Racial Differences in Eligibility for Hepatitis C Treatment
Category: HCV Treatment
Published on Tuesday, 02 August 2011 00:00
Written by James Learned
Black hepatitis C patients were significantly more likely to be deemed ineligible for treatment, primarily due to neutropenia and uncontrolled medical conditions, according to a recent study. Less strict neutrophil eligibility criteria and more effective care for chronic diseases would increase access to HCV treatment for black people.
Black hepatitis C patients were significantly more likely to be deemed ineligible for treatment, primarily due to neutropenia and uncontrolled medical conditions, according to a recent study.
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4-Drug Regimen Can Cure Genotype 1 Hepatitis C in 12 Weeks
Category: Experimental HCV Drugs
Published on Tuesday, 02 August 2011 00:00
Interim results from the Phase 2 ZENITH study show that previously untreated people with HCV genotype 1 can achieve sustained response in as little as 12 weeks using a quadruple regimen consisting of telaprevir (Incivek), the experimental HCV polymerase inhibitor VX-222, pegylated interferon, and ribavirin. A newly added arm will evaluate telaprevir, VX-222, and ribavirin without interferon.
Below is an edited excerpt fro a Vertex Pharmaceuticals press release describing the study and its findings.... Read More...
High-Dose Pegylated Interferon-α and Ribavirin in Nonresponder Hepatitis C Patients and Relationship With IL-28B Genotype (SYREN Trial)
GastroenterologyJuly 2011
"High-dose pegylated IFN-α and ribavirin, therefore, appears to be a viable option to optimize HCV clearance rates in patients who failed on standard therapy and are retreated with a triple combination of pegylated IFN-α, ribavirin, and a protease inhibitor. This option, along with the ideal treatment schedule (our results suggest that high-dose pegylated IFN-α2a should be administered once weekly, but the question remains open for pegylated IFN-α2b, which bears different pharmacokinetic properties), should now be studied in prospective clinical trials according to the IL-28B genotype........
Overall, our data suggest that high-dose pegylated IFN-α, in combination with a standard or a high dose of ribavirin, is an interesting option for combination with telaprevir or boceprevir in order to minimize the risk of resistance selection and increase the SVR rates in nonresponders to earlier standard therapy. This is reinforced by the fact that these treatments would be given for 24 to 48 weeks, and the antiviral effect was sustained over this duration in our study in patients who responded. The minimal antiviral effect of pegylated IFN-α and ribavirin to achieve a high cure rate is still unknown.
Phase II and III trials with pegylated IFN-α2b, ribavirin, and boceprevir, which included a lead-in phase with pegylated IFN-α2b and ribavirin alone, suggested that it could be of the order of 1.0-1.5 Log10 IU/mL at week 4.10, 15, 16
Results from the REALIZE Trial with pegylated IFN-α2a, ribavirin, and telaprevir, which included a lead-in phase with pegylated IFN-α2a and ribavirin alone, also suggest a threshold at 1.0 Log10 IU/mL at week 4."
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Hepatic encephalopathy does not impair quality of life in cirrhosis
Minimal hepatic encephalopathy does not impair health-related quality of life in patients with cirrhosis, reports a study in this month's issue of Liver International.
Minimal hepatic encephalopathy is a serious complication of cirrhosis.
However, the impact of minimal hepatic encephalopathy on health-related quality of life remains controversial.
The Psychometric Hepatic Encephalopathy Score remains a ‘gold standard’ for the assessment of minimal hepatic encephalopathy, but its results clearly differ between studied populations.
Dr Ewa Wunsch and colleagues from Poland studied the effect of minimal hepatic encephalopathy on patient health-related quality of life.
The research team evaluated 87 consecutive cirrhotic patients.
All patients underwent clinical and psychometric evaluation at the same day.
The research team excluded 10 subjects with overt hepatic encephalopathy confirmed with West Haven criteria.
The team finally analyzed 77 patients.
Patients with minimal hepatic encephalopathy were identified on the grounds of an altered Psychometric Hepatic Encephalopathy Score.
Health related quality of life was assessed by the Medical Outcomes Study 36-Item Short Form Health Survey and the Chronic Liver Disease Questionnaire.
Normative reference data for the Psychometric Hepatic Encephalopathy Score were established from a cohort of 305 healthy Polish subjects.
The team diagnosed 38% patients with minimal hepatic encephalopathy.
When patients with and without minimal hepatic encephalopathy were compared, health related quality of life was not significantly different in none of the Short Form-36 and Chronic Liver Disease Questionnaire domains.
