January 14, 2014

Costly Pills Put Financial Burden on Health Systems

Provided by Roll Call

By Kerry Young
Roll Call Staff
Jan. 13, 2014, 4:43 p.m

The new Sovaldi hepatitis C drug, which has a wholesale cost of $1,000 a pill, will pose a challenge to Medicare, Medicaid and prison systems during a time of austere budgets.

Sovaldi’s price already has sparked controversy among activist groups and could, in time, accelerate serious debate about how federal and state agencies buy medicines. Advocates for people with hepatitis C have welcomed Sovaldi as a true medical breakthrough while decrying the high price that its owner, Gilead Sciences Inc., intends to charge.

Gilead has said that a 28-pill bottle of Sovaldi will have a wholesale cost of $28,000, or $1,000 a pill. Many patients will take the drug for 12 weeks, or 84 days; such a course of Sovaldi would cost $84,000.

Sovaldi is seen as a leader in an expected new wave of drugs with the potential to replicate some of the rarest victories in medical science, the near total containment of a disease.

“We’ve got the first of many tools that will allow us to seriously have the discussion about eradicating hepatitis C,” said Michael Ninburg, executive director of the Hepatitis Education Project in Seattle. “In the next few years, there will be very few people living with hepatitis C who won’t be able to be cured by taking a pill, or a couple of pills, a day for 12 weeks, or in some cases maybe a little bit longer.”

The Food and Drug Administration called Sovaldi a “significant shift” in how hepatitis C will be treated. It can be used for some patients without requiring a combination of interferon injections, which are known to frequently cause side effects.

Sovaldi was the third medicine to win the FDA’s relatively new designation as a breakthrough therapy, meaning that it’s considered a substantial improvement over available treatments for a serious and potentially fatal condition.

The FDA noted in a news release that Sovaldi worked for some people who couldn’t tolerate interferon, although the new pill will be combined with injections of the older drug for some patients in other regimens. It’s intended to be taken with the generic pill ribavirin.

“It’s absolutely to be applauded,” Ninburg said. “The price, on the other hand, is an issue.”

It’s certainly a problem for government health programs. Officials at the Federal Bureau of Prisons warned Congress last year about an expected spike in the cost of treating inmates infected with hepatitis C, also called HCV, due to the introduction of new, more expensive medicines.

“More patients will be candidates for treatment and drug regimens will become more and more expensive,” the bureau said in its fiscal 2014 budget request to Congress. “As treatment indications broaden in the future and multi-drug regimens become the standard of care, the drug costs for managing HCV will grow significantly.”

Prisons host a disproportionate share of people infected with hepatitis C, according to the Centers for Disease Control and Prevention. About 3.2 million people in the United States have chronic hepatitis C, meaning that their bodies didn’t clear the liver-damaging virus on their own without treatment. The infection is primarily linked to a history of injections of illegal drugs, such as heroin, although it can be transmitted in other ways.

About 12 percent to 35 percent of inmates are chronically infected with hepatitis C, compared with 1 percent to 1.5 percent of the population outside of prisons, the CDC said. The infection can sometimes cause people to need costly organ transplants.

As it stands now, the bureau spends $4 million a year on testing for hepatitis C. More than 11,000 inmates with the infection have been identified, most of whom have not been treated yet, the bureau said.

The current course of therapy, which costs about $6,600, lasts for 48 weeks and includes injections of interferon. Many would-be patients don’t have enough time on their sentences to complete the full course by the time the treatment is offered.

When the budget request was submitted, there were two recently introduced pills — Merck & Co.’s Victrelis and Vertex Pharmaceuticals Inc.’s Incivek — that could be added to a combination of interferon and ribavirin.

“These newer agents are very expensive and could add $20,000 to $40,000 to the cost of treating one patient,” the bureau said.

Now, more expensive drugs have arrived. The Fair Pricing Coalition, which lobbies on behalf of people with HIV and hepatitis C, in November protested against the expected $66,000 price for a course of treatment with Johnson & Johnson’s recently approved Olysio hepatitis C drug. Now the Bureau of Prisons is facing the potential tab for that, plus Sovaldi.

“They dodged a bullet with the old medicines, but now the marketplace will have new, more expensive medicines with a much shorter course of treatment,” Anne Spaulding, an Emory University researcher who has studied HIV and hepatitis C in prisons, said in an interview.

In a recent paper, she and other researchers suggested modifying the current rules on the federal 340B drug discounting program, which could open the way for more prison systems to participate.

