Of Interest - Chronic hepatitis C: Treat or wait? A collection of news articles and research weighing the risks and benefits of treating HCV now vs waiting for future therapies.
Three-Quarters of HCV Patients Who Have Previously Failed Treatment and Two-Thirds of Treatment-Naive HCV Patients are Unlikely to Initiate Treatment with a Currently Available Regimen Within the Next Year
A Recent Audit of Patient Records Finds That Physicians are Foregoing Treatment of Their HCV Patients Until New Agents Become Available, According to a New Report from BioTrends Research Group
EXTON, Pa., Aug. 6, 2013 /PRNewswire/ -- BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that three-quarters of patients who have failed prior regimens, regardless of genotype, are not likely to re-treat their chronic hepatitis C virus (HCV) infection with a currently available regimen within the next year. Managing physicians cite that over half will forego re-treatment in the next year because they are waiting for new products currently in development to become available.
The ChartTrends®: Hepatitis C Virus (US) report also finds that two-thirds of treatment-naive patients, regardless of genotype, are not likely to initiate treatment with a currently available regimen within the next year. The most common reason for genotype 1 treatment-naive patients to forego treatment, according to their managing physicians, is because they are waiting for interferon-free products in development to become available, while mild progression of disease and/or little to no liver involvement are contributing factors for delaying treatment among genotype 2/3 treatment-naive patients.
"Although many patients are waiting to treat their HCV infection, one-quarter of the patients who have previously failed treatment and one-third of treatment-naive patients are likely to begin treatment within the next year with a currently available regimen," said BioTrends Research Group Associate Director Lynn Price. "Among patients who are likely to initiate treatment in the next year, 54 to 64 percent are expected to initiate a triple therapy regimen with Vertex's Incivek, while only 16 to 26 percent are estimated likely to be treated/re-treated with a regimen containing Merck's Victrelis."
The recently published report also finds that the vast majority of genotype 1 patients currently on active triple therapy, regardless of the protease inhibitor brand, have achieved early and rapid virological responses since beginning their treatment. Furthermore, nearly 80 percent of genotype 1 patients who have recently completed triple therapy, regardless of the protease inhibitor brand, have achieved a sustained virological response, four to five months post-completion of their regimen.
ChartTrends®: Hepatitis C Virus (US) is a quantitative publication based on patient audit data collected from 1,053 HCV patient charts provided by 100 gastroenterologists, 50 hepatologists and 50 infectious disease specialists in March - April 2013 in the United States. The report includes analysis of genotype 1 and genotype 2/3 patients, as well as three patient subgroups: currently treated/recently completed treatment, treatment-naive and prior-treatment failures. Through an in-depth review of patient charts, the report provides insight into how patient demographics, comorbidities and risk factors and lab values influence treatment decisions and brand selection.
About BioTrends Research Group
BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at www.bio-trends.com. BioTrends is a Decision Resources Group company.
About Decision Resources Group
Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.
All company, brand, or product names contained in this document may be trademarks of their respective holders.
For more information, contact:
Decision Resources Group
Christopher Comfort
781-993-2597
ccomfort@dresources.com
SOURCE BioTrends Research Group
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Tuesday, August 6, 2013
Monday, August 5, 2013
As the Epidemic Ages, So Do the Patients
August 1, 2013
As the Epidemic Ages, So Do the Patients
Paul E. Sax, MD reviewing O'Keefe KJ et al. AIDS Care . Paul E. Sax, MD
The majority of people living with AIDS in San Francisco are now 50 or older.
An inevitable consequence of the decline in HIV-related deaths is the aging of the population living with HIV infection.
A recent study from San Francisco — a city hit particularly hard by HIV right from the start — documents this trend. Using surveillance data from city's HIV/AIDS surveillance registry, investigators charted the ages of individuals living with a diagnosis of AIDS, using the 1992 CDC case definition. This registry is updated through linkage to local and national databases that track deaths and other vital statistics. The researchers also compared the numbers for San Francisco with those for the U.S. overall.
Of the 9796 individuals living with AIDS in San Francisco at the end of 2010, 5112 (52%) were 50 or older. The proportion of those 50 or older has increased steadily since 1990, when only 10% were in this category, compared with 24% in 2000 and 38% in 2005. Nationally, the proportion has also increased, although not to the same degree: 20% of AIDS patients in the U.S. were 50 or older in 2001 compared with 39% in 2009.
Comment
Oliver Wendell Holmes reportedly once said, “Old age is 15 years older than I am,” but in HIV research, it has repeatedly been defined as older than 50 — perhaps a response to the early days of the epidemic, which predominantly involved young men and women. Although, as the study authors note, San Francisco is the first city to reach the milestone of more than 50% of AIDS patients being at least 50 years old, these data will resonate with HIV clinicians around the country, who are all experiencing the aging of their patient populations.
Using AIDS diagnoses increases the accuracy of the surveillance data, but it is also a limitation of this study: Only individuals with advanced immunosuppression were included, rather than everyone living with HIV infection.
Editor Disclosures at Time of Publication Disclosures for Paul E. Sax, MD at time of publication Consultant / Advisory board Bristol-Myers Squibb; Gilead; GlaxoSmithKline; Janssen; Merck Grant / research support NIH; Bristol-Myers Squibb; Gilead; GlaxoSmithKline; Merck Editorial boards Medscape; UpToDate Leadership positions in professional societies Mass ID Society (Vice President)
Citation(s): O'Keefe KJ et al. People fifty years or older now account for the majority of AIDS cases in San Francisco, California, 2010. AIDS Care 2013 Jan 15; [e-pub ahead of print].
