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HCV Advocate Newsletter

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February 2009 HCV Advocate

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In This Issue:

Results: Latinos Treated with Pegasys plus Ribavirin
Alan Franciscus, Editor-in-Chief


Hepatitis C Treatment for Active Injection Drug Users and People on Methadone Maintenance
Liz Highleyman

HealthWise: More about Cirrhosis
Lucinda Porter, RN


HCV SnapShots Drugs in Development
Alan Franciscus, Editor-in-Chief


Book Review: 100 Questions & Answers about Liver Cancer
Alan Franciscus, Editor-in-Chief


Applying for Social Security Disability Online
Jacques Chambers, CLU




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Results: Latinos Treated with Pegasys plus Ribavirin
—Alan Franciscus, Editor-in-Chief

It is well-known that the effectiveness of the current standard of care – pegylated interferon plus ribavirin – is different among races and ethnic groups.  The effectiveness of current treatment in Latinos, however, has not been well-defined except for some small studies of PegIntron plus ribavirin, which have found lower treatment response rates among Latino patients.  Now, results from a study published in The New England Journal of Medicine, by M. Rodriguez-Torres, MD, will add to our understanding of HCV treatment response in Latinos. 

The objective of this study was to evaluate and compare the effectiveness of 48 weeks of treatment of Pegasys plus ribavirin (180 ug/week plus ribavirin 1000/1200 mg/day) in HCV genotype 1 Latinos vs. non-Latino white patients.  Latinos were defined as having a  geographic, historical, and cultural heritage shared among people from Spanish-speaking countries in South/Central America, Mexico, and the Caribbean and identified as white; indigenous Americans, Asians, and blacks were excluded from both groups.

The study enrolled 569 patients – 269 Latino whites and 300 non-Latino whites.   The Latino group had higher percentages of patients with an age of £ 40 years, body mass index (BMI) of more than 27 or more than 30, ALT levels higher than 3 times the normal level (25% vs. 17% of non-Latino whites), cirrhosis (13% vs. 10%), and diabetes mellitus (9% vs. 3%).  More non-Latino whites had high blood pressure (24% vs. 18% of Latinos). 

The sustained virological response (SVR = HCV undetectable 24 weeks post-treatment) was 34% in the Latino group compared to 49% in the non-Latino group.

The reason for the lower treatment response rates among Latinos could not be explained by the researchers.  The authors noted that the differences were likely because of “genetic and immune difference, in the response to HCV infection – and particularly in the proportion of patients without a response.”  Hopefully, future studies will help to answer why the two largest groups with HCV – Latinos and African Americans – do not respond as well to current medications, but even more important is the need to include more Latinos and African Americans in studies of newer medicines to treat HCV.  

Reference
Peginterferon Alfa-2a and Ribavirin in Latino and Non-Latino Whites with Hepatitis C.  N Engl J Med 360;3  NEJM.ORG January 15, 2009.


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Hepatitis C Treatment for Active Injection Drug Users and People on Methadone Maintenance
Liz Highleyman

Hepatitis C virus (HCV) is efficiently transmitted via shared needles and other injection equipment, and chronic hepatitis C is therefore common among injection drug users (IDUs).  In June 2008, Joseph Amon with the Centers for Disease Control and Prevention and colleagues, who looked at more than 5,000 IDUs in four large U.S. cities, reported an overall HCV prevalence rate of 65% during 1994-1996, falling to 35% by 2002-2004.  In some IDU networks, however, researchers have seen rates as high as 90%.

To Treat or Not to Treat?
Traditionally, many clinicians believed that current, or even recent former IDUs were not good candidates for interferon-based therapy for hepatitis C, both because they expected such patients to adhere poorly to treatment and because people with a history of substance use, depression, or mental health conditions were thought to be more susceptible to the neuropsychiatric side effects of interferon.

But data from numerous studies during the last decade began to change this perception.  In 2002, the National Institutes of Health revised its consensus guidelines for the management of hepatitis C to recommend that “treatment of active injection drug use be considered on a case-by-case basis, and that active injection drug use in and of itself not be used to exclude such patients from antiviral therapy” (the previous guidelines stated that alcohol or drug users should be abstinent for at least 6 months).  Furthermore, “methadone treatment has been shown to reduce risky behaviors that can spread HCV infection, and it is not a contraindication to HCV treatment.” (For background information on methadone maintenance for hepatitis C patients, see “Freedom to Be Cured,” by Alan Franciscus, available at www.hcvadvocate.org/hepatitis
/hepC/freedom.html
.)

