A Tale of Two New Hepatitis C Drugs

A Tale of Two New Hepatitis C Drugs

Despite discount, Merck's just approved Zepatier unlikely to win share with most US payers, except in Medicaid, according to RxScorecard™. New combo from Gilead could ensure company's dominant position among US payers.

WESTPORT, Conn., March 10, 2016 /PRNewswire/ -- It can take more than a big discount to get payers to buy into a new drug. 

Although Merck is launching its new hepatitis C virus (HCV) medicine, Zepatier, at an approximate 30% discount to the "list" price of the overwhelming market leader, Gilead's Harvoni, RxScorecard™ analysis shows that it is unlikely to make significant headway in most commercial and Medicare plans.

Meanwhile, RxScorecard™ shows that Gilead's sofosbuvir/velpatasvir (SOF/VEL) combination, likely to be approved this summer, could be a big winner, obsoleting Gilead's own Harvoni, as Harvoni sidelined Gilead's first entry, Sovaldi. But SOF/VEL will succeed only if it matches the discounting Gilead is providing with Harvoni.

Real Endpoints LLC (RE) came to these conclusions based on its proprietary tool RxScorecard™, which assesses the relative value of marketed and pipeline drugs from a payer's point of view.  RE defines value as a full assessment of a drug's efficacy, safety, convenience, adherence and economic attributes in comparison to other therapies in the indication. 

The HCV market has been enormously attractive to drug companies. According to Informa's Biomedtracker, more than 40 HCV therapies are in various stages of development, targeting a market which has grown from about $1 billion in 2013 to what will likely be $11 billion by the end of 2016.

Not too long ago, many of these competitors could have hoped to gain market share by convincing physicians of the differential value of their efficacy, safety or convenience. But in a world in which prescribing options are increasingly controlled by industrial purchasers such as insurers and pharmacy benefit managers, choices are made based on a broader combination of factors, including economics. 

Reflecting this broader analysis, RxScorecard™ shows that Zepatier has similar overall value to Harvoni in the largest subpopulation of US patients infected with HCV (previously untreated genotype 1 patients).  The problem is that Zepatier demonstrates little-to-no value in smaller subpopulations which contain a high percentage of patients likely to be diagnosed and treated, such as those with moderate-to-severe cirrhosis. 

The economic problem for payers: if they use the cheaper Zepatier in the "larger" populations, they will still have to use Harvoni for the "smaller" populations – but will forfeit the rebates Gilead provides customers who use Harvoni exclusively. 

These rebates have become a fierce battleground between pharma companies. Gilead's are known to be as high as 45% of the "list" price, reducing the effective net price from between $82,000-$94,500 to $45,000-$55,000 (Zepatier's "list" price is $54,600). The aggregate value of Gilead's rebates to payers is several billion dollars a year, an enormous competitive barrier for new entrants like Merck. By forfeiting those rebates even for the smaller patient populations in favor of Zepatier, plans could see their net HCV drug costs rise unless Merck were to dramatically increase its discount on Zepatier, probably to below $30,000.  Without these additional discounts, Zepatier use will largely be limited to specific payer segments which by law get Harvoni's post-rebate price – such as Medicaid.

Meanwhile, Gilead's SOF/VEL works quite well in virtually all patient populations, including genotypes for which Harvoni doesn't. The new combo could thus potentially become a virtual one-stop-shop for HCV therapy. If Gilead discounts SOF/VEL to the same degree it currently discounts Harvoni, payers will adopt it quickly. 

To dislodge Gilead, competitors will either need to provide increasingly large discounts or dramatically improved therapies – for example, both eliminating the HCV infection and reversing the liver disease it causes and/or blocking the development of viral resistance. But absent meaningful clinical or economic differentiation from its competitors, Gilead will continue to dominate the HCV market.

For a graphical summary of the RxScorecard™ analysis of Zepatier, SOF/VEL and other HCV marketed and pipeline drugs, contact Viviana Ramos at vramos@realendpoints.com or 203-517-4769.