( http://dx.doi.org/10.1080/09540121.2012.752565 ) -
Source - http://www.jwatch.org/na31802/2013/08/01/epidemic-ages-so-do-patients
As the Epidemic Ages, So Do the Patients
Paul E. Sax, MD reviewing O'Keefe KJ et al. AIDS Care . Paul E. Sax, MD
The majority of people living with AIDS in San Francisco are now 50 or older.
An inevitable consequence of the decline in HIV-related deaths is the aging of the population living with HIV infection.
A recent study from San Francisco — a city hit particularly hard by HIV right from the start — documents this trend. Using surveillance data from city's HIV/AIDS surveillance registry, investigators charted the ages of individuals living with a diagnosis of AIDS, using the 1992 CDC case definition. This registry is updated through linkage to local and national databases that track deaths and other vital statistics. The researchers also compared the numbers for San Francisco with those for the U.S. overall.
Of the 9796 individuals living with AIDS in San Francisco at the end of 2010, 5112 (52%) were 50 or older. The proportion of those 50 or older has increased steadily since 1990, when only 10% were in this category, compared with 24% in 2000 and 38% in 2005. Nationally, the proportion has also increased, although not to the same degree: 20% of AIDS patients in the U.S. were 50 or older in 2001 compared with 39% in 2009.
Comment
Oliver Wendell Holmes reportedly once said, “Old age is 15 years older than I am,” but in HIV research, it has repeatedly been defined as older than 50 — perhaps a response to the early days of the epidemic, which predominantly involved young men and women. Although, as the study authors note, San Francisco is the first city to reach the milestone of more than 50% of AIDS patients being at least 50 years old, these data will resonate with HIV clinicians around the country, who are all experiencing the aging of their patient populations.
Using AIDS diagnoses increases the accuracy of the surveillance data, but it is also a limitation of this study: Only individuals with advanced immunosuppression were included, rather than everyone living with HIV infection.
Editor Disclosures at Time of Publication Disclosures for Paul E. Sax, MD at time of publication Consultant / Advisory board Bristol-Myers Squibb; Gilead; GlaxoSmithKline; Janssen; Merck Grant / research support NIH; Bristol-Myers Squibb; Gilead; GlaxoSmithKline; Merck Editorial boards Medscape; UpToDate Leadership positions in professional societies Mass ID Society (Vice President)
Citation(s): O'Keefe KJ et al. People fifty years or older now account for the majority of AIDS cases in San Francisco, California, 2010. AIDS Care 2013 Jan 15; [e-pub ahead of print].
( http://dx.doi.org/10.1080/09540121.2012.752565 ) -
Source - http://www.jwatch.org/na31802/2013/08/01/epidemic-ages-so-do-patients
Researchers call for increased Hep C treatment for drug users
Researchers call for increased Hep C treatment for drug users
By Serkan Ozturk on August 5, 2013
Researchers at the Kirby Institute at the University of NSW have released new recommendations that suggest the burden of liver disease could be dramatically reduced by increasing treatment for hepatitis C infection among people who inject drugs.
In collaboration with colleagues from the International Network on Hepatitis Care in Substance Users (INHSU), the Kirby Institute published the global recommendations online last week in the journal Clinical Infectious Diseases to help mark World Hepatitis Day last Sunday.
In Australia, 226,000 people are living with chronic hepatitis C and over 10,000 new cases are reported every year. Almost 80 per cent of all infections occur among people who inject drugs, with only one percent of those people currently receiving treatment.
Kirby Institute senior lecturer and co-lead author of the recommendations Dr Jason Grebely said treatment for hepatitis C infection among people who inject drugs remained unacceptably low.
“Clinicians have been hesitant to recommend treatment in this population because of a lack of understanding about how lifestyle factors may impede successful treatment,” Grebely said.
Unlike other types of hepatitis, there is currently no vaccine to prevent hepatitis C and medication is the only way to manage the disease.
Hepatitis C can lead to serious complications such as liver failure or cancer, while ACON also believes up to 13 percent of all people living with HIV may also have hepatitis C and that co-infection remains a serious issue.
Health Minister Tanya Plibersek Health Minister announced the federal government will provide more than $220 million over five years to subsidise hepatitis C medications boceprevir (Victrelis) and telaprevir (Incivo) through the Pharmaceutical Benefits Scheme (PBS) in February.
http://www.starobserver.com.au/news/2013/08/05/researchers-call-for-increased-hep-c-treatment-for-drug-users/107185
By Serkan Ozturk on August 5, 2013
Researchers at the Kirby Institute at the University of NSW have released new recommendations that suggest the burden of liver disease could be dramatically reduced by increasing treatment for hepatitis C infection among people who inject drugs.
In collaboration with colleagues from the International Network on Hepatitis Care in Substance Users (INHSU), the Kirby Institute published the global recommendations online last week in the journal Clinical Infectious Diseases to help mark World Hepatitis Day last Sunday.
In Australia, 226,000 people are living with chronic hepatitis C and over 10,000 new cases are reported every year. Almost 80 per cent of all infections occur among people who inject drugs, with only one percent of those people currently receiving treatment.
Kirby Institute senior lecturer and co-lead author of the recommendations Dr Jason Grebely said treatment for hepatitis C infection among people who inject drugs remained unacceptably low.