Treatment Adherence and Response
In one early trial, Diana Sylvestre from Oakland’s OASIS program, a pioneer in treating substance users with hepatitis C, found that among the first 59 methadone patients to complete treatment with conventional interferon plus ribavirin at a community-based clinic, 24% prematurely discontinued therapy – not much different than the typical 20% dropout rate seen in studies of nonusers. 

The overall (all genotypes) sustained virological response (SVR) rate was 28%.  Response rates were statistically similar (about 20%-30%) among patients who did not use drugs during HCV treatment and those who used rarely or intermittently, but none who relapsed to daily use achieved SVR.  “Relapse to drug use during HCV treatment should not prompt HCV treatment discontinuation, but rather an early and aggressive attempt to intervene before the drug use becomes regular,” Sylvestre wrote in a Medical Writers Circle overview (www.hcvadvocate.org
/hcsp/articles/ Sylvestre-1.html
).

A later prospective analysis of 71 methadone patients in the same program (published in the September 2007 European Journal of Gastroenterology & Hepatology) found that 68% overall were adherent to anti-HCV therapy, and adherent patients were more likely than nonadherent ones to achieve SVR (42% vs. 4%).  Participants with and without a history of psychiatric illness had similar rates of adherence (64% vs. 72%).  Completely abstinent patients and occasional drug users were similarly adherent, but those who relapsed to regular use had significantly poorer adherence.

In 2004, Stefan Maus and colleagues from Germany reported that in a study of 50 hepatitis C patients on methadone maintenance and 50 who had not used illegal drugs or opiate substitution therapy for at least five years, overall SVR rates with pegylated interferon alfa-2b (PegIntron) plus ribavirin were 42% and 56%, respectively.  But in this study, methadone recipients were five times more likely than nonusers (22% vs. 4%) to either request to stop anti-HCV therapy or to discontinue due to nonadherence during the first eight weeks; after this point, however, discontinuation rates were similar. 

Improving Outcomes
Hepatitis C treatment for IDUs has improved over time – as it has for nonusers – as more effective antiviral drug regimens have been adopted and clinicians learned more about how to address the potential challenges of treating this population.

In a 2007 Norwegian study published in European Addiction Research, Aud Krook and colleagues found that among 17 HCV genotype 3 patients on methadone or buprenorphine maintenance who received directly administered pegylated interferon alfa-2a (Pegasys) plus ribavirin in conjunction with psychosocial support at a drug abuse treatment center, the rate of adherence was 100% and 94% achieved SVR.

In another study, reported at the 2007 Digestive Disease Week (DDW) annual meeting and in the November 2008 American Journal of Gastroenterology, Herbert Bonkovsky and colleagues analyzed 48 treatment-naive patients on methadone maintenance, comparing weekly directly-observed therapy (DOT) at methadone clinics versus self-administration of Pegasys plus ribavirin. 

Only two patients in the DOT arm and three in the self-administration arm withdrew due to adverse events, as well as six and nine patients, respectively, who did so for other reasons.  In both groups, about two-thirds took at least 80% of prescribed interferon doses for the planned duration.  The overall SVR rates were 54% and 33%, respectively (23% vs.  38% for HCV genotype 1; 91% vs.  a surprisingly low 25% for genotype 2/3).  After adjusting for other factors, DOT was a significant predictor of sustained response.

At the October 2008 meeting of the American Association for the Study of Liver Diseases (AASLD), Patrick Marcellin from the CHEOBS study team – which previously showed that prior psychiatric history was not associated with poorer response to pegylated interferon/ribavirin – presented data from a prospective analysis comparing adherence, virological response, and quality of life in 244 French patients who were either active IDUs or receiving opioid substitution therapy, 578 former users, and 1,038 non-users.

The likelihood of achieving good treatment adherence (at least 80% of planned drug doses and duration) was about 50% in all three groups.  SVR rates also did not differ significantly (58%, 51%, and 49%, respectively).  Heavier alcohol consumption, higher likelihood of psychiatric illness, and a more precarious socioeconomic situation in the active use/substitution therapy group did not negatively affect treatment response – in fact, the researchers concluded, the younger average age, shorter duration of HCV infection, less severe fibrosis, lower BMI, and greater prevalence of easier-to-treat HCV genotype 3 in this group seemed to “balance the negative parameters.”

Active Drug Users
As the CHEOBS study indicated, even people who continue active drug use (with or without opioid substitution therapy) can still benefit from hepatitis C treatment.  In the October 2008 Journal of Viral Hepatitis, Philip Bruggmann and colleagues reported on a retrospective analysis of 199 active IDUs and 301 nonusers. 