Dr Wunsch's team concludes, "Minimal hepatic encephalopathy does not affect health related quality of life."
Liver Int 2011: 31(7): 980–984
02 August 2011
Symptomatic gallstones quantification of the effects of obesity, alcohol and serum lipids on risk
The latest issue of the European Journal of Gastroenterology & Hepatology investigates the effects of obesity, alcohol and serum lipids on risk of gallstones.
The development of gallstones is influenced by obesity and alcohol.
Dr Paul Banim quantified these risks and investigate whether the etiological mechanism may involve serum lipids, for the first time using a European prospective cohort study.
The European Prospective Investigation into Cancer-Norfolk, recruited 25,639 men and women, aged 40 to 74 years, between 1993 and 1997.
At enrolment weight, height and alcohol intake were recorded and nonfasting blood samples taken to measure serum triglycerides, cholesterol, high-density lipoproteins and low-density lipoproteins.
The cohort was monitored for 14 years for symptomatic gallstones.
Every unit of alcohol consumed per week decreased risk in men by 3%
European Journal of Gastroenterology & Hepatology
The team found that symptomatic gallstones developed in 68% women.
For each additional unit of body mass index, the hazard ratio in men was 1, in women the hazard ratio was 1.08.
Every unit of alcohol consumed per week decreased risk in men by 3% with no effect in women.
The research team found that serum triglycerides increased risk in men and women.
Increased high-density lipoprotein was associated with a decreased risk in men and women.
The team observed no effects for serum cholesterol and low-density lipoprotein.
Dr Banim's team, "Obesity and alcohol influence gallstone formation, possibly in part through their effects on serum lipids."
"Reducing obesity may prevent gallstones in the population, as 38% of incident cases of gallstones were associated with a body mass index of more than 25."
Eur J Gastroenterol Hepatol 2011: 23(8): 733–74001
August 2011
Source: J Gastroenterol Hepatol
Long-Term Cohort Study of Chronic Hepatitis C according to Interferon Efficacy
Maruoka D, Imazeki F, Arai M, Kanda T, Fujiwara K, Yokosuka O;
Journal of Gastroenterology and Hepatology (Jul 2011)
Background and Aim:
We investigated the prognosis of patients with C-viral chronic liver disease (C-CLD) according to efficacy of interferon (IFN) therapy in a long-term retrospective cohort study.
Methods:
Of 721 patients with C-CLD who underwent liver biopsy between January 1986 and December 2005, 577 were treated with IFN, and 221 of these patients achieved sustained virological response (SVR) with a follow-up period of 9.9 ± 5.3 years.
Results:
The annual rate of HCC development was 2.71%/year, 2.31%/year, and 0.24%/year in untreated, non-SVR, and SVR patients, respectively. Multivariate Cox proportional regression analysis showed that the risk of HCC development was significantly lower in SVR patients than in untreated or non-SVR patients; moreover, this risk was similar in non-SVR patients and untreated patients. The annual mortality rate in overall death was 3.19%/year, 1.98 %/year, and 0.44%/year in untreated, non-SVR, and SVR patients, respectively. Multivariate Cox proportional hazards regression analysis showed that the SVR status reduced the risk ratio for overall death to 0.173, whereas the non-SVR status did not significantly reduce the risk ratio.
Conclusions:
The risk ratio of overall death and HCC development was significantly reduced in SVR patients, whereas no significant reduction was found in non-SVR patients in a long-term cohort study.
Source: J Gastroenterol Hepatol
Laparoscopic splenectomy with IFN therapy in one hundred HCV-cirrhotic patients with hypersplenism and thrombocytopenia
Akahoshi T, Tomikawa M, Kawanaka H, Furusyo N, Kinjo N, Tsutsumi N, Nagao Y, Hayashi J, Hashizume M, Maehara Y; Journal of Gastroenterology and Hepatology (Jul 2011)
Background and Aim:
We intended to determine whether laparoscopic splenectomy (Lap-Sp) contributes to treatment with interferon therapy in HCV-cirrhotic patients with thrombocytopenia caused by hypersplenism. Methods: From September 2002 to August 2009, 100 cirrhotic patients (54 men and 46 women) underwent Lap-Sp for a clinical application of interferon therapy. All the patients were Child-Pugh class A or B with thrombocytopenia (average platelet count, 56 × 10(3) /mm(3) ). The HCV genotype was type 1 in 80 patients and type 2 in 20 patients.
