Friday, January 20, 2017

Successful phase 3 trial of drug for liver cancer

Successful phase 3 trial of drug for liver cancer
Date: January 18, 2017
Source: The Mount Sinai Hospital / Mount Sinai School of Medicine

An international phase 3 trial has found that the drug regorafenib improved survival in patients with advanced hepatocellular carcinoma, a form of liver cancer, giving people who previously had no other options a better chance at survival. The trial included 152 sites in 21 countries.

An international phase 3 trial has found that the drug regorafenib improved survival in patients with advanced hepatocellular carcinoma (HCC), a form of liver cancer, giving people who previously had no other options a better chance at survival. Results from the study, which included researchers at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, were recently published online in The Lancet. The trial, funded by Bayer, included 152 sites in 21 countries.

About 40 percent of HCC cases are diagnosed at advanced stages, a point when HCC is particularly difficult to treat. This trial provides evidence that regorafenib is the first systemic treatment for patients whose HCC progressed during treatment with sorafenib, the only other drug with proven clinical benefit.

This study tested regorafenib's effectiveness as a second-line therapy on 573 patients previously treated with sorafenib, 194 of whom were given a placebo. Regorafenib, a multikinase inhibitor, significantly improved overall survival, from 7.8 months on placebo to 10.6 months with regorafenib. Two patients treated with regorafenib had their tumor shrink to an undetectable level, according to the study.

"This study represents a breakthrough in the management of hepatocellular carcinoma, since it provides evidence for clinical benefits in an area that was an unmet medical need," said Josep M. Llovet, MD, founder and Director of the Liver Cancer Program and Professor of Medicine and Liver Diseases at the Icahn School of Medicine at Mount Sinai. "Regorafenib has shown it can improve survival in patients with advanced hepatocellular carcinoma progressing on sorafenib. Previously, no treatment was available for these patients."

Dr. Llovet was a member of the clinical trial's steering committee, and Charissa Chang, MD, Assistant Professor of Medicine and Liver Diseases at the Icahn School of Medicine, was principal investigator of the Mount Sinai testing site.

The success of this trial opens the field for testing drugs in third-line treatment of HCC and provides a rationale to test regorafenib as a first-line treatment or in combination with therapies administered directly into the tumor or diseased liver in patients in an earlier stage of HCC, according to Dr. Llovet. In this trial, regorafenib was well-tolerated with manageable adverse events, according to the paper in Lancet.

In January, Bayer announced that the U.S. Food and Drug Administration (FDA) had granted priority review status for Stivarga (regorafenib) as a second-line systemic treatment for patients with hepatocellular carcinoma. This research was also presented during the European Society of Medical Oncology's World Congress on Gastrointestinal Cancer in June.

Liver cancer is the second-leading primary cause of cancer-related deaths worldwide.

Story Source:
Materials provided by The Mount Sinai Hospital / Mount Sinai School of Medicine. Note: Content may be edited for style and length.

Journal Reference:
Jordi Bruix, Shukui Qin, Philippe Merle, Alessandro Granito, Yi-Hsiang Huang, György Bodoky, Marc Pracht, Osamu Yokosuka, Olivier Rosmorduc, Valeriy Breder, René Gerolami, Gianluca Masi, Paul J Ross, Tianqiang Song, Jean-Pierre Bronowicki, Isabelle Ollivier-Hourmand, Masatoshi Kudo, Ann-Lii Cheng, Josep M Llovet, Richard S Finn, Marie-Aude LeBerre, Annette Baumhauer, Gerold Meinhardt, Guohong Han. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet, 2017; 389 (10064): 56 DOI: 10.1016/S0140-6736(16)32453-9

Berlin, January 20, 2017 – Bayer today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review to Bayer Yakuhin, Ltd., Osaka, Japan, for regorafenib in the second-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

January 4th, 2017
FDA granted priority review to an application seeking approval of Stivarga (regorafenib) for the second-line treatment of patients with hepatocellular carcinoma (HCC). Bayer noted that the priority review designation was supported by data from the Phase III RESORCE trial of patients with HCC whose disease progressed despite treatment with the company's drug Nexavar (sorafenib).

