Hepatitis C Management -- Professor Geoffrey Dusheiko
Acute liver failure, acetaminophen overdose patients displayed reduced quality of life
November 30, 2012
Using the SF-36 and the newer CDC-14 health-related quality of life (HRQOL) instrument, researchers evaluated 277 acute liver failure (ALF) patients in the ALFSG registry for 1 year and 2 years of follow-up. Researchers examined response rates to questions across different ALF subgroups and compared them to those of controls from the general population.
Among the ALF cohort, 123 liver transplant patients (LT) were compared with 154 spontaneous survivors (SS) that included 94 patients whose ALF was attributed to acetaminophen overdose (APAP-SS) and 60 others whose ALF was related to other etiologies (non-APAP-SS). CDC-14 assessments were completed at a median of 708 days after hospitalization for ALF.
The APAP-SS cohort exhibited significantly lower general health (34% of cohort compared with 14% of LT patients and 30% for non-APAP-SS patients; P=.0001) and more days of impaired physical health (9.5 vs. 6.2 and 5.6, respectively; P=.012). APAP-SS patients reported more days of anxiety, pain and depression than LT and non-APAP-SS patients (P<.0001).
In comparing SS patients with the general population, researchers said the APAP and non-APAP arms (primarily women aged younger than 55 years) reported a greater proportion of fair/poor health (32% vs. 16%) and more than 14 days of impaired mental health (31% vs. 10%) and impaired physical health (28% v. 11%) (P<.001 for all). LT patients showed similarly higher proportions than the general population for experiencing more than 14 days of impaired mental (20% vs. 10%) and physical health (20% vs. 11%) (P<.001 for both).
“Patients who spontaneously survive [ALF] tend to have poorer physical and mental health that they self-report compared with patients who get transplanted for acute liver failure,” Amol S. Rangnekar, MD, transplant hepatology fellow at Columbia University, told Healio.com. “If you specifically look among spontaneous survivors who don’t get transplanted, most of the poor health is reported by those patients who develop acute liver failure due to acetaminophen overdose.”
Rangnekar said future research could focus on whether there is a difference “between those who get transplanted for acetaminophen and those who did not. That would be the next step. We didn’t have enough of those patients to look at.”
Disclosure: The researchers report numerous financial disclosures.
For more information:
Rangnekar AS. #1636: Quality of life is significantly impaired in long-term survivors of Acute Liver Failure (ALF) and particularly in Acetaminophen Overdose Patients. Presented at: The Liver Meeting 2012; Nov. 9-13, Boston
Full Text - Thyroid Disease in Chronic Hepatitis C Infection Treated with Combination Interferon-α and Ribavirin: Management Strategies and Future Perspective.
Thyroid Disease in Chronic Hepatitis C Infection Treated with Combination Interferon-α and Ribavirin: Management Strategies and Future Perspective.
Download Full Text - PDF (287.9 KB)
Huy A. Tran, FRCPA, FFSc, FACB, FRACP, FACE1, 2, Tracey L Jones, RN3, Elizabeth A Ianna, RN3, Aidan Foy, MD, FRACP4, Glenn E M Reeves, FRCPA, FRACP2, 5
1Department of Clinical Chemistry, Hunter Area Pathology Service, Newcastle, New South Wales, Australia
2 University of Newcastle, Newcastle, New South Wales, Australia
3Department of Gastroenterology, Hunter Area Pathology Service, Newcastle, New South Wales
4Department of General Medicine, Calvary Mater Hospital, Newcastle, New South Wales, Australia
5Department of Immunopathology, Hunter Area Pathology Service, Hunter Region Mail Centre, Locked Bag 1, Newcastle, New South Wales, Australia
Methods: PubMed was searched up to June 30th, 2011 for English-language publications that contained the search terms "hepatitis C virus", "chronic hepatitis C", "HCV", "thyroid disease", "thyroiditis", "autoimmunity", "interferon-alpha" and "ribavirin". Additional publications were identified from the reference lists of papers identified by this search. All studies must be original research publications and included combination interferon-α and ribavirin use in whom thyroid disease developed. All available manuscripts were reviewed and critically analysed.
Results: The prevalence of thyroid disease before combination IFN-α and Ribavirin therapy ranges from 4.6 to 21.3%; during therapy 1.1 to 21.3% and after therapy 6.7 to 21.3%. The commonest thyroid disease is thyroiditis. The frequency of thyroid testings and diagnostic criteria for the various thyroid conditions are not standardised and many publications are retrospective.
Conclusion: Patients undergoing this therapy should have a strictly standardised protocol in order to detect and manage developed thyroid disease appropriately. However, current published reports are heterogeneous and inconsistent. Based on current available literature, we recommend monthly screening test with thyrotropin level whilst receiving combination interferon-α and ribavirin therapy. Free thyroid hormone parameters can be sequentially be performed if thyrotropin levels are abnormal.
Show References **Full Text Available Here
HCV Advocate Newsletter
AASLD 2012 Part 1: HCV Therapies
Alan Franciscus, Editor-in-Chief
HCV Snapshots: AASLD 2012
Lucinda K. Porter, RN
HealthWise: - 2012 Liver Meeting Update
Lucinda K. Porter, RN
Disability & Benefits:Are There Benefits to a Reverse Mortgage?
Jacques Chambers, CLU
Updates @ HCV Advocate
HCV Drug Pipeline
Updated - (November 29)
- Posted by HCV New Drugs
- File Under HIV
“The number of gay and bisexual men being diagnosed with HIV in the UK reached an "all-time high" in 2011” BBC News reports, while the Daily Mail warns “A record 100,000 people in the UK with the HIV virus, but a quarter ‘do not even know they are infected’”.
As National HIV Testing week draws to a close and World AIDS day approaches, the Health Protection Agency (HPA) have published a report on HIV in the UK.
The report is wide-ranging and covers:
- the number of people living with HIV in the UK
- the number of new HIV diagnoses
- the treatments and outcomes
- prevention and control
While at first glance, the fact that the number of people living with HIV in the UK has increased, this is actually due to advances in treatment. Due to the introduction of antiretroviral drugs (ARVs) in the 1990s, which help prevent the HIV virus from spreading, HIV, at least in the UK, is now rarely fatal.
ARVs have transformed HIV from a fatal condition to a chronic condition in which more people live for longer.
Also, the number of new cases of HIV has actually fallen, however, a cause for concern is the increase in the number of new cases among men who have sex with men, and now accounts for approximately 50% of all new cases of HIV.
HIV is also more common in black Africans. This may be explained by the ongoing HIV epidemic in Africa: more than half of heterosexual people with HIV living in the UK were born in Africa.
The report recommends:
- the implementation of safer sex programmes
- promoting condom use
- the introduction of regular testing for at-risk groups
- testing for people living in areas with a high prevalence of the virus
What are the main findings of the report?
The report found that:
- The number of people living with HIV has increased. By the end of 2011, an estimated 96,000 people were living with HIV in the UK, corresponding to 1.5 people with HIV per 1,000 of population. The explanation for the increase is that HIV infection can now be considered a chronic life-long infection due to the availability of antiretroviral therapy (ART)
- It is estimated that a quarter of people living with HIV are unaware of their infection. The prevalence of HIV is highest among men who have sex with men (47 people with HIV per 1,000) and the black African community (37 per 1,000).
- The number of people receiving a diagnosis of HIV has decreased. In 2011, 6,280 people were diagnosed with HIV in the UK, corresponding to one new diagnosis per 10,000 population. The decrease in the number of new diagnoses is mainly due to a decrease in the number of diagnoses reported among people from countries with high HIV prevalence.
- Approximately 50% of new HIV cases were diagnosed in men who have sex with men.
- Mother to baby HIV transmission rates are low, with less than 1% of babies born to women with diagnosed HIV acquiring the infection perinatally. The overall perinatal transmission rate is 2%. This is due to advances in treatment, which mean it is now usually possible to prevent a baby from acquiring an HIV infection from their mother.
- Fewer people are being diagnosed late (with low CD4 cell count – a type of immune cell – the higher the CD4 count, the more advanced the disease is). However, despite this decline, approximately half of new diagnoses are late diagnoses. People diagnosed late have a tenfold increased risk of dying within a year of diagnosis.
- 72,660 people with HIV received care in 2011, with the majority (88%) receiving ART. Due to suppression of the virus by ART, most people (87%) were unlikely to be infectious.
- There were 460 AIDS diagnoses reported in 2011, mainly in people diagnosed late. AIDS, or acquired immune deficiency syndrome, is a term used to describe the final stages of an HIV infection in which the immune system is so weakened that a person becomes vulnerable to life-threatening infections.
