FDA - Inks Used in Certain Tattoo Kits Cause Infections

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Inks Used in Certain Tattoo Kits Cause Infections

Tempted to get a tattoo? Today, people from all walks of life have tattoos, which might lead you to believe that tattoos are completely safe.

But beware—there may be associated health risks.

Recently, the Food and Drug Administration (FDA) became aware of a problem after testing inks in home use tattoo kits marketed by White and Blue Lion, Inc. FDA has confirmed bacterial contamination in unopened bottles of the company’s inks.

According to Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors, using these inks for tattoos could cause infection. “FDA has confirmed one case of skin infection involving a consumer that used this company’s tattoo products,” Katz says, “and we are aware of other reports linked to tattoo products with similar packaging.”

Risks Can Be Severe
According to Katz, “Tattooing poses a risk of infection to anyone, but the risk is particularly high for those with pre-existing heart or circulatory disease, diabetes or compromised immune systems.”
She notes that injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo. Signs of localized infection include redness, swelling, weeping wounds, blemishes, or excessive pain at the site. If you experience any of these signs, seek medical care right away. Even after a localized infection has healed, the area may be permanently scarred.

Further, an infection that is left untreated or inadequately treated could spread through the bloodstream (a process known as sepsis). These infections may be associated with fever, shaking chills (rigors) and sweats. If these symptoms arise, treatment with antibiotics, hospitalization and/or surgery may be required.

Products Recalled, But Risk Remains
White and Blue Lion, Inc. recalled contaminated products on July 11, 2014, but FDA is still concerned that consumers and professional tattoo artists may be purchasing or using contaminated home tattoo kits and inks from other distributors.

Specifically, how can you identify kits and inks that you should not use because they may be contaminated? FDA advises you to watch out for inks intended for permanent makeup or traditional body tattoos that:

• have no brand name, carry a dragon logo, and/or are missing the name and place of business of the manufacturer or distributor,
• are sold singly and in kits containing anywhere from five to 54, or perhaps more, bottles of inks of various colors, and
• are marked with “Lotch” [sic] and Batch numbers, and “Date produced” and “Best if used by” dates.

“If you’re buying tattoo inks or getting a tattoo from a professional tattoo artist, you should first examine the products to determine whether the inks or kits meet the above descriptions,” cautions Katz.

FDA’s goal is to encourage consumers and tattoo and permanent make-up artists to take certain precautions and to urge potentially infected clients to seek medical care. “Reporting an infection to FDA and the artist is important in order for FDA to investigate, and to enable the artist to take steps to prevent others from becoming infected,” says epidemiologist Katherine Hollinger, D.V.M., M.P.H., from the Office of Cosmetics and Colors.

What to Do
Consumers and tattoo artists should do the following:

• Seek immediate medical care if you experience any signs of infection.
• Don’t use tattoo inks and kits that have no brand name, carry a dragon logo, and/or are missing the name and place of business of the manufacturer or distributor.
• Dispose of tattoo inks that meet this description.
• Do not use recalled kits.
• Report adverse events or side effects through FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Updated: August 7, 2014

For additional information addressing Hepatitis and tattoos visit:
The Official Blog of the Hepatitis and Tattoos Website
Part of the Hepatitis C Support Project and the HCV Advocate
Be sure to check out our other blogs: The HBV Advocate Blog and the The HCV Advocate News & Pipeline Blog

High HCV Response Rates With Daclatasvir/Asunaprevir: Phase III Data

Reuters Health Information

High HCV Response Rates With Daclatasvir/Asunaprevir: Phase III Data

By Anne Harding

August 07, 2014

NEW YORK (Reuters Health) - A combination of daclatasvir plus asunaprevir yielded high rates of sustained virological response (SVR) in treatment-naive patients with hepatitis C 1B infection, including those with cirrhosis, in a multinational phase III trial.