About Real Endpoints
Real Endpoints (RE) is a healthcare information and analytics company that prepares healthcare providers, payers and pharmaceutical companies for the value-based healthcare economy. For information on other RxScorecards beyond hepatitis C, contact Viviana Ramos at vramos@realendpoints.com.

Learn more at www.realendpoints.com

This content was issued through the press release distribution service at Newswire.com. For more info visit: http://www.newswire.com

VA expands hepatitis C treatment to all patients with the virus

VA expands hepatitis C treatment to all patients with the virus
Patricia Kime, Military Times

The Veterans Affairs Department will begin providing hepatitis C treatment to all veterans in its health system who have the virus, regardless of their disease stage, VA officials said Wednesday.

Having received a boost in funding from Congress late last year for the costly medications needed to cure hepatitis C, the VA is now able to treat the 174,000 veterans in its health system who have the disease, according to a VA release.

VA Under Secretary for Health Dr. David Shulkin said that while the cost previously was too prohibitive to treat all but the sickest patients, VA now can treat all veterans with the virus who are eligible for VA health care, either in a VA facility or through the Veterans Choice program.

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Merck Applauds the U.S. Department of Veterans Affairs (VA) for Broadening Treatment Access for Veterans with Chronic Hepatitis C Infection

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, applauds the U.S. Department of Veterans Affairs (VA) for broadening access to treatment for Veterans with chronic hepatitis C virus (HCV) infection.


“We are grateful to Congress and to pharmaceutical leaders like Merck that are committed to our Veterans who have nobly served our nation.”Tweet this

ZEPATIER (elbasvir and grazoprevir) was approved Jan. 28, 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic HCV genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA, and was recently added to the VA National Formulary.

Merck introduced ZEPATIER with a price and access strategy to broaden and accelerate access to treatment for patients covered in commercial or public plans, including our country’s Veterans. The Veteran population is disproportionally affected by chronic HCV with an estimated 180,000 Veterans infected with the virus. Despite the availability of highly effective direct acting anti-viral (DAA) regimens for more than two years, the VA estimates that only about one in five of these Veterans have been treated with these DAA regimens over that period.

“As the single largest provider of chronic hepatitis C care in the United States, our goal has been to treat every Veteran with HCV infection,” said Sloan Gibson, deputy secretary for the Department of Veterans Affairs. “We are grateful to Congress and to pharmaceutical leaders like Merck that are committed to our Veterans who have nobly served our nation.”

ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child-Pugh B or C). ZEPATIER also is not for use with organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If ZEPATIER is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen.

“This is a good example of how government and industry can work together toward a shared goal in the best interests of public health – particularly for our Veterans who are so deserving. We are thankful and privileged to have worked in partnership with the VA to help accelerate access to chronic hepatitis C treatment for America’s Veterans,” said Kenneth C. Frazier, chairman and CEO, Merck. “The VA is now leading the way for the U.S. in showing what is possible in the fight against chronic hepatitis C.”

Selected Safety Information about ZEPATIER (elbasvir and grazoprevir)

Elevations of alanine transaminase (ALT) to greater than 5 times the upper limit of normal (ULN) occurred in 1% of subjects, generally at or after treatment week 8. These late ALT elevations were typically asymptomatic and most resolved with ongoing or completion of therapy. Healthcare professionals should perform hepatic lab testing on patients prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic lab testing should be performed at treatment week 12.

Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces. Healthcare providers should consider discontinuing ZEPATIER if ALT levels remain persistently greater than 10 times ULN. ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalized ratio.

The concomitant use of ZEPATIER with certain drugs may lead to possible clinically significant adverse reactions from greater exposure to ZEPATIER or concomitant drugs. Coadministration of ZEPATIER is not recommended with certain strong CYP3A inhibitors (e.g., ketoconazole or the cobicistat-containing regimens of elvitegravir/cobicistat/emtricitabine/tenofovir [disoproxil fumarate or alafenamide]). Healthcare professionals should not exceed atorvastatin 20mg/daily or rosuvastatin 10mg/daily when given with ZEPATIER. If ZEPATIER is given with fluvastatin, lovastatin or simvastatin, healthcare professionals should give the lowest statin dose necessary and closely monitor for statin-associated adverse events. If ZEPATIER and tacrolimus are coadministered, frequent monitoring of tacrolimus whole blood concentrations, changes in renal function and tacrolimus-associated adverse events is recommended.