“Clinicians have been hesitant to recommend treatment in this population because of a lack of understanding about how lifestyle factors may impede successful treatment,” Grebely said.
Unlike other types of hepatitis, there is currently no vaccine to prevent hepatitis C and medication is the only way to manage the disease.
Hepatitis C can lead to serious complications such as liver failure or cancer, while ACON also believes up to 13 percent of all people living with HIV may also have hepatitis C and that co-infection remains a serious issue.
Health Minister Tanya Plibersek Health Minister announced the federal government will provide more than $220 million over five years to subsidise hepatitis C medications boceprevir (Victrelis) and telaprevir (Incivo) through the Pharmaceutical Benefits Scheme (PBS) in February.
http://www.starobserver.com.au/news/2013/08/05/researchers-call-for-increased-hep-c-treatment-for-drug-users/107185
Should You Take Dietary Supplements?
A Look at Vitamins, Minerals, Botanicals and More
When you reach for that bottle of vitamin C or fish oil pills, you might wonder how well they’ll work and if they’re safe. The first thing to ask yourself is whether you need them in the first place.
More than half of all Americans take one or more dietary supplements daily or on occasion. Supplements are available without a prescription and usually come in pill, powder or liquid form. Common supplements include vitamins, minerals and herbal products, also known as botanicals.
People take these supplements to make sure they get enough essential nutrients and to maintain or improve their health. But not everyone needs to take supplements.
“It’s possible to get all of the nutrients you need by eating a variety of healthy foods, so you don’t have to take one,” says Carol Haggans, a registered dietitian and consultant to NIH. “But supplements can be useful for filling in gaps in your diet.”
Some supplements may have side effects, especially if taken before surgery or with other medicines. Supplements can also cause problems if you have certain health conditions. And the effects of many supplements haven’t been tested in children, pregnant women and other groups. So talk with your health care provider if you’re thinking about taking dietary supplements.
“You should discuss with your doctor what supplements you’re taking so your care can be integrated and managed,” advises Dr. Craig Hopp, an expert in botanicals research at NIH.
Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods, not as drugs. The label may claim certain health benefits. But unlike medicines, supplements can’t claim to cure, treat or prevent a disease.
“There’s little evidence that any supplement can reverse the course of any chronic disease,” says Hopp. “Don’t take supplements with that expectation.”
Evidence does suggest that some supplements can enhance health in different ways. The most popular nutrient supplements are multivitamins, calcium and vitamins B, C and D. Calcium supports bone health, and vitamin D helps the body absorb calcium. Vitamins C and E are antioxidants—molecules that prevent cell damage and help to maintain health.
Women need iron during pregnancy, and breastfed infants need vitamin D. Folic acid—400 micrograms daily, whether from supplements or fortified food—is important for all women of childbearing age.
Vitamin B12 keeps nerve and blood cells healthy. “Vitamin B12 mostly comes from meat, fish and dairy foods, so vegans may consider taking a supplement to be sure to get enough of it,” Haggans says.
Research suggests that fish oil can promote heart health. Of the supplements not derived from vitamins and minerals, Hopp says, “fish oil probably has the most scientific evidence to support its use.”
The health effects of some other common supplements need more study. These include glucosamine (for joint pain) and herbal supplements such as echinacea (immune health) and flaxseed oil (digestion).
Many supplements have mild effects with few risks. But use caution. Vitamin K, for example, will reduce the ability of blood thinners to work. Ginkgo can increase blood thinning. The herb St. John’s wort is sometimes used to ease depression, anxiety or nerve pain, but it can also speed the breakdown of many drugs—such as antidepressants and birth control pills—and make them less effective.
Just because a supplement is promoted as “natural” doesn’t necessarily mean it’s safe. The herbs comfrey and kava, for example, can seriously damage the liver.
“It’s important to know the chemical makeup, how it’s prepared, and how it works in the body—especially for herbs, but also for nutrients,” says Haggans. “Talk to a health care provider for advice on whether you need a supplement in the first place, the dose and possible interactions with medicine you’re already taking.”
For vitamins and minerals, check the % Daily Value (DV) for each nutrient to make sure you’re not getting too much. “It’s important to consider the DV and upper limit,” says Haggans. Too much of certain supplements can be harmful.
Scientists still have much to learn even about common vitamins. One recent study found unexpected evidence about vitamin E. Earlier research suggested that men who took vitamin E supplements might have a lower risk of developing prostate cancer. “But much to our surprise, a large NIH-funded clinical trial of more than 29,000 men found that taking supplements of vitamin E actually raised—not reduced—their risk of this disease,” says Dr. Paul M. Coates, director of NIH’s Office of Dietary Supplements. That’s why it’s important to conduct clinical studies of supplements to confirm their effects.
Because supplements are regulated as foods, not as drugs, the FDA doesn’t evaluate the quality of supplements or assess their effects on the body. If a product is found to be unsafe after it reaches the market, the FDA can restrict or ban its use.
Manufacturers are also responsible for the product’s purity, and they must accurately list ingredients and their amounts. But there’s no regulatory agency that makes sure that labels match what’s in the bottles. You risk getting less, or sometimes more, of the listed ingredients. All of the ingredients may not even be listed.
A few independent organizations conduct quality tests of supplements and offer seals of approval. This doesn’t guarantee the product works or is safe; it just assures the product was properly made and contains the listed ingredients.