Response rates were nearly as high in patients who either hadn't responded to peginterferon alfa (IFN) plus ribavirin, could not tolerate the drug combination, or who were ineligible to take it, according to Dr. Michael Manns of Hannover Medical School in Hannover, Germany and colleagues.

They reported the findings online July 28 in The Lancet.

"In this study it really showed that there is almost no significant side effects beyond the placebo," Dr. Manns told Reuters Health in a telephone interview. "The drawback is that it's a 24-week treatment."

Both drugs are being developed by Bristol-Myers Squibb and are expected to be approved in the U.S. and Europe in September, Dr. Manns said.

If the drug combination is approved, he noted, it will be the first oral regimen including two direct-acting antiviral agents (DAA) made by the same company. Daclatasvir would also be the first non-structural protein 5A (NS5A) inhibitor to be approved, Dr. Manns said. "Now with this drug we are able to intervene with three different steps in the hepatitis C life cycle."

In the HALLMARK-DUAL study, Dr. Mann and colleagues at 116 sites in 18 countries enrolled 307 treatment-naive patients, 205 patients who had not responded to IFN and ribavirin, and 235 patients who were either medically ineligible for IFN and ribavirin, could not tolerate the drug combination, or both. A third of patients had cirrhosis.

Treatment-naive patients were initially randomized to daclatasvir 60 mg once a day and asunaprevir 100 mg twice daily, or placebo, for 12 weeks. Afterward, the patients in the active-treatment group continued on the drug combination for 12 more weeks, while the placebo group patients were switched to a different daclatasvir plus asunaprevir study.

Everyone else - i.e., the non-responders and ineligible, intolerant, or ineligible/intolerant patients - received open-label daclatasvir plus asunaprevir for 24 weeks.

Ninety percent of patients in the treatment-naive group had a sustained virological response, as did 82% of the non-responders and 82% of the ineligible/intolerant group, the researchers found.

During the initial 12 weeks of the study, adverse event rates and grade 3 or 4 laboratory abnormalities were similar for the placebo and active-treatment groups. Rates of serious adverse events were 6% in the treatment-naive group, 5% among non-responders, and 7% in the ineligible/intolerant group. Adverse events leading to discontinuation occurred in 3%, 1%, and 1% of patients in each group, respectively.

Response rates were similar for patients with cirrhosis or without cirrhosis, except in patients with significant portal hypertension and thrombocytopenia, Dr. Manns noted.

Signature-resistance-associated variants (RAV)s in NS5A or NS3 sequences were the only baseline predictors for treatment failure in the HALLMARK-DUAL trial, Dr. Ed Gane of Auckland City Hospital in New Zealand noted in an editorial accompanying the study.

"This association suggests that testing for these RAVs should be done before asunaprevir plus daclatasvir are started and that this regimen should be avoided in affected patients," Dr. Gane writes.

Several other DAAs have recently been approved or awaiting approval, Dr. Gane noted. "When combined with targeted testing and treatment of populations who transmit infection...these DAA regimens might eventually eliminate HCV infection," he adds. "The only barrier to achieving this goal will be the ability to access these new therapies."

In developing countries with high rates of HCV, IFN-based treatments may still be the treatment of choice, given the costliness of DAAs, according to Dr. Gane. He concludes: "As almost 75% of all patients with HCV infection reside in economically deprived regions of eastern Europe, Asia, and the Middle East, consideration should be given to discounting prices in those regions. Eradication of HCV infection worldwide will only be achievable through universal access to HCV testing and new DAA regimens."

SOURCE: http://bit.ly/UYh8ri

Related
This study is currently recruiting participants
United States, California
Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus (RHACE 1)

France
Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)

Not yet recruiting
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1

Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

Listen-Solving Sovaldi: David Harlow Talks Value-Based Payment with Cyndy Nayer

August 07, 2014
Solving Sovaldi: David Harlow Talks Value-Based Payment with Cyndy Nayer

We have been deluged with stories about the $100-a-pill medication for Hepatitis C. Is it really worth $87,000? (Well, it's cheaper than a $600,000 liver transplant.) I had the opportunity to speak with Cyndy Nayer, of the Center of Health Engagement, about the issues surrounding this drug and its use, value-based approaches to payment, and the question of whether we are able to solve this problem in our current environment at all.