- In 2011, there were 500 deaths among people diagnosed with HIV. Approximately 50% of people who died were aged at least 50 years old.
The report recommends:
- Implementing safer sex programmes promoting condom use and HIV testing are a priority, particular for higher risk groups, including men who have sex with men and black African communities.
- In areas with high HIV prevalence (prevalence greater than 2 per 1,000 people aged between 15 and 59 years old), routine HIV testing should be performed for all general medical admissions and people registering at GP practices. GPs should offer and recommend HIV testing.
- HIV testing should be offered to people with tuberculosis and people with HIV should be screened for tuberculosis.
- The benefits of treatment with antiretroviral drug treatments should be discussed with all people receiving HIV care.
- HIV care needs to be continually monitored to ensure it continues to be of high quality.
How is HIV treated in the UK?
There is no vaccine or cure for HIV, but treatments are improving. People living with diagnosed HIV in the UK can expect a near-normal life expectancy, particularly if they are diagnosed early. ART is the mainstay of HIV treatment. Standard antiviral therapy consists of a combination of antiretroviral drugs that act to suppress the virus by reducing the growth and reproduction of HIV.
How do I reduce my risk of contracting HIV?
The two most effective ways of reducing your risk are:
- always use a condom during sex, including anal and oral sex
- if you are an injecting drug user never share needles with anyone else
Men who have sex with men?’
While most of us would use the term ‘gay’ or ‘homosexual’ to describe men who have sex with men, sexual health professionals prefer the term ‘Men who have sex with men’ or MSM.
There are a number of reasons for this:
- the term gay implies exclusively homosexual sexual behaviour, but there are many men who have sex with both men and women
- there are some cultures in which having sex with men is not seen as being gay – ‘gayness’ is only associated with effeminate behaviour
Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on twitter.
Links to the headlines
A record 100,000 people in UK with the HIV virus, but a quarter 'do not even know they are infected'. Daily Mail, November 29 2012
Record numbers of UK gay men test positive for HIV. The Guardian, November 29 2012
Alarm As HIV Cases In UK Soar To Record High. Sky News, November 29 2012
Health Protection Agency. HIV in the United Kingdom: 2012 Report (PDF 2.365 MB). Published online November 20 2012
Painkillers May Protect Liver
By Crystal Phend, Senior Staff Writer, MedPage Today
Published: November 29, 2012
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner
View Video at MedPage Today
Nonsteroidal anti-inflammatory drugs, especially aspirin, may help prevent serious liver problems, a large observational study suggested.
Aspirin users were 41% less likely to develop hepatocellular carcinoma and 45% less likely to die from chronic liver disease than non-users, both statistically significant differences, Vikrant V. Sahasrabuddhe, MBBS, DrPH, of the National Cancer Institute in Rockville, Md., and colleagues reported.
Other NSAIDs were also associated with reduced mortality from chronic liver disease, but not with less liver cancer, among the more than 300,000 middle-age and older participants in the National Institutes of Health-AARP Diet and Health Study cohort.
"These associations are prominent with the use of aspirin, and if confirmed, might open new vistas for chemoprevention of hepatocellular carcinoma and chronic liver disease," the researchers wrote in the Dec. 5 issue of the Journal of the National Cancer Institute.
The findings were not unexpected based on prior results in colorectal and other cancer types, Boris Pasche, MD, PhD, an oncologist at the University of Alabama at Birmingham, noted in an interview with MedPage Today.
"We are seeing a growing body of evidence suggesting that taking aspirin long-term prevents the development of several types of cancer" in populations taking the NSAID for cardiovascular event prevention, he explained.
However, aside from being a possible additional benefit when indicated for cardioprotection, aspirin might not be either necessary or that useful for protecting the liver, according to other experts.
For one thing, there are already good strategies that don't raise bleeding risk the way NSAIDs do, Isra G. Levy, MBBCh, MSc, and Carolyn P. Pim, MD, both of the University of Ottawa and Ottawa Public Health in Ontario, noted in an accompanying editorial.
"In practice," they wrote, "we know and understand the causes of most cases of chronic liver disease and primary liver cancer: viral infections, especially hepatitis B virus (HBV) and hepatitis C virus (HCV), and alcohol. And we already have cheap, readily available interventions to prevent a substantial majority of such diseases."
Furthermore, the risk of developing hepatocellular carcinoma is low enough in the general population that chemoprevention wouldn't make sense when weighed against the bleeding risk, commented Mary Ann Huang, MD, a hepatologist at Henry Ford Hospital in Detroit.
The higher-risk population for whom preventive strategies are needed -- those with cirrhosis -- likely wouldn't be good candidates either because they are also at higher risk of bleeding, Huang told MedPage Today in an interview.
Still the NIH-AARP study results may be good enough to warrant a prospective trial to see whether the benefit would outweigh the risk in that population, Pasche suggested.
The joint Diet and Health study included 300,504 adults ages 50 to 71 years at enrollment who reported their NSAID use on a baseline questionnaire.
The cohort was pulled from six states (California, Florida, Louisiana, New Jersey, North Carolina, and Pennsylvania) and two metropolitan areas (Atlanta and Detroit).
Among the respondents, 73% reported aspirin use and 56% used other NSAIDs.
Altogether, any aspirin or non-aspirin NSAID use was associated with reduced relative risks of:
- 0.63 for developing hepatocellular carcinoma (95% CI 0.46 to 0.87)
- 0.49 for risk of death due to chronic liver disease (95% CI 0.39 to 0.61)
The effect was even greater, with relative risks of 0.51 and 0.50, when looking at those participants who exclusively used aspirin versus those who didn't take any NSAIDs.
Other NSAID use was associated with a reduced risk of chronic liver disease mortality, with a relative risk of 0.74 (95% CI 0.61 to 0.90) that dropped to 0.66 (95% CI 0.48 to 0.91) when looking at those who used only non-aspirin NSAIDs versus no NSAIDs.
But the effect on hepatocellular carcinoma incidence wasn't significant in either case with non-aspirin NSAIDs, and the effect on death from chronic liver disease was significant only in those who used it on a monthly rather than daily or weekly basis.
Aspirin's effects were independent of frequency of use.
All the results were adjusted for age, sex, race or ethnicity, body mass index, cigarette smoking, alcohol consumption, and diabetes.
The researchers suggested that the apparent advantage of NSAID use in the cohort may have been due to anti-inflammatory or other mechanisms.
They acknowledged, though, that the lack of dose response and finding of only monthly links to non-aspirin NSAID use "suggests that the findings should be interpreted with some caution, because they may also reflect an unmeasured confounder."
Huang pointed to the lack of data on cirrhosis and hepatitis status and the single time point of NSAID use ascertainment.
Although there wasn't any reporting of duration or indication for NSAID use, a sensitivity analysis excluding participants who said they had a history of heart disease or hypertension as "a proxy for cardiovascular indication and longer duration of NSAID use, particularly low-dose aspirin), yielded hazard rate ratios similar to those of the overall cohort and suggested minimal potential for confounding by indication."
Primary source: Journal of the National Cancer Institute
Sahasrabuddhe VV, et al "Nonsteroidal Anti-inflammatory Drug Use, Chronic Liver Disease, and Hepatocellular Carcinoma" J Natl Cancer Inst 2012: 104; 1808–1814.
Additional source: Journal of the National Cancer Institute
Levy IG, Pim CP "An Aspirin a Day: The Allure (and Distraction) of Chemoprevention" J Natl Cancer Inst 2012: 104.
Hepatitis C screening advised for some adults
The U.S. Preventive Services Task Force has posted a draft recommendation statement on screening for hepatitis C virus infection in adults.
For adults at high risk, including those with any history of intravenous drug use and people who received blood transfusions prior to 1992, the Task Force proposes screening for HCV infection. The Task Force also said clinicians should consider screening adults born between 1945 and 1965.
Millions of people in the United States are infected with HCV, and many are unaware of their condition, in large part because they may not have any symptoms, according to a Task Force statement. HCV infection is a leading cause of liver cirrhosis, end-stage liver disease, liver cancer and liver transplants.
"Since symptoms may not appear until decades after a person is infected, detection and treatment can help prevent liver damage, liver cancer and deaths from hepatitis C," Kirsten Bibbins-Domingo, MD, PhD, a Task Force member, said in a news release.
In recent years, there have been substantial advances in the effectiveness of treatment for hepatitis C. These advances also have reduced the potential side effects and harms of diagnosis and treatment, the Task Force noted.