“Products sold nationally in the stores and online where you usually shop should be fine,” Coates says. “According to the FDA, supplement products most likely to be contaminated with pharmaceutical ingredients are herbal remedies promoted for weight loss and for sexual or athletic performance enhancement.”
To make it easy to find reliable information, NIH has fact sheets on dietary supplements at http://ods.od.nih.gov/factsheets/list-all/. NIH also recently launched an online Dietary Supplement Label Database at www.dsld.nlm.nih.gov. This free database lets you look up the ingredients of thousands of dietary supplements. It includes information from the label on dosage, health claims and cautions.
For more personalized, on-the-go information about dietary supplements, check out NIH’s free updated app for your smart phone or tablet: My Dietary Supplements (MyDS). You can access it at http://myds.nih.gov.
The MyDS app provides the latest supplement information and lets you keep track of the vitamins, minerals, herbs and other products you take. You can even keep track of supplements taken by your parents, spouse or children.
“Deciding whether to take dietary supplements and which ones to take is a serious matter,” says Coates. “Learn about their potential benefits and any risks they may pose first. Speak to your health care providers about products of interest and decide together what might be best for you to take, if anything, for your overall health.”
Source - http://newsinhealth.nih.gov/issue/aug2013/feature1
Photo Credit - phytoguide.com
Sunday, August 4, 2013
Hepatitis C- High discontinuation rate noted for direct-acting antiviral therapy
High discontinuation rate noted for direct-acting antiviral therapy
By: DENISE NAPOLI, IMNG Medical News
Despite high rates of early clinical response, 30% of veterans taking direct-acting antivirals for hepatitis C discontinued treatment by week 24.
The findings highlight "the challenges associated with maintenance of these regimens" in a real-world cohort, wrote Pamela S. Belperio, Pharm.D., and colleagues. The study appears in the August issue of Clinical Gastroenterology and Hepatology.
Dr. Belperio of Veterans Affairs Palo Alto (Calif.) Health Care System, looked at 859 patients registered with the VA’s Clinical Case Registry for HCV who initiated triple therapy with pegylated interferon, ribavirin, and either boceprevir (n = 661) or telaprevir (n = 198) before Jan. 1, 2012, at 94 different VA facilities.
The authors determined how long the patient took the drug by looking at medication dispensed dates, and patients were classified as having response rates of "undetectable" if HCV RNA levels at their most recent assay were undetectable.
Patients’ mean age was 57 years; most of the patients were male. Patients with HIV or hepatitis B virus coinfection, hepatocellular carcinoma, or liver transplantation were excluded.
Even so, "Up to 13% of boceprevir-treated veterans and 24% of telaprevir-treated veterans would have been excluded from the phase III trials [of these therapies] based on hematologic exclusion criteria used in the telaprevir trials," Dr. Belperio wrote.
Despite this, the authors found that by week 12, 76% of all treatment-naive, noncirrhotic patients taking boceprevir had achieved undetectable viral loads, as had 78% of telaprevir patients.
By 24 weeks, those numbers were 74% for boceprevir patients and 60% for telaprevir patients.
However, the researchers also found that about one-third of patients discontinued treatment with either boceprevir or telaprevir before 24 weeks (30% and 34%, respectively; P = .37), with an incidence of hematologic adverse events that was both higher and more pronounced than has been reported in clinical trials of direct-acting antivirals (DAAs), wrote Dr. Belperio.
Indeed, anemia of at least grade 1 (hemoglobin below normal limits but greater than or equal to 10 g/dL) occurred in 50% of patients in both DAA groups, "which is up to a 15% increased incidence of anemia over what has been reported elsewhere."
There was also significant thrombocytopenia for both drugs, which Dr. Belperio said was four times higher than in clinical trials. In fact, her group reported that 66% of patients taking boceprevir had grade 1 thrombocytopenia. (platelets below normal limits but greater than or equal to 75,000/mm3), as did 59% of patients taking telaprevir.
"This may reflect the greater proportion of cirrhotic patients in our cohort compared with the clinical trials; however, it is concerning given the limited strategies currently available to manage thrombocytopenia and the unknown effect that PEG dose reductions may have on sustained virologic response in the context of DAA-based therapies," they wrote.
There also was a portion of patients for whom treatment was determined to be futile, according to Food and Drug Administration specifications: 9% of patients receiving boceprevir at week 12 and 5% at week 24, as well as 6% of telaprevir patients at week 4, 4% at week 12, and 7% at week 24.
The authors conceded several limitations to this study, including that they were unable to assess reasons for early treatment discontinuation.
Nevertheless, the data "offer clinicians a perspective on expectations of early response and safety of DAA regimens in routine clinical practice, allowing a more nuanced discussion between providers and patients regarding the risks and benefits of embarking on DAA-based treatment."
The authors disclosed that one coinvestigator has previously received grant support from Gilead Sciences, maker of HCV therapies. They disclosed no other conflicts of interest.
08/01/13
http://www.gihepnews.com/single-view/high-discontinuation-rate-noted-for-direct-acting-antiviral-therapy/de644968728281122928cb4c50eb579f.html
By: DENISE NAPOLI, IMNG Medical News
Despite high rates of early clinical response, 30% of veterans taking direct-acting antivirals for hepatitis C discontinued treatment by week 24.
The findings highlight "the challenges associated with maintenance of these regimens" in a real-world cohort, wrote Pamela S. Belperio, Pharm.D., and colleagues. The study appears in the August issue of Clinical Gastroenterology and Hepatology.