Similar proportions in both groups (66% vs. 61%, respectively) took at least 80% of planned doses of antiviral therapy.  Again, active IDUs were slightly more likely than nonusers to achieve SVR (69% vs.  60%), but the difference did not reach statistical significance.  The study authors concluded that “our study shows no relevant direct influence of IV drugs on the efficacy of anti-HCV therapy among adherent patients.”

In another study presented at the 2008 DDW and AASLD meetings, Olga Anagnostou and colleagues from Greece evaluated adherence and response rates in 18 active IDUs, 54 patients on methadone maintenance, and 74 former IDUs (in recovery for at least one year) who were treated with interferon-based therapy between 2000 and 2007. 

Overall, 75% completed therapy, with no significant differences in adherence between the groups.  SVR rates were also statistically similar: 59% for active users, 62% for methadone patients, and 50% for former users.  But regardless of drug use status, adherent participants were about three times more likely to achieve a sustained response than non-adherent patients (59% vs. 20%). 

Finally, in an Australian study reported at AASLD 2008, Joe Sasadeusz and colleagues analyzed 53 chronic hepatitis C patients on opioid substitution therapy (75% methadone, 25% buprenorphine) treated with Pegasys plus ribavirin; one-quarter continued to inject

illegal drugs during treatment or follow-up.  About 60% of genotype 1 patients treated for 48 weeks and 84% of patients with other genotypes treated for 24 weeks achieved 80% adherence, with similar withdrawal rates in the active user and abstinent groups. 

SVR rates were 36% for genotype 1 and 71% for non-1 patients.  As with the prior studies, patients who continued to inject drugs while on methadone were actually more likely to achieve SVR than abstinent patients (63% vs.  53%).  Though generally not statistically significant, this consistent trend warrants further study.

Integrated Care
The 2002 NIH consensus panel recommended that IDUs with hepatitis C should be managed by a multidisciplinary team that includes both hepatologists and substance use specialists. 

As reported at AASLD 2008, French researchers retrospectively analyzed the medical records of 176 patients, including 85 IDUs, who received hepatitis C care between September 2006 and March 2007.  Compared with nonusers, IDUs were more likely to be HIV coinfected (75% vs. 34%) and to have severe fibrosis or cirrhosis (43% vs. 34%); overall, about half had HCV genotype 1. 

IDUs whose care was managed jointly by hepatology and addiction specialists were more likely to decide to start antiviral therapy and had an SVR rate similar to that of non-IDUs (45% vs. 38%, respectively), while IDUs who did not benefit from joint follow-up had significantly poorer sustained response (20%).  Another study presented at the same meeting found that IDUs who attended peer support groups were more likely to remain engaged in hepatitis C care.

In summary, people on methadone or other opioid maintenance – and even active drug users – can be successfully treated for hepatitis C as long as they achieve good adherence to antiviral therapy.  And, as Sylvestre noted, current and former IDUs on average have more advanced liver fibrosis than non-users, and therefore have a more urgent need for prompt anti-HCV treatment. 

Because addiction is often a recurring condition, active and recovering IDUs should be counseled about how to prevent HCV transmission to others, as well as reinfection after successful antiviral treatment; they also should receive the hepatitis A and B vaccines. 

Methadone or other opioid maintenance can help IDUs stabilize their lives, and because it requires regular visits, provides an opportunity for directly observed therapy and ongoing support around adherence and side effects.  In the future, “STAT-C” drugs such as HCV protease and polymerase inhibitors may offer effective treatment options without injections and with fewer side effects than interferon-based therapy.