"Based on what we know today, the Task Force concluded that screening provides substantial benefits for people at high risk," Bibbins-Domingo said. "We also found that screening people from the baby boom generation also provides real, although smaller, benefits."
Comments on the draft recommendation statement can be submitted from Nov. 27 to Dec. 24. All public comments will be considered as the Task Force develops its final recommendation.
For more information on the draft recommendation and to comment, visit www.uspreventiveservicestaskforce.org/draftrec2.htm.
Lessons From The Liver Meeting: Sagient's John Tucker Names Companies That Could Reignite The Hepatitis C Industry
November 30, 2012 by: Life Sciences Report | includes: ACHN, GILD, IDIX, MRK, MVRBF.PK, VRTX
The hepatitis C (HCV) market was white hot in 2011 and through the beginning of 2012, but investors have gotten the message that new HCV drugs are not going to rival cancer and cardiovascular drugs for profits. In this interview with The Life Sciences Report, analyst John Tucker of Sagient Research discusses a handful of stocks that could benefit from new, patient-friendly HCV therapies with enough revenue to propel shares upward.
The Life Sciences Report: You have just returned from the 63rd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston ("The Liver Meeting"). I know it took place over five days, but could you briefly talk about the focus?
John Tucker: The AASLD meeting covers a broad range of issues around diseases of the liver-everything from alcoholic liver disease to priority rules for liver transplants to viral hepatitis. It is wide-ranging, but recent developments in the treatment of hepatitis C (HCV) were a major focus, simply because there has been so much progress in the area.
TLSR: We've seen a lot of interest around drug development for HCV. It was pretty trendy last year for investors. What does the HCV sector look like today?
JT: Currently HCV is treated with a 6-12-month regimen of interferon, ribavirin and a protease inhibitor (either Vertex Pharmaceuticals Inc.'s (VRTX) Incivek (telaprevir) or Merck & Co. Inc.'s (MRK) Victrelis (broceprevir)). The presence of interferon in these regimens is a problem because it must be injected and because it has severe side effects. At the European Association for the Study of the Liver (EASL) meeting in April, we saw the first detailed presentations of highly efficacious interferon-free treatment regimens. This was a watershed moment.
Since then there have been refinements in the treatments, and at AASLD we saw a lot more detail on what is possible-especially with regard to the competitive profiles of regimens in development by different companies. In the near-term the competition is likely to be mainly between Gilead Sciences Inc. (GILD) and Abbott Laboratories (ABT). Gilead has some two- and three-drug treatment regimens in development, some of which potentially involve only a single daily pill. Abbott's regimens are more complex, but might be applicable to a wider range of patients and/or allow for fewer total weeks of treatment. Bristol-Myers Squibb Co. (BMY) has a slightly earlier-phase regimen of three drugs that looks interesting.
TLSR: There was an article in the Nov. 14, 2012 issue of the Wall Street Journal regarding Gilead Sciences' $11 billion acquisition of Pharmasset Inc., which had been collaborating with Bristol-Myers Squibb in development of a combination therapy for HCV. That deal may have stalled development of a promising therapy. Comment?
JT: At EASL, Gilead and Bristol-Myers disclosed very high cure rates with an interferon-free regimen incorporating Gilead's nucleoside analog GS-7977 and Bristol's NS5A inhibitor, daclatasvir. Gilead chose not to develop this combination, but instead to develop a similar combination of GS-7977 and its own NS5A inhibitor, GS-5885. This pushed back the availability of the first interferon-free treatment regimen for patients with the most common form of the virus by six months to a year, which angered some HCV patients and patient advocacy groups. Gilead's decision was likely related to the large sum it spent on the acquisition of GS-7977 from Pharmasset. Sharing revenues with Bristol would make it more difficult for the company to recover its investment.
TLSR: You were trained as an organic chemist, and you worked in industry as a medicinal chemist. Excluding interferons for a moment, would you address the different classes of drugs used in HCV?
JT: Let me mention first that HCV is, in many ways, like HIV. With HIV, scientists learned very early on that if a patient was treated with one drug or one class of drugs, resistance developed very rapidly. To suppress HIV the standard cocktail involves at least three drugs-three actually being very common. Investigators have found something very similar in HCV. One important difference is that HCV can be cured, so patients don't have to be on lifelong therapy as they do in HIV.
There are four categories of HCV drugs that operate by different mechanisms.
Nucleoside analog HCV polymerase inhibitors prevent the synthesis of viral RNA. Importantly, the virus seems to be completely unable to develop resistance to this class of drug. Some members of this class, such as GS-7977, are also among the more potent HCV drugs developed to date. In spite of these attractive properties, nucleoside inhibitors are not potent enough to effect a cure as monotherapy. They must be combined with at least one additional drug.
In HCV, as in HIV, protease inhibitors are also used. These prevent processing of certain viral proteins. If you block processing, you don't get functional viral proteins. These are typically quite potent, but the barrier to resistance development is not quite as high as for nucleoside analogs. In many, if not most, trials of protease inhibitor-based combinations, you see at least a few patients failing therapy due to resistance development.
A typical interferon-free treatment regimen consists of a nucleoside analog or protease inhibitor combined with an inhibitor from one of the classes I'll discuss next. An older HCV drug, ribavirin, is sometimes thrown into the mix as well.
Non-nucleoside polymerase inhibitors, as the name implies, inhibit the HCV polymerase. They bind to a different site on the enzyme than nucleoside analogs and prevent viral reproduction. They tend to be less potent than protease inhibitors and usually have a fairly low barrier to resistance development.
Then there's a class called NS5A inhibitors. An NS5A is an enzyme that has no counterpart in HIV. It is unique to HCV. Typically these inhibitors are fairly potent. First-generation NS5A inhibitors, like Bristol's daclatasvir and Gilead's GS-5885, have a relatively low barrier to resistance development in HCV genotype 1a, which is the most common viral strain in the U.S. Second-generation NS5A inhibitors seem to be a lot like protease inhibitors: They are potent and have a higher barrier to resistance development.
TLSR: Given the progress and the large number of products in development, what are the unmet needs in HCV today?
JT: The buzz we heard at AASLD was mainly concern that the patients being enrolled in most ongoing clinical trials are not representative of the patients that doctors see in their practices. Companies were presenting 12-week treatment regimens with 90-100% cure rates. We are happy to see that kind of success, but most of the clinical trials exclude hard-to-treat patients. We don't see a lot of trials with interferon-free treatment regimens that include patients with cirrhosis of the liver, which is historically much harder to cure. I've seen estimates that as many as 25% of HCV patients seeking treatment are cirrhotic.
We also don't see trials that include patients who are HIV-coinfected. This is a pretty big group. An estimated 1.2 million people in the U.S. are infected with HIV, and about 30% of them are coinfected with HCV, so about 400,000 HCV patients in the country are coinfected with HIV.
In addition, cure rates with the old interferon/ribavirin treatment regimen were only about 40%, so another 200K or so people in the U.S. are prior treatment failures. We don't see a lot of trials with new treatment regimens that include these patients. One important exception is the Abbott regimen, which included 93% of patients who were previously treated with interferon and ribavirin but failed to achieve a cure.
It could be that 30-40% of patients seeking treatment belong to one of these hard-to-treat groups, and have not been widely included in clinical trials of interferon-free treatment regimens.
TLSR: John, it sounds like you're saying that drug developers don't want to dirty up the drug labels with clinical trial data on patients who have comorbidities. They would just like to get the drugs through the pipeline and into the market prior to testing in patients with complicating factors.
JT: My guess is the U.S. Food and Drug Administration (FDA) will require drug developers to look at some of these groups. I'm a former pharmaceutical guy, so I tend to look at it more sympathetically. Frankly, I think developers were surprised at how well these drugs have been working, so they initially picked treatment populations they thought they had a good chance with. Also, it would have been unethical to run trials in hard-to-treat patients before demonstrating success in easier-to-treat patients, because if patients fail treatment they could end up infected with multidrug-resistant virus.
TLSR: That's the opposite model of what we do in cancer drug development.
JT: Yes. Cancer usually can't be cured once it has become metastatic. The goal is to extend life as long as possible, and drugs are tested first in patients who have become resistant to older drugs. But HCV is curable, and it is more of a priority to avoid resistance development.
TLSR: Can these unmet needs translate into big gains for investors, or is this a population of patients largely uncovered by insurance and unable to pay for therapies?
JT: It is like the obesity market. Just because you have the disease doesn't necessarily mean you're ever going to be treated. There are substantial numbers of people out there who are uninsured. And since it takes so long for cirrhosis or liver cancer to develop, many will die of other causes before their HCV becomes an issue.
