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Week Ending: July 24, 2010
Alan Franciscus
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This Issue:
July 18, 2010
SciClone Announces Enrollment of First Patient In Its Phase 2 Trial of SCV-07 In Hepatitis C
http://discusspharmacy.com
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the enrollment of its first patient at the Atlanta Gastroenterology Associates in Atlanta, GA, in a phase 2 trial of SCV-07 for the treatment of hepatitis C (also known as HCV). This multicenter, multidose, open-label study is designed to evaluate the safety and immunomodulatory effects of SCV-07 as a monotherapy or in combination with ribavirin in non-cirrhotic patients with genotype 1 chronic HCV who have relapsed after at least 44 weeks of treatment with pegylated interferon and ribavirin.
“During our previous phase 2A clinical trial of SCV-07 as a monotherapy to treat patients with chronic hepatitis C infections, we were pleased by the safety data and were very encouraged by the efficacy signal, namely, a reduction of viral loads and a corresponding increase in neopterin concentration in some patients after only seven days of SCV-07 administration,” said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone. “SciClone is eager to investigate further SCV-07’s potential to enhance the immune response against hepatitis C and to determine whether the compound is capable of improving the current standard of care treatment.”
“Currently approved therapies for the treatment of HCV can have significant side effects and often fall short of providing the most important treatment outcome, sustained viral response,” said Kenneth Sherman, MD, PhD, Gould Professor of Medicine, Department of Internal Medicine at the University of Cincinnati, and a principal investigator in SciClone’s study. “We are very excited by what appears to be SCV-07’s ability to enhance patients’ immune function without adding significant toxicity. Should ongoing clinical trials show the benefits of adding SCV-07 to ribavirin, it has the potential to become incorporated into standard treatment practices in the future.”
The study, which will monitor biomarkers of immune activation and HCV viral load dynamics, will include two treatment cohorts of 20 patients each, who will receive SCV-07 at a dose of either 0.1 mg/kg or 1.0 mg/kg. The treatment period will be approximately eight weeks long, including four weeks of SCV-07 monotherapy followed by four weeks of SCV-07 in combination with ribavirin. In addition, there will be three follow-up visits within seven weeks after the completion of treatment.
For more information on SciClone’s phase 2 trial of SCV-07 in the treatment of HCV, please visit http://www.clinicaltrials.gov.
About SCV-07
SCV-07 is a small molecule which stimulates the immune system through inhibition of STAT3-dependant signaling and the resulting effects on T-helper 1 cells, which are essential for clearance of viral infections. SCV-07 has shown a good safety profile in several early stage clinical trials in healthy volunteers and subjects with HCV at various doses. SciClone is also carrying out a phase-2, randomized, double-blinded, placebo-controlled trial of SCV-07 for the treatment of oral mucositis in patients with head and neck cancers undergoing chemo-radiation. The topline results from this trial are expected to be announced in the first half of 2010.
SCV-07 is protected by composition of matter patents as well as multiple method of treatment patents. SciClone has exclusive worldwide rights to SCV-07 outside of Russia, where the molecule has recently been approved for stimulation of depressed immune systems.
Source: SciClone Pharmaceuticals
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July 19, 2010
St. Louis VA Medical Center Problems Identified More Than a Year Ago
http://www.aboutlawsuits.com
A former sterility processing employee says that supervisors at a St. Louis VA medical center ignored warnings that they were practicing improper sterility procedures a year before the facility was forced to warn more than 1,800 veterans that they may have been exposed to blood borne diseases while undergoing dental procedures at the facility.
Earlene Johnson testified before the U.S. House of Representatives Veterans’ Affairs committee last week, telling lawmakers that her efforts to warn about inadequate sterility procedures fell on deaf ears at the John Cochran Veterans Administration Hospital in St. Louis, and her persistence led to her being fired while on disability leave. The VA hearing was called in response to 1,812 warning letters the hospital sent out to veterans in late June telling them they needed to be tested for HIV and Hepatitis C.
The letters were sent after hospital officials determined that dental technicians took it upon themselves to wash dental tools using soap and water, instead of sending them to be cleaned properly by the hospital department charged with sanitizing and sterilizing medical instruments. While the instruments were still sent on later to be cleaned, the breach in proper protocol could have still led to veterans being put at risk, hospital officials said. The improper cleaning procedures went on from February 2009 until March 2010, when inspectors discovered the error.
“I warned management that they needed to go to every auxiliary department to ensure no one was sterilizing any instrument or anything that pertains to Sterile Processing,” Johnson said in her written testimony, in which she says she was rebuffed when she tried to take her concerns to higher levels. “Afterwards, I started being harassed and intimidated because of my warning.” Johnson said she was eventually fired while on medical leave and is suing to get her job back.
Committee Chairman Bob Filner said in his testimony that lawmakers also appeared to have been stonewalled and did not receive the information they needed in a timely manner. He also chastised hospital officials for trying to dismiss the hearing as a political ploy in the media.
The VA hospital system has faced substantial criticism over the quality of medical treatment provided at other medical clinics in multiple states throughout the course of 2009. Investigators from the Nuclear Regulatory Commission reported in June that a cancer unit at the Philadelphia VA Medical Center mishandled nearly 100 cases involving radiation treatment and suggested that staff involved had altered records to cover mistakes. The VA is also still dealing with the fallout from colonoscopy problems at VA centers in Tennessee, Georgia and Florida, where contaminated equipment exposed thousands of veterans to hepatitis, HIV and other blood borne diseases. Lawmakers blasted the VA in a hearing last July for the repeated lapses in veteran care.
“My biggest concern is that we’ve been here before,” said Rep. Hilner, referring to the sterility problems with colonoscopy equipment. “Clearly, VA has had issues with ensuring the sterility of reusable medical equipment in the past and clearly thy have yet to resolve these problems.”
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A New Era in HCV Drug Development
http://biopharmareport.blogspot.com
Jason Chew
Pegylated interferon plus ribavirin is the current standard of care for HCV treatment. However, it is a 48-week treatment and is only effective in about 50% of patients. On top of that, patients must deal with the inconvenience of injections and side effects that include fatigue, depression, anemia, and rash.
Now, a new generation of so-called “direct acting” antivirals is expected to change the way HCV is treated, lead by the protease inhibitor teleprevir from Vertex. In a Phase III trial, it was shown that a short 12-week treatment of teleprevir on top of Peg-interferon plus ribavirin resulted in a cure rate of 75% compared to just 44% with Peg-interferon plus ribavirin alone for 48 weeks. In the most likely scenario, teleprevir will reach the market toward the end of 2011, with a similar drug from Schering-Plough, boceprevir, following soon after.
The World Health Organization estimates 200 million people worldwide are infected with HCV, with an additional 3 to 4 million contracting the disease each year. The global market for HCV treatment is currently around $2 to $3 billion. With the advent of new available treatments, this market is expected to increase to more than $8 billion by 2016.
Teleprevir and boceprevir are only the first in a long list of novel HCV treatments moving through the pipeline. There are now four main classes of direct acting oral antivirals in clinical trials:
- NS3/4A protease inhibitors- these are the most advanced agents; Teleprevir is among them
- Non-nucleoside NS5B polymerase inhibitors- many are in development
- Nucleoside NS5B polymerase inhibitors- these are showing a great deal of promise
- NS5A inhibitors- most recently developed
The market for these novel medicines is still in its infancy, with no drugs approved for by the FDA, yet there are no fewer than 14 companies working on these four classes of HCV treatments. Companies with market caps ranging from less than $100 million to greater than $100 billion are involved in this work.