References

  • Anagnostou, O.  et al.  Drug users with chronic hepatitis C who are adherent to antiviral treatment will finally benefit from therapy.  Digestive Disease Week 2008.  San Diego, CA.  May 17-22, 2008.  Abstract S1013.
  • Anne, G.  et al.  Specific joint hepatology–addiction medicine follow-up of hepatitis C treatment for intravenous drug users (IDU) or ex-IDU improves treatment response.  59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008).  San Francisco.  October 31-November 4, 2008.  Abstract 1286.
  • Bonkovsky, H.  et al.  Efficacy and safety of peginterferon alfa-2a/ribavirin in methadone maintenance patients: randomized comparison of direct observed therapy and self administration.  Digestive Disease Week 2007.  Washington, DC.  May 19-24, 2007.  Abstract M1861.
  • Bonkovsky, H.  et al.  Efficacy and safety of peginterferon alfa-2a/ribavirin in methadone maintenance patients: randomized comparison of direct observed therapy and self-administration.  American Journal of Gastroenterology 103(11): 2757-2765.  November 2008.
  • Bruggmann, P.  et al.  Active intravenous drug use during chronic hepatitis C therapy does not reduce sustained virological response rates in adherent patients.  Journal of Viral Hepatitis 15(10): 747-752.  October 2008.
  • Grebely, J.  et al.  Three year follow-up of a multidisciplinary care and peer support model for the engagement of IDUs in care and treatment for HCV infection.   AASLD 2008.  Abstract 1305.
  • Krook, A.  et al.  Hepatitis C treatment of opioid dependants receiving maintenance treatment: results of a Norwegian pilot study.  European Addiction Research 13(4): 216-221.  2007.
  • Manolakopoulos, S.  and others.  Adherence and response rate to antiviral treatment do not seem to be affected by intravenous drug use in patients with chronic hepatitis C under substitution therapy.   AASLD 2008.  Abstract 1257.
  • Mauss, S.  et al.  A prospective controlled study of interferon-based therapy of chronic hepatitis C in patients on methadone maintenance.  Hepatology 40(1): 120-124.  July 2004.
  • Melin, P.  et al.  Impact of the use of drugs and substitution treatments on the antiviral treatment of chronic hepatitis C (HCV): analysis of compliance, virological response and quality of life (CHEOBS).  AASLD 2008.  Abstract 1222.
  • Sasadeusz, J.  et al.  Pegylated interferon alfa-2a (Peg-2a) plus ribavirin (RBV) for patients with chronic hepatitis C virus (HCV) on opioid pharmacotherapy: virological outcomes, psychological impact and safety.  AASLD 2008.  Abstract 1311.
  • Sylvestre, D.L.  Treating hepatitis C in methadone maintenance patients: an interim analysis.  Drug & Alcohol Dependence 67(2): 117-123.  July 2002.
  • Sylvestre, D.  et al.  The impact of barriers to hepatitis C virus treatment in recovering heroin users maintained on methadone.  Journal of Substance Abuse Treatment 29(3): 159-165.  October 2005.
  • Sylvestre, D.  et al.  Adherence to hepatitis C treatment in recovering heroin users maintained on methadone.  European Journal of Gastroenterology & Hepatology 19(9): 741-747.  September 2007.



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HealthWise: More about Cirrhosis
—Lucinda Porter, RN

Cirrhosis was the subject of last month’s column. Two points were emphasized. One, the majority of those with chronic hepatitis C virus infection (HCV) will not progress to advanced liver disease. However, roughly one in five of those with HCV have cirrhosis. This leads to the second point. A full, productive life is possible even with this level of liver damage. Now we’ll go into more detail, concluding with how to help ourselves live with cirrhosis or avoid it altogether.

The best way to prevent cirrhosis is to eliminate or minimize excess inflammation. Living with HCV means there is already a potential source of inflammation. This is the result of the immune system’s attempt to eradicate HCV. Over time, inflammation may lead to tissue damage, or fibrosis. If the damage becomes severe, the liver hardens into cirrhosis. Fibrosis is common with HCV but does not usually advance to cirrhosis. If it does, progression to cirrhosis usually takes twenty or more years.

Treatment is a potential remedy for HCV-induced damage. The liver has remarkable recuperation power, so removing the source of damage allows the liver to recover. Even if HCV isn’t permanently eradicated, there is often some benefit. For example, I underwent treatment in 2003. My liver biopsy showed dramatic improvement although I had not had a sustained response. Even cirrhotic patients have shown improvement from treatment. 

There are other potential causes of liver inflammation. Alcohol is a common one. The amount of alcohol that can cause tissue damage is surprisingly low. The maximum safe alcohol allowance for healthy adult women without liver disease is one drink daily. For healthy adult men without liver disease, that maximum is 2 drinks daily. These recommendations drop to zero for those with HCV, substance abuse, other medical conditions, pregnancy or those taking medications.

Even those without risk factors must exercise caution when drinking alcohol. Safe alcohol use is measured as one 12-ounce bottle of beer or wine cooler, one 5-ounce glass of wine, or 1.5 ounces of 80-proof distilled spirits. A glass of wine is likely to exceed 5 ounces when enjoying an evening with friends.  It is easy to rationalize a second or third drink if you only drink on weekends. However, this excess puts extra load on the liver. Over time, this can amount to tissue damage.