Having deeper discounts on drugs would make it easier for prison systems to manage the cost of the new wave of hepatitis therapies. For now, the requirements associated with the 340B program, such as the need for an entity other than the prison to have control of the medical records of covered patients, have prevented many states from trying this option, Spaulding said.

“Hepatitis C treatment has a high price tag,” she said. “Prisons don’t want to pay the high price tag up front when they will not recoup the downstream benefits of avoiding the expensive treatment for end-stage liver disease.”

A change in Medicare policy also could spur demand for Sovaldi. The agency appears likely to act on a June 2013 recommendation from the U.S. Preventive Services Task Force, which advocated for a one-time screening for hepatitis C in people born between 1945 and 1965.

About 2.1 million of those infected with the disease in the United States are baby boomers, with perhaps 1.5 million unaware that they have this condition, according to the CDC. Many may have contracted it before 1992, when screening began of blood donations for the hepatitis C virus. Getting these people appropriate care and treatment could prevent more than 120,000 deaths.

There could be a quick uptake of Sovaldi in the United States, according to a December report from Phil Nadeau, a biotechnology analyst with Cowen and Company. He said that as many as 50,000 people could be treated in the United States with Sovaldi in 2014 alone, helping drive global sales of the drug to $3 billion for the year.

The haggling currently allowed for drugs in the United States in private plans and some Medicaid plans could lower the price for treatment with Sovaldi to about $70,000 a patient for a 12-week course.

Medicaid programs may also be another major market for Sovaldi and the newer hepatitis drugs.

A study presented in May at one of the world’s largest gatherings of liver specialists, known as Digestive Disease Week, found the rate of hepatitis C infection was more than twice as high among people on Medicaid compared with those with private insurance, with 663 cases for every 100,000 people on the state-federal health program and 302 for every 100,00 in the other group. People in the Medicaid group also were less likely to have had treatment for hepatitis than those with private health insurance, 20 percent versus 27 percent.

“The development of interferon-free regimens may increase eligibility for treatment,” concluded the paper, whose lead writer was an employee of the drugmaker AbbVie, which is developing a competitor pill to Sovaldi.

kerryyoung@cqrollcall.com

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Also See: What Is a Hepatitis C Drug Worth?

amfAR Launches Hep C Study in Asia

by Winnie McCroy
EDGE Editor
Tuesday Jan 14, 2014

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amfAR’s new study will help how how to treat hepatitis C in a resource-limited setting
(Source:amfar.org)

In an effort to implement care for those suffering from hepatitis C in Asia, amfAR’s Therapeutic Research, Education and AIDS Training (TREAT Asia) is conducting a study on how to implement care in a resource-limited setting that can be replicated in the region, where treatment is very costly and rarely accessible. Two hundred HIV-positive patients with hepatitis C infection and signs of liver disease will be offered free treatment.

"As rates of hepatitis C and HIV co-infection continue to rise around the world, managing co-infection is one of the most important clinical challenges we face today," said amfAR CEO Kevin Robert Frost.

It is estimated that approximately five million people worldwide are co-infected with HIV and the hepatitis C virus (about 15 percent of all those living with HIV). People co-infected with HIV and hepatitis C have higher rates of progression to hepatitis C-related liver disease, which has become a significant cause of death in people living with HIV.

This is the first time a study is being done in Asia to show how to implement care in a resource-limited setting that can be replicated in the region, where treatment is very costly and rarely accessible.

Led by amfAR’s TREAT Asia program, the study will be implemented in four partner HIV treatment centers: Cipto Mangunkusumo General Hospital in Jakarta, Indonesia; the HIV-NAT/Thai Red Cross AIDS Research Center in Bangkok, Thailand; the National Hospital for Tropical Diseases in Hanoi, Vietnam; and the University of Malaya Medical Centre in Kuala Lumpur, Malaysia.

In this study, a total of 200 HIV-positive patients with confirmed chronic hepatitis C infection and signs of liver disease will be offered free hepatitis C treatment. The treatment model will include the integration of hepatitis C treatment within routine HIV care, use of a simplified treatment protocol, intensive patient disease education, treatment preparedness and adherence support, as well as peer support.

"The resources needed to effectively treat them remain out of reach for most due to the high cost of hepatitis C medicines and the overall lack of experience with treating co-infected patients in the region," said Annette Sohn, M.D., amfAR vice president and director of TREAT Asia.
The study is sponsored by amfAR, the study drugs are provided by Merck Sharp and Dohme under its Investigator-Initiated Study Program, and hepatitis C molecular viral load and genotyping tests are provided by Abbott.