To divine the future of HCV drug development, it may be intuitive to look at the history of HIV drugs. Both HCV and HIV are RNA viruses, and some of the most effective early drugs to treat HIV were protease inhibitors. Over time, new classes of drugs were developed that were more potent and had fewer side effects. Scientists found that combinations of multiple drugs taken together worked the best; HIV became highly treatable even though no cure was found. Single pills containing a cocktail of antiviral drugs became the standard of care. Importantly, the current leader in the HIV market was not among the first entrants, it usurped the throne by developing a superior treatment.
Now as teleprevir heads towards market, drug makers are already at work on combinations of direct acting drugs. None of the compounds in development today work as monotherapies. The first generation of these combination drugs are protease inhibitor plus non-nucleoside NS5B polymerase inhibitor or protease inhibitor plus nucleoside NS5B polymerase inhibitor. The former of these is slightly more advanced in the clinic. The ultimate goal is to find a combination of oral drugs, which will eradicate the virus without the need for the addition of Peg-interferon plus ribavirin.
With four drug classes, the number of drug combinations is quite large. It is expected that similar to HIV treatment, these drug combos will consist of from two to four different compounds. Certain combinations of three drugs have now been shown to be synergistic together. It is not necessary that each of the drugs in the combo come from a different drug class. For instance, multiple polymerase inhibitors, each attacking different sites on the polymerase, can be used together, allowing for an even greater diversity of drug combinations.
In my opinion, it is almost a certainty the neither of the first two protease inhibitors will reign as standard of care in HCV treatment for very long. They have a significant head start on other compounds, but both have similar weaknesses. Neither can be taken once-daily, and resistant strains have already been identified for both compounds. Early stage protease inhibitors are now being developed that are more potent against the NS3/4A protease by greater than 100 fold, may have the potential for once-daily dosing, and have been shown to be active against HCV strains resistant to teleprevir and boceprevir. It is also thought that nucleoside polymerase inhibitors may have an advantage over other compound classes due to the high barrier it presents to the creation of resistant viral strains.
With the rapid advances in drug development, some predict treatment time may be reduced to as short as six weeks. The HCV space will be fascinating to watch in the coming years as new treatments become approved.
Patients around the world have reason for optimism.
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July 20, 2010
HCV Raises Risk of Stroke, Maybe MI, in HIV-Positive US Veterans
http://www.iasociety.org
Mark Mascolini
In US veterans with HIV, hepatitis C virus (HCV) coinfection independently raised the risk of cerebrovascular disease (such as stroke) and marginally upped the risk of acute myocardial infarction (MI). Because the veterans population is largely male and has free access to care, it is unclear how closely the findings apply to other HIV-positive populations.
HCV is associated with lower cholesterol levels, but how HCV infection affects risk of MI and cerebrovascular disease in people with HIV had not been well studied. This analysis involved 19,424 HIV-positive veterans, 6183 of them (31.6%) with HCV infection. The study focused on veterans cared for during the earlier part of the current antiretroviral era: 1996 to 2004.
Compared with veterans infected only with HIV, those also infected with HCV were significantly less likely to have high cholesterol (18.0% versus 30.7%, P < 0.001). But HCV-coinfected veterans were more likely to have hypertension (43.8% versus 35.6%, P < 0.001), more likely to have type 2 diabetes mellitus (16.2% versus 11.1%, P < 0.0001), and more likely to smoke (36.7% versus 24.7%, P = 0.009).
In analyses not adjusted for other risk factors, rates of acute MI and cerebrovascular disease were significantly higher in HCV-coinfected veterans than in veterans without HCV: 4.19 versus 3.36 events per 1000 patient-years for acute MI (P < 0.001) and 12.47 versus 11.2 events per 1000 patient-years for cerebrovascular disease (P < 0.001).
A statistical analysis that factored in diabetes, hypertension, age, and duration of antiretroviral therapy determined that cerebrovascular disease was 20% more likely in veterans with HCV than in those without HCV (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.04 to 1.38), and this increased risk was statistically significant (P = 0.013). In this analysis acute MI was 25% more likely in veterans with HCV, but this higher risk fell short of statistical significance (HR 1.25, 95% CI 0.98 to 1.61, P = 0.072).
Acute MI was significantly more likely in veterans with hypertension (HR 2.05, P < 0.001), older age (HR 1.79, P < 0.001), and longer duration of antiretroviral therapy (HR 1.12, P = 0.0411).
Source: R. Bedimo, A.O. Westfall, M. Mugavero, H. Drechsler, N. Khanna, M. Saag. Hepatitis C virus coinfection and the risk of cardiovascular disease among HIV-infected patients. HIV Medicine. 2010; 11: 462-468.
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Depression Overlooked in Patients with Hepatitis C; Compromising HCV Therapy
healthnews@wiley.com
Researchers from Denmark, Sweden, Norway and Finland (the NORDynamIC project group) have observed that depressive symptoms in patients with hepatitis C virus (HCV) infection are commonly overlooked in routine clinical interviews, and that treatment-induced depression compromises the outcome of HCV therapy. A second U.S. study found that patients with chronic infection had lower (work) productivity and incurred higher medical benefit costs than those without HCV. Both studies are available in the August issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).
HCV is a blood-born infection causing inflammation and destruction of liver cells. When inflammation lasts longer than six months there is ongoing liver cell injury which is defined as chronic HCV. The standard treatment protocol for chronic HCV is weekly injections of peg-interferon alfa-2a in combination with daily oral ribavirin for 24 to 48 weeks. However, this combination treatment can lead to major depression or other psychiatric complications in a number of HCV patients which may require premature termination of the antiviral therapy.
Peter Leutscher, M.D., Ph.D., and colleagues estimated the value of routine medical interviews in diagnosing depression in chronic HCV patients receiving peg-interferon/ribavirin therapy using the Major Depression Inventory (MDI). The MDI is a self-rating depression scale with a dual functionality in diagnosing major depression and in measurement of depression severity. Of the 325 HCV patients enrolled in the study, 6% were observed with major depression at baseline. Among the remaining 306 patients, 37% (n=114) developed depression while on HCV combination therapy. “According to the MDI criteria, we found that only 32% of the 114 patients with major depression were correctly diagnosed during routine medical interviews,” noted Dr. Leutscher.
Researchers also noted that the emergence of major depression frequently led to premature discontinuation of the peg-interferon/ribavirin therapy. Those patients with higher MDI scores (30 and over) were more likely to have a diminished treatment outcome. “A self-report instrument such as the MDI scale may be a useful tool for health providers to identify patients at risk for depression during HCV therapy,” recommended Dr. Leutscher.
Article: “Evaluation of Depression as a Risk Factor for Treatment Failure in Chronic Hepatitis C.” Peter Derek Christian Leutscher, Martin Lagging, Mads Rauning Buhl, Court Pedersen, Gunnar Norkrans, Nina Langeland, Kristine Mørch, Martti Färkkilä, Simon Hjerrild, Kristoffer Hellstrand, and Per Bech. Hepatology; Published Online: April 29, 2010 (DOI: 10.1002/hep.23699); Print Issue Date: August 2010.
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Lower Patient Productivity and Higher Healthcare Benefit Costs Add to Burden of HCV Infection
healthnews@wiley.com
Another HCV study published this month in Hepatology compared healthcare benefit costs and productivity issues for patients with and without chronic HCV infection. A total of 339,456 U.S. subjects were evaluated—1664 employees with HCV and 337,792 in the healthy control. Rich Brook, lead study author said, “We found that employees with HCV infection experience significant health-related work absences, greater health benefit costs, and further comorbidity than those without infection.”