EMA validates Gilead's marketing authorization application for Sofosbuvir/Velpatasvir/Voxilaprevir

Links Of Interest
Research and news

European Medicines Agency Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)

– SOF/VEL/VOX Granted an Accelerated Assessment by the European Medicines Agency –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 20, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated and is now under assessment by the European Medicines Agency (EMA).

“Direct-acting antiviral treatments have transformed our ability to treat hepatitis C; however, for some patients who have failed to achieve a cure with these regimens, effective and well-tolerated therapies are still needed,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-acting antiviral therapy, in Europe and around the world.”

The MAA for SOF/VEL/VOX is supported by data from two Phase 3 studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the fixed-dose combination in direct-acting antiviral (DAA)-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A inhibitor-containing regimen. Across the two studies, 97 percent of patients treated with SOF/VEL/VOX (n=430/445) achieved the primary efficacy endpoint of SVR12. The MAA also includes data from two additional phase 3 studies (POLARIS-2 and POLARIS-3), which evaluated 8 weeks of SOF/VEL/VOX in 611 DAA-naïve patients with genotypes 1-6. In POLARIS-3, 96 percent of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea.

SOF/VEL/VOX for the treatment of HCV will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway and Iceland. The review will follow an accelerated procedure reserved for medicinal products expected to be of major public health interest. Gilead also submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for SOF/VEL/VOX on December 8, 2016.

SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established.

About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the European Commission or other regulatory agencies, including the FDA, may not approve SOF/VEL/VOX for the treatment of chronic hepatitis C and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize SOF/VEL/VOX for chronic hepatitis C. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10­Q for the quarter ended September 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Wednesday, January 18, 2017

Scaling-up HCV treatment to achieve WHO targets by 2030

Accepted Articles

Scaling-up HCV treatment to achieve WHO targets by 2030
Graham Cooke

Accepted manuscript online: 10 January 2017
DOI: 10.1111/tmi.12837

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WHO recently launched a new strategy for tackling viral hepatitis with ambitious goals for reducing both deaths and new infections by 2030 [1]. Antiviral therapy is one only part of a multi-faceted strategy needed to tackle viral hepatitis, but for hepatitis C (HCV), the absence of an effective vaccine means that achieving these targets is going to require substantial scale-up of HCV treatment. Reaching the target of treating 80% of those in need by 2030 will require reaching at least 70 million people [2].....

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Article Of Interest
HCV Universal Treatment Access /Global Elimination - Targeted direct-acting antiviral treatment for chronic hepatitis C: A financial reality or an obstacle to elimination? - Editorial

Researchers discover a protein that protects against fatty liver

Researchers discover a protein that protects against fatty liver

A team co-headed by scientists at the Institute for Research in Biomedicine (IRB Barcelona) and the IDIBAPS Biomedical Research Institute (part of the Hospital Clínic de Barcelona) has revealed the capacity of the CPEB4 protein to prevent fatty liver disease.

This condition generally leads to chronic inflammation (non-alcoholic steatohepatitis), which can trigger fibrosis, cirrhosis and ultimately liver cancer. This study on the basic biology of the liver paves the way to examine therapeutic strategies to fight and prevent fatty liver disease. The results have appeared in Nature Cell Biology this week.

CPEB4 and fatty liver

Non-alcoholic fatty liver is characterised by the accumulation of fat deposits in hepatocytes. The development of this condition is determined by many factors that have not been well described to date. However, obesity and lifestyle, as well as aging, are associated with an increase in the incidence of this disease. Also, a number of large-scale genomics studies have linked variants of the CPEB4 gene with the impairment of fat metabolism.

