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June 2008 HCV Advocate

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EASL 2008
Alan Franciscus, Editor-in-Chief

Chronic Hepatitis C in Children
Liz Highleyman

HealthWise: Health and Money
Lucinda Porter, RN


Latinos and HCV Treatment
Alan Franciscus, Editor-in-Chief


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EASL 2008
Alan Franciscus, Editor-in-Chief

This year’s EASL (European Association for the Study of Liver Disease) conference was held in Milan, Italy.  EASL is becoming one of the premiere liver disease conferences and is comparable in its scope and importance to the AASLD (American Association for the Study of Liver Disease) Conference held in the United States.  This article will review the data presented on HCV drugs being developed to treat hepatitis C.  

Telaprevir is an HCV protease inhibitor that is being developed by Vertex. It is currently the furthest along in clinical development among the new antivirals.  Of note, it was recently announced that the phase 3 clinical trial had enrolled the first patients.  At EASL two key phase II study results were presented: final results from the PROVE1, and SVR12 data from the PROVE2 trials, as well as preliminary data from Study 107 – a study that is investigating the treatment of prior non-responders, null responders and relapsers from the PROVE1, 2 and 3 clinical trials.

Telaprevir

PROVE1
The final results of the PROVE1 trial were presented at EASL.  In this trial there were 250 genotype 1 treatment-naïve patients.  The patients were divided into 4 treatment arms and the patient characteristics were fairly balanced between the arms.  A description of the treatment arms and the intent to treat (ITT) SVR rates are listed below.* 

Arm A:  75 patients treated with Pegasys plus ribavirin for 48 weeks (control arm).  SVR = 41%

Arm B:  79 patients treated with telaprevir plus Pegasys/ribavirin for 12 weeks, then treated for an additional 36 weeks with Pegasys plus ribavirin.  SVR = 67%

Arm C:  79 patients treated with telaprevir plus Pegasys/ribavirin for 12 weeks followed by an additional 12 weeks of treatment with Pegasys/ribavirin. SVR=61%

Arm D:  17 patients treated telaprevir plus Pegasys/ribavirin for 12 weeks – no further treatment. SVR=35%

*Medication doses: 
Telaprevir (750 mg or placebo) TID, Pegasys (180 ug injected once weekly), and ribavirin (dosed by body weight at either 1000 or 1200 mg a day).

Importantly, these results confirm early data that the optimal treatment duration is 24 weeks – the  relapse rate in the arms that included telaprevir was significantly lower (0-2%) in those who were HCV RNA negative at weeks 4 and 12.  

The most common types of serious side effects reported were skin rashes, gastrointestinal events, and anemia.  The incidents of overall serious side effects were higher in the telaprevir arms: 11% in the telaprevir groups compared to 5% in the group that received pegylated interferon and ribavirin only.  Treatment discontinuation rates through week 12 due to adverse events were higher in the telaprevir arms (18%) compared to those who did not receive telaprevir (4%).  The incidence of severe rash was 7% in the participants who received telaprevir. 

PROVE2
The PROVE2 study design is similar to that of PROVE1 and has enrolled 323 HCV genotype 1 treatment naïve patients.  The clinical trial is being conducted in Europe.  The trial also included an arm of telaprevir and Pegasys, but without ribavirin.  The interim results were similar to PROVE1 with 68% SVR12 in the arm that received 24 weeks of treatment.  Final results are expected later this year. 

Bottom Line

The final results from PROVE1 and the SVR12 results from PROVE2 have confirmed that 24 weeks of treatment produced comparable sustained virological response rates when the same treatment regime was given for 48 weeks. 

There have been some concerns raised about anemia, but the incidence of anemia was only slightly higher in the telaprevir arms and resolved after treatment was discontinued.  The severe rash is also another concern, but the rate of treatment discontinuation due to the rash was relatively low, and the rash also resolved after treatment was discontinued.

Study 107
The preliminary results from Study 107 on the retreatment of the people in the PROVE1, PROVE2, and PROVE3 control arms who did not receive telaprevir were included in this study.  Participants from the PROVE studies were eligible for Study 107 if they were either null responders, partial responders or relapsers.  Participants who discontinued treatment because of side effects were not eligible for Study 107.