Research results found HCV infected workers had 4.15 more total annual absence days and processed 7.5% fewer units of work per hour than those in the control group. Healthcare benefit costs were also significantly higher in the HCV group with a total incremental difference of $8,352 per year, including $490 in indirect (absence) costs.
Prior studies estimate that 180 million people are affected by HCV worldwide, and currently a vaccine to treat this disease is not available. Experts project that HCV will lead to a substantial health and economic burden over the next 10 to 20 years. “Our research supports this finding and provides a real world evaluation of HCV’s impact on productivity and healthcare benefit costs in the workplace,” concluded Mr. Brook.
Article: “The Impact of Hepatitis C Viral (HCV) Infection on Work Absence, Productivity, and Healthcare Benefit Costs.” Jun Su, Richard A. Brook, Nathan L. Kleinman, Patricia Corey-Lisle. Hepatology; Published Online: May 26, 2010 (DOI: 10.1002/hep.23726); Print Issue Date: August 2010.
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Viramune Boosts Hep C Treatment Efficacy in People with HIV
http://www.aidsmeds.com
Tim Horn
People coinfected with HIV and hepatitis C virus (HCV) who receive Viramune (nevirapine) may respond better to pegylated interferon/ribavirin HCV treatment compared with those receiving Kaletra (lopinavir/ritonavir), according to a retrospective study reported Tuesday, July 20, at the XVIII International AIDS Conference in Vienna.
It is known that some nucleoside reverse transcriptase inhibitors—such as didanosine (Videx EC), zidovudine (found in Retrovir, Combivir and Trizivir) and abacavir (found in Ziagen, Epzicom and Trizivir)—may decrease the efficacy and tolerability of HCV therapy. This is likely due to different interactions and toxicities, explained Jose Mira, MD, of the Hospital Universitario de Valme in Seville, Spain.
The information about whether protease inhibitors and non-nucleoside reverse transcriptase inhibitors influence sustained virologic responses (SVRs) to HCV therapy—defined as undetectable HCV levels six months after discontinuing treatment—among coinfected patients is limited and contradictory.
According to Mira, the use of protease inhibitors during HCV therapy led to a worse rate of response to pegylated interferon/ribavirin—the standard treatment for HCV—in a previous clinical trial. However, this association was not found in other studies performed in populations of coinfected patients.
It has also been reported that patients receiving Viramune-based antiretroviral (ARV) therapy show lower HCV viral loads than those treated with regimens containing a protease inhibitor or Sustiva (efavirenz). This finding, Mira added, could have a positive influence on the response to HCV therapy among individuals taking Viramune.
Based on these observations, Mira’s group decided to compare the efficacy of pegylated interferon/ribavirin among HIV/HCV-coinfected patients taking either Viramune- or Kaletra-based ARV regimens. This wasn’t an actual clinical trial, but rather a retrospective review of coinfected patients taking either ARV, along with pegylated interferon and ribavirin, at one of 20 hospitals throughout Spain.
The review included 165 patients, averaging 42 years old. Seventy-one patients were treated with Viramune, and 94 were treated with Kaletra.
It’s important to note that there were imbalances in the study population. The proportion of patients who were either male or had advanced liver fibrosis or cirrhosis was higher among individuals who took Kaletra. On the other hand, the percentage of patients with low levels of pre-HCV treatment viral loads was greater in the Viramune group.
In the strict intention-to-treat analysis, 56 percent of patients treated with Viramune experienced SVRs, compared with 37 percent of those receiving Kaletra. Among those with HCV genotypes 1 and 4—the most difficult to treat forms of HCV—the results were 43 versus 25 percent, respectively. Among those with easier to treat genotypes 2 and 3, the results were 78 versus 59 percent, respectively. These differences, Mira reported, were statistically significant, meaning they were all too great to have occurred by chance.
Eight percent of the patients in the Viramune group, compared with 23 percent of patients in the Kaletra group, were HCV treatment non-responders. This difference was statistically significant.
However, the differences in the rates of relapse, HCV viral load breakthrough, discontinuations due to adverse events and voluntary dropout were similar in both groups.
Because both groups were different regarding baseline HCV viral loads and fibrosis state, Mira’s group analyzed SVR rates by stratifying the population according to these important parameters. Among patients with high HCV viral loads (600,000 copies or greater), 58 percent of those who were receiving Viramune, compared with 31 percent of those taking Kaletra, experienced an SVR. Among patients with advanced fibrosis (a score of F3 or F4), 60 percent of the subjects in the Viramune group, compared with 36 percent of patients in the Kaletra group, achieved an SVR.
Upon analyzing the data for the specific factors associated with an SVR, the following were found to be positive variables: HCV genotype 2 or 3, use of ARV therapy including Viramune, and greater than 80 percent adherence to HCV treatment.
In conclusion, Mira stressed that controlled clinical trials are warranted to confirm the positive effects of Viramune on the efficacy of HCV therapy in people living with HIV.
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July 21, 2010
Does Nevirapine Improve Hepatitis C Treatment Outcomes in HIV/HCV Co-Infected Individuals?
http://www.aidsmap.com
Liz Highleyman
Mira J et al. Concomitant nevirapine therapy is associated with higher efficacy of pegylated interferon plus ribavirin among HIV/hepatitis C virus-coinfected patients. Eighteenth International AIDS Conference, Vienna, abstract TUAB0101, 2010.
HIV/hepatitis C (HCV) co-infected people who included nevirapine (Viramune) in their antiretroviral therapy (ART) regimen were more likely to achieve sustained response to interferon-based therapy for chronic hepatitis C, according to a Spanish study presented on Tuesday at the Eighteenth International AIDS Conference in Vienna.
The researchers suggested nevirapine may lower HCV viral load and thereby improve treatment response, but an alternative explanation is that people who are prescribed this drug are less sick at the outset, and therefore more likely to respond to HCV treatment in any case.
Jose Mira, from Valme University Hospital in Seville, and colleagues evaluated the effectiveness of chronic hepatitis C treatment using pegylated interferon plus ribavirin in HIV/HCV co-infected patients using different antiretroviral regimens.
Prior research suggested that certain nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) used to treat HIV are associated with poorer response to interferon, perhaps due to drug interactions or intensified side-effects.
The role of non-nucleoside reverse transcriptase inhibitors (NNRTIs) and HIV protease inhibitors is less well studied, and what research there is has produced conflicting findings. A study called RIBAVIC, for example, found that use of HIV protease inhibitors was associated with less successful hepatitis C treatment, but others have not seen a similar link.
Some reports suggest that co-infected patients on nevirapine-based ART have lower plasma HCV RNA levels than those treating their HIV with a protease inhibitor or an alternative NNRTI, efavirenz (Sustiva, Stocrin). Lower HCV viral load, in turn, is a predictor of better hepatitis C treatment outcomes.
Mira's team retrospectively compared the efficacy of hepatitis C treatment between 71 HIV/HCV co-infected individuals taking nevirapine and 94 taking lopinavir/ritonavir (Kaletra) at hospitals in Spain between 2002 and 2009. All participants rounded out their ART regimens with tenofovir (Viread) plus either 3TC (Epivir) or emtricitabine (Emtriva).
Baseline demographic factors were similar in both study arms. About three-quarters of participants were men, the median age was just over 40 years, and about 80% had a history of injecting drug use. Both groups had well-controlled HIV disease with a CD4 cell count of approximately 450 cells/mm3. About 60% in both groups had hard-to-treat HCV genotypes 1 or 4.
But significantly more participants in the lopinavir/ritonavir group had advanced liver fibrosis (stage F3 or greater; 52 vs 21%) and high baseline HCV viral load (> 600,000 IU/ml; 73 vs 44%).