Given the nature of employment-based health insurance (even in an Obamacare world), and even given steps taken in the right direction by commercial ACOs, I have serious questions about whether long-term value-based payment structures can work (i.e., paying for a 90-day supply of a medication over three years), but Cyndy is more optimistic. If big pharma, payors and the health care delivery system are able to collaborate around this issue, then maybe there's hope for us after all.

Have a listen to our conversation (it clocks in at about 25 minutes; transcript to be posted as soon as it is available).

Listen here............

Related
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi 

How Can We Tell if Patients are Still at Risk for HCC after HCV Therapy?

Hepatitis C - Enanta Advances Into Combination Studies with Alisporivir (DEB025)

Enanta Pharmaceuticals’ HCV NS5A Inhibitor EDP-239 Advances into Combination Studies with Alisporivir (DEB025)

WATERTOWN, Mass., Aug 07, 2014 (BUSINESS WIRE) -- Enanta Pharmaceuticals, Inc. /quotes/zigman/14557530/delayed/quotes/nls/enta ENTA +0.24% a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that Novartis has advanced EDP-239, Enanta’s NS5A inhibitor for hepatitis C virus (HCV), into drug combination studies with alisporivir (DEB025), a cyclophilin inhibitor being developed by Novartis. These combination studies are part of Enanta’s existing collaboration with Novartis for the development of new combination therapies for the treatment of HCV using Enanta’s NS5A inhibitors.

EDP-239 is a direct-acting anti-viral (DAA) that directly inhibits replication of HCV. Alisporivir (DEB025) blocks HCV replication by targeting proteins in the host cell that are critical to replication of the hepatitis C virus (HCV). As a host-targeting antiviral (HTA), alisporivir (DEB025) is expected to have a high barrier to HCV resistance. It has also demonstrated in vitro anti-HCV activity across multiple HCV genotypes. As the most advanced oral HTA1, alisporivir (DEB025), when combined with EDP-239, may be an attractive drug combination for the next-generation of interferon-free HCV therapies.

The phase 1 combination study conducted by Novartis is investigating the pharmacokinetics, safety, and tolerability of alisporivir (DEB025) and EDP-239 when co-administered to healthy adult subjects and is scheduled to enroll 42 healthy subjects.

For more information on the complete study design, please visit www.clinicaltrials.gov .
“EDP-239 in combination with a cyclophilin inhibitor such as alisporivir provides a new combination of mechanisms to explore in the clinic,” commented Jay R. Luly, Ph.D., President and CEO. “The advancement of EDP-239 in partnership with Novartis provides Enanta with another opportunity to participate in additional HCV regimens under development.”

About EDP-239
EDP-239 is Enanta’s lead NS5A inhibitor for HCV infection. NS5A is a non-structural (NS) viral protein that is essential to viral replication of HCV. EDP-239 has demonstrated potent activity against major HCV genotypes when tested in the replicon assay, which is a common in vitro test for determining potency of an active compound in reducing HCV replication. In addition, EDP-239 has additive or synergistic antiviral activity when used in combination with other anti-HCV therapeutics (DAA and HTA) in reducing HCV replication. Enanta's NS5A program and intellectual property estate in the HCV field were derived from its internal drug discovery efforts.

NS5A Collaboration with Novartis
On February 16, 2012, Enanta entered into a license and collaboration agreement with Novartis for the development, manufacture and commercialization of its lead development candidate, EDP-239, and other NS5A inhibitor compounds. Under the terms of the agreement, Enanta received an upfront payment of $34 million and an $11 million milestone payment and is eligible to receive up to a total of $395 million in milestone payments if certain clinical, regulatory, and commercial milestones are met. Enanta is also eligible to receive tiered double-digit royalties on worldwide sales of products.