Results:
Pure laparoscopic or hand-assisted laparoscopy was performed in 78 and 22 patients, respectively, without mortality. Conversion to open surgery was not required in any of the patients. The platelet counts improved (mean platelet count 172 × 10(3) /mm(3) 1 month after surgery) and IFN therapy was started in 97 patients. In this study period, 36 patients obtained a sustained virologic response. Eight patients discontinued IFN therapy because of depression, neutropenia or other reasons.
Conclusions:
Lap-Sp permits most patients with HCV cirrhosis and hypersplenism to receive sufficient IFN therapy. Therefore, Lap-Sp can become a strong supportive surgery for cirrhotic patients who require antiviral therapy.
Liver Cancer
Response to Locoregional Embolization Predicts Survival in Liver Cancer
By: DENISE NAPOLI, Internal Medicine News Digital Network
Radiographic response to locoregional embolization of hepatocellular carcinoma predicted survival, Dr. Khairuddin Memon and colleagues reported in the August issue of Gastroenterology.
The finding is the first to substantiate the prognostic value of tumor response to chemoembolization and radioembolization in hepatocellular carcinoma (HCC), they wrote (Gastroenterology 2011 August [doi: 10.1053/j.gastro.2011.04.054].
"Based on these findings, consideration should be made to develop treatments for HCC that not only prolong [time to progression], but also elicit radiographic tumor response," added Dr. Memon of the department of radiology at Northwestern Memorial Hospital in Chicago.
According to Dr. Memon, between 2000 and 2008, 463 patients with HCC were treated at the authors’ institution using transarterial locoregional therapies – either transarterial chemoembolization (TACE) or yttrium-90 radioembolization (Y). All of these patients had unresectable HCC and bilirubin levels less than 3.0 mg/dL.
For the present analysis, the authors subsequently excluded all patients who underwent transplant, exhibited portal venous thrombosis or extrahepatic metastases at baseline, or had a Child-Pugh score greater than B7.
Survival outcomes were analyzed for the remaining 159 patients with respect to their response to TACE or Y therapy. Most of the patients (74%) were male, and 40% were younger than 65 years of age.
Response status was assessed using both World Health Organization criteria and European Association for Study of the Liver (EASL) guidelines. Patients were assessed using computed tomography or magnetic resonance imaging at 1 month after treatment and then at scheduled 2- to 3-month intervals.
The authors found that patients who were responders at the 6-month posttreatment landmark according to WHO criteria had an overall median survival of 31.6 months, compared with 13.7 months for 6-month WHO nonresponders (P = .069).
Judging by EASL guidelines, however, the difference reached significance: 6-month landmark EASL responders had a median overall survival of 24.6 months, versus 13.2 months for nonresponders (P = .002).
Highly significant differences were found when the participants were divided into two groups based on response or nonresponse at 12 months. By WHO criteria, median overall survival for responders at 12 months was 36.4 months, versus 11.1 months for nonresponders (P = .004). And by EASL standards, median survival was also 36.4 months for responders, versus 9.7 months for nonresponders (P less than .0001).
The authors also analyzed risk of death in the 6 months following each landmark. They found that WHO responders at the 6-month landmark had a 6.6% rate of death in this window, versus 15.5% among nonresponders – a nonsignificant difference (P = .707).
However, according to EASL standards, the rate of death in the 6 months following the 6-month landmark was 4.7% among responders versus 20.6% among nonresponders (P = .046).
Moreover, the death rate in the 6 months following the 12-month landmark was 0% for WHO responders, versus 31.5% for nonresponders (P = .010), and it was 4% and 32.7%, respectively, by EASL guidelines (P = .013).
The authors added that baseline tumor size was not a significant factor affecting survival in a univariate analysis.
"Our data show that responders by WHO/EASL criteria live longer than nonresponders from the landmark onwards, with the exception of WHO 6-month landmark (near significance); the trend is clear," wrote the authors.
Randomized controlled trials "will be required to validate this concept and establish radiographic response as a surrogate of the true end point (survival)."
Dr. Memon and his fellow researchers declared no conflicts of interest associated with this study
Alnylam concludes liver cancer drug Phase I trial
PBR Staff Writer
Published 02 August 2011
US based drug developer Alnylam Pharmaceuticals has concluded an open label, multi-center, dose escalation Phase I trial evaluating ALN-VSP as a treatment for advanced solid tumors with liver involvement.