Participants were treated for chronic hepatitis C for the first time using a standard regimen of pegylated interferon (Pegasys or PegIntron) plus weight-adjusted ribavirin. People with HCV genotypes 1 or 4 were treated for 48 weeks, whilst those with the more responsive genotypes 2 or 3 completed treatment after 24 weeks. About 90% of participants in both groups reported good adherence. They were permitted to use blood cell growth factors to manage the side-effects of neutropenia due to interferon and anaemia caused by ribavirin.
People taking nevirapine were significantly more likely than those taking lopinavir/ritonavir to achieve sustained virological response (SVR), or continued undetectable HCV viral load six months after finishing treatment. In an intent-to-treat analysis, overall SVR rates were 56 vs 37%, respectively (43 vs 25% for patients with genotypes 1 or 4; 78 vs 59% for those with genotypes 2 or 3).
Lack of SVR was mainly attributable to non-response, occurring in 8% of nevirapine recipients and with 23% of lopinavir/ritonavir recipients. Rates of relapse, viral breakthrough and discontinuation due to adverse events were similar in both arms.
When participants were classified according to viral load, however, divergent response associated with antiretroviral drug choice was only apparent amongst participants with high HCV viral load.
The researchers concluded that HIV/HCV co-infected people who use nevirapine for ART respond better to pegylated interferon plus ribavirin than those who use lopinavir/ritonavir. Mira proposed that the lower HCV viral load levels seen in nevirapine users might account for this difference in response rates.
Session moderator Jürgen Rockstroh called this interpretation into question, however. Whilst Mira credited nevirapine with lowering HCV viral load, another possible explanation is that participants taking lopinavir/ritonavir may be sicker on average, because traditional ART sequencing starts with a NNRTI-based regimen and moves on to protease-based therapy as HIV disease progresses.
People at later stages of HIV disease may have reduced immune response to hepatitis C and higher levels of inflammation or other factors that contribute to increased HCV viral load and accelerated liver fibrosis progression – both of which predict poorer response to interferon.
But Mira disagreed that the study was biased in this way, noting that differences in interferon response between nevirapine and lopinavir/ritonavir recipients was still apparent after adjusting for HCV viral load and extent of liver fibrosis.
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Prevention and Treatment Can Block Worldwide Health Threat Hepatitis with Many Forms
http://www.nydailynews.com
BY Katie Charles
The specialist: Dr. Douglas Dieterich on viral hepatitis
As a professor of medicine with more than 30 years of experience, Dieterich is a gastroenterologist and internist who treats outpatient liver disease. He sees about 60 viral hepatitis patients a week.
Who's at risk
Viral hepatitis is an umbrella term for the disease that results from several specific viruses that primarily attack the liver and cause inflammation. Researchers have identified strains of hepatitis A, B, C, D and E, which have different modes of transmission.
"Hepatitis B and C are a huge problem," says Dieterich. "Hepatitis B is the biggest worldwide infection, with probably 1 billion people infected, and hepatitis C affects another 500 million or more people worldwide." About 3 million-5 million Americans have hepatitis B, and doctors speculate that as many as 10 million may have hepatitis C, with the majority of cases remaining undiagnosed.
Diagnosing and treating viral hepatitis is essential because it is the main cause of cirrhosis and liver cancer. "These are very preventable and treatable diseases," says Dieterich. "There's a vaccine for hepatitis B, which is most often passed from mother to infant or sexually transmitted."
There's no vaccine for hepatitis C, which is transmitted via blood, but doctors have increasingly effective medications for treating both hepatitis B and C.
The groups at highest risk of hepatitis B are people born in Asia and sub-Saharan Africa, where 10% of the population is infected. "The No. 1 method of transmission worldwide is maternal fetal transmission at birth," says Dieterich. "Even at a major hospital in New York last year; the transmission rate from infected mothers to their babies was almost 10%."
Less easily transmitted than hepatitis B, hepatitis C is spread through blood. "Its main risk factors are anything with blood-to-blood contact: IV drug use, intranasal cocaine, tattoos, body piercing, needle sticks for health-care professionals, manicures and pedicures," says Dieterich.
For Americans, a major risk is having received a transfusion before 1992, when effective screening for hepatitis C came into use. "Generally, it's transmitted by blood, not by sex, but there is an outbreak of hepatitis C in HIV-positive men who have sex with other men," says Dieterich.
Another risk factor for hepatitis C is being born in the developing world. As much as 25% of the population in Egypt and the former Soviet Union has hepatitis C, and 13% of the population in Pakistan has it.
"In the past, health organizations were giving out one vial of vaccine and one syringe for the whole village or the whole classroom" in some areas, says Dieterich.
About 2% of the population in the U.S. is infected, but because doctors think only 10% of cases have been diagnosed, the real number of hepatitis C cases in this country may be as many as 10 million.
Signs and symptoms
All the strains of hepatitis have the same signs and symptoms. "The most common manifestation is no signs and symptoms," says Dieterich. "This is why screening is the key to diagnosis." Doctors can do a simple blood test that screens for all hepatitis strains from one blood draw, for a total cost of $35. "It's my strongly held opinion that everyone should be screened for hepatitis," says Dieterich. "Then you can be vaccinated for A and B if you're not immune, and treated for B or C if you are infected."
During acute infection, some patients do experience
hepatitis symptoms. The most common warning signs to look out for are fatigue and yellow eyes, pale-colored stools and cola-colored urine.
Traditional treatment
There are successful medical therapies available for both hepatitis B and C. "Hepatitis B is hard for us to understand but easy to treat," says Dieterich. "We have very good medicines that can prevent the virus from replicating, thus preventing it from causing cirrhosis and liver cancer."
However, doctors can't usually cure hepatitis B. "Right now we approach this disease like diabetes and hypertension — if we control it, the long-term complications can be prevented," adds Dieterich.
Early detection is key because it allows doctors to manage the virus before it causes liver damage. "The pills are oral and very effective, with virtually no side effects," says Dieterich. "But it can be hard for people to understand that they have to take the drugs for the rest of their life."
About 3% of people per year clear hepatitis B on treatment compared to less than 1% of those not on treatment.
In contrast, hepatitis C is easy to understand but more difficult to treat. It can, however, be cured. "Once it's cured, it's cured," says Dieterich. "However, the treatment is currently difficult, consisting of a once-a-week shot of interferon, accompanied by the pill ribavirin taken twice daily."
The therapy lasts for either 24 or 48 weeks, depending on what kind of hepatitis C is involved. The success rate is 40%-80%, but the side effects can be very taxing. "The good news is that a new wave of less-difficult treatment options is just over the horizon," says Dieterich.
Research breakthroughs
"We're about to have a huge revolution in the treatment of hepatitis C," says Dieterich. "There are about 26 new drugs converging on the disease right now."
Doctors expect the first two will be approved by the FDA in the third quarter of 2011. In clinical trials, one drug increased the cure rate by 40%-75%, and for half of the patients, it cut treatment from 48 to 24 weeks.
"Those are the first shots fired in this revolution," says Dieterich. "In 10 years, we'll probably be able to treat hepatitis C without using interferon, which has the worst side effects of these drugs."
It is important, though, not to delay treatment in anticipation of new therapies. The death rate from hepatitis C is expected to quadruple in the next 10 years in the U.S., and many people cannot afford to wait for treatment.
Questions for your doctor
Two good questions for your doctor are, "Have I been vaccinated for hepatitis A and B?" and "Am I immune?" The doctor can tell both things from a blood test. If your test for hepatitis B or C is positive, ask "Can you refer me to a specialist who treats hepatitis B and C aggressively?"
What you can do
- Get informed.
