community $119.6 million from the procurement of low-cost HIV medicines, and its generic partners have distributed 7.26 million patient-years of treatments. The organisation is working on more than 50 development projects to bring MPP-licensed HIV antiretrovirals to market. These antiretrovirals include new promising treatments as well as WHO-recommended HIV medicines for first and second-line treatment for adults and children of all age groups.

About the Medicines Patent Pool (MPP)

The Medicines Patent Pool is a United Nations-backed organisation offering a public-health driven business model that aims to lower the prices of HIV medicines and facilitate the development of better-adapted HIV treatment, such as simplified “fixed-dose combinations” (FDCs) and special formulations for children, through voluntary licensing and patent pooling. Founded and fully funded by UNITAID, the MPP works with a range of stakeholders — communities of people living with HIV, civil society, governments, industry and international organisations. To date, the MPP has signed agreements for twelve antiretrovirals with six patent holders and is working with 14 manufacturers on more than 50 projects to develop HIV-licensed medicines.


Thursday, November 5, 2015

FDA Approves Gilead's Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

U.S. Food and Drug Administration Approves Gilead's Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Date(s): 5-Nov-2015 12:48 PM

For a complete listing of our news releases, please click here

- Gilead's First TAF-based Regimen Demonstrates High Efficacy with Improved Renal and Bone Parameters Compared to TDF-based Regimens -

FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 5, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive FDA approval.

Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA levels less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya. No dosage adjustment of Genvoya is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.

Genvoya has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B. Further important safety information, adverse drug reactions and drug interactions are listed below.

Photos and multimedia gallery available at

TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's Viread® (tenofovir disoproxil fumarate, TDF), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a lower dose and there is 91 percent less tenofovir in the bloodstream.

"As the HIV patient population ages there is an increased risk for development of age- and treatment-related comorbidities, including low bone mineral density and renal impairment. This is due to the combination of HIV infection, antiretroviral treatments and the natural aging process," said David Wohl, MD, Associate Professor of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill and lead author of the Genvoya efficacy analysis. "Given its demonstrated efficacy and safety profile, Genvoya represents an important new treatment option for a range of patients who are either new to therapy or who choose to switch treatments."

Genvoya was studied in a Phase 3 HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients. The approval is supported by 48-week data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients in which the regimen met its primary objective of non-inferiority compared to Stribild®(elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF). In the combined analysis of the studies, 92.4 percent of Genvoya patients and 90.4 percent of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at Week 48. Tests of certain renal and bone laboratory parameters also favored Genvoya over Stribild.

Additionally, the approval is supported by a Phase 3 study (Study 109) evaluating Genvoya among virologically suppressed patients who switched from TDF-based regimens. The study enrolled 1,436 subjects and 1,196 had reached the 48-week time point at the time of filing. Among those patients, Genvoya was found to be statistically non-inferior to the TDF-based regimens based on the percentages of patients with HIV-1 RNA levels less than 50 copies/mL at Week 48. Patients receiving Genvoya also demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with the TDF-based regimens. Finally, data from Phase 3 studies evaluating Genvoya among adolescents and patients with mild-to-moderate renal impairment supported the approval.

"While exceptional progress has been made in the field of HIV, there is still a need for new treatment options that may help improve the health of people as they grow older with the disease," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "For more than 25 years, Gilead has been committed to changing the trajectory of HIV management and we are now pleased to introduce Genvoya, the first in a portfolio of TAF-based products that have the potential to advance the long-term treatment of HIV."

Two other TAF-based regimens are currently under evaluation by the FDA. The first is an investigational, fixed-dose combination of emtricitabine 200 mg and tenofovir alafenamide 25 or 10 mg (F/TAF) for use in combination with other antiretroviral agents. The second is an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF). Emtricitabine and tenofovir alafenamide are from Gilead and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

F/TAF and R/F/TAF are investigational products and have not been determined to be safe or efficacious.

Genvoya does not cure HIV infection or AIDS.