Dr. Belperio of Veterans Affairs Palo Alto (Calif.) Health Care System, looked at 859 patients registered with the VA’s Clinical Case Registry for HCV who initiated triple therapy with pegylated interferon, ribavirin, and either boceprevir (n = 661) or telaprevir (n = 198) before Jan. 1, 2012, at 94 different VA facilities.
The authors determined how long the patient took the drug by looking at medication dispensed dates, and patients were classified as having response rates of "undetectable" if HCV RNA levels at their most recent assay were undetectable.
Patients’ mean age was 57 years; most of the patients were male. Patients with HIV or hepatitis B virus coinfection, hepatocellular carcinoma, or liver transplantation were excluded.
Even so, "Up to 13% of boceprevir-treated veterans and 24% of telaprevir-treated veterans would have been excluded from the phase III trials [of these therapies] based on hematologic exclusion criteria used in the telaprevir trials," Dr. Belperio wrote.
Despite this, the authors found that by week 12, 76% of all treatment-naive, noncirrhotic patients taking boceprevir had achieved undetectable viral loads, as had 78% of telaprevir patients.
By 24 weeks, those numbers were 74% for boceprevir patients and 60% for telaprevir patients.
However, the researchers also found that about one-third of patients discontinued treatment with either boceprevir or telaprevir before 24 weeks (30% and 34%, respectively; P = .37), with an incidence of hematologic adverse events that was both higher and more pronounced than has been reported in clinical trials of direct-acting antivirals (DAAs), wrote Dr. Belperio.
Indeed, anemia of at least grade 1 (hemoglobin below normal limits but greater than or equal to 10 g/dL) occurred in 50% of patients in both DAA groups, "which is up to a 15% increased incidence of anemia over what has been reported elsewhere."
There was also significant thrombocytopenia for both drugs, which Dr. Belperio said was four times higher than in clinical trials. In fact, her group reported that 66% of patients taking boceprevir had grade 1 thrombocytopenia. (platelets below normal limits but greater than or equal to 75,000/mm3), as did 59% of patients taking telaprevir.
"This may reflect the greater proportion of cirrhotic patients in our cohort compared with the clinical trials; however, it is concerning given the limited strategies currently available to manage thrombocytopenia and the unknown effect that PEG dose reductions may have on sustained virologic response in the context of DAA-based therapies," they wrote.
There also was a portion of patients for whom treatment was determined to be futile, according to Food and Drug Administration specifications: 9% of patients receiving boceprevir at week 12 and 5% at week 24, as well as 6% of telaprevir patients at week 4, 4% at week 12, and 7% at week 24.
The authors conceded several limitations to this study, including that they were unable to assess reasons for early treatment discontinuation.
Nevertheless, the data "offer clinicians a perspective on expectations of early response and safety of DAA regimens in routine clinical practice, allowing a more nuanced discussion between providers and patients regarding the risks and benefits of embarking on DAA-based treatment."
The authors disclosed that one coinvestigator has previously received grant support from Gilead Sciences, maker of HCV therapies. They disclosed no other conflicts of interest.
08/01/13
http://www.gihepnews.com/single-view/high-discontinuation-rate-noted-for-direct-acting-antiviral-therapy/de644968728281122928cb4c50eb579f.html
Triple therapy underutilized in HCV
Triple therapy underutilized in HCV
By: DENISE NAPOLI, IMNG Medical News
Fewer than 20% of patients with hepatitis C virus genotype 1 receive triple therapy with boceprevir or telaprevir, according to Dr. Emerson Y. Chen and colleagues. The results are in the August issue of Clinical Gastroenterology and Hepatology.
The "disappointingly low use of the new therapies, even after a decade without novel medications," suggests that real-world use of these drugs is hampered by factors including safety and the low predicted response rates in prior nonresponders, they wrote.
Dr. Chen of the University of Texas Southwestern Medical School, Dallas, looked at 487 patients with HCV genotype 1 presenting to one of two academic outpatient hepatology practices in Dallas and Miami.
The majority of patients were between 50 and 60 years of age, male, and white. More than two-thirds had private insurance, and half of the patients were treatment naive.
Overall, the authors found that 91 patients (18.7%) were started on triple therapy (boceprevir or telaprevir plus pegylated interferon and ribavirin) while the remaining 396 patients remained untreated.
Dr. Chen then assessed the reasons for treatment deferral. The most common, he found, was contraindication (50.5%), including complications of liver disease and medical comorbidities. The next biggest reason cited for treatment deferral was "patient choice" (22.5%), which included concerns about side effects, limited success rates, financial issues, or inability to commit time for treatment. Finally, the presence of less advanced liver disease (17.4%) and the anticipation (among providers and patients alike) of better future therapies (9.6%) were also factors in triple therapy refusal.
"Although several expert panels for treatment recommendations are available, there exists an uncertainty among providers regarding selecting patients without major contraindications for triple therapy now over newer direct-acting antiviral therapy later," they added.
Next, the researchers compared the triple therapy patients with therapy deferrals.
In univariate analysis, they found that about three-fourths of patients who chose to initiate triple therapy had fibrosis stage 3 or were cirrhotic, although less than 10% had a history of overt decompensation.
"In contrast, among those who deferred treatment, more than 20% had decompensated liver disease, and 46% had early [an] fibrosis stage," they wrote.