The concomitant use of ZEPATIER and certain drugs may cause significant decrease of elbasvir and grazoprevir plasma concentrations, which may lead to reduced therapeutic effect of ZEPATIER and possible development of resistance. Coadministration of ZEPATIER is not recommended with moderate CYP3A inducers (e.g., nafcillin, bosentan, etravirine, modafinil).

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache and nausea. In subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache.

About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets

ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotype 1 or 4 infection in adults. The dosing regimens and durations for treatment with once-daily ZEPATIER for chronic HCV GT1 or GT4 infection in patients with or without cirrhosis, HIV-1 co-infection or renal impairment are as shown in the table below. For patients with chronic HCV GT1a infection, testing for the presence of NS5A resistance-associated polymorphisms (positions 28, 30, 31 or 93) is recommended prior to starting treatment with ZEPATIER to determine the optimal dosage regimen and duration.

Patient Population				Treatment				Duration
GT1a: Treatment-naïve or PegIFN/RBV-experienced* without baseline NS5A polymorphisms†				ZEPATIER				12 weeks
GT1a: Treatment-naïve or PegIFN/RBV-experienced* with baseline NS5A polymorphisms†				ZEPATIER with RBV				16 weeks
GT1b: Treatment-naïve or PegIFN/RBV-experienced*				ZEPATIER				12 weeks
GT1a or GT1b: PegIFN/RBV/PI-experienced§				ZEPATIER with RBV				12 weeks
GT4: Treatment-naïve				ZEPATIER				12 weeks
GT4: PegIFN/RBV-experienced*				ZEPATIER with RBV				16 weeks

*Patients who have failed treatment with peginterferon alfa (PegIFN) + RBV.
†NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31 or 93.
§Patients who have failed treatment with PegIFN/RBV + HCV NS3/4A protease inhibitor (PI): boceprevir, simeprevir or telaprevir. For GT1a-infected PegIFN/RBV/PI-experienced patients with one or more baseline NS5A resistance-associated polymorphisms (positions 28, 30, 31 or 93), the optimal ZEPATIER-based treatment regimen and duration of therapy has not been established.

About Merck

Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visitwww.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA

This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2015 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for ZEPATIER (elbasvir and grazoprevir) at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf and the Patient Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf

Cancer death rates decline but increase in liver cancer deaths cause for concern

Annual Report to the Nation: Cancer death rates continue to decline

Increase in liver cancer deaths cause for concern

The Report to the Nation on the Status of Cancer (1975-2012) shows that death rates continued to decline for all cancers combined, as well as for most cancer sites for men and women of all major racial and ethnic populations. The overall cancer death rates for both sexes combined decreased by 1.5 percent per year from 2003 to 2012. Incidence rates—new cancer cases that are diagnosed per 100,000 people in the U.S.—decreased among men and remained stable for women between 2003 and 2012.

The ongoing drop in cancer incidence in most racial and ethnic groups is due, in large part, to progress in prevention and early detection. Fewer deaths from cancer in those same groups may also reflect better treatments. Tobacco control efforts have contributed to lower rates of lung cancer, the leading cause of cancer death in both men and women, as well as many other types of cancer.

The report also examines trends in liver cancer. In contrast to the trends for most other cancers among both men and women, death rates due to liver cancer have increased the most compared with all cancer sites, and liver cancer incidence rates have also increased sharply.

“The latest data show many cancer prevention programs are working and saving lives,” said CDC Director Tom Frieden, MD, MPH. “But the growing burden of liver cancer is troublesome. We need to do more work promoting hepatitis testing, treatment, and vaccination.”