In the U.S., the National Health and Nutrition Examination Survey found 3-3.1M people with HCV. About two years later a broader survey included the homeless and people in prison, where the infection rate is very high. Now we think about 5M Americans are infected. Of that number, it's questionable whether 2M will be treated. And half of people who have HCV don't even know they are infected.
It makes a big difference whether a quarter, a third, a half or two-thirds of the HCV-positive population undergoes treatment. Some people will die of unrelated causes without ever knowing they have the disease. Others will learn they are infected as a result of developing end-stage liver disease or cancer; for some of these patients it will be too late to treat the virus. I don't think we'll know the answer to your question until we have the drugs out there.
Another big issue is that most of these infections are historical, going back to IV drug use in the 1970s and transfusions that occurred before testing of the blood supply began in 1992. Unlike other infectious diseases, the pool of patients will shrink as people get cured. There are few new infections occurring.
TLSR: Are there too many companies in this space?
JT: My gut feeling is that HCV will produce a negative net present value (NPV) for the pharmaceutical industry as a whole because there are too many companies chasing the market.
TLSR: So, the HCV market is crowded?
JT: Yes. There are more than 40 drugs in phase 2 and phase 3 development at this point. It appears that a limited set of drugs have outsized potential, and that a lot of drugs continuing in development have potential that is less obvious. In many cases the drug regimens that remain in development are clearly inferior to others that will reach the market sooner. How these companies expect to displace an entrenched competitor with an inferior product is beyond me. One cannot help but wonder why some of these programs have not been killed.
TLSR: Let's track back to Gilead for a moment. It did pay up for Pharmasset. How is that working?
JT: It seems very clear that Gilead is going to have an important role in this market. Its GS-7977 (sofosbuvir), which was acquired in the Pharmasset deal, is very potent. It's a nucleotide polymerase inhibitor, and has a very high barrier to resistance. Only one or two patients out of more than 1,000 treated with GS-7977 have shown any sign of a resistant virus, and the resistance mutations that have been observed lead to profoundly reduced replication competence. Gilead has combined GS-7977 with an internal compound, GS-5885, an NS5A inhibitor, and shown that patients can be treated successfully for HCV genotype 1 without interferon. In what is essentially a small phase 2 trial, the GS-7977/GS-5885 combination has gotten wonderful results in easy-to-treat patients-as much as a 100% cure rate after only 12 weeks.
GS-7977 and GS-5885 have each been studied in combination with other drugs in multiple clinical trials, so their safety is well characterized and surprises are unlikely at this point. Gilead recently initiated the first phase 3 trial of this combination, and at this point the likelihood of a successful phase 3 program and eventual approval seems very high. The GS-7977/GS-5885 therapy has reasonable potential to work in the more difficult-to-treat patient populations, but we don't have data yet for the studies in these patients. There's some possibility that ribavirin or some third drug may be added in these cases. Alternatively, the combination might succeed by increasing the duration of treatment.
Gilead is also looking at a combination of GS-7977 + ribavirin in less-common genotypes 2 and 3. Multiple phase 3 trials of this combination have completed recruiting and we expect it to be approved for genotype 2 and 3 patients in early 2014.
TLSR: What could go wrong for Gilead's HCV program?
JT: There seems to be a widespread assumption that it will dominate the HCV market. That may or may not be true. If another company does well, there's downside for Gilead. I don't know how much upside there is because all of the assumptions are positive right now.
TLSR: Gilead has been the best performer in the group of companies that we are talking about today. It's up 76% over the past 52 weeks, and it's even up 7% from one month ago, when almost all stocks in all industries have suffered. Everything has to go perfectly for Gilead, is that what you're saying?
JT: Yes. Assuming everything goes as well as could reasonably be expected for Gilead, the company's therapy will cure more than 90% of genotype 1 patients in 12 weeks or less with a single daily pill. That would be awesome.
Other companies like Abbott and Bristol are developing more complicated regimens involving three or four drugs. These involve taking pills twice a day instead of once a day, which is less convenient and can be confusing for patients. The combinations may be more potent than Gilead's, however, and might be developed for treatment regimens shorter than 12 weeks. If Abbott or Bristol can cure patients in a shorter time than Gilead, they could take a significant piece of the market.
It is also possible that Gilead's two-drug combination will not work well in difficult-to-treat patients, and a third drug such as ribavirin will be needed to make this combination work in many patients. Since ribavirin must be taken twice a day, this would eliminate some of Gilead's simplicity advantage.
TLSR: Gilead's market cap is now $54.3B.
JT: It's big. My bear thesis is that one or two years after GS-7977 hits the market with this wonderful combination, another company will come out with a single daily pill that cures 90-100% of patients in only eight weeks, or even six. That might happen, for example, with a combination of a nucleotide analog and a protease inhibitor or second-generation NS5A inhibitor, essentially combining two "strong" anti-HCV drugs. The combinations in late-stage development today can loosely be characterized as combining a strong anti-HCV drug with one or more others that are less potent or have a relatively low barrier to resistance development.
As it is widely expected to dominate the HCV market, Gilead is also the most vulnerable to uncertainty when it comes to determining how big the HCV market really is. I am concerned that investors may be overestimating the size of the market.
TLSR: Another company?
JT: Vertex Pharmaceuticals, with a $9B market valuation, is interesting, though declining revenues from Incivek are a concern. Incivek, a protease inhibitor, is a first-generation HCV drug used in combination with interferon and ribavirin. This combination has all the side effects associated with interferon, and telaprevir has some serious side effects as well. In clinical trials around 10% of patients dropped out due to problems such as severe rash, anemia, fatigue, nausea, diarrhea and vomiting; some reports suggest that the dropout rate is much higher in clinical practice.
We've already seen Incivek sales drop in anticipation of better drugs reaching the market in the 2014-2015 timeframe. Vertex also has an approved drug for a subset of cystic fibrosis patients. It also has preliminary data suggesting some efficacy in a second, larger, set of cystic fibrosis patients, but the efficacy in these patients is not fully established.
Vertex has recently signed an agreement with Alios BioPharma [private] for the potent pan-genotypic nucleotide analog HCV polymerase inhibitor ALS-2200 [now VX-135]. ALS-2200 recently entered phase 2 development, and so far its properties look very similar to Gilead's 7977 drug. Vertex has initiated a phase 2 trial of ALS-2200 in combination with ribavirin, and other planned phase 2 trials will examine combinations of ALS-2200 with Glaxo's non-nucleoside polymerase inhibitor GSK2336805, Incivek or Johnson & Johnson (JNJ) protease inhibitor TMC435 (simeprevir). The combinations incorporating both a nucleoside analog and a protease inhibitor are expected to be particularly potent, as I have mentioned.
TLSR: What about a smaller stock?
JT: Medivir AB (MVRBF.PK), with a market cap of about $300M, has licensed its protease inhibitor TMC435 to J&J, and it is now in phase 3. Medivir's market cap dropped fairly precipitously around the time of EASL, back in April, because TMC435 was being developed in combination with interferon. At EASL it became obvious that interferon-containing treatment regimens are probably going out the door fairly rapidly because the newer interferon-free combinations are coming along very well and are much better tolerated. J&J and Medivir are now looking at TMC435 in several interferon-free treatment regimens, including an internal program and combinations with Gilead's nucleotide GS-7977 and Vertex's nucleotide ALS-2200. There is potential for nice things to happen with Medivir out of these studies.
Investors are skeptical that Gilead will develop the GS-7977/TMC435 combination because Gilead's collaboration with Bristol-Myers got very nice results, but the company chose not to develop the combination because apparently it didn't want to share revenue. However, the prospect of a very potent, once-daily ALS-2200/simeprevir combination reaching the market might compel Gilead to develop the GS-7977/simeprevir combination. For a partner looking for a protease inhibitor to combine with their own drug, TMC435 is an obvious choice because of its advanced stage of development and clean side effect profile.
TLSR: Achillion Pharmaceuticals Inc. (ACHN) is also a small-cap stock, with a $522M valuation. Is it interesting?
JT: Yes. Achillion has two interesting assets. The company's protease inhibitor, ACH-1625 [sovaprevir], demonstrates a high barrier to development of resistance. Based on early results in a phase 2 study it appears to provide reasonably good (but not outstanding) cure rates relative to other protease inhibitors in combination with interferon and ribavirin.