Looking at patients’ mean Model for End-Stage Liver Disease scores, cirrhotic patients who deferred treatment registered a 9.3, compared with 7.3 for patients who elected to undergo triple therapy treatment (P less than .001). Additionally, 90% of cirrhotic patients on treatment were Child-Pugh class A compared with 63% in the nontreatment group (P = .003).
Commenting on the findings, Dr. Chen wrote that "although patients with mild fibrosis or persistently normal liver function tests have often not been recommended for repeat biopsy or treatment, they would likely benefit from treatment before they become older or develop contraindications.
"Nevertheless, many hepatologists appear to be recommending deferral of treatment for patients with mild to moderate fibrosis, waiting for the second-generation direct-acting antivirals with even higher sustained virologic response rates" and fewer side effects.
"Newly diagnosed treatment-naive patients along with those with less advanced liver disease will benefit from society-wide consensus regarding therapy initiation now or at a later time."
The authors disclosed funding from the Doris Duke Charitable Foundation and the University of Miami. Two authors disclosed ties to Merck, maker of boceprevir and ribavirin, and Vertex, which makes telaprevir.
08/01/13
http://www.gihepnews.com/single-view/triple-therapy-underutilized-in-hcv/e0fffac94f561b3865bd4904d07050eb.html
By: DENISE NAPOLI, IMNG Medical News
Fewer than 20% of patients with hepatitis C virus genotype 1 receive triple therapy with boceprevir or telaprevir, according to Dr. Emerson Y. Chen and colleagues. The results are in the August issue of Clinical Gastroenterology and Hepatology.
The "disappointingly low use of the new therapies, even after a decade without novel medications," suggests that real-world use of these drugs is hampered by factors including safety and the low predicted response rates in prior nonresponders, they wrote.
Dr. Chen of the University of Texas Southwestern Medical School, Dallas, looked at 487 patients with HCV genotype 1 presenting to one of two academic outpatient hepatology practices in Dallas and Miami.
The majority of patients were between 50 and 60 years of age, male, and white. More than two-thirds had private insurance, and half of the patients were treatment naive.
Overall, the authors found that 91 patients (18.7%) were started on triple therapy (boceprevir or telaprevir plus pegylated interferon and ribavirin) while the remaining 396 patients remained untreated.
Dr. Chen then assessed the reasons for treatment deferral. The most common, he found, was contraindication (50.5%), including complications of liver disease and medical comorbidities. The next biggest reason cited for treatment deferral was "patient choice" (22.5%), which included concerns about side effects, limited success rates, financial issues, or inability to commit time for treatment. Finally, the presence of less advanced liver disease (17.4%) and the anticipation (among providers and patients alike) of better future therapies (9.6%) were also factors in triple therapy refusal.
"Although several expert panels for treatment recommendations are available, there exists an uncertainty among providers regarding selecting patients without major contraindications for triple therapy now over newer direct-acting antiviral therapy later," they added.
Next, the researchers compared the triple therapy patients with therapy deferrals.
In univariate analysis, they found that about three-fourths of patients who chose to initiate triple therapy had fibrosis stage 3 or were cirrhotic, although less than 10% had a history of overt decompensation.
"In contrast, among those who deferred treatment, more than 20% had decompensated liver disease, and 46% had early [an] fibrosis stage," they wrote.
Looking at patients’ mean Model for End-Stage Liver Disease scores, cirrhotic patients who deferred treatment registered a 9.3, compared with 7.3 for patients who elected to undergo triple therapy treatment (P less than .001). Additionally, 90% of cirrhotic patients on treatment were Child-Pugh class A compared with 63% in the nontreatment group (P = .003).
Commenting on the findings, Dr. Chen wrote that "although patients with mild fibrosis or persistently normal liver function tests have often not been recommended for repeat biopsy or treatment, they would likely benefit from treatment before they become older or develop contraindications.
"Nevertheless, many hepatologists appear to be recommending deferral of treatment for patients with mild to moderate fibrosis, waiting for the second-generation direct-acting antivirals with even higher sustained virologic response rates" and fewer side effects.
"Newly diagnosed treatment-naive patients along with those with less advanced liver disease will benefit from society-wide consensus regarding therapy initiation now or at a later time."
The authors disclosed funding from the Doris Duke Charitable Foundation and the University of Miami. Two authors disclosed ties to Merck, maker of boceprevir and ribavirin, and Vertex, which makes telaprevir.
08/01/13
http://www.gihepnews.com/single-view/triple-therapy-underutilized-in-hcv/e0fffac94f561b3865bd4904d07050eb.html
Watch: Hooked on heroin-Pill crackdown opens door to heroin in suburbs
The following two stories discuss the serious rise in heroin use by teenagers - in a suburb near you.
The article by Ian Kullgren offers a look into Black-tar heroin making its way into the US from Mexico, the author also tells the story of a young woman who contracted HCV through drug use.
The CBS video covers a heartbreaking heroin overdose, the loss of a child and the mothers mission to save other children from the addictive drug.
Pill crackdown opens door to heroin in suburbs
By Ian Kullgren
Ashley, who asked that The Dispatch not use her real name to avoid legal consequences, said she became infected two years ago with hepatitis C, transmitted by a dirty needle. She tries to treat her disease with children’s gummy vitamins.
THE COLUMBUS DISPATCH
Sunday August 4, 2013 5:59 AM
An influx of Mexican black-tar heroin is causing a deadly wave of addiction in central Ohio and across the state, fueled by drug dealers looking to profit from growing demand for prescription-painkiller alternatives.