About Enanta
Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. Enanta is discovering, and in some cases developing, novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.

Source
BUSINESS WIRE

How Can We Tell if Patients are Still at Risk for HCC after HCV Therapy?

How Can We Tell if Patients are Still at Risk for HCC after HCV Therapy?

Kristine Novak

For patients with chronic Hepatitis C virus infection, high levels of α-fetoprotein after therapy can identify those at risk for hepatocellular carcinoma (HCC), researchers report in the July issue of Clinical Gastroenterology and Hepatology.

In persons with chronic HCV infection, lack of sustained virologic response (SVR) 24 weeks after the end of interferon therapy is a significant risk factor for HCC. Although many pretreatment factors certainly affect HCC incidence, little is known about post-treatment factors—many change during the course of interferon therapy.

Only 1.3% to 4.7% of patients who eradicate their HCV infection with interferon therapy develop HCC within 5 years. Conversely, patients who do not eradicate their HCV infection with interferon therapy have a high incidence of HCC, yet many remain cancer-free for long periods.

Tsugiko Oze et al. performed a prospective study to evaluate risk factors for HCC incidence separately between the 2 groups, which have distinct levels of risk for HCC.

Oze et al. knew that serum levels of alanine aminotransferase, α-fetoprotein, and liver fibrosis usually decrease with interferon therapy. Could these be factors that affect later risk for HCC?

Oze et al. collected specimens and data from 2659 patients with chronic hepatitis C without a history of HCC before and during treatment with interferon and ribavirin (48 to 72 weeks for HCV genotype 1 or 24 weeks for HCV genotype 2) in Japan.

HCC developed in 104 patients during a mean observation period of 40 months. Older age, being male, lower platelet counts, higher baseline levels of α-fetoprotein, and lack of an SVR were overall risk factors for HCC.

Among patients with SVRs, levels of α-fetoprotein and alanine aminotransferase significantly decreased after therapy. Post-treatment risk factors for HCC among patients with SVRs included higher levels of α-fetoprotein 24 weeks after the end of treatment and older age.

Among patients without SVRs, risk factors for HCC included higher levels of α-fetoprotein 24 weeks after the end of treatment, integrated level of alanine aminotransferase, older age, and being male.

Level of α-fetoprotein 24 weeks after the end of treatment (≥10 ng/mL, 10–5 ng/mL, or <5 ng/mL) was a better predictor of HCC incidence than pretreatment level among patients with and without SVRs.

Therefore, the level of α-fetoprotein 24 weeks after the end of treatment was associated strongly with HCC incidence irrespective of SVR.

Oze et al. would like to investigate whether the results obtained from this study apply to patients with cirrhosis, who are at greatest risk for HCC. Also, it will be important to determine whether the level of α-fetoprotein reduces HCC incidence in patients treated with interferon-free regimens (direct-acting antivirals).

Although level of α-fetoprotein can be a comprehensive surrogate marker for HCC risk in relation to various factors, such as liver inflammation and fibrosis, Oze et al. propose that α-fetoprotein is a marker for HCC, independent of liver inflammation.

Oze et al. conclude that, in clinical practice, even if HCV and eradicated and serum level of alanine aminotransferase is normal, careful surveillance for HCC was needed for patients with levels of α-fetoprotein of 5 ng/mL or greater.

Patients who do not achieve SVRs and have high levels of α-fetoprotein and alanine aminotransferase should be carefully monitored.

Source

AbbVie begins 'first-of-its-kind' hep C charity pilot

Will work with Addaction Cornwall and The Hepatitis C Trust

Addaction's David Baldock (left) and Len Gooblar, head of strategic health initiatives at AbbVie

AbbVie begins 'first-of-its-kind' hep C charity pilot

AbbVie is piloting a new UK programme to validate different approaches to improving hepatitis C testing and treatment in those with a history of injection drug use.