"This is the first time a study is being done to show how we can implement treatment of hepatitis C in routine HIV care in Asia," said Nicolas Durier, M.D., M.P.H., TREAT Asia’s director of research and one of the study’s principal investigators. "We hope that the model of care we have developed and our study findings will lead to replication and scale-up of hepatitis C treatment across the region, as well as bolster advocacy efforts aimed at expanding the availability of treatment."

Launched in 2001, TREAT Asia (Therapeutics Research, Education, and AIDS Training in Asia) is a cooperative network of clinics, hospitals, and research institutions working together with civil society to ensure the safe and effective delivery of HIV/AIDS treatments throughout Asia and the Pacific, and now encompasses 23 adult and 21 pediatric clinical sites and HIV support programs across the region.

amfAR, The Foundation for AIDS Research, is one of the world’s leading nonprofit organizations dedicated to the support of AIDS research, HIV prevention, treatment education, and the advocacy of sound AIDS-related public policy. Since 1985, amfAR has invested more than $366 million in its programs and has awarded grants to more than 2,000 research teams worldwide.

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PUBLIC RELEASE DATE:14-Jan-2014

Contact: Kim Newman
sciencenews@einstein.yu.edu
718-430-3101
Albert Einstein College of Medicine

January 14, 2014 - (BRONX, NY) - The first study of hepatitis C infection among different Hispanic groups in the U.S. has found that infection with the virus varies widely, with Puerto Rican Hispanics much more likely than other groups to be infected. The study, led by researchers at Albert Einstein College of Medicine of Yeshiva University, highlights which Hispanic populations would benefit most from increased hepatitis C testing and treatment. It was published today in the online edition of the Journal of Infectious Diseases.

Hepatitis C is a viral disease that primarily affects the liver and is caused by the hepatitis C virus. The virus is usually spread through contact with the blood of an infected person, often from sharing needles to inject drugs. Many people were also infected through blood transfusions before testing of donated blood began in 1992. About 150 million people worldwide are now infected with hepatitis C, including three to four million in the U.S., according to the Centers for Disease Control and Prevention (CDC). The majority of infected people don't know they're infected, since it may take decades for the virus to cause liver damage severe enough to cause symptoms.

"Until now, national health surveys that assessed hepatitis C's prevalence among U.S. Hispanics have looked only at Mexican-Americans," said Mark Kuniholm, Ph.D., lead author of the study and assistant professor of epidemiology & population health at Einstein. "As a result, no one knew whether the rates were higher or lower in other Hispanic populations. It turns out that there's a dramatic variation in prevalence, with infection rates ranging from less than 1 percent in Hispanic men of South American or Cuban background to 11.6 percent in men of Puerto Rican background – a more than 10-fold difference. This suggests that it's not appropriate to lump all U.S. Hispanics into a single, broad at-risk group."

The prevalence of hepatitis C infection found for men in other Hispanic groups are: Mexican (1.9 percent), Dominican (1.5 percent), Central American (1 percent), South American (.4 percent), and Cuban (0.8 percent). Hispanic women generally had a lower prevalence of hepatitis C infection than men, with Puerto Rican background women having the highest prevalence (3.9 percent) among Hispanic women. The overall prevalence of hepatitis C among men and women in the U.S. is 1.3 percent, according to the National Health and Nutrition Examination Survey (NHANES). The researchers said it was not clear why the prevalence of hepatitis C was highest among Hispanic men and women of Puerto Rican background compared with Hispanics of other backgrounds.

The Einstein study used data collected on 11,964 individuals as part of the Hispanic Community Health Study/Study of Latinos, a National Institutes of Health-funded study of Hispanic adults from four communities (Bronx, Miami, Chicago and San Diego). It was led by Robert Kaplan, Ph.D., the Dorothy and William Manealoff Foundation and Molly Rosen Chair in Social Medicine and professor of epidemiology & population health, and by Gloria Ho, Ph.D., professor of epidemiology & population health, both at Einstein.

"Clearly, our findings strongly support the need for community-based campaigns to increase testing and treatment in the Hispanic population," said Dr. Kuniholm. "But in our view, outreach efforts should be redoubled in those communities with large numbers of people of Hispanic background and a high prevalence of the disease.. For example, if you're in Miami with its mostly Cuban Hispanic population, the cost effectiveness of extra screening may be less than in the Bronx or Chicago, which both have large Puerto Rican communities. Extra efforts to increase screening may be warranted in those communities."