Patient Assistance Programs

Gilead's U.S. Advancing Access® program provides assistance to patients in the United States who are uninsured, underinsured or who need financial assistance to pay for their medications, including Genvoya.

The program offers support services for patients and providers, including:
Access to counselors who can help patients and their providers with insurance-related needs, including identifying coverage options.
The Advancing Access Copay Coupon Program, which provides co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.
The Advancing Access Patient Assistance Program and Truvada Medication Assistance Program, which will provide Gilead medications at no charge for eligible patients with no other insurance options.

Additionally, Gilead is working closely with the ADAP Crisis Task Force, as the company has done for each of its other HIV medications, to provide discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure access to Genvoya for patients who receive medications through these programs.

Information about how to apply for any of these forms of assistance can be found at or by calling 1-800-226-2056 between 9:00 a.m. and 8:00 p.m. (Eastern).

Important U.S. Safety Information for Genvoya

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs in combination with other antiretrovirals.
Genvoya is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Genvoya have not been established in patients coinfected with HIV-1 and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate, and may occur with Genvoya. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Genvoya. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Coadministration: Do not use with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Do not use with drugs that strongly induce CYP3A as this may lead to loss of efficacy and possible resistance to Genvoya. Do not use with alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, or St. John's wort.

Warnings and precautions
Other antiretroviral products: Do not coadminister with other antiretroviral products, including products containing any of the same active components, tenofovir disoproxil fumarate, lamivudine, ritonavir, or adefovir dipivoxil.
Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Genvoya therapy and monitor for adverse reactions.
Fat redistribution or accumulation have been observed in patients receiving antiretroviral therapy.
Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of Genvoya, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate Genvoya in patients with CrCl <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Genvoya in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.

Renal monitoring: In all patients, monitor estimated creatinine clearance (CrCl), urine glucose, and urine protein prior to initiating and during therapy. In patients with chronic kidney disease, additionally monitor serum phosphorus. If serum creatinine increases >0.4 mg/dL from baseline, closely monitor for renal safety.
Bone mineral density (BMD) and mineralization: Decreases in BMD have been reported with the use of tenofovir prodrugs. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss. Mineralization defects, including osteomalacia associated with PRT, have been reported with the use of TDF-containing products.

Adverse reactions
Common adverse reactions (incidence =5%; all grades) in clinical studies were nausea (10%), diarrhea (7%), headache (6%), and fatigue (5%).

Drug interactions
Prescribing information: Consult the full prescribing information for Genvoya for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
Metabolism: Genvoya can increase the concentration of drugs metabolized by CYP3A, CYP2D6, P-gp, BCRP, OATP1B1 or OATP1B3. Drugs that inhibit CYP3A, P-gp, or BCRP can increase the concentrations of components of Genvoya. Drugs that induce CYP3A or P-gp can decrease the concentrations of components of Genvoya.
Drugs affecting renal function: Coadministration of Genvoya with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir and the risk of adverse reactions.

Dosage and administration
Dosage: Patients 12 years and older (=35 kg): 1 tablet taken orally once daily with food.
Renal impairment: Not recommended in patients with CrCl <30 mL/min.
Hepatic impairment: Not recommended in patients with severe hepatic impairment.
Testing prior to initiation: Test patients for HBV infection.

Pregnancy and breastfeeding
Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.
Breastfeeding: Emtricitabine has been detected in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed.

About Gilead

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. Gilead has operations in more than 30 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, including the risk that physicians may not see the benefits of prescribing Genvoya. In addition, marketing authorizations for F/TAF and R/F/TAF may not be approved by the FDA or other regulatory authorities, and any marketing approvals, if granted, may have significant limitations on their use. 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 September 30, 2015, 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.

U.S. Full Prescribing Information, including BOXED WARNING, for Genvoya is available at

U.S. Full Prescribing Information, including BOXED WARNING, for Stribild, Truvada and Viread are available at

Genvoya, Stribild, Truvada and Viread are registered trademarks of Gilead Sciences, Inc., or its related companies.