A concerted state effort to curb rampant prescription-pill use in recent years shut down “pill mills” and prompted doctors to cut the number of doses.
But many medical and law-enforcement experts in central Ohio and across the state say the strategy has inadvertently led to increased heroin use.
Columbus’ central location between border crossings — the Mexican border, Miami, Detroit and New York — has made it a hub for foreign drug traffickers. Multikilo shipments arrive daily, some worth more than $1 million, said Assistant U.S. Attorney Michael Hunter, who serves on the Organized Crime Drug Enforcement Task Force for Ohio’s southern district.
Dealers reap profits of double or triple the wholesale value while keeping street prices well below prescription pills’ in an effort to attract new users.
One pill can cost $80 on the street. Because of increased supply in the Columbus area, users can buy about a gram of heroin for as little as $5 — less than a pack of cigarettes, said Orman Hall, director of the Ohio Department of Alcohol and Drug Addiction Services.....
Officers with the Drug Enforcement Administration, the Franklin County sheriff’s office and the Columbus Division of Police raided eight trafficking houses in June, seizing 11 kilograms of heroin and $115,000 cash, and arresting 16 Mexican nationals for operating a drug ring in Hilliard, the Far West Side and Grove City.
Black-tar heroin — a black, sticky substance that looks like coal — is made exclusively in Mexico and started appearing in Columbus in 1998, said Sam Quinones, a Los Angeles Times reporter writing a book about heroin in the Midwest.
Continue reading @ THE COLUMBUS DISPATCH
Hooked on heroin in the suburbs
Source - CBS
Heroin, the scourge of a by-gone era and widely perceived to be a
thing of the past, is making a resurgence, and its reach is spreading into
suburban communities across America. Maureen Maher of "48 Hours" reports on the
troubling rise in heroin use among suburban high school and college-age
kids.
Friday, August 2, 2013
Baseline MELD Score Predicts Hepatic Decompensation during Therapy in Patients with Chronic Hepatitis C and Advanced Cirrhosis
Research Article
Baseline MELD Score Predicts Hepatic Decompensation during Antiviral Therapy in Patients with Chronic Hepatitis C and Advanced Cirrhosis
Citation: Dultz G, Seelhof M, Herrmann E, Welker M-W, Friedrich-Rust M, et al. (2013)
Baseline MELD Score Predicts Hepatic Decompensation during Antiviral Therapy in Patients with Chronic Hepatitis C and Advanced Cirrhosis.
PLoS ONE 8(8): e71262. doi:10.1371/journal.pone.0071262
Editor: James Fung, The University of Hong Kong, Hong Kong
Received: February 28, 2013; Accepted: June 27, 2013; Published: August 1, 2013
Copyright: © 2013 Dultz et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: The authors have no support or funding to report.
Competing interests: The authors have declared that no competing interests exist.
Introduction Only
Full Text Available @ PLOS ONE....
Chronic hepatitis C virus (HCV) infection is a major health burden with more than 170 million infected individuals worldwide. Progression to liver cirrhosis is observed in 2–35% of the patients after 20–25 years of chronic infection and once liver cirrhosis is established, the cumulative 5-year risk to develop hepatocellular carcinoma (HCC) is estimated to be 17% [1], [2].
For more than one decade, available antiviral treatment consisted of a dual therapy with pegylated interferon alfa-2a or -2b (peginterferon) in combination with the guanosine analog ribavirin leading to sustained virologic response (SVR) rates in approximately half of the patients [3], [4]. Licensing of the new HCV protease inhibitors boceprevir and telaprevir, as part of a triple therapy for untreated HCV genotype 1 patients and those who failed previous treatment, represents a milestone in HCV treatment. Untreated patients undergoing triple therapy achieve significantly higher SVR rates (66–75%) as compared to those receiving the dual therapy alone (37–44%) [5], [6], [7]. Patients with a previous virologic relapse, partial response, or non-response to peginterferon and ribavirin also benefit when retreated with boceprevir or telaprevir-containing triple therapies [8], [9].
It is well established, that the presence of advanced fibrosis or compensated liver cirrhosis negatively influence a patient’s individual chance for achieving an SVR [10]. In turn, patients with advanced disease may benefit most from antiviral therapy since it was demonstrated in several long-term follow up cohort studies that SVR can prevent hepatic decompensation, development of hepatocellular carcinoma, and is associated with reduced overall mortality [11], [12], [13], [14]. Albeit still unsatisfactory, subanalyses of the pivotal boceprevir and telaprevir trials have shown that SVR rates for patients with advanced fibrosis and liver cirrhosis receiving triple therapy are higher as compared to those receiving peginterferon and ribavirin alone (52–62% vs. 33–38%) [5], [6].
In patients with more severe disease, e.g. patients with advanced cirrhosis and those on the waiting list for liver transplantation, successful antiviral therapy in selected cases may halt the progression of liver disease, can prevent HCV re-infection of the transplanted liver and subsequently leads to a decrease of post-transplant morbidity and mortality [15], [16], [17], [18], [19], [20]. However, SVR rates in those patients have been shown to be poorer (approximately 25%) and peginterferon and ribavirin in those patients is associated with potentially life-threatening side effects and discontinuation rates ranged from 20–100%.