The pharma company will partner with two charities on the programme, which it described as 'a first-in-class pilot' that will use an evidence-based approach encompassing workforce training, peer-to-peer education and buddying (one-on-one support that helps people through their hospital and treatment journey).

Drug users are a typically hard to reach population who find it difficult to access traditional models of care.

AbbVie, Addaction Cornwall - the local branch of the national drug and alcohol charity, and The Hepatitis C Trust are hoping that the successful completion of their pilot programme will be followed by a national roll-out in 2015.

It is estimated that in England there are 160,000 people living with chronic hepatitis C infection, 19,705 of them in the South West, and 1,398 in Cornwall.

Sue Clark, operations director, Addaction Cornwall, said: “We are proud to be leading the way in piloting a ground-breaking partnership programme to improve the health of our communities, while contributing toward a longer-term vision of eliminating the hepatitis C virus (HCV) in the South West.”

Beyond testing and treating people with a history of injection drug use, the new programme hopes to free up NHS resources and reduce community-acquired transmission of hepatitis C.

Source

New Hepatitis-C drug Sovaldi 99% cheaper in India

New Hepatitis-C drug 99% cheaper in India

Rupali Mukherjee,TNN

Aug 6, 2014, 05.04 AM IST

MUMBAI: There is some hope for hepatitis C patients in India. Amid mounting criticism over the eye-popping price of Sovaldi, the first breakthrough treatment for hepatitis C virus, US pharma firm Gilead Sciences has offered to introduce the drug in India at nearly 99% discount of the US price.

The blockbuster hepatitis C drug will cost about $900 (around Rs 54,000) in India for a 12-week course of treatment. That would be a fraction of the $84,000 (over Rs 50 lakh) price tag for the same treatment in US.

Gilead Sciences will adopt a tiered pricing structure here, like the one for HIV treatment in developing countries like India.

"The pricing of Sovaldi in India at $300 per bottle, is our low income pricing, similar to the price negotiated with Egypt for its government-run programme. We hope with local production by our partners in India, higher volumes and continued research & development on the drug will lead to a further reduction in prices at a later stage", Gregg Alton, executive V-P (corporate & medical affairs), Gilead Sciences told TOI in a telecon from the US.

"We have set three basic pricing tiers (based on a country's per capita income and hepatitis C prevalence) that serve as the starting point for negotiations with national governments. The tiers are low-income, low middle-income and upper-middle income," Alton said.

The pricing and launch of the breakthrough treatment of hepatitis C is crucial for India, which has one of the highest incidence of the virus, with over 12 million chronically infected, according to WHO.

However, even at $900, many patients will still not be able to afford the therapy in India. The cost will escalate for those who are prescribed a six-month treatment.

Alton said existing treatment in India is more expensive than the one his company will offer. Also, Sovaldi prices are expected to fall with generic competition and local manufacture.

Existing hepatitis C treatment in India is expensive (Rs 3,75,000 or $6000), complex (24-48 weeks of injectables) and has serious side-effects.

Gilead also plans to license its new therapy to Indian generic manufacturers, who will then supply lower cost versions of the drug in the country, and across global markets. It is in talks with its HIV drug pasrtners -- Ranbaxy, Mylan, Strides Arcolab -- to finalise an agreement for Sovaldi. The licensee agreements could be finalised by September, Alton said.

At present, the company has initiated clinical trials of the drug in India, with results expected in 2015-end. While Gilead Sciences has applied for multiple patents in India on sofosbuvir, even before its grant the company is already embroiled in a fight. A patient group, Delhi Network of Positive People, and UK-based intellectual property law firm, Initiative for Medicines Access and Knowledge, have together filed an opposition to prevent Gilead from gaining a patent in India

Source- The Times Of India 

In The News

Aug 8 Forbes

Even At $900 (Vs. $84,000 In US) Hep C Cure Sovaldi's Cost Could Be Unacceptable In India

Indian officials are quick to point out that 80% of their populace are without insurance and that even at $900, the price of Sovaldi is beyond the reach of many. But this won’t necessarily stop hepatitis C patients in India from getting the drug. It is not uncommon for the Indian government to take actions that impact the ability of a foreign company to sell drugs in India that are deemed too expensive. 