But what has me more excited is a second-generation NS5A inhibitor, ACH-3102, which has a substantially higher barrier to development of resistance variants than first-generation NS5A inhibitors such as daclatasvir and GS-5885. It is also quite potent compared to other NS5A inhibitors. NS5A inhibitors traditionally have been limited in their potential efficacy against HCV genotype 1a because resistance develops rapidly. Note that genotype 1a is the version of HCV that's most prevalent in the U.S. ACH-3102 achieved very strong reductions in viral load in a single-dose monotherapy study, which was quite impressive. Achillion is planning a phase 2 trial combining ACH-1625 and ACH-3102, as well as a combination study of ACH-3102 + ribavirin. The ACH-1625/ACH-3102 combination can probably be counted as a combination of two "strong" HCV inhibitors, a combination I believe is of special interest.
TLSR: You are clearly positive on Achillion and Medivir. Which do you like better?
JT: I like Achillion, but I don't like it quite as well as Medivir. Achillion doesn't have the financial resources to develop its in-house assets by itself. It needs a partner. Medivir is already partnered up, which eliminates some uncertainty. It is cheap and its drug is better characterized.
TLSR: What about Idenix Pharmaceuticals Inc. (IDIX)? Its IDX184 combination with IDX320 is on clinical hold by the FDA.
JT: Although Idenix has dropped a lot recently following the clinical hold on its nucleotide IDX184, it still seems pricey to me. I think investors are too optimistic about IDX184 and the company's patent interference with Gilead.
TLSR: Its market cap is just above $600M and down about 43% over the past six months.
JT: I think it may still be overpriced. I don't think IDX184 will come out of clinical hold. Even if it does, IDX184 is a less potent drug. It is an example of a less-efficacious drug coming to market two years after the market leader and trying to displace it. It's not the only drug doing that in HCV; there are others as well. I know some investors are very bullish on Idenix, but I do not understand their reasoning.
TLSR: Is there another company you wanted to mention?
JT: Investors should be aware of Merck's MK-5172/MK-8742 combination, in which 5172 is an NS3 protease inhibitor and 8742 is a second-generation NS5A inhibitor. The combination is showing a high barrier to resistance, but the company's market cap is too big, and it won't move the needle there. Pure plays in HCV are pretty limited because of the acquisitions that have already taken place in the space. Pharmasset has been acquired, as well as Inhibitex Inc. (INHX) and Anadys Pharmaceuticals Inc.
TLSR: Thank you. I've enjoyed this, John.
JT: Me too. Thank you for having me.
Prior to joining Sagient Research, John Tucker was the director of medical chemistry for ChemBridge Corp., and before that served as principal scientist for Elan Corp. His research career spans 16 years, during which he performed drug discovery research in metabolic diseases, cancer, HIV, antibacterials, and Alzheimer's disease. Tucker received his doctorate in organic chemistry from UCLA, working in the research group of Nobel Laureate Donald Cram. Tucker also earned a master's degree in business administration from the Anderson School of Management at UCLA.
1) George S. Mack of The Life Sciences Report conducted this interview. He personally and/or his family own shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of The Life Sciences Report: None. Johnson & Johnson and Merck & Co. are not affiliated with Streetwise Reports. Streetwise Reports does not accept stock in exchange for services. Interviews are edited for clarity.
3) John Tucker: I personally and/or my family own shares of the following companies mentioned in this interview: None. I personally and/or my family am paid by the following companies mentioned in this interview: None. I was not paid by Streetwise Reports for participating in this interview.
- Thursday, November 29, 2012
- Posted by HCV New Drugs
- File Under GS-7977 now Sofosbuvir
Hepatitis C drug shows promise in late-stage trial
No patient in the placebo group achieved an undetectable virus level 12 weeks after completing the therapy, Gilead said.
The safety profile of the drug was similar to that observed in prior studies, and there were few treatment discontinuations due to adverse events, Gilead said.
The company said it would submit the full data from the study for presentation at a scientific conference and will share data from additional late-stage studies in early 2013.
Gilead expects to submit its first regulatory filings for sofosbuvir by mid-2013, Chief Scientific Officer Norbert Bischofberger said.
Copyright © 2012 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Study results indicate potential link between chronic HCV, depression
- November 29, 2012
Researchers assessed data on 15,263 adult patients collected from the National Health and Nutrition Examination Survey between 2005 and 2010. All participants had chronic hepatitis C or chronic hepatitis B; alcohol-related liver disease (ALD), defined as elevated aminotransferases and daily alcohol consumption of more than 20 g; or nonalcoholic fatty liver disease (NAFLD), defined as elevated aminotransferases without the presence of excessive alcohol consumption or other liver diseases. Depression was evaluated according to patient responses to the PHQ-9 survey.
“There have been some small studies in the past that have shown some association of depression with chronic hepatitis C, fatty liver disease and alcoholic liver disease,” Heshaam M. Mir, MD, research manager in the Liver & Obesity program at Inova Fairfax Hospital in Falls Church, Va., told Healio.com. “We wanted to see if those results translated to population-based studies.”
Multivariate analysis indicated that chronic HCV was independently associated with depression (OR=2.87; 95% CI, 1.78-4.62), in addition to other factors, including injection drug use (OR=52.86; 95% CI, 32.87-85.03), smoking (OR=6.20; 95% CI, 1.62-23.68) and black race (OR=2.50; 95% CI, 1.50-4.18). No association was observed between depression and chronic HBV, ALD or NAFLD.
Factors associated with NAFLD included diabetes (OR=1.54; 95% CI, 1.11-2.13) and insulin resistance (OR=2.65; 95% CI, 1.98-3.55), while ALD was associated with moderate-to-heavy smoking (OR=3.64; 95% CI, 3.09-4.30) and Mexican-American ethnicity (OR=1.55; 95% CI, 1.30-1.84). Researchers also observed associations between chronic HBV and black (OR=5.09; 95% CI, 2.41-10.76) or Hispanic race (OR=4.74; 95% CI, 2.32-9.70).
“Based on the results we found, the only association [with depression] is with chronic HCV,” Mir said, noting that this cross-sectional study allowed for the attribution of associations, but not causality. “We know that the current interferon-based regimens for HCV are known to have serious side effects, including psychiatric effects. If a patient is coming in with certain disorders, like depression, it’s important to keep that in mind before starting them on an interferon-based regimen.”
Disclosure: Researcher Zobair M. Younossi has served as a consultant for Salix and has served on advisory committees and/or review panels for Vertex and Tibotec.
For more information:
Otgonsuren M. P953: Association of Chronic Liver Disease with Depression: A Population-Based Study. Presented at: The Liver Meeting 2012; Nov. 9-13, Boston.
Metformin may protect against hepatocellular carcinoma
- November 29, 2012
Researchers performed a literature review incorporating three cohort and four case-control studies on 11,503 patients with hepatocellular carcinoma (HCC), within a total cohort of 158,371 patients. All studies involved patients exposed to either metformin, thiazolidinediones (TZD) and/or sulfonylureas and either provided RRs or ORs or included sufficient data for them to be calculated.
Across all studies, metformin use was associated with a decreased incidence rate of HCC (unadjusted OR=0.42; 95% CI, 0.24-0.73), with significant heterogeneity (I2=92%, P<.01). TZDs (unadjusted OR=0.50; 95% CI, 0.26-0.98) also were associated with reduced HCC incidence, while sulfonylureas were linked to an increased rate (unadjusted OR=1.46; 95% CI, 1.08-1.97). Investigators also observed significant heterogeneity in TZD and sulfonylurea results (I2=84% for TZD; I2=74% for sulfonylureas, P<.01 for both). Subgroup analysis indicated that all results were more pronounced among the four Western studies than in the three studies of Asian populations, as well as among hospital-based studies compared with population-based studies.
“Metformin did seem to protect against HCC in diabetic patients, although there were some confounding factors,” researcher Preet Paul Singh, MD, Mayo Clinic in Rochester, Minn., told Healio.com. “It’s too early to say what dose of metformin is needed, how long we should do this for or at what time we should start it. There are a lot of other questions that still need to be answered in terms of recommending this widely in application. … But if somebody’s already on metformin, and at risk of getting HCC, you might want to continue them on that medication rather than try and switch them, if you can help it.”
For more information:
Singh S. #513: Oral anti-diabetic agents and the risk of Hepatocellular Cancer: A Systematic Review and Meta-analysis. Presented at: The Liver Meeting 2012; Nov. 9-13, Boston.
Since 2001, at least 48 outbreaks have occurred that CDC is aware of: 21 of these outbreaks involved transmission of hepatitis B or hepatitis C, and the other 27 represented outbreaks of bacterial infections, most of which involved invasive bloodstream infections. All these outbreaks were not from intrinsically contaminated products received from a pharmacy or drug company.