Key findings on liver cancer:
From 2008 to 2012, liver cancer incidence increased an average of 2.3 percent per year overall, and the liver cancer-related death rate increased by an average of 2.8 percent per year among men and 3.4 percent per year among women.
In all racial and ethnic populations, about twice as many men as women were diagnosed with liver cancer.

Between 2008 and 2012, liver cancer incidence rates were highest among non-Hispanic American Indian/Alaska Native men followed by non-Hispanic Asian/Pacific Islander men.
Hepatitis C and liver cancer-associated death rates were highest among those born in 1945-1965; these also represent the majority of Americans with hepatitis C infection.

“Research over the past decades has led to the development of several vaccines that, given at the appropriate ages, can reduce the risk of some cancers, including liver cancer,” said Douglas Lowy, M.D., acting director of the National Cancer Institute. “Determining which cancers can be effectively prevented by vaccines and other methods is one of our top priorities at NCI and one which we believe will truly make a difference in cancer incidence and mortality trends.”

The authors noted that, in the United States, a major contributing factor to liver cancer is hepatitis C virus (HCV) infection. A little more than 20 percent of the most common liver cancers are attributed to HCV infection. Compared with other adults, people born during 1945-1965 have a six times greater risk of HCV infection. CDC recommends all people born during 1945-1965 receive a one-time test for HCV. Diagnosis of HCV, followed by treatment, can greatly reduce the risk of liver cancer.

“We have the knowledge and tools available to slow the epidemic of liver cancer in the U.S., including testing and treatment for HCV, hepatitis B vaccination, and lowering obesity rates,” said Otis W. Brawley, M.D., chief medical officer of the American Cancer Society. “We hope that this report will help focus needed attention and resources on liver cancer.”

Hepatitis B virus (HBV) infection also increases the risk for liver cancer. HBV is a common risk factor for liver cancer for Asian/Pacific Islander populations, especially among Asians not born in the United States, and CDC recommends universal HBV testing for this population. Fortunately, rates of HBV infection are declining worldwide due to increases in hepatitis B vaccination of children beginning at birth.

Obesity and type 2 diabetes can cause cirrhosis, or scarring of the liver, which can progress to liver cancer and is associated with excessive alcohol use; from 8 to 16 percent of liver cancer deaths are attributed to excessive alcohol use.

“Collecting and analyzing high-quality cancer surveillance data is essential for tracking the benefits of screening and other prevention efforts,” said Betsy Kohler, executive director, North American Association of Central Cancer Registries. “Data from an estimated 97 percent of all newly diagnosed cancer cases in the US are used in this report.”

The Report to the Nation is released each year in a collaborative effort by the American Cancer Society, the Centers for Disease Control and Prevention, the National Cancer Institute, and the North American Association of Central Cancer Registries.

To view the full Report, go to http://onlinelibrary.wiley.com/doi/10.1002/cncr.29936/full

For a Q&A on this Report, go to http://www.cdc.gov/cancer/dcpc/research/articles/arn_7512.htm

For Spanish translation of this press release, go tohttp://www.cdc.gov/Spanish/MediosdeComunicacion/comunicados/p_
informe_anual_tasas_mortalidad_cancer_0300916.html

To learn more about hepatitis, go to www.cdc.gov/hepatitis

Fatty Liver Disease: Latest Update on What You Need to Know

Fatty Liver Disease: Latest Update on What You Need to Know

by DR. JOE GALATI on 03/08/2016

Fatty liver disease, also called NASH (nonalcoholic steatohepatitis) and NAFLD (nonalcoholic fatty liver disease) is a common disease of the liver. It is caused by truncal obesity, diabetes, elevated cholesterol, hypothyroidism, and hypertension. Together, all of these disorders is called metabolic syndrome.

In a select group of patients, fatty liver can progress to cirrhosis of the liver, liver cancer, and the possible need for liver transplant.

Fatty liver can be treated with weight loss, diet, and exercise. In select cases, the damage to the liver can be reversed. Fatty liver disease needs to be taken seriously, and not ignored. If you have been diagnosed with fatty liver, it requires attention.