- The American Liver Foundation (liverfoundation.org) and Hepatitis B Foundation (hepb.org) have excellent Web sites that are easy to navigate.
- Get tested and get vaccinated.
- "One test should be enough, unless you have further risks," says Dieterich. "Everyone should be vaccinated against hepatitis A and B."
- Having liver enzyme levels that are normal is no guarantee that you don't have hepatitis, and is not an effective way to test for hepatitis.
- Protect your liver.
- Don't drink alcohol or take over-the-counter medicines in excess. Practice safe sex, and don't share needles.
- Be careful about instruments that can transmit blood.
- "If you get a tattoo, make sure they change the needle and ink," says Dieterich. "Bring your own instruments for manicures and pedicures."
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Risk Behaviors for Hepatitis B High, Vaccination Remains Low among Adults
http://www.infectiousdiseasenews.com
– by Melissa Foster
ATLANTA — Hepatitis B vaccination rates among adults remain stagnant, even though about one-fifth of 18- to 44-year-olds have reported engaging in behaviors that place them at higher risk for infection, data presented at the 2010 International Conference on Emerging Infectious Diseases suggest.
An estimated 43,000 new hepatitis B virus infections occurred during 2007, according to CDC researchers, with most appearing in unvaccinated adults with multiple sex partners, men who have sex with men and injection drug users.
To investigate the prevalence of these risk behaviors among adults aged 18 to 44 years, the researchers reviewed nationally representative data on sexual behaviors and drug use from population-based surveys — including the National Survey of Family Growth, the General Social Survey and the National Survey on Drug Use and Health — conducted between 2000 and 2008. The researchers applied this information to 2009 U.S. Census data to determine the proportion of the population engaging in risk behaviors for HBV.
Analysis yielded the following results for adults aged 18 to 44 years during the past year:
- 16.5% to 19.3% had at least two sexual partners.
- 0.2% to 0.4% had used illicit drugs by injection.
- 5% to 6% of men had ever had a male sex partner..
Overall estimates revealed that 19.3% to 22.8% of U.S. adults in this age group reported risk behaviors that indicate immunization with the hepatitis B vaccine. This information should aid physicians and public health officials in setting aside an appropriate amount of resources and improving programs that offer and promote hepatitis B vaccination, the researchers said.
For more information:
* Reilly ML. #3. Presented at: 2010 International Conference on Emerging Infectious Diseases; July 11-14, 2010; Atlanta.
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Hepatitis C and Insulin Resistance
http://www.diabeteshealth.com
We have known for several years that Hepatitis C, a common cause of liver cirrhosis and cancer, also makes people three to four times more likely to develop Type 2 diabetes. In studying the insulin resistance of 29 people with Hepatitis C, Australian researchers have confirmed that they have high insulin resistance, a precursor to diabetes. However, almost all insulin resistance occurs in muscle, with little or none in the liver, a very surprising finding given that Hepatitis C is a liver disease.
Dr Kerry Lee Milner and Professor Don Chisholm from Sydney's Garvan Institute of Medical Research, in collaboration with Professor Jacob George from the Storr Liver Unit, University of Sydney at Westmead Hospital, have published their study in the prestigious international journal, Gastroenterology, now online.
Insulin, a hormone made by the pancreas, helps the body use glucose for energy. The two most important organs that respond to insulin are the liver and muscle. A healthy liver responds to insulin by not producing glucose, while healthy muscle responds by using glucose. An insulin resistant liver produces unwanted glucose, while insulin resistant muscle cannot absorb it from the bloodstream, leading to high levels of sugar in the blood.
"Contrary to all expectations, not only did we find no significant insulin resistance in the liver of the patients in the study, half of them suffered from a strain of Hepatitis C that causes about three times the normal level of fat to accumulate in the liver," said Professor Chisholm.
"The fifteen people with very high levels of fat in the liver had the same degree of insulin resistance as the fourteen that didn't have fatty livers."
"A number of important investigators around the world have been arguing that fat in the liver is an extremely important determinant of insulin resistance, perhaps the most important. At least in this context, we've shown that not to be the case."
"Before you get Type 2 diabetes, you must become insulin resistant and your insulin producing cells must also fail to compensate. Insulin resistance alone will not give you diabetes."
"In our study, we gave intravenous glucose, a specific stimulus to insulin secretion, and showed that insulin secretion was not impaired in Hepatitis C patients compared to our control group."
"This finding tells us that people with Hepatitis C who develop diabetes probably have susceptible insulin-producing cells, and would probably get it anyway - but much later in life. The extra insulin resistance caused by Hepatitis C apparently brings on diabetes at 35 or 40, instead of 65 or 70."
"More work now needs to be done into why Hepatitis C causes insulin resistance in muscle. That will give us better insight into the behaviour of the disease."
"At this stage, it is helpful for people with Hepatitis C to understand insulin resistance and what it can mean for them. If they have relatives with Type 2 diabetes, they will be genetically prone to developing it themselves and so would be advised to manage their diets very carefully and take plenty of exercise - to slow onset."
About Hepatitis C
Hepatitis C is a blood-borne virus and in Australia is caused mainly by drug users sharing needles, but also by unsterile tattooing or body piercing. There is no vaccine for Hepatitis C, unlike Hepatitis A and B.
Around 212,000 Australians suffer from chronic Hepatitis C, 80,000 - 85,000 of them in NSW. Across Australia, there are roughly 10,000 new infections each year.
There are 6 strains of Hepatitis C - the participants in this study were selected because they had either of two common strains in Australia, Genotype 1 and Genotype 3. The latter strain causes significant fat deposits in the liver.
While it is not noted in the media release above, the study observed that the degree of insulin resistance is a negative predictor of anti-viral treatment. In other words, the greater the insulin resistance, the less responsive people will be to treatment.
Between 50-80% of people who are treated for Hepatitis C are successfully treated, leaving 20-50% who do not respond. Treating with lifestyle changes or an insulin sensitiser may reduce this percentage - as well as delaying onset of diabetes.
The study found that predictors of insulin resistance were viral load and subcutaneous fat. This suggests the possibility that the virus alters either fat supply or alters the cell signaling proteins released from subcutaneous fat, either of which could generate insulin resistance.
About Garvan
The Garvan Institute of Medical Research was founded in 1963. Initially a research department of St Vincent's Hospital in Sydney, it is now one of Australia's largest medical research institutions with nearly 500 scientists, students and support staff. Garvan's main research programs are: Cancer, Diabetes & Obesity, Immunology and Inflammation, Osteoporosis and Bone Biology, and Neuroscience. The Garvan's mission is to make significant contributions to medical science that will change the directions of science and medicine and have major impacts on human health. The outcome of Garvan's discoveries is the development of better methods of diagnosis, treatment, and ultimately, prevention of disease.
Source: Garvan press release
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July 22, 2010
NVHR Responds to New York Times Article on Hepatitis C Testing
http://www.prnewswire.com
WASHINGTON, July 22 /PRNewswire-USNewswire/ -- In response to today's New York Times article, "Hope against Hepatitis C," Andrew Muir, M.D., M.H.S., Director, Gastroenterology/Hepatology Research, Duke Clinical Research Institute and Steering Committee Member of the National Viral Hepatitis Roundtable (NVHR) released the following statement:
"Today's New York Times article details potential promising new drug therapies that could significantly improve the way we treat individuals infected with hepatitis C. Regrettably, the article suggests that expanded screening for hepatitis C may not be warranted. This approach is wrong and contrary to the direction in which we should and must move our health care system, particularly through improved access to care under health care reform. More than 5 million Americans are estimated to be infected with viral hepatitis B or C – and most are unaware they are infected as there are often few symptoms. Our health care system misses most infected individuals, who only learn that they have hepatitis C once they have progressed to liver cancer, cirrhosis, or liver failure. At that juncture, treatment options are limited and success rates are lower.