ALN-VSP is a systemically delivered RNAi therapeutic which includes two siRNAs intended to target two genes critical for the growth and development of cancer cells: vascular endothelial growth factor (VEGF) and kinesin spindle protein (KSP), also known as eglin 5 (Eg5).
In the trial, the patients were treated at doses ranging from 0.1 to 1.5 mg/kg. Alnylam Clinical Research senior director Jared Gollob said the results of ALN-VSP Phase I trial demonstrated safety and tolerability of multiple doses of ALN-VSP in addition to evidence for anti-tumor activity and proof of RNAi mechanism from tissue biopsy samples.
HIV/HCV
Impact of HAART Exposure and Associated Lipodystrophy on Advanced Liver Fibrosis in HIV/HCV-coinfected Patients
Are patients with HIV/HCV coinfection more likely to progress to liver failure than patients with HCV alone?
The impact of antiretroviral drug exposure and associated lipodystrophy and/or insulin resistance (IR) on advanced liver fibrosis in HIV/HCV-coinfected patients is not fully documented.
Journal of Viral Hepatitis, August 2011
Meth Use Fuels Higher Rates of Unsafe Sex, HIV Risk in Young Men Who Have Sex with Men
Released: 8/1/2011 12:00 PM EDT
Embargo expired: 8/1/2011 4:00 PM EDT
Source: Johns Hopkins Medicine
Aug. 1, 2011
One in three meth users reports sex with an HIV-infected person
Newswise — A study by researchers at Johns Hopkins Children’s Center and elsewhere shows that methamphetamine use can fuel HIV infection risk among teenage boys and young men who have sex with men (MSM), a group that includes openly gay and bisexual men, as well as those who have sex with men but do not identify themselves as gay or bisexual.
The researchers said that nearly one-third (20) of the 64 participants who reported recent meth use also reported sex with an HIV-infected person, while half reported sex with an injection drug user. More than half, 34, said they have had unprotected sex.
While previous research has linked risky sexual behaviors to drug use in MSM, the new study is the first multi-city analysis to also include teenagers, a group made especially vulnerable by lack of experience, the investigators say.
The team’s findings, published in the Aug. 1 issue of the Archives of Pediatrics & Adolescent Medicine, underscore the need for HIV prevention programs to factor in the role of substance abuse, the investigators say.
“Drug use is closely linked to risk-taking behaviors, including sexually risky behaviors, so any HIV prevention efforts must, by definition, include drug use prevention and treatment of those with known drug problems,” said senior investigator Jonathan Ellen, M.D., a pediatrician and adolescent health specialist at Johns Hopkins Children’s Center.
Methamphetamine ¬ a popular and relatively cheap street drug ¬ heightens sexual response and lowers inhibitions, the researchers note.
“Add meth and you have a formula that leads to increased sexual risk in a group that already has higher prevalence of HIV,” says study co-investigator Nancy Willard, M.S., a researcher at Johns Hopkins.
The NIH-funded asked 595 males, ages 12 to 24, from eight major U.S. cities, including New York City, Baltimore and Washington, D.C., to describe their use of methamphetamine, other hard drugs and their sexual behavior.
Overall, recent meth users were more likely than those with no recent drug use to have had sex with an HIV-positive person (33 percent vs. 11 percent), to have history of sexually transmitted infections (52 percent vs. 21 percent), to have had sex with an injection drug user (52 percent vs. 11 percent) and to have sex with multiple partners in the past three months (86 percent vs. 63 percent). Meth users were also more likely to report having unprotected sex than those without recent drug use (67 percent vs. 46 percent). And recent meth users were also more likely than those with no recent drug use to be or have been homeless (72 percent vs. 28 percent) and less likely to be enrolled in school (36 vs. 60 percent).
The researchers caution that any drug abuse ¬ not just methamphetamine ¬ can push up the rates of risky behavior. Indeed, participants who reported having used other hard drugs such as cocaine, crack, heroin and ecstasy, were more likely than non-drug users to have sex with HIV-infected partners (24 vs. 11 percent) and more likely to have sex with injection drug users (20 percent vs. 10 percent)
Researchers from other institutions included Peter Freeman, M.P.H., and Robert Garofalo, M.D., of Children’s Memorial Hospital at Northwestern University, and Robert Harris, Ph.D., of Westat Inc.