Sadly, risk for cirrhosis is increasing along with our waistlines. Excess fat in the liver may lead to a fatty liver. This may lead to inflammation. Left unheeded, the inflamed liver may become scarred and hardened.

Those at risk for fatty liver disease tend to have other diet-related conditions, such as obesity, diabetes, or high triglycerides. However, someone without these problems may still develop a fatty liver.  The movie Super Size Me is a good illustration. For thirty days, Morgan Spurlock ate only McDonald’s food. Simultaneously, he reduced his exercise level to the national average. Before the month was over, Spurlock was sick. Lab tests confirmed this, including abnormal liver enzymes. In one month, Spurlock developed a fatty liver. 

So, if you are overweight, try to lose those extra pounds. Do this slowly and wisely. Don’t try to lose more than a pound or two weekly. Discuss this with your medical provider, particularly if you have diabetes or high triglycerides. Include regular physical activity in your fitness goals.

Drugs may cause liver damage.  Not just illegal ones, but prescribed and over-the counter drugs. Best known for liver toxicity is excess acetaminophen or Tylenol®, although it is generally safe if taken as prescribed. This drug is often combined with other drugs, such as cold or pain medications. Drug-induced inflammation commonly occurs when a patient is unaware of the amount of acetaminophen he or she is taking. Discuss your medications with your medical provider. Always take medications as directed.

Dietary supplements may also cause liver damage or may interact with foods, drugs, or other supplements. Excess iron and vitamin A are noteworthy examples. Discuss dietary supplements with your medical provider. Spend some time doing research and choose supplements carefully.

For more information about dietary supplements and the liver, check out HCSP’s fact sheets such as HCV & CAM: Dietary Supplements to Avoid

Regular Checkups
While visiting his physician, a patient started to hyperventilate. “I’m sure I’ve got cirrhosis,” he exclaimed. The doctor asked, “Why do you think that? The liver is a non-complaining organ, so you wouldn’t feel any discomfort if you had cirrhosis.” “Exactly!” said the patient. “Those are my precise symptoms.”

The silent nature of liver disease is one of the reasons that regular medical check-ups are important. Each physician will tailor their recommendations for each patient, likely ordering regular blood tests and physical exams. Here are some general guidelines:

No cirrhosis – minimal fibrosis (Stage 0-early stage 2)

  • Annual physical exam
  • Yearly or twice-yearly lab tests, including liver panel and complete blood count (CBC); regular viral load tests are unnecessary unless you are undergoing treatment  
  • Liver biopsy every 5 years

No cirrhosis – moderate to severe fibrosis (late stage 2-3)

  • Yearly or twice yearly physical exam
  • Every six months – lab tests, including liver panel and complete blood count (CBC); regular viral load tests are unnecessary unless you are undergoing treatment  
  • Liver biopsy every 3 to 5 years
  • Late stage 3 fibrosis – ultrasound and alpha-fetoprotein (AFP) lab test may be ordered every 6 months

Cirrhosis (stage 4)

  • Regular, more frequent physical exams, depending on severity
  • Regular, more frequent labs, depending on severity – more extensive tests ordered including AFP; regular viral load tests are unnecessary unless you are undergoing treatment  
  • Regular ultrasound; liver biopsy only if necessary; other diagnostic tests may be ordered

What You Can Do
There are measures you can take to help stave off cirrhosis or live with it if you are already there. Here are some recommendations:

  • Abstain from alcohol
  • Discuss all your medicines with your medical provider, including over-the-counter, herbs and other supplements
  • Do not exceed the recommended dose of acetaminophen (Tylenol®)
  • Maintain a normal weight
  • Do not eat wild mushrooms unless you are 100% sure of their safety
  • Avoid exposure to vibrio vulnificus, an organism found inraw or under cooked shellfish
  • Those with cirrhosis and open sores may need to avoid the ocean in areas where there is a risk of vibrio vulnificus exposure
  • Keep immunizations current
  • Consider HCV treatment

Drinking coffee may provide some benefit – specifically the caffeinated kind. The studies are small and although caffeine use is associated with liver tissue (histological) improvement, correlation is not the same as causation. Links about caffeine and the liver are included at the end of this article.

Cirrhosis is a scary subject but it does not mean that life is over. Some have used potentially life-threatening diagnoses as opportunities to make lifestyle changes. They turned their health around and lead full lives. Sometimes the end is actually the beginning.

Additional Information
Bennet Cecil, MD’s HCV Cirrhosis is a Life Threatening Disease published by HCSP’s Medical Writers’ Circle

Alan Franciscus’s Disease Progression: What is Cirrhosis?