Continue reading...


Aug 7 WSJ

How Much? Gilead Will Charge $900 for Sovaldi in India
By Ed Silverman

The pricing reflects an effort by Gilead to forestall the sort of criticism the pharmaceutical industry has often encountered when selling life-saving medicines in poorer countries, which have often complained bitterly that many of its citizens have been unable to afford some treatments.

India has become the latest country where the Sovaldi hepatitis C treatment will be offered for $900 per patient. The move comes a few weeks after the manufacturer, Gilead Sciences, is making the medication available for the same price in Egypt.

Read More »

Aug 6 - New York Times

Why the Price of Sovaldi Is a Shock to the System

Gilead Sciences, its manufacturer, says its price is comparable to existing treatments for hepatitis C, a viral disease that causes liver damage, including cirrhosis and cancer in some cases. The company also describes it as a breakthrough drug, and essentially in a class of its own. Because it is more effective than existing therapies and has many fewer side effects, it is much more popular. A Gilead executive described it as a “new price to the system.”

Continue reading..... 

Inside Views Compulsory Licences Needed For Affordable Hepatitis C Innovative Drug Regimens

Inside Views Compulsory Licences Needed For Affordable Hepatitis C Innovative Drug Regimens 
Published on 5 August 2014 @ 2:52 am

Disclaimer: the views expressed in this column are solely those of the authors and are not associated with Intellectual Property Watch. IP-Watch expressly disclaims and refuses any responsibility or liability for the content, style or form of any posts made to this forum, which remain solely the responsibility of their authors.

Intellectual Property Watch

By Daniele Dionisio

Summary: Compulsory licences should be issued to roll out generic versions of innovative HCV drugs. Only generic competition can push down the extortionate prices of these lifesaving medicines, while placing equitable access and public interest before monopolistic pharma companies’ business strategies.

A leading cause of liver cancer and cirrhosis, infection by hepatitis C virus (HCV) affects at least 185 million people worldwide, 85% of whom live in low (13%) and middle (72%) income countries. Around 15% of Egypt’s population, for example, is infected – the world’s highest prevalence – while it is estimated that 12 million people in India have hepatitis C.

Nearly 350,000 people are killed by hepatitis C yearly, where preventive vaccines are lacking.

And this occurs at a time when at least 1.2 million people in Japan and three million Americans suffer from hepatitis C, while the infection is a major European public-health challenge (between 0.4% and 3.5% of the population in different EU Member States), as the most common single cause of liver transplantation.

Up to last year, the success rate of available treatments was poor, with a ribavirin-interferon combination being effective in less than 50% of patients after a year (while being fraught with important side effects), and directly acting newer drugs not exceeding 75% sustained response without fully eliminating the need for ribavirin-interferon therapy.

But in recent months innovative medicines have been approved that can cure most HCV infections and do not require interferon in many cases. By directly blocking essential steps for HCV to replicate, they have shown convincing efficacy, mainly when used in combination (functional cure rates in excess of 90% after 12 week treatment), with a good safety profile. These medicines include Bristol-Myers Squibb daclatasvir (Daklinza®), Gilead sofosbuvir (Sovaldi ®), Janssen simeprevir(Olysio®), and Bristol-Myers Squibb asunaprevir (Sunvepra®).

And new entries are expected soon, now that big companies are increasingly engaged in bids and acquisition deals to procure new components for more effective, powerful combination regimens. As an example, Merck will buy the biotechnology company Idenix Pharmaceuticals for $3.85 billion, aiming, as reported, to add a drug from Idenix to its own combination of two agents and develop a once-a-day pill for all C virus subtypes in as little as four week treatment.