The scientists at IRB Barcelona depleted CPEB4 expression in mouse livers in order to study the function of this protein. They observed that the mice developed fatty liver as they aged. Furthermore, young CPEB4-depleted mice fed a high-fat diet also developed this condition in a more pronounced manner.

Carlos Maíllo, first author of the article and PhD student at IRB Barcelona funded by a “la Caixa” grant, has described the molecular function of CPEB4. He reveals that this protein is essential to drive the liver stress response.

Specifically, under stress, caused by uncontrolled ingestion of fats for example, the endoplasmic reticulum—a cell organelle associated with protein synthesis and folding and lipid metabolism—stops its activity in order to re-establish cell equilibrium. This “clean-up” mechanism is orchestrated by CPEB4 and varies in function of the time of day—being more active in humans during the day (when the liver has most work) and dropping off at night.

Without CPEB4, the endoplasmic reticulum is unable to activate the stress response, thus causing hepatocytes to accumulate the lipids produced by the fatty liver.

New treatments?
Raúl Méndez, ICREA researcher at IRB Barcelona and co-leader of the study, explains that “knowledge of the hepatic function of CPEB4 could be useful as a predictive marker for those people with variants of this protein, thus serving to prevent this condition, for example, through improvements in diet and better choice of eating times. Such knowledge could also contribute to the development of treatments that boost the clean-up process”.

The researchers have managed to reverse fatty liver disease in mice by treatment with a drug called Tudca, which is currently used for other disorders. This drug exerts the same function as the proteins that are activated by CPEB4 and that are responsible for cleaning up the cell, namely chaperones. “In the future it may be possible to design molecules like Tudca that specifically target CPEB4, thus enhancing the liver clean-up process,” proposes Méndez.

“This basic research study does not have a direct and immediate clinical application, but it lays down the foundation for the applied science that follows,” says Mercedes Fernández, co-leader of the study and head of the group at IDIBAPS and the Biomedical Research Networking Center of Hepatic and Digestive Diseases (CIBEREHD).

Fernández warns, “Given the obesity epidemic in the US and worldwide, an increase in those affected by non-alcoholic fatty liver disease is expected in the coming decades and we still do not have a suitable treatment for this condition; A fundamental understanding of this medical problem is therefore essential for development of novel treatment strategies.”

It is estimated that between 80 and 100 million people in the US alone suffer from fatty liver disease. People with this disease have an increased risk of cirrhosis and liver cancer. Moreover, liver cancer incidence has more than tripled since 1980 and is the primary cause of death in patients with cirrhosis.

This study has received funding from the Worldwide Cancer Research Foundation in the UK, the Spanish Association Against Cancer (AECC), the Fundación Botín by Banco Santander through its Santander Universities Global Division, the Spanish Ministry of Economy and Competitiveness/ERDF and the Government of Catalonia.

Reference article:
Carlos Maillo, Judit Martín, David Sebastián, Maribel Hernández-Alvarez, Mar García-Rocha, Oscar Reina, Antonio Zorzano, Mercedes Fernandez and Raúl Méndez

Circadian- and UPR-dependent control of CPEB4 mediates a translational response to counteract hepatic steatosis under ER stress

Nature Cell Biology (2017) DOI: 10.1038/ncb3461
Article Source

Hepatitis C Treatment: What to Expect in 2017

ARC Journal of Hepatology and Gastroenterology
Volume-1 Issue-1, 2016, Page No: 9-16

Hepatitis C Treatment: What to Expect in 2017
Andreia Gi1, Ana Miguel Matos1,2, Cristina Luxo1,2

Hepatitis C virus infection is a substantial health problem on a global scale [1] It is estimated that approximately 185 million people live with hepatitis C worldwide, with 350,000–500,000 patients dying each year from liver disease associated with hepatitis C[2]. However, something is about to change. In the latest years, there has been a shift in treatment paradigm due to the discovery and approval of direct-acting antiviral agents [3]. Nevertheless, these regimens still included ribavirin, which increased side effects, cost, and inconvenience of treatment. Moreover, improved treatment options for patients who did not respond to prior direct-acting antiviral agents (and may have drug-resistant virus) and for hepatitis C virus genotype 3 infection, with or without cirrhosis, were desirable. Thus, three new promising direct-acting antiviral agents were developed to fulfill these significant unmet medical needs [4,5]