CDC released a table of select recent outbreaks and patient notification events that occurred in a variety of settings, including primary care clinics, pediatric offices, ambulatory surgical centers, pain clinics, imaging facilities, oncology clinics, and even health fairs. (Download a PDF of the table).
The “One & Only Campaign” aims to eradicate outbreaks from unsafe medical injections by raising awareness among patients and healthcare providers about proper practices. The campaign is a public health effort produced by the SIPC, a collaboration of several medical societies, state health departments, private medical companies, and patient advocates led by the CDC.
Through targeted education and awareness efforts, the One & Only Campaign empowers patients and healthcare providers to insist on nothing less than safe injections – every time, for every patient. Since 2009, the campaign has developed toolkits and materials for providers and patients, including a clinician toolkit, a checklist, posters, a video, and a continuing education webinar. The Centers for Disease Control and Prevention (CDC) and Safe Injection Practices Coalition (SIPC) have also promoted awareness of safe injection practices at a wide variety of national and state meetings, conferences, and training activities.
Medscape Medical News
Hepatitis C Responds Better to Triple Antiviral Therapy
Nov 26, 2012
Sustained virological response (SVR) rates for the most common chronic hepatitis C virus (HCV) infection may be "substantially higher" if newer triple-therapy regimens are administered compared with the standard dual-therapy approaches, according to a study published online November 26 in the Annals of Internal Medicine.
Roger Chou, MD, from the Oregon Health & Science University in Portland, and colleagues assessed 458 full-text studies identified through multiple databases and published between 1947 and 2012. The publications included randomized trials of antiviral treatments and cohort studies on clinical outcomes and SVR after antiviral treatment.
No study, however, assessed comparative clinical effectiveness of antiviral treatments because of the long time course for HCV complications to develop. The researchers instead used SVR rates as a surrogate endpoint because SVR after antiviral treatment "appears to be associated with improved clinical outcomes."
Dual therapy with pegylated interferon combined with ribavirin became the standard HCV treatment in the early 2000s, and the US Food and Drug Administration approved the antiviral agents boceprevir and telaprevir in 2011 for chronic HCV genotype 1; this genotype accounts for about 75% of HCV infection cases in the United States.
"Understanding the comparative effectiveness of antiviral regimens is critical for making informed treatment decisions for HCV infection," the researchers write. Their review focuses on comparative effectiveness for treatment-naive patients and on whether effectiveness varies according to clinical and demographic characteristics. They used "the absence of detectable HCV RNA in the serum six months after the end of a course of therapy" as their definition for SVR.
The researchers found that in 2 clinical trials (n = 1097 and 520) that evaluated the triple therapy of boceprevir, pegylated interferon alfa-2b, and ribavirin compared with dual therapy without boceprevir for HCV genotype 1, the triple therapy was associated with a greater likelihood for SVR than dual therapy alone (pooled relative risk [RR], 1.8 [95% confidence interval (CI), 1.6 - 2.1]; I2, 0%; pooled absolute increase, 31 percentage points [95% CI, 23 - 39 percentage points]).
They also found that 3 trials (n = 189 - 250) concluded that a 24-week triple therapy regimen including telaprevir, pegylated interferon, and ribavirin was associated with a greater likelihood of SVR compared with a 48-week dual therapy without telaprevir (pooled RR, 1.5; 95% CI, 1.3 - 1.8; I2, 0%).
The review includes many other findings. For example, in trials comparing dual therapy of ribavirin plus pegylated interferon alfa-2a (180 μg/kg/week) with alfa-2b (1.5 μg/kg/week), alfa-2b was associated with a lesser likelihood of SVR than alfa-2a (pooled RR, 0.87 [95% CI, 0.80 - 0.95]; I2, 27%; pooled absolute difference, 8 percentage points [95% CI, 3 - 14 percentage points]).
"Across all antiviral regimens, absolute treatment response rates across regimens are lower in older patients, black patients, and patients with higher baseline viral load, genotype 1 infection, or more advanced fibrosis," the researchers write.
Limitations include that their analysis is based only on English-language articles and that pooled estimates based on a small number of trials should be interpreted cautiously.
The researchers conclude, "The relative ineffectiveness of dual therapy for genotype 1 infection has led to ongoing efforts to identify more effective treatments. Recent trials found triple therapy with boceprevir or telaprevir superior to dual therapy, with SVR rates approaching the 70–80 percent observed in trials of dual therapy for genotype 2 or 3 infection. This has important implications for treatment as well as for screening, since screening benefits depend in part on the effectiveness of available treatments."
This study was supported by the Agency for Healthcare Research and Quality. The authors have disclosed no relevant financial relationships.
Ann Intern Med. Published online November 26, 2012.
- Posted by HCV New Drugs
- File Under transmission
Researchers have found no clear proof that any intervention reduces the risk for mother-to-child transmission of hepatitis C virus (HCV) infection. More than 40,000 children are born to HCV-positive women each year.
Up to 10 percent of those children are HCV-positive due to maternal transmission. Researchers reviewed published evidence on mode of delivery, labor management strategies, and breastfeeding practices to determine their effect on risk of mother-to-infant transmission of HCV. The researchers found no clear evidence that any of the interventions reduce the risk of transmission.
There was limited evidence that prolonged rupture of membranes could increase risk of mother-to-child transmission, suggesting that physicians should avoid prolonged rupture of membranes in women with HCV infection. The researchers found that avoidance of breastfeeding is not warranted to reduce risk of vertical transmission.
- Posted by HCV New Drugs
- File Under HCV News
Earlier this year, the Centers for Disease Control and Prevention called for hepatitis C testing for all baby boomers, who make up three-quarters of people in the United States with the infection.
Hepatitis C is passed through blood. Along with drug users who share needles, people who had a blood transfusion or received an organ transplant before mandatory viral testing began in 1992 are also at increased risk of hepatitis C.
Between 1 and 2 percent of people in the U.S. have hepatitis C, which can cause cirrhosis and liver failure over many years. Among the baby boomer generation, that rate is between 3 and 4 percent.
Side effects of the newest drugs, known as boceprevir (Victrelis) and telaprevir (Incivek), include anemia and rashes. Those medications are added to a combination regimen of ribavirin and peginterferon alfa (also commonly known as Pegasys and Peg-Intron), which has been the standard of treatment since the early 2000s.
Evidence reviews completed for the task force also suggest that for pregnant women with hepatitis C, delivering a baby via cesarean section or avoiding breastfeeding does not cut down on virus transmission. That suggests transmission may occur while a fetus is still in utero, Dr. Roger Chou and colleagues from Oregon Health & Science University in Portland said.
Hwang suggested screening could be useful for women who are considering becoming pregnant. Then if they are positive for hepatitis C, women can be treated and reduce their viral levels before there's a risk of passing the virus on to the baby.
Galectin Receives US Patent for Second Drug Class to Treat Chronic Liver Disease with Fibrosis (Scarring) and Cirrhosis
Nov. 26, 2012, 9:15 a.m. EST
Galectin Therapeutics Receives US Patent for Second Drug Class to Treat Chronic Liver Disease with Fibrosis (Scarring) and Cirrhosis
NORCROSS, Ga., Nov 26, 2012 (BUSINESS WIRE) -- Galectin Therapeutics /quotes/zigman/9334018/quotes/nls/galt GALT +18.29% , the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office for a divisional patent of Patent Number 8,236,780 "Galactose-prolonged polysaccharides in a formulation for antifibrotic therapies". The patent covers key methods of derivation and use for the Company's galactomannan-based carbohydrate galectin inhibitor compounds, for use in patients with chronic liver disease associated with the development of fibrosis, established liver fibrosis or end-stage scarring, or cirrhosis. Fibrotic disease of the liver is highly prevalent in the population because all chronic liver diseases, including viral hepatitis, fatty liver and alcohol abuse, result in fibrosis of the liver for which there are no currently approved pharmaceutical therapies.
"This patent broadens Galectin Therapeutics' intellectual property to include two distinct classes of galectin inhibitors for the treatment of liver fibrosis, a highly prevalent and critical medical condition with no approved treatments other than transplantation," said Peter G. Traber, MD, President, CEO and CMO of Galectin Therapeutics. "The intellectual property protection for our galactomannan (GM)-based compounds augments our IP portfolio, which already contains coverage for galacto-rhamnogalacturonan (GR)-based compounds, thus enabling a pipeline of candidates with drugs from each class that can be evaluated for the treatment of fibrosis."