Needless to say, the high prices the companies are paying for such endeavors will eventually be over-rewarded by the billions of dollars in annual sales a successful drug regimen could secure. Purportedly , Sovaldi ® already helped Gilead rake in, since its debut last December, about $2.3 billion in the first three months of this year, in compensation of $11 billion the company spent in 2011 to obtain the rights to sofosbuvir through its acquisition of Pharmasset.

Good news for big pharma profits, these circumstances turn into bad news when it comes to prices the manufacturers apply for a 12-week course of each breakthrough regimen.

Nothing less than scandalous, estimated prices, averaging from $133,000 to $200,000 for a two-drug new combination regimen (against trifling production costs!), definitely impair affordability and put these drugs beyond the grasp of most of the 90% of hepatitis C patients in low- and middle-income countries where a 12-week course of treatment should cost no more than $500, as firmly believed by Médecins Sans Frontières.

What’s more, following inclusion of these drugs in April 2014 WHO treatment guidelines for hepatitis C virus, the cost issue has become all the more critical for national budgets in the resource-limited and affluent countries as well.

As such, it comes as no surprise that, according to allowances in India’s Patent Law as regards lack of real innovation, oppositions were recently filed with the competent authority in India against granting Sovaldi® a patent.

As an effect of the mounting pressure against prices out-of-reach for national health insurances, big pharma has begun negotiating bilateral agreements and voluntary licence (VL) deals with country governments and generic manufacturers. In the Gilead cases with Egypt and India, Sovaldi® has been priced at $900 for a 12-week course, and negotiations are in progress with Indian manufacturers to produce generic sofosbuvir.

Unfortunately, as reported, while the price agreed with Egypt would rank beyond the reach of the domestic health budget, voluntary licence negotiations with India are feared to exclude export to many middle-income countries with high HCV burden.

Likely, this is not happening by chance at a time when international donors are cutting support to middle-income economies and the brand industry is eagerly looking to these fast-growing markets where a number of well-off elites who can afford out-of-pocket spending (at least 300 million people in India, 800 million in China), now live.

Admittedly, although VLs, as part of the flexibilities laid down in the World Trade OrganizationTRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, do include permission for export, a number of constraints limit this model basically because the originators actually hold control over the whole manufacturing, distribution and pricing chain of steps: an unbalanced mechanism.

On the contrary, unrestrained competition by compulsory licences (CLs), another flexibility provision in TRIPS, would be a far better mechanism for maximizing the affordability byallowing“…someone else to produce the patented product or use the patented process without the consent of the patent holder”.

This would also be the case for an allowance for export agreed upon through a 2003 WTO waiver (the “August 30th Decision”) that permits export under CLs to countries unable to manufacture key medicines themselves.

On these grounds, compulsory licences should be issued at once to roll out generic versions of innovative HCV drugs. Only generic competition would be up to pushing down the extortionate prices of these lifesaving medicines, while making equitable access and public interest overcome monopolistic pharma companies’ business strategies.

To the point, cheap generic versions of state-of-the-art HCV drugs would reasonably be within reach. Relevantly, publisheddata this year argue that generic-drug makers would be able to roll out these medicines at $100–250 for a 12-week course.

Overall, these considerations align with a resolution on hepatitis unanimously adopted by member states at WHO General Assembly in May.

Among others, the resolution urges member states …(12) to consider, as necessary, national legislative mechanisms for the use of the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights in order to promote access to specific pharmaceutical products;…

The resolution also requests the Director General ….(9) to support Member States with technical assistance in the use of trade-related aspects of intellectual property rights (TRIPS) flexibilities when needed, in accordance with the global strategy and plan of action on public health, innovation and intellectual property;…

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Starting February 2012, Dionisio is Head of the research project Geopolitics, Public Health and Access to Medicines (GESPAM). He may be reached at d.dionisio@tiscali.it https://twitter.com/DanieleDionisio

Source