To make an appointment with Dr. Galati and his colleagues, call 713-794-0700, or visit the web at www.texasliver.com

More than 2 million people co-infected with HIV and hepatitis C

More than 2 million people co-infected with HIV and hepatitis C
UNIVERSITY OF BRISTOL

An estimated 2.3 million people living with HIV are co-infected with hepatitis C virus (HCV) globally, a new study by the University of Bristol and the London School of Hygiene & Tropical Medicine has found.

Of these, more than half, or 1.3 million, are people who inject drugs (PWID). The study also found that HIV-infected people are on average six times more likely than HIV-uninfected people to have HCV infection, pointing to a need to improve integrated HIV/HCV services.

HIV and HCV infections are major global public health problems, with overlapping modes of transmission and affected populations. Globally, there are 37 million people infected with HIV, and around 115 million people with chronic HCV infection. However, very little was known about the extent of HIV/HCV coinfection prior to this study, which was the first global study of its kind.

Sponsored by the World Health Organisation (WHO), the study was published online in The Lancet Infectious Diseases on February 24. WHO commissioned the study to inform an update of its guidelines on screening of coinfections and initiation of antiretroviral therapy, and to inform regional and national strategies for HCV screening and management.

The study systematically reviewed 783 medical studies from worldwide sources to build the first global estimates on the prevalence of HIV/HCV co-infection (measured by HCV antibody) as a public health problem.

Dr Philippa Easterbrook, from WHO's Global Hepatitis Programme said: "The study shows that not only are people with HIV at much higher risk of HCV infection, groups such as people who inject drugs have extremely high prevalence of HCV infection - over 80 Per cent. There is a need to scale-up routine testing to diagnose HCV infection in HIV programmes worldwide, especially among high-risk groups, as the first step towards accessing the new, highly curative HCV treatments."

Dr Lucy Platt, lead author and senior lecturer from the London School of Hygiene & Tropical Medicine said: "Despite a systematic search of published and unpublished literature, estimates were identified in only 45 per cent of countries and the study quality was variable. Improvement in the surveillance of HCV and HIV is imperative to help define the epidemiology of coinfection and inform appropriate policies for testing, prevention, care and treatment to those in need. This is especially the case in countries with growing populations of PWID and also in sub-Saharan Africa where the burden of coinfection is large due to high burden of HIV."

Professor Peter Vickerman, from the University of Bristol's School of Social and Community Medicine said: "This study shows how important injecting drug use is in driving the epidemic of HCV in people with HIV infection, especially in eastern European and central Asian countries. It also shows the need to scale up prevention interventions, such as needle and syringe programmes and opioid substitution therapy, as well as access to HIV and HCV treatment, to reduce morbidity and new infections."

The study focusses on prevalence of HCV antibodies that measures exposure to HCV but not active infection. Measuring the presence of active virus and the need for treatment requires an additional more costly viral test, which very few of the reviewed studies had done. Around 20-30 per cent of people exposed to HCV and found positive with antibody will clear the virus.

The study shows the greatest burden of HIV/HCV coinfection in Eastern Europe and central Asia, where there are an estimated 607,700 cases (27 per cent of all cases), particularly among PWID. The sub-Saharan African region accounts for 19 per cent of all cases, with 429,600 cases, due to high burdens of HIV.

The researchers included studies with estimates of HCV coinfection in the main HIV population, as well as sub-groups of PWID, men who have sex with men, heterosexually exposed and pregnant women, other high-risk groups and the general population. Studies were eligible if they included a minimum of 50 individuals.

The search focused on published medical literature, and excluded samples drawn from populations with other comorbidities, or undergoing interventions that put them at increased risk of coinfection.

The full article is available at: http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00485-5/fulltext

For further information, contact:

Simon Davies
University of Bristol
Tel: + 44 (0)117 928 8086 (office); 07866 783248 (mobile)
Email: simon.l.davies@bristol.ac.uk

Source

Is U.S. Demand for New Hepatitis C Drugs About to Explode?

Investment Commentary

Is U.S. Demand for New Hepatitis C Drugs About to Explode?