In 2012, the Centers for Disease Control and Prevention recommended that all Baby Boomers (people born from 1945 through 1965) be tested for hepatitis C. Those at increased risk for hepatitis C infection should also be tested, including people who ever injected illegal drugs (even if they did so only once or many years ago), have abnormal liver tests, received donated blood or organs before 1992, have been exposed to blood at work through needle sticks or injury with a sharp object, or were ever on hemodialysis.

The study's findings take on added importance with the development of a new class of hepatitis C drugs, recently approved by the FDA that can potentially cure more than 80 percent of people infected with hepatitis C. "In the past, treating hepatitis C was often very difficult and was associated with severe side effects," said Dr. Kuniholm. "The newer treatments cause far fewer side effects and are more effective and more convenient to take."

###

The paper is titled "Prevalence of Hepatitis C Virus Infection in US Hispanic/Latino Adults: Results from the NHANES 2007-2010 and HCHS/SOL Studies." In addition to Drs. Kuniholm, Kaplan and Ho, other Einstein contributors are Molly Jung, M.P.H., Ryung Kim, Ph.D., and Howard Strickler, M.D., M.P.H. Additional contributors are James E. Everhart, M.D., M.P.H., at National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; Scott Cotler, M.D., at Loyola University Medical Center, Maywood, IL; Gerardo Heiss, M.D., Ph.D., and Marston Youngblood, M.A., M.P.H. at University of North Carolina, Chapel Hill, NC; Geraldine McQuillan, Ph.D., at U.S. Centers for Disease Control and Prevention, Hyattsville, MD; and Bharat Thyagarajan, M.D., at University of Minnesota, Minneapolis, MN.

The Hispanic Community Health Study/Study of Latinos is supported by contracts from the National Heart, Lung, and Blood Institute to the University of North Carolina (N01-HC65233), University of Miami (N01-HC65234), Albert Einstein College of Medicine (N01-HC65235), Northwestern University (N01-HC65236), and San Diego State University (N01-HC65237). The following Institutes/Centers/Offices contribute to the HCHS/SOL through a transfer of funds to the NHLBI: National Institute on Minority Health and Health Disparities, National Institute on Deafness and Other Communication Disorders, National Institute of Dental and Craniofacial Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Neurological Disorders and Stroke, NIH Institution-Office of Dietary Supplements. Dr. Kuniholm is supported in part by the National Center for Advancing Translational Sciences, through CTSA grants UL1RR025750 and KL2RR025749.

The authors report no conflicts of interest.

About Albert Einstein College of Medicine of Yeshiva University

Albert Einstein College of Medicine of Yeshiva University is one of the nation's premier centers for research, medical education and clinical investigation. During the 2013-2014 academic year, Einstein is home to 734 M.D. students, 236 Ph.D. students, 106 students in the combined M.D./Ph.D. program, and 353 postdoctoral researchfellows. The College of Medicine has more than 2,000 full-time faculty members located on the main campus and at its clinical affiliates. In 2013, Einstein received more than $155 million in awards from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore Medical Center (http://www.montefiore.org/), the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Through its extensive affiliation network involving Montefiore, Jacobi Medical Center–Einstein's founding hospital, and five other hospital systems in the Bronx, Manhattan, Long Island and Brooklyn, Einstein runs one of the largest residency and fellowship training programs in the medical and dental professions in the United States.

For more information, please visit http://www.einstein.yu.edu and follow us on Twitter @EinsteinMed.

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Bristol-Myers Ties Hepatitis C Success to Gilead’s Pill

By Drew Armstrong Jan 14, 2014 8:25 AM ET

Bristol-Myers Squibb Co. will try to grab an early share of the multibillion-dollar market for new hepatitis C treatments by piggybacking its experimental drug with Gilead Sciences Inc.’s approved pill.

Bristol-Myers and Gilead are among several companies developing new hepatitis C therapies relying on combinations of two or more drugs. Those regimens are being approved by regulators one drug at a time for a hepatitis C market analysts estimate may reach $100 billion over a decade.

Bristol-Myers is seeking European approval of its drug, daclatasvir, and wants to pair it with Gilead’s Sovaldi before Gilead gains clearance for its second hepatitis C treatment. They will do the same in the U.S. if they can get a broad approval from regulators, said Charles Bancroft, the chief financial officer for Bristol-Myers, in an interview at the JPMorgan Chase & Co. health-care conference in San Francisco.