"Precisely because we do not know which individuals with hepatitis C will advance to these terrible diseases, it is critical that our public health infrastructure be modernized to achieve early detection of new infections and also to screen for individuals within specific risk groups, such as baby boomers and disproportionately affected populations. Once individuals are aware of their status, they will be empowered with this information, not only to make treatment choices, but also lifestyle choices to decrease their likelihood of disease progression and not to spread this infectious disease to others. In our current health care system, there are far too few options for diagnosis, care, and treatment. Unless or until the health care system provides access to all persons in need of hepatitis C treatment, it is important for the pharmaceutical industry to provide comprehensive compassionate care programs for those who are un/under insured.
"We can't prevent or treat what we don't know, which is why screening is critical. Access to screening would capture more infected individuals who can respond favorably to early intervention, reduce transmission, avoid needless medical expenses, and ultimately save thousands of lives annually."
NVHR is a coalition of more than 150 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. www.nvhr.org
SOURCE National Viral Hepatitis Roundtable
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Achillion Pharmaceuticals Announces Nomination of NS5A Inhibitor as a Lead Clinical Candidate for Treatment of HCV
http://www.marketwatch.com
ACH-2928 Demonstrates Excellent Potency Against HCV RNA Replication, Holds Potential for Combination Therapy
NEW HAVEN, Conn., Jul 22, 2010 (GlobeNewswire via COMTEX) -- Achillion Pharmaceuticals, Inc. /quotes/comstock/15*!achn/quotes/nls/achn (ACHN 2.52, +0.01, +0.42%) , a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced the nomination of a lead clinical candidate in its fourth proprietary program against hepatitis C virus (HCV) infection. The candidate, ACH-2928, is an NS5A inhibitor that in preclinical studies has demonstrated excellent potency against HCV RNA replication, as well as good pharmacokinetic and safety profiles.
"The overall profile of ACH-2928 demonstrates that it is highly active and retains potency against HCV genotypes 1a and 1b, as well as across other genotypes. The compound's high potency, in the picomolar range, and its favorable pharmacokinetic properties strongly suggest once-daily dosing," said Milind S. Deshpande, Ph.D., Executive Vice President and Chief Scientific Officer of Achillion. "Importantly, we believe ACH-2928 is highly effective in combination with NS3 protease inhibitors, NS5B polymerase inhibitors, interferon and ribavirin."
Michael D. Kishbauch, Achillion's President and CEO, stated, "The nomination of this novel NS5A clinical candidate is both exciting and significant. The treatment paradigm for HCV is moving toward combination therapies, and we are now poised to pursue our own combination therapies, putting ACH-2928 together with our highly potent protease inhibitors, ACH-1625 and ACH-2684. The development of our fourth proprietary HCV program underscores the depth of our robust drug discovery expertise in this important therapeutic area. We have initiated IND-enabling testing of ACH-2928, and plan to initiate combination treatment in 2011."
"The nomination of ACH-2928 is further evidence of our expertise in HCV drug discovery and structure-based design. We continue to build discrete intellectual property estates to which we retain all commercial rights," concluded Kishbauch.
SOURCE: Achillion Pharmaceuticals, Inc.
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People with HIV/Hepatitis C Co-Infection More Likely to Develop Osteoporosis
http://www.aidsmap.com
Liz Highleyman
HIV-positive people co-infected with hepatitis C virus (HCV) may be more likely to develop osteoporosis (porous bones) and sustain fractures than individuals with either virus alone, according to a US study presented this week at the Eighteenth International AIDS Conference in Vienna.
Roger Bedimo, from the Veterans Administration North Texas Healthcare System, looked at osteoporotic fractures, or breaks in the wrist, vertebrae or hip due to loss of bone mineral density.
Numerous studies have found lower than average bone density and higher risk of osteoporosis amongst people with HIV, although there remains controversy about whether this is attributable to the virus itself, antiretroviral drugs, or other factors.
Bone loss may be related to toxic damage to the bones or to metabolic changes that produce an imbalance in natural bone turnover, so that old bone material is reabsorbed faster than new bone can be produced to replace it.
Approximately one-third of HIV-positive people are co-infected with chronic hepatitis C, which is also linked to low bone mineral density and increased risk of fractures. Bone loss is a growing concern as this population ages. Bedimo pointed out that, while women are more likely to sustain fragility fractures, men are more likely to die from fracture-related complications.
Numerous studies have found lower than average bone density and higher risk of osteoporosis amongst people with HIV
Using ICD9 diagnostic codes in medical records, the researchers retrospectively identified all patients in the Veterans Affairs' Clinical Case Registry who were diagnosed with HIV between 1988 and 2009 and subsequently sustained osteoporotic fractures.
The analysis included 56,660 HIV-positive people. Almost all were men, the average age was 45 years and one-third were co-infected with hepatitis C. About two-thirds had taken antiretroviral therapy (ART), for an average duration of about four years. Participants were followed for just over five years on average, for a total 305,237 person-years of observation.
The investigators compared fracture rates between people with HIV alone and those with HIV/HCV co-infection. They then looked at the influence of other factors linked to bone loss including age, race/ethnicity, body weight, ART use, diabetes, chronic kidney disease, and smoking.
Bedimo acknowledged that they could not reliably estimate nutrition status or alcohol or drug use based on medical records, but these would be important risk factors to consider.
During the observation period, 951 people sustained at least one osteoporotic fracture. Most fractures (451) affected the wrist, followed by 308 broken hips and 106 vertebra fractures.
The fracture rate for people with HIV alone was 2.54 per 1000 person-years, rising to 3.25 per 1000 person-years amongst HIV/HCV co-infected participants. Looking only at data from the combination ART era (1996 to 2009), the corresponding rates were 2.86 and 4.06 per 1000 person-years, respectively.
Using these numbers, the researchers then calculated the impact of co-infection and the other confounding factors on fracture risk.
Whilst 51% of people who sustained fractures were HIV/HCV co-infected, this fell to 31% amongst fracture-free individuals. Both single-factor and multivariate analysis found co-existing HCV infection to be a significant independent predictor of osteoporotic fractures, with hazard ratios of 1.27 and 1.43, respectively. In other words, co-infection was associated with a 27 to 43% increase in risk.
In accordance with prior research, people of African descent were significantly less likely to sustain fractures, whilst older age, low body mass index, and tobacco use were linked to significantly higher risk. Bedimo explained that the apparent reduction in wrist fractures at the oldest ages was likely to be attributable to a reduction in strenuous activities that can lead to trauma.
In this study, however, chronic kidney disease and diabetes were not significant predictors of fracture risk after adjusting for other factors. Use of antiretroviral therapy was found to be protective. During the ART era, sustaining an osteoporotic fracture increased the risk of death by 77%.
These findings led Bedimo and colleagues to conclude that HCV co-infection is a significant risk factor for osteoporotic fractures in HIV-positive people, and that fractures appear to be increasing amongst HIV/HCV co-infected people during the ART era.
One limitation of this study is that the researchers only looked at fractures and did not take into account measures of bone mineral density, which could reveal bone loss at earlier stages.
During the discussion after the presentation, co-infection researcher Juan Macias suggested that HCV probably does not directly cause bone changes, but chronic hepatitis C can lead to liver cirrhosis, a known risk factor for bone damage.
Reference
Bedimo R et al. HCV co-infection is associated with a high risk of osteoporotic fractures among HIV-infected patients. Eighteenth International AIDS Conference, Vienna, abstract TUAB0104, 2010.