"GM-CT-01, our first galactomannan-based compound, has demonstrated an excellent safety profile in over 100 patients and could be moved rapidly forward in Phase 2 clinical trials in fibrosis," commented Traber. "GM-CT-01 could be useful as a follow-on compound to GR-MD-02, our lead clinical compound in fibrosis, for stand-alone or combination therapeutic approaches. Preclinical results of both our GM- and GR-based candidates have shown reversal of fibrosis in rodent models of disease."
The major claim is for a method of obtaining the galectin inhibitor compound, obtaining a composition for parenteral administration in an acceptable pharmaceutical carrier and administering to a subject having at least one of the following: chronic liver disease associated with the development of fibrosis, established liver fibrosis or cirrhosis. The use covers inhibiting or slowing the progression of fibrosis or the reversal of fibrosis.
About Galectin Therapeutics
Galectin Therapeutics /quotes/zigman/9334018/quotes/nls/galt GALT +18.29% is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com .
Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings. We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
SOURCE: Galectin Therapeutics
Galectin Therapeutics Inc. Peter G. Traber, MD, 678-620-3186 President, CEO, & CMO email@example.com
Copyright Business Wire 2012
Cold Supplements, from Airborne to Zinc
Berkeley Wellness Letter
A cure or preventive for the common cold has been a holy grail for medical researchers and drug companies. So far nothing has worked—medications for colds simply relieve some symptoms temporarily, at best. No wonder, then, that people are tempted by the cold-fighting and/or immunity-boosting claims made for many dietary supplements. Do any of them stand up to scientific scrutiny?
Some supplements with purported cold-fighting ability are single nutrients or herbs. Others try to impress with a mind-numbing list of ingredients.
The best known supplement that throws the kitchen sink at colds, Airborne contains vitamins (A, C, E), minerals (magnesium, zinc, and selenium), and echinacea, ginger, and a bouquet of other herbs. In 2008 the Federal Trade Commission accused the company of making unproven claims about curing and preventing colds and flu; the company had to pay a $30 million settlement. So now the ads and packages merely say that Airborne “supports” the immune system (wink, wink).
Some of the ingredients in Airborne and other formulas have been tested in controlled studies, with inconsistent results (see below). But there have been no clinical trials testing the specific formulas, at least none that have been published in peer-reviewed journals.
Our take: Forget about Airborne and similar formulas. They’re a waste of money. And if taken often, Airborne may weaken bones because of its relatively high level of vitamin A.
Lab research suggests that this herbal remedy, usually Echinacea purpurea, can stimulate the immune system and have direct antiviral and anti-inflammatory effects. But human studies on echinacea’s effect on colds or immunity have had inconsistent results. Commercial preparations vary widely in the species and the parts of the plants used, making it hard to compare results. Two large well-designed studies in 2010 and 2011 found that echinacea was not better than a placebo at preventing colds or reducing their severity.
Our take: The claims about echinacea for colds have yet to be supported by solid research.
Despite a common belief that garlic can prevent colds, there has been remarkably little human research on this. This year a study in Clinical Nutrition found that an aged garlic extract taken for three months did not reduce the incidence of colds or flu, but did reduce their severity somewhat when they did occur.
Our take: Garlic is no more likely to keep away colds than to repel vampires, unless you eat it raw and the smell makes cold sufferers stay away from you.
Like echinacea, this herbal cure-all can affect certain aspects of the immune system, though it’s not clear what practical significance this has. Commercial preparations vary widely. A few preliminary studies suggest that Cold-fX, a patented standardized extract of North American ginseng, may help reduce the frequency and severity of colds (and flu) when taken twice daily throughout the winter, a claim allowed by Health Canada, which functions like the our FDA. There’s no evidence that it can provide relief once you have symptoms, though marketers have sometimes claimed or strongly suggested this. In the U.S., Cold-fX is available only online.
Our take: Cold-fX may help against colds and flu when taken daily for several months. But at about $30 a month, we don’t think it’s worth it. Moreover, long-term use raises questions about possible interactions with drugs (such as the blood thinner warfarin) and potential problems in people with certain health conditions (such as autoimmune disorders).
These supplements contain “friendly” bacteria that are supposed to strengthen immunity, among other proposed benefits. But studies on whether they can curb colds and other respiratory infections have been inconsistent. One problem is that supplements use countless different strains and doses. In 2011 the Cochrane Collaboration, which evaluates medical research, concluded that probiotics may help prevent acute respiratory infections, though there were limitations in the studies and no data for older people.
Our take: We don’t recommend probiotic supplements for cold prevention. We’ll discuss probiotics in an upcoming issue.
This gained popularity in the 1970s when Linus Pauling claimed it could prevent and alleviate colds. However, numerous studies have failed to confirm any benefit. According to a Cochrane Collaboration review in 2010, vitamin C supplements do not prevent colds, except perhaps in people exposed to severe physical stress, such as marathon runners and skiers. And research on the vitamin’s potential role in reducing the severity and/or duration of cold symptoms when taken at their onset has yielded mixed results.
Our take: The tide has turned against vitamin C. If there were a significant benefit, it wouldn’t be so hard to prove.
Some experts believe that vitamin D can help protect against respiratory infections, in part because it plays key roles in the immune system. Many studies have found that people with low blood levels of D are at increased risk for colds and other upper respiratory tract infections.
But the few clinical trials have had mostly disappointing results. For instance, a study from Winthrop Hospital in New York in 2009 found that 2,000 IU of vitamin D a day, taken for 12 weeks, did not reduce the risk of upper respiratory tract infections. And in a study from New Zealand in the Journal of the American Medical Association in October, monthly megadoses of D (100,000 IU), taken for 18 months, also did not reduce the risk. The great majority of subjects in both studies started with sufficient blood levels of D, however, so it’s not known if people who were deficient would have benefited.
Our take: There are some good reasons to take vitamin D supplements, notably for bone health—but not for cold prevention. For more on vitamin D, see WellnessLetter.com/vitaminD.
This mineral is also essential for immunity. In lab studies, large amounts of zinc can block cold viruses from adhering to the nasal lining and/or replicating themselves. Earlier this year a Cochrane Collaboration review concluded that, compared to a placebo, zinc lozenges can shorten colds by about a day and reduce their severity somewhat, particularly when started within 24 hours of the first symptoms, though not all the studies found a benefit. Another 2012 research review, in the Canadian Medical Association Journal, came to similar conclusions. There is no good research showing that zinc will prevent colds, however.
Our take: Because of possible side effects (nausea, diarrhea, cramps, and a bad taste in the mouth) and questions about the effectiveness of some formulations, the Cochrane authors concluded that zinc lozenges, taken during the first day of symptoms, are “advised with caution.” We agree. Prolonged use of high doses of zinc can interfere with the absorption of copper and actually impair immune function. Don’t use any zinc product that’s applied directly in the nose; this can damage the sense of smell, possibly permanently.
Bottom line: There’s no convincing evidence that any supplement can prevent or treat colds. “Cold remedies,” including many over-the-counter drugs, may well make you feel better, since they have a strong placebo effect. That is, if you expect or hope that a remedy is going to help, there’s a fair chance it will, whether it contains vitamins, herbs, or just plain old sugar. And, of course, remedies may seem to work because colds go away on their own. Though we don’t recommend them, it probably can’t hurt to take such products when you feel a cold coming on, but taking them throughout cold season, as is sometimes recommended, increases the risk of adverse effects.
How long are you contagious?
As a general rule, adults with a cold will be able to infect others one day before symptoms appear, and up to five days or so after becoming sick. Infants and children are able to transmit these viral infections for seven days or longer. The precise number of days for transmission can vary from person to person, and also depends on the length of the illness. Those in poor health tend to get sick more easily. Children are also more likely to catch (and transmit) colds.
Cold viruses, abundant in nasal secretions, are mainly transmitted via hands. When you blow your nose, touch your face, or wipe your eyes, the virus transfers to your hands, and then to whatever or whomever you touch. To avoid spreading or catching a cold, the No.1 precaution is to wash your hands often and well. Hand sanitizers are a good option when you’re not near a sink.
Coughing and sneezing can also spread germs, of course. If you don’t have a tissue, instead of sneezing or coughing into your hand, do it into your sleeve or crook of your arm to avoid contaminating your hand.
If you think you’re getting sick, limit your contacts. When around someone who is sick, stay at least six feet away. Cold viruses can’t travel much farther than that through the air. Don’t share utensils, phones, or towels.
Issue: December 2012
- Posted by HCV New Drugs
- File Under transmission
500 anti-HCV-positive, HIV-negative index persons and their long-term heterosexual partners were studied. Couples were interviewed separately for lifetime risk factors for HCV infection, within-couple sexual practices and sharing of personal grooming items. Blood samples were tested for anti-HCV, HCV RNA, and HCV genotype and serotype. Sequencing and phylogenetic analysis determined the relatedness of virus isolates among genotype-concordant couples.