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

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Gilead's Sovaldi Tied to Slow Heartbeat in Hepatitis C Patients

Gilead's Sovaldi Tied to Slow Heartbeat in Hepatitis C Patients

Gilead Sciences Inc.’s blockbuster hepatitis C medicine Sovaldi may trigger an abnormally slow heartbeat and put patients at risk of passing out, according to French doctors who said treatments containing the drug should be used with caution.

The report, in a letter to the New England Journal of Medicine, detailed episodes of a slowing heart rate that developed within the first 10 days of Sovaldi therapy in three of 415 patients treated in 2014 at the Hopital Cochin’s hepatology and cardiology group in Paris. All three received pacemakers within a week to ensure their hearts maintained a healthy rhythm.

The report of potential heart toxicity with Sovaldi comes less than a month after AbbVie Inc.’s rival medicine Viekira Pak was tied to the deaths of seven patients from liver failure, prompting U.S. regulators to restrict use of the drug in select patients and urge closer supervision for others. The French doctors said patients getting Sovaldi, known chemically as sofosbuvir, or other treatments that contain the medicine may benefit from heart monitoring when the drugs are first given.

Monday, November 2, 2015

O'Neill Institute launches Hepatitis Policy Project-Focus on issues/barriers of access to treatments for hepatitis C

O'Neill Institute launches Hepatitis Policy Project


WASHINGTON (Oct. 29, 2015) -- The O'Neill Institute for National and Global Health Law, a part of the Georgetown Law, announces the launch of the Hepatitis Policy Project (HPP) to focus on issues and barriers of access to effective treatments for hepatitis C. The HPP is led by health policy expert Jeffrey S. Crowley, an O'Neill Institute Distinguished Scholar.

According to the U.S. Centers for Disease Control and Prevention, hepatitis C-related deaths are on the rise as are rates of liver disease and liver cancer, which are often caused by hepatitis C.

The agency also says the vast majority of adults infected with hepatitis C are baby boomers (those born between 1945 and 1965) and most don't know they have it. Many were infected in the 1970s and 1980s when rates of the disease were highest.

"It's critical that people with hepatitis C have access to effective treatments to prevent its progression for two key reasons," explains Crowley. "The CDC says the longer infected people live with hepatitis C, the more likely they are to get sick. And, if we experience widespread onset of liver disease and liver cancer, we'd see a tremendous strain on the health care system's ability to treat these diseases in addition to an inability to fulfill the demand for organs that inevitably would be needed for transplantation."

Gilead Sciences Inc. provided a grant to support the establishment of the HPP and the addition of Sonia L. Canzater, J.D., M.P.H., a new O'Neill Institute Associate. She joined the HPP in October after completing an internship at the U.S. Department of Health and Human Services. Canzater will be a key contributor to the HPP's mission to support hepatitis C consumer education and advocacy organizations by providing legal and policy research on key issues.

"Sonia's diversity of experience working in public health, and her legal training gives her the technical skills to help us establish our Hepatitis Policy Project and conduct important policy research that will expand access to hepatitis treatment and services that carry the promise of dramatically reducing the scope of the hepatitis C epidemic in the United States," Crowley says. "I look forward to her critical leadership on these important issues."


Crowley also serves as program director for the National HIV/AIDS Initiative at the O'Neill Institute.

The O'Neill Institute for National and Global Health Law at Georgetown University is the premier center for health law, scholarship, and policy. Its mission is to contribute to a more powerful and deeper understanding of the multiple ways in which law can be used to improve the public's health, using objective evidence as a measure. The O'Neill Institute seeks to advance scholarship, science, research, and teaching that will encourage key decision-makers in the public, private, and civil society to employ the law as a positive tool for enabling more people in the United States and throughout the world to lead healthier lives.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Find Way to Focus on Dietary Supplement Safety, Experts Say

Find Way to Focus on Dietary Supplement Safety, Experts Say
--Pre-market registration, clearer disclaimers, better standards for identifying substances are good first steps to a safer market for supplements

Newswise — A former principal deputy commissioner of the U.S. Food and Drug Administration is proposing a solution to the current gridlock over the regulation of dietary supplements: Focus less on whether these vitamins, minerals and herbal extracts actually do what they claim and instead take important steps to improve their safety.