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Hep C Treatment Effective in HIV Patients with Normal Liver Enzymes
http://www.aidsmeds.com
by Tim Horn
People infected with HIV and hepatitis C virus (HCV) who have normal liver alanine transaminase (ALT) levels may benefit from pegylated interferon/ribavirin treatment, according to new data presented Tuesday, July 21, at the XVIII International AIDS Conference in Vienna. These results are important, as people with HCV and normal ALT levels are frequently told that treatment is not necessary.
As explained by Miguel Angel Von Wichmann, MD, of the Hospital Donostia in Madrid, normal ALT levels in the setting of chronic HCV infection are typically considered a factor related to slow progression to end-stage liver disease. However, he said, 80 percent of people with chronic HCV and normal ALT levels eventually develop some degree of liver disease, including significant progression to fibrosis and the development of liver cancer.
At least one study in people infected with HCV, but not HIV, has demonstrated that sustained virologic responses (SVRs)—an undetectable viral load maintained for at least six months after discontinuing treatment—are comparable among those with normal ALT levels versus those with elevated ALT levels. Whether this observation also holds true for people coinfected with HIV and HCV has, until now, been virtually unknown.
Von Wichmann and his colleagues conducted a study involving 68 HIV/HCV coinfected patients, divided into two groups. The first group included 35 patients with at least five normal ALT values over a 24-month period; the second group included 33 patients with persistently elevated ALT levels. All patients received pegylated interferon plus ribavirin (1,000 to 1,200 mg a day).
Twenty-four weeks of data from the 72-week study were presented by Von Wichmann in Vienna. Patients were, on average, 43 years old at the time of study enrollment; 77 percent were men. Roughly 74 percent had HCV genotypes 1 or 4—the most difficult to treat—and slightly more than half of the patients in each group had high HCV viral loads (greater than 800,000). Most patients had undetectable HIV viral loads.
SVR rates will not be known until therapy is discontinued at week 48 and the week-72 follow-up period has been reached. Von Wichmann reported, however, that early virologic responses (EVRs) were comparable between the two groups.
About 52 percent of case patients, compared with 68 percent of control patients, had undetectable HCV viral loads after 12 weeks of treatment—both encouraging results believed to be highly predictive of SVRs once treatment is discontinued. But it’s important to note that the difference between the two groups was not statistically significant, meaning it could have been due to chance.
Another measure of EVR—a greater than 2-log reduction in HCV viral load—was also reported. This was documented in 80 percent of the case volunteers and 96.4 percent of the control volunteers. Again, the difference was not found to be statistically significant.
The incidence of moderate-to-severe side effects, including hair loss, white blood cell decreases, flu-like symptoms, chest pain and weakness, was similar in both groups—roughly 46 percent.
At week 24, people in the group had higher CD4s: 300 cells versus 224.5 cells in the control group. Though this difference was statistically significant, it is also worth pointing out that patients in the case group tended to have higher CD4s upon entering the study (557 cells), compared with controls (409.5 cells).
Not surprisingly, ALT levels decreased in both groups, with those in the case group maintaining ALT levels significantly lower than those in the control group.
“These preliminary data,” Von Wichmann’s group concluded, “suggest that combination pegylated interferon and ribavirin in HIV-HCV coinfected patients with persistently normal ALT levels achieves comparable response values to patients with elevated ALT, with an adequate safety profile. Further analysis are needed to confirm these data and support the use of pegylated interferon plus ribavirin in these patients in clinical practice.”
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July 23, 2010
Hepatitis C Virus Can Remain Viable for Months in a Liquid Environment at Low Temperatures
www.hivandhepatitis.com
By Liz Highleyman
SUMMARY: Hepatitis C virus (HCV) can survive and remain infectious in a liquid environment for up to 5 months at cool temperatures, according to a German study described in the June 15, 2010 Journal of Infectious Diseases. Various alcohols and antiseptics reduced HCV RNA to undetectable levels, but the antiviral effect diminished when hand disinfectants were diluted.
Sandra Ciesek and colleagues looked at the infectivity, environmental stability, and susceptibility to chemical disinfectants of HCV grown in laboratory cell cultures.
Until recently, HCV could not be grown in laboratory cultures, so the antiviral activity of disinfectants against HCV was estimated based on studies using the structurally similar bovine viral diarrhea virus, the investigators noted as background. But the recent development of an HCV infection model system has allowed direct assessment.
The study authors analyzed HCV RNA levels using quantitative real-time polymerase chain reaction (PCR). Genome stability was determined by introducing recovered viral RNA into Huh7.5 cells.
Results
- HCV infectivity in a liquid environment was detectable for up to 5 months at lower temperatures.
- Different alcohols and commercially available antiseptics reduced HCV to undetectable levels.
- Diluting hand disinfectants reduced their virucidal activity.
The researchers noted that the risk of HCV infection may not be accurately gauged by determining HCV RNA levels, since viral infectivity and viral load copy numbers did not directly correlate.
The results, they suggested, "should be useful in defining rigorous disinfection protocols to prevent nosocomial transmission of HCV" in healthcare settings.
Investigator affiliations: Division of Experimental Virology, Twincore, Centre for Experimental and Clinical Infection Research, Joint venture between Hannover Medical School and the Helmholtz Centre for Infection Research; Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; Institute of Medical Microbiology, University Hospital Essen, Essen, Germany; MikroLab, Bremen, Germany.
7/16/10
Reference
S Ciesek, M Friesland, J Steinmann, and others. How stable is the hepatitis C virus (HCV)? Environmental stability of HCV and its susceptibility to chemical biocides. Journal of Infectious Diseases 201(12): 1859-1866 (Abstract). June 15, 2010.
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Anesthesia Misuse Could Lead to Hepatitis Virus Transmission
http://hamaraphotos.com
By Geeta
Washington, July 23 (ANI): A new study has revealed that hepatitis B virus (HBV) and hepatitis C virus (HBC) can be transmitted during intravenous administration of anesthesia.
In the study, doctors found that anesthesia contamination, not endoscopy contamination, was the cause of infection.
Efforts are needed to better educate the health-care community on the importance of strict adherence to sterile techniques when using any form of anesthesia.
The study findings highlight the fact that many instances of health care-related HBV and HCV virus transmission probably go undetected. The true magnitude of this problem is therefore unknown.
Doctors investigated an outbreak of acute HBV and HCV infections among patients who received anesthesia during endoscopy procedures from the same anesthesiologist in two different gastroenterology clinics. They identified six cases of outbreak-associated HCV infection and six cases of outbreak-associated HBV infection in one clinic; one outbreak-associated HCV infection was identified in a second clinic.
All affected patients in both clinics received propofol from this anesthesiologist, who inappropriately used a single-use vial of propofol for multiple patients. Reuse of syringes to re-dose patients, with resulting contamination of medication vials used for subsequent patients, likely resulted in viral transmission.
These findings are consistent with other investigations of HBV and HCV infection in health-care settings: contamination of anesthesia or other IV medications was far more likely to be responsible for transmission of HBV or HCV than the equipment used in the patients’ medical procedures.
The doctors’ study results increase concerns regarding infection control practices and use of shared medication vials for anesthesia administration to multiple patients, especially in outpatient settings where infection control oversight is limited and procedures such as endoscopies are increasingly performed.
Physicians diagnosing patients with acute viral hepatitis should report these cases to their local health department and carefully consider the role of health-care exposures, especially among those who do not report traditional risk factors for infection.
Together, increased education and policies limiting use of medication vials to single patients for IV anesthesia should reduce the risk for health care-associated HBV and HCV transmission.