Bendu Walker, M.P.H., also of Johns Hopkins, was co-author on the paper.Related on the Web:
Higher HIV Risk in Black Gay Men Linked to Partner Choice, Risk Perception http://www.hopkinschildrens.org/Higher-HIV-Risk-in-Black-Gay-Men.aspx
STI, HIV Counseling Inadequate in Male Teens http://www.hopkinschildrens.org/newsDetail.aspx?id=8302&terms=Arik+Marcell
Healthy You
Using humor to evaluate negative experiences can improve emotional health
Eva Valenti on August 1st, 2011
Stanford psychologists have confirmed the importance of a positive attitude when it comes to dealing with stressful health situations. In a recently published study, researchers Andrea Samson, PhD, and James Gross, PhD, asked participants to make jokes – either positive or negative – about an initially disturbing image (e.g. a car accident or corpse). Those who did so reported showed both increases in positive emotions and decreases in negative emotions. Joking was especially effective for those who used positive, optimistic humor to evaluate the image
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FYI-Bath salts are just the latest in a line of synthetic versions of illegal drugs, including synthetic marijuana, sometimes sold as "spice."
Federal ban proposed for synthetic drug Synthetic hallucinogens known as “bath salts” would be banned nationwide, under a bill sponsored by Wisconsin U.S. Sen. Herb Kohl.
The bill complements a new law in Wisconsin.
By: Rich Kremer, Wisconsin Public Radio, Superior Telegram
Synthetic hallucinogens known as “bath salts” would be banned nationwide, under a bill sponsored by Wisconsin U.S. Sen. Herb Kohl. The bill complements a new law in Wisconsin.
The term “bath salts” covers a range of designer drugs that when consumed, produce effects similar to cocaine and ecstasy. While bath salts were banned through a state law enacted earlier this summer, they can still be purchased online.
Sen. Kohl’s bill aims to create a national ban on the chemicals that go into making bath salts. Barron County Sheriff Chris Fitzgerald says he welcomes state and federal bans, because bath salts are very dangerous.
“If you take meth, cocaine and ecstasy and put them together you get bath salts,” he says.
Fitzgerald says six young people in Barron County wound up in the emergency room after using them. Despite the state law and pending federal legislation banning the drugs, there’s concern that new varieties of bath salts -- made of currently legal chemicals -- might be on the horizon.
But Jeff Wiswell of the Wisconsin Sheriff’s Association says law enforcement will be ready if that happens.
“If these new fronts break out, eventually the laws will be changed, the scientists will go to work, DEA will deal with it and the bottom line is we’ll pass more laws and there’ll be people doing hard time,” he says.
The American Association of Poison Control Centers says its centers across the U.S. have received nearly 3,500 calls about bath salts this year, up from just 300 in 2010.
Cocaine-like drug sold as 'bath salts' at corner store
CTV News.ca Staff
For most people the term "bath salts" suggests crystals to be poured into a tub of hot water for a relaxing soaking experience. But the term is also the name of a powerful new designer drug that can be bought at the corner store, and has been linked to several deaths in the United States.
Bath salts can be snorted or injected by users looking for a euphoric high, similar to that offered by cocaine or methamphetamine. But they can also cause terrifying hallucinations and suicidal urges.
The synthetic drug, one of many products to be manufactured to mimic the effects of illicit drugs, has so far eluded regulators because its label bears the warning, "not for human consumption."
But users who are buying the bath salts at convenience stores and other local markets know exactly what they're getting.
"Everybody who's trying these things knows what's going on," says Jim Williams of the Washington Poison Center.
A gram of bath salts can cost US$80, and despite the price tiny bottles fly off the shelves.
"I've never seen a drug progress from never heard of, never abused, never seen in a period of three months, to becoming an epidemic," says ER physician Dr. William Dempsey.
Use of the drug has been linked to a number of deaths in the U.S. Dickie Sanders, 21, shot himself in the head after using bath salts, while Elijah Taylor threw himself into traffic.
"In his mind, he thought he was being smart because it wasn't illegal," said Elijah's father, Eldon.
Johnny Salazar was high on bath salts when he burned his own son's hands when the child touched his bible.
"My son was a good son, is a good son. And this drug has destroyed a lot of children," says Connie Salazar, Johnny's mother.
Bath salts are just the latest in a line of synthetic versions of illegal drugs, including synthetic marijuana, sometimes sold as "spice."
But the latest drug craze has taken lawmakers by surprise, and worries even seasoned health professionals, such as emergency room physician Dr. Ronald Strony.
"In my 17 year career in emergency medicine," Strony says, "this is one of the most dangerous drugs that I've never seen."
With a report from CTV's Los Angeles Bureau Chief Tom Walters
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