Insurers allegedly denying eligible patients access to pricey new Hepatitis C drugs will have their day in court.

Last year the Senate Finance Committee spent a lot of time investigating whether or not Gilead Sciences (NASDAQ:GILD) intended to maximize revenue from its franchise of groundbreaking hepatitis treatments. Surprising nobody, the investigation concluded maximizing revenue was indeed Gilead's goal, but it also unearthed some startling facts about coverage restrictions.

An underserved population
The low percentage of infected patients treated in 2014 is stunning. An estimated 2.7 million Americans are infected with hepatitis C. Just over a third of the population is covered by Medicaid or Medicare. That year less than 2.4% of roughly 700,000 Medicaid enrollees with Hepatitis C were treated with Sovaldi. In a seperate disclosure from Medicare, just 57,397 beneficiaries were treated with Sovaldi, Harvoni, or the now obsolete Olysio.

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Cost Keeps HCV Care Out of Reach

WATCH

Cost Keeps HCV Care Out of Reach
CDC Expert Commentary
John W. Ward, MD

March 07, 2016

Recent clinical trials have demonstrated that new, simple-to-use treatment regimens for persons living with HCV infection are safe and highly effective, leading to cure in the vast majority of patients—the public health implications of which could be profound. The effectiveness of a combination of sofosbuvir and velpatasvir in patients who have failed to respond to previous treatment and in those with decompensated cirrhosis, a contraindication for earlier HCV treatment regimens, is also very promising, with high rates of cure regardless of HCV genotype.[3]

Given the benefits of safe, easy-to-use, and curative HCV therapy, why be concerned about the impact of HCV on individuals and the public as a whole? The answer is simple:Patients do not benefit from a drug that they cannot afford.

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Holiday time delaying crackdown on counterfeit hepatitis medication

Counterfeit Versions of Gilead’s Blockbuster Hepatitis C Drug Found in Israel
Counterfeits of Gilead’s mega-blockbuster hepatitis C treatment Harvoni, which is generating billions per quarter in sales for the company, are emerging in Israel.

Switzerland’s drug regulator Swissmedic said over the weekend that the plastic bottles of the counterfeits, which originated in India, were imported via a Swiss trading company and “contain white instead of genuine yellow film-coated tablets,” the regulator said.

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Holiday time delaying crackdown on fake medicine
By Shwe Yee Saw Myint | Monday, 07 March 2016
A health official on leave is causing a hold-up in the government’s response to counterfeit hepatitis medication.

The Food and Drug Administration said is waiting for approval to clampdown on the distribution of fake pills in the wake of a World Health Organization alert sent out at the end of February.

“We got information from the WHO and planned to respond quickly to this alert but we still do not have any permission from the health department of the Ministry of Health yet,” Dr Theingi Zin, director of drug control at the FDA, told The Myanmar Times.

She said the FDA wants to issue a public alert about the drugs through state media outlets.

“This is a really big issue because patients are buying and taking this medicine to help their disease but according to the WHO alert this medicine is fake,” she added.

The WHO warned hepatitis C patients to avoid the drug brands “Ledso” and “Dakavir”. The medications were packaged in bottles that listed the manufacturer as a pharmaceutical company named PHARCO based in Alexandria, Egypt. The company denied making drugs under either name or in the combination of compounds listed on the bottles....

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WHO warns of fake drugs
By Laignee Barron | Friday, 04 March 2016

Beware of fake hepatitis medication ​The World Health Organization has warned hepatitis C patients that counterfeit medications are being sold in Myanmar.

Drugs branded as “Ledso” and “Dakavir” are fakes, according to an alert put out by the WHO.

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Factory making fake Hepatitis C drug raided
Mar 1
Assisted by the Federal Investigation Authority (FIA), personnel of the Drug Regulatory Authority of Pakistan (DRAP) raided one of the local industries in Islamabad’s Kahuta industrial area here Saturday, leading to the discovery of unlawful manufacturing of Sofasbuvir tablets, which are used for the treatment of Hepatitis C, and Everlong tablets, the registration of which has long been withdrawn.
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