Joshua M. Sharfstein, MD, associate dean for public health practice and training at the Johns Hopkins Bloomberg School of Public Health, and Akshay Kapoor, MSPH, a recent graduate of the school, argue that the market for dietary supplements is riddled with unsafe products that may be spiked with pharmaceuticals, poorly manufactured or absent the stated ingredients.

Yet despite hundreds of recalls and outbreaks associated with death and disability, federal law on supplements has not shifted to strengthen oversight and protect the integrity of the market. What’s keeping progress from being made, Sharfstein and Kapoor say, is an ongoing dispute over whether the products work. Manufacturers and many consumers think they do. Many public health officials and doctors think they don’t. Calling a truce on these questions of efficacy, Sharfstein and Kapoor argue, can bring people together to improve safety.

Their paper appears Nov. 2 in the journal Drug Testing and Analysis.

“The key equation in drug regulation is benefit versus risk. That is, do the potential benefits from using the drug outweigh the potential risks?” Sharfstein says. “This framework, however, has led to gridlock for dietary supplements. An alternative framework is access with safety. That is, can we find a way ensure that dietary supplements are safe for consumers to take?”

Surveys have shown that Americans want assurance that their supplements will be safe, but they want to make their own decisions about whether they are effective.
Sharfstein says that many manufacturers would likely support stronger safety controls if they were not tied with greater scrutiny of claims about the products. These perspectives open a door to compromise that advances safety and protects public health, Sharfstein and Kapoor say.

A recent study in the New England Journal of Medicine estimated 23,000 emergency department visits in the United States every year can be attributed to adverse events related to dietary supplements. Roughly 100 million Americans purchase supplements each year, including calcium for osteoporosis and multivitamins for general health as well as supplements for sexual dysfunction, joint health and weight loss. U.S. sales of dietary supplements reached an estimated $36.7 billion last year, according to the National Institutes of Health.

Federal law allows manufacturers to make many types of claims, though they are not permitted to make claims about treating or preventing specific diseases such as diabetes, cancer or heart disease. The FDA’s authority over dietary supplements is limited by federal law and has left the agency unable to protect consumers effectively, Sharfstein says.

The FDA also has limited capabilities when it comes to overseeing manufacturing standards for supplements. There are by most estimates at least 15,000 domestic and international manufacturers of supplements sold in the United States, with most of the raw materials originating overseas. Across all of these manufacturers, FDA conducts just 400 inspections of their facilities a year, the researchers say. The agency finds significant deficiencies in about two-thirds of all the inspections it conducts, with most facilities cited for multiple, serious violations.

Hundreds of times a year, FDA recalls dietary supplements that contain pharmaceuticals. Examples include tainted sexual enhancement products that contained prescription erectile dysfunction drugs sildenafil (Viagra) and tadalafil (Cialis); weight-loss products containing banned pharmaceuticals; and sports supplements that contain antihistamines and anabolic steroids. However, research has shown that recalled supplements are still available for sale and that efforts by FDA to keep tainted products from reaching the market in the first place have not been successful.

Sharfstein and Kapoor say progress on safety can proceed in three phases. The first would be a requirement for manufacturers to register each dietary supplement product with the FDA and greater authority for the FDA to require more detailed disclaimers on products so the public better understands the nature of the agency’s oversight. Requiring registration of supplements would give the FDA the opportunity to deny manufacturers that have poor track records the ability to sell new supplements.

A second phase would have the FDA establish standard manufacturing procedures accompanied by a standard laboratory technique to characterize each product sold, making manipulation and adulteration of products more difficult.

The third phase would give the FDA enhanced authority to strengthen surveillance of potential adverse effects with the authority to suspend sales during an agency review when there is sufficient concern and to remove ingredients that pose a significant risk. Such a standard would be far more effective than the current approach, which sets an unreasonably high standard for action, Sharfstein says.