In many countries, sustainability has been the buzzword across all stakeholders. Still, direct-acting antiviral agents have demonstrated a favorable cost-effectiveness profile [6] and their exceptional cure rates have already helped establish the concept that chronic hepatitis C virus infection can be cured in most, if not all, affected individuals.

This review summarizes the clinical potential of velpatasvir-sofosbuvir, velpatasvir-voxilaprevir-sofosbuvir and glecaprevir-pibrentasvir, discussing key results and future directions. Its aim is to highlight the significance of a future free from hepatitis C.

Keywords: Hepatitis C Virus, Direct-Acting Antiviral Agents, Sustained Virologic Response, Cure, Difficult-To- Treat Populations

HCV - Hepatitis C virus
HCC - Hepatocellular carcinoma
SVR - Sustained Virologic Response
IFN - Interferon
RBV - Ribavirin
DAAs - Direct-acting antiviral agents
SOF – Sofosbuvir
VEL – Velpatasvir
VOX - Voxilaprevir

The Hepatitis C virus (HCV) is a small-enveloped virus of the Flaviridae family and genus Hepacivirus, [7] with a single-stranded positive RNA molecule of approximately 9.6 kb [8]. Prior to the discovery of the viral agent, HCV was mainly transmitted via blood products. Since then, injection drug use has arisen as the major mode of transmission in developed countries [2]

The main problem is that, following exposure to HCV, only a minority of patients clears the acute infection, whereas 80% persist with life-long chronic viremia[9] Chronic HCV infection is a serious, progressive, and potentially life-threatening disease [10,11] If left untreated, over time it can cause liver damage or failure due to the development of cirrhosis. This liver complication can lead patients at substantial risk of decompensated disease and hepatocellular carcinoma (HCC), [12] which impose a considerable burden on affected people, healthcare systems and society [13,14] Early diagnosis could help prevent these consequences, but HCV infection is often undiagnosed because it is usually asymptomatic during decades and so, the majority of HCV-infected individuals are unaware of their infection [15].

The goal of treatment in all infected individuals, regardless of which of the six major genotypes are present, remains the achievement of a sustained virologic response (SVR) in which circulating HCV RNA is undetectable (with the use of a highly sensitive assay) following treatment. When a SVR is achieved, there is a 99% chance that the hepatitis C infection is cured [13,16]. Historically, SVR was defined as HCV RNA levels below a designated threshold of quantification 24 weeks after completion of treatment (SVR24)[17]. However, more recent data shows that viral clearance 12 weeks post-treatment (and sometimes, even 8 weeks) correlates closely to SVR24[18]. Therefore, an undetectable HCV RNA at 12 weeks after treatment (SVR12) is considered an appropriate primary efficacy endpoint [19] and translates into “cure” for nearly all patients[13]

2. Direct-Acting Antiviral Agents Versus Interferon-Based Therapies
The new regimens for HCV mean a breakthrough novelty in the history of anti-HCV treatment. Previous treatments for HCV were often long and difficult. Many lasted from 24 to 48 weeks and showed suboptimal efficacy in viral response with a range of commonly occurring significant side effects, which impaired therapeutic compliance[20]. Nowadays, HCV patients can benefit from a less complex administration schedule and expect interferon (IFN) and even ribavirin (RBV)-free combinations. This results in a reduction of the incidence and severity of adverse events, optimizing quality of life during therapy and improving adherence to direct-acting antiviral agents (DAAs).

3. Sofosbuvir-Velpatasvir
Sofosbuvir-velpatasvir (EPCLUSA®) is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In clinical studies, sofosbuvir-velpatasvir (SOF-VEL) had high overall cure rates. (Table 1) The most common side effects were headache and tiredness [21].