Caffeine articles:
www.medpagetoday.com/MeetingCoverage
/AASLD/11647

www.hcvadvocate.org/news/NewsUpdates
_pdf /Advocate 2007/advocate0907.pdf


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HCV SnapShots – Drugs in Development
Alan Franciscus, Editor-in-Chief

This month’s SnapShots article will focus on the recent news about drugs in development to treat hepatitis C – including the start of a new study of R7128, results from a small phase I study of ITMN-191, a new HCV polymerase inhibitor being developed by Idenix (IDX184), Anadys’ impressive results with ANA598, a new clinical study to evaluate a once-a-month dose of albuferon, and a few new developments on Bristol-Myers’ bold new entrance into the HCV drug treatment arena.  

R7129
Pharmasset and Roche announced on January 12, 2009 that they will launch a large phase 2b study of R7128, an HCV nucleoside polymerase inhibitor, in combination with Pegasys and ribavirin.  The new study will enroll about 400 HCV genotypes 1 and 4 treatment-naïve patients into five different treatment arms.  The trial will evaluate different doses of R7128 (500 mg to 1000 mg twice a day (bid)) in combination with standard doses of Pegasys plus ribavirin.  Treatment durations will be either 24 or 48 weeks based on a patient’s rapid virological response.  

In the previous Phase I study of R7128 in combination with Pegasys plus ribavirin, 81 HCV treatment-naïve patients who were treated for 4 weeks achieved viral load reductions of 3.8 log10 IU/mL to 5.1 log10 IU/mL in the R7128 combination arms compared to 2.9 log10 IU/mL in those who received Pegasys plus ribavirin (without R7128).   

Primary data from the new study is expected to be released late in 2009.

INFORM-1
R7128 and ITMN-191 (listed above) together with ribavirin (without interferon) are being tested as the first interferon-free combination therapy.  The results should give us a lot of information about the effectiveness of these drugs and also tell us if there are any synergistic effects from combining these antiviral compounds.

IDX184
Idenix Pharmaceuticals announced on January 12, 2009 that it was initiating a small Phase I/II proof-of-concept study of IDX184, an HCV nucleotide polymerase inhibitor.  This will be a double-blinded, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and antiviral activity of IDX184 in HCV genotype 1 treatment-naïve patients.  The doses will range from 25 to 100 mcg once-a-day dosing (SID).  Eight patients will receive IDX184 and 2 will receive placebo.

ANA598
In a small phase I study of Anadys’ ANA598, an HCV polymerase inhibitor, it was found that in the 8 patients who received 200 mg of ANA598 for 3 days there was a range of viral load reductions from 1.4 to 3.4 log10.  The 8 patients were either HCV genotype 1a or 1b.  The drug was generally well-tolerated.  The decline in HCV viral load is impressive, but more studies with more patients and a longer duration of treatment are needed to determine if the viral load reductions can be sustainable and more importantly if there are any drug toxicities. 

ITMN-191
On January 12, 2009 InterMune reported on the results from a small phase I study of ITMN-191 in combination with Pegasys and ribavirin.  In this study, there were six arms of  ITMN-191 (either 100, 200, 300 mg every 8 hours or 400, 600, 900 mg every 12 hours) combined with Pegasys plus ribavirin.  There was also one placebo arm.  A total of 57 HCV genotype 1 treatment-naïve patients were treated for 14 days.  After 14 days of treatment, the log drop in HCV RNA (viral load) was from 5.5 to 5.7 log10. 

There were two levels of detection limits: < 25 IU/mL and < 9.3 IU/mL.  The group that received 200-300 mg every 8 hours (50 and 57% respectively) achieved the best results. 

The medications were generally well-tolerated.  There were 4 serious adverse events (AEs) reported:  two were sciatica (nerve pain from a compressed back disc) which the researchers believed were unrelated to the study drug; the other two AEs were neutropenia and indirect bilirubin elevation, but it was noted that the frequency and severity was similar to that seen in the placebo arm. 

A phase 2b study is expected to begin in the second quarter of 2009 using various doses of ITMN-191, dosed every 8 or every 12 hours with treatment durations of 12 or  24-weeks.

Albuferon – New Study
Human Genome Sciences announced that Novartis has initiated a new study of albuferon to treat 375 HCV genotype 2 and 3 patients with a once-a-month injection of albuferon (900, 1200, or 1500 mcg) in combination with ribavirin for a 24 week duration.  The trial will also include a control arm using Pegasys plus ribavirin.  The study will assess the safety, tolerability and effectiveness of albuferon compared to Pegasys – both interferons in combination with ribavirin. 