“Stories in the media about bad outcomes associated with some supplements are gaining traction and the behavior of some manufacturers could tarnish the image and reputation of the entire industry,” Sharfstein says. “It’s time we actually made progress and we’re going to have to find a path to do it. We need to think about safety first.”

“Breaking the Gridlock: Regulation of Dietary Supplements in the United States” was written by Akshay Kapoor and Joshua M. Sharfstein.

Innovative Calculator Tool Giving Insight into the Costs of Hepatitis C beyond Anti-Virals

Primrose Healthcare Provides an Innovative Calculator Tool, Giving Insight into the Costs of Hepatitis C beyond Anti-Virals

PHOENIX--(BUSINESS WIRE)-- Primrose Healthcare has just launched an innovative calculator tool to help health insurers and other payers uncover and better understand the total costs associated with the hepatitis C virus (HCV) within their populations. The calculator references the data and analysis from the Milliman, Inc. study, “The burden of hepatitis C virus disease in commercial and managed Medicaid populations,” and other user-input assumptions to estimate costs for a payer’s specific population.

While many payers may concentrate on managing anti-viral medication treatment costs, they may not closely focus on the underlying medical cost drivers within the population. The calculator analysis provides payers with a complete picture of typical non-antiviral treatment costs, including prevalence and key cost drivers such as stage of liver disease (i.e. chronic HCV, cirrhosis, etc.), other non-antiviral medication treatment costs and medical costs.

“Calculator analyses run to date clearly show that new medication treatments are not the only reason for high costs among the HCV populations,” said Henri Cournand, CEO of Primrose Healthcare. “Payers focused on medication costs alone are missing out on a valuable opportunity to improve health and reduce per-member-per-month costs related to managing these patients. This really comes to light when you consider that the average annual incremental non-antiviral drug medical costs for an individual with HCV are $21,888—four times higher than those without HCV.”

These costs are driven by the HCV population’s unique characteristics as outlined in the Milliman study. Patients within a commercial population with HCV have:
3-4 times more emergency room (ER) visits
3-4 times greater rates of mental health disorder
5-6 times greater inpatient admission rates
9-10 times greater rate of alcohol dependence and/or alcoholic liver disease
20 times higher rates of drug dependence/abuse

Additionally, the calculator also estimates the “future” costs associated with HCV and liver care. Thanks to advancements in anti-viral medications, many individuals are cured of the virus. However, many of those same patients will suffer from liver damage and require care long after their cure. The calculator breaks down the associated costs based on the disease progression to give payers a clearer picture of their overall healthcare expenses.

Ultimately, the calculator tool—an industry first— is designed to help payers evaluate their existing hepatitis C management program and make decisions to modify or enhance it. To that end, the calculator can model payer-specific results, which can be used to inform their approach to managing individuals with hepatitis C and the associated costs.

According to Cournand, “Payers must develop a consistent approach for HCV patients that should include not just anti-viral medications but also intensive outreach to address comorbidities, poor treatment adherence, behavioral health issues and substance abuse.”

To request a calculator analysis for your population, please contact Karlynn Billings or Richard Diefenderfer at Finally, to view the Milliman study referenced above, please visit the Primrose Healthcare website at

Sunday, November 1, 2015

Medicaid officials want to expand access to pricey hepatitis C drug

Medicaid officials want to expand access to pricey hepatitis C drug

Staff writer

Health care officials in Washington state thought thousands of Medicaid patients would line up to receive a breakthrough hepatitis C treatment that went on the market late last year.

Yet by June, the state had treated only a third as many hepatitis C patients as it had planned for — about 1,200 people.

Now, the state’s Medicaid authority wants to use the $44 million it didn’t spend over the past year to start covering the drug for a wider range of patients, instead of just the sickest ones.

State officials estimate about 75,000 to 100,000 people in Washington have hepatitis C, a blood-borne virus that can cause liver failure or liver cancer if left untreated. Nationwide, many people living with the disease are low-income patients who are eligible for Medicaid, officials said.

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