Clinical Study (Reference)Number of patients (% cirrhosis)HCV genotype (%)Treatment HistorySVR12 by Genotype, Cirrhosis and Treatment Experience
ASTRAL-1 (22)740 (19%)1
Treatment-naïve and treatment- experiencedSOF - VEL, 12 weeksGenotype 1a98% (206/210)
Genotype 1b99% (117/118)
Genotype  2100% (104/104)
Genotype  4100% (116/116)
Genotype  597% (34/35)
Genotype  6100% (41/41)
Without Cirrhosis99% (496/501)
With Cirrhosis99% (120/121)
Treatment- naïve99% (418/423)
Treatment- experienced99% (200/201)
ASTRAL-2 (23)266(14%)2(100%)Treatment-naïve and treatment- experienced SOF - VEL, 12weeksTreatment- naïve without cirrhosis99% (99/100)
SOF + RBV, 12 weeksTreatment- naïve without cirrhosis96% (92/96)
SOF - VEL, 12 weeksTreatment- naïve with cirrhosis100% (15/15)
SOF + RBV, 12 weeksTreatment- naïve with cirrhosis93% (14/15)
SOF - VEL, 12 weeksTreatment- experienced without cirrhosis100% (15/15)
SOF + RBV, 12 weeksTreatment- experienced without cirrhosis81% (13/16)
SOF - VEL, 12 weeksTreatment- experienced with cirrhosis100% (4/4)
SOF + RBV, 12 weeksTreatment- experienced with cirrhosis100% (4/4)
ASTRAL-3 (23)552(30%)3(100%)Treatment-naïve and treatment- experiencedSOF - VEL, 12 weeksTreatment- naïve without cirrhosis98% (160/163)
SOF + RBV, 24 weeksTreatment- naïve without cirrhosis90% (141/156)
SOF - VEL, 12 weeksTreatment- naïve with cirrhosis93% (40/43)
SOF + RBV, 24 weeksTreatment- naïve with cirrhosis73% (33/45)
SOF - VEL, 12 weeksTreatment- experienced without cirrhosis91% (31/34)
SOF + RBV, 24 weeksTreatment- experienced without cirrhosis71% (22/31)
SOF - VEL, 12 weeksTreatment- experienced with cirrhosis89% (33/37)
SOF + RBV, 24 weeksTreatment- experienced with cirrhosis

4. Sofosbuvir-Velpatasvir-Voxilaprevir
Four Phase 3 clinical studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) evaluated a once-daily, fixed-dose combination of sofosbuvir (SOF), a nucleotide analog NS5B polymerase inhibitor; velpatasvir (VEL), a pangenotypic NS5A inhibitor; and voxilaprevir (VOX; GS-9857), an investigational pangenotypic NS3/4A protease inhibitor, for the treatment of genotype 1,2,3,4,5 and 6 chronic HCV infection. (Table 3)

The most common adverse events among patients who received SOF-VEL-VOX were headache, fatigue, diarrhea and nausea. The overall incidence of adverse events was similar to placebo or SOF- VEL. Among the 1,056 patients who received SOF-VEL-VOX in the four studies, only a patient receiving SOF-VEL-VOX for 12 weeks discontinued due to an adverse event[26]. These results show that this new three-drug co-formulation with different mechanisms of action and high barrier to resistance can provide high cure rates for patients who had previously failed treatment with other DAAs.

Table 2. Summary of clinical studies of sofosbuvir-velpatasvir in special populations

3. Summary of clinical studies of sofosbuvir-velpatasvir-voxilaprevir

5. Glecaprevir-Pibrentasvir

Glecaprevir-pibrentasvir is an investigational, pan-genotypic regimen that is being evaluated (table 4) not only as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, but also in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.