In “the potential approval of daclatasvir in Europe, the label should be expansive enough to use with sofosbuvir,” Bancroft said, referring to Solvadi by its scientific name. “Hopefully what we do in Europe, we can parlay some of that to here in the U.S.,”

Bristol-Myers, based in New York, is focusing its effort on antiviral treatments, cancer drugs and specialty medicines. It ended its work on diabetes treatments last month, selling a stake in a joint venture with London-based AstraZeneca Plc for as much as $4.3 billion.

Bristol-Myers shares fell 1.4 percent to $55.42 in New York trading yesterday. Gilead, based in Foster City, California, dropped 2.3 percent to $73.41.

4 Million Americans

The move on the hepatitis C pills is a part of a competition by drugmakers to reach the market with new treatments that are more convenient and produce fewer side effects than current therapies including injections. About 4 million Americans have the viral infection, which can cause liver cirrhosis, and U.S. health officials recommended every American born from 1945 to 1965 get tested for the disease.

Gilead’s Sovaldi became the first all-oral treatment for certain hepatitis C patients when it was approved in December by the U.S. Food and Drug Administration. Johnson & Johnson and Medivir AB won FDA approval in November for their pill, Olysio, to be used in combination with other medicines including current treatments.

Gilead is testing other drugs to produce a full combination treatment, which may not be available until the end of 2014 or the beginning of 2015. Bristol-Myers’s combination may not be ready until later.

The drugs from Gilead and Bristol-Myers have been studied together. In a trial of 41 patients released last year, every patient who took the drugs and was followed up with was free of the virus 12 weeks later. The companies haven’t been able to reach an agreement on further testing, though.

Sales Estimates

The combinations are projected to be blockbusters once approved. Gilead’s Sovaldi is priced at $84,000 per treatment, and is projected to sell $8.22 billion in 2016, according to an average of 11 analysts’ estimates compiled by Bloomberg. Abbvie Inc. and Merck & Co. are also developing treatments.

“My personal view is that Gilead is going to get the lion’s share, bni ushealth strut there is room for other players,” Bancroft said. Once combinations from Bristol-Myers and rivals are cleared for the market, competition will drive prices down, he said.

Gilead said it is moving ahead with its combination out of necessity.

“We believe that we have been able to advance the development of this fixed-dose combination much more quickly than would have been possible with any inter-company collaboration,” Norbert Bischofberger, Gilead’s head of research and development, said in an e-mail. “Gilead remains focused on delivering the simplest and safest all-oral treatment regimen to patients as quickly as possible.”

To contact the reporter on this story: Drew Armstrong in New York at darmstrong17@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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What Is a Hepatitis C Drug Worth?

Provided by Roll Call

By Kerry Young
Roll Call Staff
Jan. 13, 2014, 4:41 p.m

The founder of the company that discovered the Sovaldi hepatitis C drug, which has been listed with a cost of $1,000 for a single pill, says that it’s fairly cheap to make the basic ingredients for this well-regarded new medicine. It may cost only about $1,400 to manufacture a 12-week supply, or 84 pills, of the key ingredient in Sovaldi, excluding the costs of manufacturing plants, solvents, formulation, encapsulating and marketing.

That’s the estimate that Raymond F. Schinazi, a founder of Pharmasset Inc. and a noted infectious-disease researcher at Emory University, put forward in a paper published in December in the journal Trends in Microbiology.

By now, Gilead Sciences Inc., which bought Pharmasset in January 2012 for $11.4 billion, may have brought down the production cost further, Schinazi said in a recent interview. “It could be even less than that,” Schinazi said.

Pharmaceutical companies have long experience with making pills, with some products having been made in large scale for more than a century.

“Even aspirin, but they still charge you a significant markup for that,” Schinazi said. “With new drugs like Sovaldi, or sofosbuvir as we used to call it, the company needs to recover its investment in research.”

Gilead has argued that spending for Sovaldi now will save programs such as Medicaid and Medicare and the Department of Veterans Affairs on future health costs, because people whose hepatitis C infections are treated with the drug will not need future treatment for serious liver damage or organ transplants.

The nonprofit AIDS Healthcare Foundation has accused Gilead of “unbridled greed,” and some activists have pointed to the high price that Gilead paid for Pharmasset as a reason for Sovaldi’s pricing. Schinazi, who said he has no stake in Gilead, says there was a “bidding war” for Pharmasset with the aim of capturing Sovaldi. The drug, intended to be combined with the generic ribavirin, is considered a breakthrough in hepatitis C treatment.

There’s little consensus about how much it costs to develop drugs, with estimates ranging as high as $1.7 billion for a new product.