BMS
Bristol-Myers Squibb (BMS) is jumping into the HCV drug research arena big time with various announcements over the last couple of months.  In January BMS announced that it has struck a 1.2 billion dollar deal with ZymoGenetics to codevelop ZymoGenetics’ long-acting type III interferon, PEG-interferon lambda.  Under the agreement, BMS will help to codevelop the longer acting form of interferon and will jointly sell and share in the profits in the United States and Europe.   BMS announced in December that it has signed an agreement with Arris Pharmaceutical Corporation to develop HCV protease inhibitors.  Under the agreement, BMS will have exclusive rights to the development and marketing of any protease inhibitors that are discovered during the terms of this agreement. 
In addition to these stories, BMS also has three HCV drugs currently in phase I/II studies. 

Clinical trial information
www.clinicaltrials.gov


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Book Review: 100 Questions & Answers about Liver Cancer
Alan Franciscus, Editor-in-Chief

Most people living with hepatitis C won’t have to deal with disease progression that could lead to liver cancer.  However, since we don’t know who will and who won’t develop cancer it is of utmost importance that people with chronic HCV receive regular medical care and monitoring.  Another important component of getting the best possible medical care is that people with HCV should take an active role in their healthcare – one which includes learning as much as possible about all of the aspects of hepatitis C and working closely with medical providers.  

A series of books called ‘100 Questions & Answers’ offers detailed information about a wide variety of topics including hepatitis C and the possible complications of HCV disease progression.  One book, 100 Questions & Answers about Liver Cancer, has a wealth of information about liver cancer, is well-written and presented in a way that the average layperson can easily read and comprehend.  The book is broken down into the following sections:

  • The Basics – a brief description of the liver and its functions, and a short summary description of different types of liver cancer
  • Risk Factors – an overview of the incidence of liver cancer, who is at risk, the causes and how these factors cause damage to the liver
  • Screening – the who, what and how of screening for liver cancer
  • Diagnosing and Staging – symptoms and how liver cancer is diagnosed
  • Coping with the Diagnosis – dealing with the emotional and practical aspects of a diagnosis of liver cancer
  • Treatment – what therapies are available to treat liver cancer, the decision makers, treatment of liver tumors, liver resection, liver transplantation, various forms of chemotherapy, and which ones are used and why
  • Cancer-Related Practical Issues – the emotional side of all of the issues that come up with liver cancer, practical information about diet, side effects of treatment, and complications
  • Cirrhosis-Related Practical Issues – common questions that patients may have about treatment-related side effects
  • Social and End-of-Life Issues – as the title suggests information about death and dying issues such as a description of a hospice, advance directives, preparing for death – all issues that everyone should think about, but especially those who face liver cancer. 
  • Glossary – a simple glossary of terms

I would highly recommend that anyone with hepatitis C read this book – learning as much as we can about all the aspects of hepatitis C, including liver cancer, will prepare us for the worst case scenario.  If there is one criticism of this book it would be that the section “Social and End-of-Life Issues” was too short and didn’t provide me with enough information to help me really understand end-of-life issues.  But that could be another book in the series because of the complex emotional issues that people who are facing death must deal with.

100 Questions & Answers About Liver Cancer, by Ghassan K. Abou-Alfa, MD & Ronal DeMatteo, MD. Jones and Bartlett Publishers 978-443-5000. Amazon link.


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Applying for Social Security Disability Online
Jacques Chambers, CLU

Applying for disability benefits from Social Security can be a cumbersome and slow process. Due to staffing that has not kept up with the demand, it can take anywhere from six to twenty-six weeks or even longer to get a decision on your claim.

Just starting the process can be time consuming due to the amount of paperwork required to start a claim. Once the paperwork is turned in to the Social Security office, someone there then has to enter all that information into their computer system. Because of that, it can take up to two weeks for the file to be opened in their system and sent to the Analyst to actually begin work on it.

It is now possible to speed up at least the initial claim filing process by entering all the information in your home computer before you go to the Social Security office. With an internet connection, you can enter the information from your own computer at your leisure and submit it directly into the Social Security system.

At one time, applications were taken online, but they were processed internally with no way to speak to the person handling the claim or to send additional information. That has now changed. Now you can enter the information on line and have it transmitted to your local Social Security office where it is processed locally.

Social Security has issued a press release on this program. It is available for anyone wishing to apply for Social Security Disability Benefits as well as retirement. It is not yet available to persons applying for Supplemental Security Income (SSI) benefits due to the need for financial information to determine eligibility.