This investigational, pan-genotypic regimen of glecaprevir-pibrentasvir is showing to be well tolerated with a favorable safety profile in these difficult-to-treat populations. The most commonly reported adverse events included fatigue and nausea.

Table 4. Summary of clinical studies of glecaprevir-pibrentasvir

6. Discussion
Although the post-marketing phase always requires a careful evaluation of data from the “everyday” clinical practice experience, clinical trials have showed that these new DAA combinations have resolved most issues related to HCV treatment compared with the past regimens. Despite the approval of the first DAAs which have provided high cure rates and simplified treatment for most HCV patients, HCV genotype 3-infected patients with cirrhosis, patients with chronic kidney disease and those who have failed previous treatment with DAAs continued to represent an unmet medical need. In the era of velpatasvir-sofosbuvir, velpatasvir-voxilaprevir-sofosbuvir and glecaprevir- pibrentasvir, DAA therapy provides a new way to manage these difficult-to-treat HCV-infected patients, who are at a high risk of serious conditions[30]. They are now contemplated and are therefore expected to have a much better prognosis than they have had until very recently. Perhaps, soon, we may no longer have difficult-to-treat populations.

The advent of new generation oral antiviral therapy has led to major improvements in efficacy and tolerability but has also resulted in an explosion of data with increased treatment choice complexity [31].

Thus, clinicians need more detailed, accurate and timely information in order to choose the right regimen for individual patients and educate them. When they counsel and guide their patients, these ones are less likely to be anxious or resistant about taking steps toward possible cure. However, cure does not prevent reinfection and so, it is crucial to advise patients on measures that will reduce their risk (avoid alcohol intake and sexual and injection risk behaviors, eat a balanced diet and take exercise are some examples).

7. Conclusion
DAAs have shown that it is possible to minimize the spread of HCV and the morbidity and mortality associated with HCV infection[32].

Despite the financial controversy around their high costs, which have served as a major barrier for more widespread use, many stakeholders recognize now their long-term cost-benefits and the advantages of a future free from hepatitis C are manifest.

It is true that patients undergoing treatment need systematic monitoring before, during and after therapy, but these new treatment options have offered them hope and re-awakening. It is a clear evolution compared with the previous IFN-based therapies.

8. Future Directions
At a future time, treatment failure and resistance can occur and become a clinical challenge to be solved[30,33].

However, before them, there are already some questions that should concern us. First one is why is the association of RBV with DAAs, in some cases, increasing the SVR12 rate and shortening the duration of treatment? Then, at what point is it no longer worth treating a patient? Will we have the financial capacity to treat reinfected-patients? Will this simplicity of therapeutic regimen encourage risk behaviors in the future?

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AASLD and IDSA  clinical guidelines fall short of conflict of interest standards

Prominent clinical guidelines fall short of conflict of interest standards
From Twitter To Treatment Guidelines, Industry Influence Permeates Medicine
Two committees that developed guidelines for the management of high cholesterol and hepatitis C did not fully comply with standards set by the Institute of Medicine in 2011 to limit the number of industry-funded panelists. The Institute of Medicine required that fewer than half of guideline writers have commercial ties and that all chairs and co-chairs have no conflicts. But in both cases, at least one chairperson received money from industry and, in the case of the hepatitis C guidelines, a substantial majority of panelists also received money.

Moreover, the authors noted, when separate committees with no commercial conflicts developed guidelines for cholesterol and hepatitis C, the recommendations were more conservative and called for less expensive first-line treatments.
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Increased conflict of interest policies needed for guideline committees, advocacy organizations
The guideline for cholesterol by the American College of Cardiology and American Heart Association, as well as the guideline for hepatitis C virus treatment by the American Association for the Study of Liver Diseases and Infectious Diseases Society of America did not fully meet the Institute of Medicine standards for commercial conflict of interest management, according to studies published in JAMA Internal Medicine. The authors noted that modest or substantial industry support was common among many patient advocacy organizations, and that such support could influence their positions.
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