Recently, preliminary data from the French early access program for telaprevir and boceprevir (CUPIC study) reporting antiviral efficacies and the occurrence of adverse events in more than 400 cirrhotic patients receiving antiviral triple therapy were presented [21]. About 38–48% of the cirrhotic patients experienced serious adverse events during the first 16 weeks of antiviral triple therapy and 8 patients died.
Thus, decision making for antiviral therapy in patients with (advanced) liver cirrhosis remains a clinical challenge facing the dilemma of increased SVR rates on the one hand and therapeutic schedules that are associated with increased complications and fatal outcomes on the other hand [22]. Moreover, predictive factors in cirrhotic patients that are associated with serious adverse events and/or hepatic decompensation during antiviral therapy are poorly defined.
The aim of this retrospective cohort study was to define baseline characteristics that can help to predict the risk for hepatic decompensation in HCV patients with advanced liver cirrhosis during antiviral therapy with peginterferon and ribavirin. Clinical events indicating hepatic decompensation (ascites, hepatic encephalopathy, upper gastrointestinal bleeding, hospitalization) as well as laboratory data were recorded at baseline and during a follow up period of 72 weeks.
Continue To Full Text Article
Baseline MELD Score Predicts Hepatic Decompensation during Antiviral Therapy in Patients with Chronic Hepatitis C and Advanced Cirrhosis
Citation: Dultz G, Seelhof M, Herrmann E, Welker M-W, Friedrich-Rust M, et al. (2013)
Baseline MELD Score Predicts Hepatic Decompensation during Antiviral Therapy in Patients with Chronic Hepatitis C and Advanced Cirrhosis.
PLoS ONE 8(8): e71262. doi:10.1371/journal.pone.0071262
Editor: James Fung, The University of Hong Kong, Hong Kong
Received: February 28, 2013; Accepted: June 27, 2013; Published: August 1, 2013
Copyright: © 2013 Dultz et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: The authors have no support or funding to report.
Competing interests: The authors have declared that no competing interests exist.
Introduction Only
Full Text Available @ PLOS ONE....
Chronic hepatitis C virus (HCV) infection is a major health burden with more than 170 million infected individuals worldwide. Progression to liver cirrhosis is observed in 2–35% of the patients after 20–25 years of chronic infection and once liver cirrhosis is established, the cumulative 5-year risk to develop hepatocellular carcinoma (HCC) is estimated to be 17% [1], [2].
For more than one decade, available antiviral treatment consisted of a dual therapy with pegylated interferon alfa-2a or -2b (peginterferon) in combination with the guanosine analog ribavirin leading to sustained virologic response (SVR) rates in approximately half of the patients [3], [4]. Licensing of the new HCV protease inhibitors boceprevir and telaprevir, as part of a triple therapy for untreated HCV genotype 1 patients and those who failed previous treatment, represents a milestone in HCV treatment. Untreated patients undergoing triple therapy achieve significantly higher SVR rates (66–75%) as compared to those receiving the dual therapy alone (37–44%) [5], [6], [7]. Patients with a previous virologic relapse, partial response, or non-response to peginterferon and ribavirin also benefit when retreated with boceprevir or telaprevir-containing triple therapies [8], [9].
It is well established, that the presence of advanced fibrosis or compensated liver cirrhosis negatively influence a patient’s individual chance for achieving an SVR [10]. In turn, patients with advanced disease may benefit most from antiviral therapy since it was demonstrated in several long-term follow up cohort studies that SVR can prevent hepatic decompensation, development of hepatocellular carcinoma, and is associated with reduced overall mortality [11], [12], [13], [14]. Albeit still unsatisfactory, subanalyses of the pivotal boceprevir and telaprevir trials have shown that SVR rates for patients with advanced fibrosis and liver cirrhosis receiving triple therapy are higher as compared to those receiving peginterferon and ribavirin alone (52–62% vs. 33–38%) [5], [6].
In patients with more severe disease, e.g. patients with advanced cirrhosis and those on the waiting list for liver transplantation, successful antiviral therapy in selected cases may halt the progression of liver disease, can prevent HCV re-infection of the transplanted liver and subsequently leads to a decrease of post-transplant morbidity and mortality [15], [16], [17], [18], [19], [20]. However, SVR rates in those patients have been shown to be poorer (approximately 25%) and peginterferon and ribavirin in those patients is associated with potentially life-threatening side effects and discontinuation rates ranged from 20–100%.
Recently, preliminary data from the French early access program for telaprevir and boceprevir (CUPIC study) reporting antiviral efficacies and the occurrence of adverse events in more than 400 cirrhotic patients receiving antiviral triple therapy were presented [21]. About 38–48% of the cirrhotic patients experienced serious adverse events during the first 16 weeks of antiviral triple therapy and 8 patients died.
Thus, decision making for antiviral therapy in patients with (advanced) liver cirrhosis remains a clinical challenge facing the dilemma of increased SVR rates on the one hand and therapeutic schedules that are associated with increased complications and fatal outcomes on the other hand [22]. Moreover, predictive factors in cirrhotic patients that are associated with serious adverse events and/or hepatic decompensation during antiviral therapy are poorly defined.
The aim of this retrospective cohort study was to define baseline characteristics that can help to predict the risk for hepatic decompensation in HCV patients with advanced liver cirrhosis during antiviral therapy with peginterferon and ribavirin. Clinical events indicating hepatic decompensation (ascites, hepatic encephalopathy, upper gastrointestinal bleeding, hospitalization) as well as laboratory data were recorded at baseline and during a follow up period of 72 weeks.
Continue To Full Text Article
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