Pharmasset, though, had an accumulated deficit of about $325 million for its roughly 13 years as an independent company, a time in which it worked on several other potential drugs in addition to advancing Sovaldi as far as testing in patients, according to a filing with the Securities and Exchange Commission.

“We were very efficient, extremely efficient. We have a lot of experience,” said Schinazi, whose other biotechnology ventures included Triangle Pharmaceuticals, which Gilead bought in 2003.

But Schinazi stressed that biotechnology of all sizes, startups such as Pharmasset and giants like Gilead, face long odds in their work with Sovaldi. The high prices charged for the products that make it to market compensate for failures unknown to most of the public, he said.

“There’s a whole cemetery full of drugs that have failed in this particular class of compounds, a huge cemetery. You have got to look at that,” Schinazi said. “We got a bit lucky but we also did amazingly good science.”

kerryyoung@cqrollcall.com

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Also See: Costly Pills Put Financial Burden on Health Systems

Hepatitis C: More Affordable Treatment Possible

Medscape Medical News

Jennifer Garcia

January 13, 2014

Large-scale manufacture of drugs used to treat patients infected with the hepatitis C virus (HCV) can be accomplished at much lower costs than current pricing schemes, according to a study published online January 6 in Clinical Infectious Diseases.

The US Food and Drug Administration (FDA) recently approved new drugs for HCV, including sofosbuvir and simeprevir. The drugs are expected to dramatically improve care for patients with HCV.

However, the cost of these game-changing drugs may put them out of reach of many patients. At this time, in the United States, the cost of 12 weeks of HCV therapy with simeprevir is $66,000, and with sofosbuvir it is $84,000.

In a new study, Andrew Hill, PhD, from the University of Liverpool, United Kingdom, and colleagues, estimated the cost of HCV treatment, using similar market dynamics as those used to dispense antiretroviral therapy to patients with HIV in developing countries.

Given their similar chemical structure and mechanism of action, the researchers compared 5 direct-acting antiviral HCV drugs (DAAs) — daclatasvir, sofosbuvir, simeprevir, faldaprevir, and ribavirin — with their closest analogues used in the treatment of HIV and used these data to estimate manufacturing costs per gram of drug.

The authors determined that the cost of a 12-week course of HCV therapy could be as little as $100 to $250 a person. These estimated treatment costs were based on an intended treatment population of at least 1 million patients and included a 40% margin for finished production.

The authors note that 12 of the 20 countries with the largest HCV epidemics are classified as low- or lower-middle-income countries and point out that their results demonstrate that more affordable therapy is possible. "These low prices coupled with the high [sustained virological response] rates established in several trials [show] the potential for large-scale, low cost HCV treatment in developing countries, with the potential to repeat the model of low-cost HIV treatment that has benefitted millions of people," write Dr. Hill and colleagues.

In an interview with Medscape Medical News, Dr. Hill said, "We need the health authorities in the highest-burden countries to work with the World Health Organization for a plan for large-scale treatment of hepatitis C. Eradication of this disease is possible, if there is the political will."

When asked whether he felt the current price for new DAAs for HCV therapy is justified, Dr. Hill responded: "We need to separate the cost of treatment in North America and Europe from the cost in low- and middle-income countries. There should be large-scale access programs set up to treat people with hepatitis C at minimum cost in high-burden countries such as India, Egypt, Indonesia, and Nigeria."

Already, legal initiatives have been filed in India in an effort to prevent a major pharmaceutical company from obtaining a patent on one of these new HCV drugs. This would allow for production of a low-cost generic formulation and drastically reduce the cost of treatment in that country.

Dr. Hill and colleagues acknowledge there are limitations to their analysis, including a lack of detailed production information about specific DAAs and the fact that these estimates assume no patent restrictions on production. They note that voluntary or compulsory licenses that allow for the production of generic formulations will be necessary to make these cost estimates a reality.

"Every company developing drugs for hepatitis C needs a plan for ensuring access to their drugs in low- and middle-income countries," concluded Dr. Hill. "In the future, access to treatment for hepatitis C should be available together [with] treatment for HIV," he said.

One author has received consultancy payments from Janssen Pharmaceuticals that are not connected with this project. Another author has received consultancy and travel grants from other pharmaceutical companies that are also not associated with this project. The other authors have disclosed no relevant financial relationships.

Clin Infect Dis. Published online January 6, 2014. Full text

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Also See: Minimum costs for producing Hepatitis C Direct Acting Antivirals, for use in large-scale treatment access programs in developing countries