HCV-positive index persons were mostly Non-Hispanic Whites, with median age 49 years (range 26-79) and median 15 years (range 2-52) of sexual activity with their partners. Overall, HCV prevalence among partners was 4% (n=20), and 9 couples had concordant genotype/serotype. Viral isolates in 3 couples (0.6%) were highly related, consistent with transmission of virus within the couple. Based upon 8377 person-years of follow-up, the maximum incidence rate of HCV transmission by sex was 0.07% per year (95% CI: 0.01, 0.13) or ∼1 per 190,000 sexual contacts. No specific sexual practices were related to HCV-positivity among couples.
The results of this study provide quantifiable risk information for counseling long-term monogamous heterosexual couples in which one partner has chronic HCV infection. In addition to the extremely low estimated risk for HCV infection in sexual partners, the lack of association with specific sexual practices provides unambiguous and reassuring counseling messages. (HEPATOLOGY 2012.).
Copyright © 2012 American Association for the Study of Liver Diseases.
Reducing the cost of new hepatitis C drugs
Daclatasvir, Harvoni (ledipasvir/sofosbuvir) and Sovaldi.
An index of articles & research weighing the pros and cons over the high price of hepatitis C drugs.
Class Action Lawsuit Challenges the Exorbitant Pricing of Gilead's Hepatitis-C Drug Sovaldi - The situation has Medicaid plans and insurers nationwide groping for the right balance. Worldwide patients are unable to afford treatment, while others wait in the wings on coverage.
U.S. FDA Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir)
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
Bristol-Myers: FDA Blocks Hepatitis C Drug for Now
U.S. regulators have declined to approve Bristol-Myers Squibb's daclatasvir as part of a combination hepatitis C treatment with another antiviral drug called asunaprevir.
FDA approves Medivir's Olysio (simeprevir) in combination with Gilead Sciences' Sovaldi (sofosbuvir)
-Expanded indication includes both treatment-naïve and treatment-experienced adult patients with or without cirrhosis-
Medivir AB (Nasdaq Stockholm:MVIR) announces that the U.S. Food and Drug Administration (FDA) has approved Olysio® (simeprevir) in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C infection in adult patients as part of a combination antiviral treatment regimen
MSF responds to BMS commercial strategy for hepatitis C drug daclatasvir in developing countries
Médecins Sans Frontières (MSF) responds to the news of BMS’s plans on access and licencing for daclatasvir: “Unfortunately, history seems to be repeating itself with BMS, who haven’t learnt from the company’s poor track record responding to the HIV epidemic; it is disappointing that BMS is choosing to lock out millions of people from gaining affordable access to daclatasvir, and will not commit to registering the drug in all countries that have a hepatitis C burden, even those that do not represent a commercial opportunity for BMS.
Updated daily, categorized by genotype and pharmaceutical company, with links to breaking news, clinical data, commentary and slide-sets from premier Hepatitis C websites.
Hepatitis C New Drug Research: Conference Reports
Blog - AASLD
Gilead has published both U.S. Prescribing Information and Patient Information, on their support website., In addition check out HCV Advocates new factsheet for; Genotype 1:Treatment: Harvoni (Sofosbuvir & Ledipasvir), other factsheets include; Sovaldi: Genotype 1 Triple Therapy, Sovaldi: Genotype 2 & 3 and Sovaldi: Genotype 4 Triple Therapy
In case you missed it; HCV Newsetters: Everything you need to know about Gilead's Harvoni
France uses tax to put pressure on hepatitis C drug prices
(CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application (MAA) for Harvoni®, an investigational once-daily tablet combining the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Ledipasvir/Sofosbuvir - Gilead Submits NDA to Japan’s PMDA
Bristol-Myers Squibb’s Daklinza (daclatasvir), Approved By European Commission - for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Daklinza, when used in combination with sofosbuvir, is an all-oral, once daily regimen that yields cure rates of up to 100%
Daklinza + sofosbuvir offers potential cure for a broad range of EU HCV patients, including those with advanced liver disease, genotype 3 and protease inhibitor failures
PBAC decisions – a mixed bag for Australians living with Hepatitis C
Hepatitis Australia today welcomed the recommendation to add simeprevir (Olysio) to the Pharmaceutical Benefits Scheme (PBS) for the treatment of genotype 1 chronic hepatitis C.
Responding to the PBAC decision to reject an application to subsidise the antiviral medication sofosbuvir (Sovaldi), Ms Tyrrell said “it’s a sad day when access to game-changing therapy is denied. This is a bad outcome for people living with hepatitis C”.
UK Recommends Covering Sovaldi Hepatitis C Pill
PegLambda Discontinued by BMS
Vertex to stop selling hepatitis C drug Incivek
To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
ClinicalTrials.gov: updated in the last 30 days
Hepatitis C Clinical Trials - FDA Approved And Investigational Drugs
News, Research And Clinical Trials
See **Clinical Trials @ HCV Advocate For Enrollment Information
AbbVie is a new, independent biopharmaceutical company composed of Abbott’s former proprietary
News and Research
ABT-450/ritonavir/ombitasvir/dasabuvir with or without ribavirin,
r = ritonavir
**Clinical Trials @ HCV Advocate-AbbVie
News and Research
**Clinical Trials @ HCV Advocate-Achillion
News and Research
In January 2014 Boehringer Ingelheim announced the development of deleobuvir would not be continued since recent findings from phase III trials did not suggest sufficient efficacy.
Faldaprevir - On June 20 2014 Boehringer Ingelheim announced it will withdraw all regulatory filings for faldaprevir, which had been granted accelerated assessment by the European Medicines Agency, and will discontinue further development of the protease inhibitor.
**Clinical Trials @ HCV Advocate-Boehringer Ingelheim
News and Research
**Bristol-Myers withdraws FDA NDA for asunaprevir
**Clinical Trials @ HCV Advocate-Bristol-Myers Squibb (BMS)
FDA Approved News and Research
(Sofosbuvir) now Sovaldi
Before FDA Approval
GS-7977 sofosbuvir /GS-5885 ledipasvir,
GS-0938 and Sofosbuvir
Sofosbuvir/Ledipasvir plus GS-9451
Sofosbuvir/Ledipasvir plus GS-9669
GS-7977 now Sofosbuvir and simeprevir (TMC435)
**Clinical Trials @ HCV Advocate-Gilead
News and Research
**Clinical Trials @ HCV Advocate-Idenix
News and Research
Simeprevir now Olysio
Before FDA Approval
Simeprevir now Olysio and Daclatasvir
New - OLYSIO™ (Simeprevir) and Sovaldi (Sofosbuvir)
GS-7977 now Sofosbuvir and simeprevir (TMC435)
Simeprevir (TMC435)-Before FDA Approval
**Clinical Trials @ HCV Advocate-Tibotec / Janssen
News and Research
FDA Approved - Victrelis (Boceprevir)
**Clinical Trials @ HCV Advocate-Merck
News and Research
**ClinicalTrials.gov - Danoprevir
News and Research
**ClinicalTrials.gov - Miravirsen
FDA Approved News and Research
**Vertex to stop selling hepatitis C drug Incivek
..Vertex said it will license an experimental hepatitis C drug called VX-135 to Alios BioPharma..As a reminder (VX-135) is still on partial clinical hold by the FDA in the U.S.
**Clinical Trials @ HCV Advocate-Vertex
Prescribing and patient information, financial assistance, research and news
Sovaldi is approved in HCV genotypes 1 and 4, treatment-naïve adults in combination with PEG-IFN and ribavirin and the first approved interferon-free treatment regimen for people with HCV genotypes 2 and 3. Overall cure rates are at 80%, response rates and treatment duration varies, depending on genotype, viral and host factors.
Prescribing and patient information, articles and important updates
Johnson & Johnson's protease inhibitor OLYSIO (Simeprevir) is approved for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
'Mix-and-match` approach to new hepatitis C drugs
The European Association for the Study of the Liver has issued new guidelines for the treatment of hepatitis C which recommend that wherever possible, patients should be treated with the newest direct-acting antivirals.
EASL is also encouraging European physicians to combine products from different pharmaceutical companies to achieve the most potent interferon-free regimens, often in advance of full phase III trial data, in its new hepatitis C treatment guidelines issued in April at the International Liver Congress in London.
Lucinda K. Porter, RN, the author of "Free from Hepatitis C" has graced the HCV community with a second book "Hepatitis C Treatment One Step at a Time" available now on Amazon.
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