The study was published in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute. (ANI)
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Hepatitis C: Cure and Control Needed Now
http://newsblaze.com
By Bobby Ramakant - CNS Policy Adviser
Hepatitis C virus (HCV) co-infection occurs in an estimated one quarter of HIV-infected persons in Europe, Australia, and the United States.
"As use of highly active antiretroviral drugs has markedly reduced opportunistic infections, HCV-related liver disease has emerged as a leading cause of death. HIV infection adversely affects both the natural history and the treatment of hepatitis C" said Dr David L Thomas, Division of Infectious Diseases, Johns Hopkins School of Medicine, USA.
For people living with HIV (PLHIV) Hepatitis C (Hep C) is a major public health challenge that can and should be controlled.
"We have a serious condition and we have clear evidence that it can be controlled" said Dr David Thomas.
Two clear solid grounds why it is important to control HCV are: It is common and very severe.
The incidence of Hep C is scary - in Baltimore, Europe or Australia, HCV occurs in 70% to up to 100% among PLHIV who acquire infection through injecting drug use (IDU).
In India, whether it is Chennai in South India, or north-east India, Hep C rates among PLHIV who acquire HIV through injecting drug use are very similar and shocking. However there are several others who just have HCV and not HIV, said Dr David.
Hep C also infects PLHIV who acquired infection through heterosexual or homosexual routes.
60% of persons who acquire HCV go on to have chronic hepatitis infection. HCV viral load is also high if person is co-infected with HIV.
"HIV decreases response to HCV treatment - can have half of treatment outcome than HIV negative individuals" said Dr David Thomas.
HIV infection adversely affects all stages of Hep C or HCV infection.
"Risk of liver failure was higher among individuals living with HIV than those individuals who were similar with regards to HCV but HIV negative" said Dr Thomas.
The antiretroviral (ARV) therapy is not sufficient to:
- Reduce the HCV RNA load
- Restore treatment response
- Prevent cirrhosis or liver failure
However antiretroviral therapy (ART) significantly reduces mortality among people co-infected with HIV and HCV.
"Markedly lower survival for HIV/HCV co-infected persons was observed in Denmark (2000-2005)" said Dr Thomas.
HCV transmission can be prevented. Dr Thomas listed few clear points of action to prevent HCV:
- Transfusion transmission has stopped where screening is done
- Nosocomial spread reduced where bloodborne precautions observed
- HCV incidence among IDU has declined
"Even in places where harm reduction measures are in place, HCV continues. HCV is more transmissible than HIV, so measures to control HIV are not going to be enough, they need to be intensified" said Dr Thomas.
Very few people co-infected with HIV and HCV are currently receiving testing, and treatment for HCV.
There is a clear need for harm reduction measures to intensified and expanded, testing for HCV to be expanded and HCV treatment be made available widely.
"Let's rejoice in the fact that today we have treatments that work... what we need I the political will to go the extra mile to deliver universal access" had said J Montaner, which is so much in context to improve responses to HCV and HIV co-infection.
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July 24, 2010
Lawmakers Debate Whether to Extend, Expand, End Syringe Sales
http://www.mercurynews.com
By Josh Richman
Oakland Tribune
California lawmakers are mulling whether to extend or expand a state program allowing over-the-counter sales of syringes without a prescription to curb the spread of HIV, hepatitis and other diseases.
Without action, such sales will become illegal at this year's end -- and public health authorities suggest that could be a deadly tragedy.
The current law, signed by Gov. Arnold Schwarzenegger in 2004, lets counties choose whether to let pharmacists sell up to 10 syringes to someone without a prescription; it also makes an exception to drug-paraphernalia laws to allow possession of up to 10 syringes if acquired through an authorized source. Every greater Bay Area county except Napa chose to take part in this Disease Prevention Demonstration Project. Contra Costa was first in December 2004, and Santa Clara was last in January 2006.
"Our Board of Supervisors stepped up to the plate the month before the legislation went into effect and hats off to them, that was very forward-thinking," said Christine Leivermann, AIDS Program Director in the Contra Costa Health Department's Public Health Division.
"We have seen over time downward trends in the number of new AIDS cases attributed to injected drug use" as well as reduced cases of hepatitis C, she said, and while nobody can definitively attribute all of that to needle access, "certainly having access to clean needles has helped reduce the transmission of blood-borne diseases, so we need something."
AB1701 by Assemblyman Wes Chesbro, D-Arcata, would extend the existing law for eight more years, still leaving it to city councils or county supervisors to decide whether to opt in and let pharmacies choose to take part. The Assembly passed this bill April 5 on a 49-27 vote, and the state Senate Health Committee approved it last month on a 6-1 vote; it's now pending before the Senate Appropriations Committee.
SB 1029 by state Sen. Leland Yee, D-San Francisco, would permanently give all California pharmacists discretion to sell and give adults the right to possess up to 30 syringes to adults without a prescription. The state Senate passed Yee's bill on a 21-8 vote May 28; the Assembly Health Committee and Business, Professions and Consumer Protection Committee passed it in June; and it's now pending before the Assembly Appropriations Committee.
All votes on both bills basically have been along party lines with Democrats in favor and Republicans opposed; state Sen. Lou Correa, D-Santa Ana, crossed the aisle to vote with Republicans against Yee's bill. Republicans expressed concerns that Yee's bill would replace local control with a one-size-fits-all, top-down approach, and that it doesn't specify how often someone could buy 30 syringes -- each day, perhaps.
Leivermann said she has no opinion on which bill is better, but Glenn Backes, a public policy consultant to the Drug Policy Alliance and the California Hepatitis Alliance, said Yee's bill would cut costs and widen access.
"Basically, if it is good policy for the residents of Bay Area counties, then it is good policy for the residents of Central Valley counties," Backes said. "Especially given that the indigent ill are a burden on all taxpayers, a burden on the state general fund, no matter where they reside in the state. Allowing adults to spend their own money to protect their health and the health of others is the only proven way to reduce the rate of HIV and hepatitis without spending a dime of city, county or state money."
The most recent legislative analysis shows the California Medical Association, the California Pharmacists Association, the California Psychiatric Association, the Republican Liberty Caucus, the Alameda County Board of Supervisors and many other groups support Yee's bill, with no opponents on record.
The existing law required the state Department of Public Health to evaluate the pilot program's effects and report back to the Governor and Legislature by Jan. 15 of this year. Finally released just last week, the report found syringe-sharing is rarer in places that opted into the program, and there's no evidence the program has caused drug use or crime to rise. Accidental needle-stick injuries to law enforcement officers remain rare with no difference between areas that do and don't take part in the program, the report found, and there's been no rise in unsafely discarded syringes.
But more time is needed to see whether the program has reduced HIV infection rates, the report said. The state's HIV infection tracking system dates back only a few years, and though its tracking of AIDS cases began in 1993, the long incubation period between HIV infection and AIDS diagnosis makes that an unreliable way to measure the effect of prevention measures in place for less than a decade.
The state report says the two-step opt-in process for legalizing over-the-counter syringe sales -- first at the county or city level, then by each pharmacy -- limits the program's benefits while spawning inconsistency and confusion over what's legal where. Leaving implementation to local governments' discretion "could require more time and commitment than some already overburdened health departments can handle," it said, suggesting that deleting this from future laws "could provide better access to this important prevention intervention."
Kabir Hypolite, director of the Alameda County Public Health Department's Office of AIDS Administration, basically agreed, framing clean needle availability as one of the few successful means of reducing HIV transmission. "These are critical programs."
Although he hasn't read the Chesbro and Yee bills, he said, "I know that Mr. Yee is a very responsible legislator and he represents San Francisco which also has been dealing with this epidemic for a very long time, so I would have.
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