Below is the complete press release from Social Security, followed by more information on the process:

EASIER WAY TO COMPLETE DISABILITY REPORT — ONLINE

Applying for disability benefits from Social Security is easier than it’s ever been before.  Until recently, the disability report had to be completed manually.  Now, you can save time by completing it online and sending it to us electronically. 

An important part of applying for disability benefits for adults is completing the adult disability report, or form 3368.  The report asks important questions about your disabling condition, medical records, health care provider contact information, and information about your educational and work history.  This information is important to help us determine your disability.

We use your disability report and information to help us answer these five questions:

  1. Are you working?
  2. Is your disabling condition severe enough to limit your ability to do work?
  3. Is your condition on our list of impairments, and is it expected to last for at least a year or end in death?
  4. Can you do the work now that you did in the past?
  5. Can you do any other work?

There are two versions of the adult disability report that can be completed online, depending on whether you are the person applying for benefits, or a professional representative.

If you are applying for disability benefits on your own behalf, you can complete the online disability report at the following link. https://secure.ssa.gov/apps6z/i3369/ee001-fi.jsp

If you are representing a disabled person, you can complete our professional version of the disability report.  Examples of representatives include attorneys and non-attorney representatives, employees of government agencies, social agencies, hospitals, nursing care facilities, homeless shelters, or non-profit agencies, and anyone else who assists applicants in applying for disability benefits. 

If you are representing someone and want to apply for benefits on their behalf, you can go to the following website to complete their adult disability report.
https://secure.ssa.gov/apps6z/
i3368PRO/main.html/

Keep in mind that in addition to the disability report, we will also need a completed application for disability benefits.  The online application can be found at the following address. http://www.socialsecurity.gov/
applyfordisability/

To learn more about Social Security, visit our website at www.socialsecurity.gov, or call us at 1-800-772-1213 (TTY 1-800-325-0778).

To open a file for disability, there are two primary forms that must be completed, the Adult Disability Report (SSA-3368-BK) and the Application for Disability (formerly SSA-16-F6). The 3368 report can be found in two places on line as shown in the above article. This is because the 3368 can be completed by you personally or it can be completed by your appointed representative if you have hired one.

However, the Application for Disability must be completed by you because it requires an electronic signature, swearing to the accuracy of the statements. Your representative can help you complete it as long as you are present to “sign” the document.

There are several advantages to filing these documents online. First, the forms ask for a substantial amount of information. They want to know not only about your condition and when you stopped work, but they also need all your medical providers’ names, addresses, phone numbers, as well as when they were seen and why. They want a list of all your prescriptions and your educational background. They also want to know all the different types of jobs you have had in the past fifteen years and the job duties of each. It takes time and research to complete these forms.

It is very easy to complete these forms online. They automatically adjust questions based on your prior statements; they give you ample opportunity to make comments about your condition. They even have an option that allows you to stop, save your work, and come back to it later. Your file is assigned a code which you can reenter and start back on the form where you left off.

Once you have completed the documents, the program will question possible errors, note blanks, and allow you to check them for completeness. You also are able to and really should print out a complete copy of the forms.

Then you are ready to submit the forms. Once submitted, they can no longer be retrieved or revised. When the Submit button is clicked, the documents are sent electronically to the Social Security Field Office nearest your ZIP Code.

Normally, you will be called by that office within three working days of submitting the forms. If you don’t hear from them, you will need to call the toll-free number (800-772-1213) as local offices do not list their numbers. Ask them to follow up on your submission.

Often you will need to show an original or certified copy of your birth certificate. You need to show them your checkbook so they can record the numbers for direct deposit. They may ask to see other items as well, such as military discharge papers, or recent paycheck stubs or W-2 forms.

It is recommended that you take those requested items into Social Security. They will examine the documents, photocopy them, and return them to you. Note that many advocates do not recommend going to Social Security personally if you “don’t look sick.” That advice doesn’t really make much sense. First, you don’t want to trust valuable documents like an original birth certificate to the mails.

Second, the person you meet with at Social Security is not the one who decides if you are disabled. That person has no medical training at all. It is an entirely different office, a state agency, which reviews medical records and determines disability,

Once you are in touch with the local office, you can schedule an appointment to go in to present any requested documents. An alternative would be to call the toll-free number before submitting the documents and make an appointment at your local office. Submit the documents a day or two before your scheduled appointment, and they will retrieve them at the appointment.

By initially filing your disability forms online, you shorten the processing time by at least two weeks, plus you can make sure that the information is entered correctly.


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