The dosing of this study is as follows:

12 weeks of telaprevir (750 mg TID), Pegasys (180 ug-injected weekly) plus ribavirin (1000/1200 mg/day) followed by 12 weeks of  Pegasys plus ribavirin alone (24 week treatment duration)

Included in the study design was a stopping rule: if HCV RNA was higher than 25 IU/mL at weeks 4 and 12, the treatment was stopped.    

Interim Analysis

A total of 72 patients have received at least one dose of the study medicines.  Of these, 63 are currently on treatment – for this analysis there were 60 patients who completed 4 weeks of therapy, 36 patients who completed 8 weeks of therapy and 16 patients who completed 12 weeks of therapy.   The preliminary results found that at week 4, 83% achieved HCV RNA less than 25 IU/mL and that all the patients who continued treatment beyond week 4 maintained their viral responses by weeks 8 and 12.  The range of viral breakthrough was very low (3%), and those who developed viral breakthrough were identified early on.  Based on these positive treatment response rates, the protocol has been amended so that the relapsers and partial responders will receive 12 weeks of telaprevir in combination with 24 or 48 weeks of Pegasys plus ribavirin.  The patients who were previous non-responders will receive telaprevir, Pegasys and  ribavirin for 12 weeks followed by 48 weeks of Pegasys plus ribavirin therapy. 

The side effect profile was similar to what has been previously reported in telaprevir, Pegasys and ribavirin therapy.  Two patients discontinued treatment due to pleuritis/costochondritis (inflammation and pain in the lungs and chest), and a generalized rash.

Bottom Line

These results, although very preliminary, are encouraging because the early response rates are the highest yet seen in a population of HCV patients who are in the greatest need of treatment.  It is hoped that this positive trend of improved treatment outcomes will carry over to the PROVE3 study that is retreating HCV genotype 1 prior non-responders.  The PROVE3 study is a blinded study so no preliminary or interim results have been announced.  But stay tuned – the results from PROVE3 are expected mid-2008.  This study will give us a much better picture of the effectiveness of telaprevir, Pegasys, and ribavirin therapy in a non-responder group of genotype 1 patients.  It is definitely the ONE to watch.

Boceprevir

Boceprevir is an HCV protease inhibitor that is being developed by Schering Plough. Of note, on May 21, 2008 Schering announced the initiation of 2 phase III studies of boceprevir/PegIntron and ribavirin. Interim results from the SPRINT-1 study were released at EASL.  The study aim was to evaluate the most effective treatment strategy for HCV genotype 1 treatment-naïve patients.  The aims included determining the most optimal treatment duration (28 vs. 48 weeks), the dose of ribavirin (800-1300 mg/daily vs. 400-1000 mg/daily), whether treatment would benefit from a lead-in phase (PegIntron plus ribavirin) before beginning boceprevir (800 mg TID), or if the triple combination of boceprevir, PegIntron, and ribavirin from the beginning of therapy produced the best treatment results. The baseline characteristics were similar across the treatment arms except that more males were included in the PegIntron plus ribavirin control group than in the boceprevir arms. 

The SVR12 data from the two 28-week boceprevir arms was presented.  In the group that received the PegIntron plus ribavirin (lead-in phase), followed by the addition of boceprevir there was a 57% SVR12 compared to 55% of the group who received boceprevir, PegIntron and ribavirin (triple therapy) from the beginning of treatment.  In those patients who achieved a rapid virological response (HCV RNA negative after 4 weeks of treatment), the lead-in group, 86% achieved an SVR12 compared to 74% achieving an SVR12 in the group that received the triple therapy from the beginning. 

The side effect profile between the boceprevir and the PegIntron arms were similar except there was more anemia and dysgeusia (taste changes) in the boceprevir arm.  The discontinuation rates were higher in the boceprevir arms (11 and 15%) compared to the PegIntron plus ribavirin control arm (8%).   

The interim results suggest that a shorter duration of treatment (28 weeks total) that includes a lead-in phase with PegIntron plus ribavirin prior to the introduction of boceprevir produces higher treatment response rates and that a rapid virological response is a good predictor of treatment response.  

Bottom Line

These are also very encouraging early results.  The final results of all of the treatment arms will give us a much better idea of the effectiveness of boceprevir compared to PegIntron plus ribavirin therapy.  The good news about this study is that the design of the phase III study will include a lead-in phase and a shorter duration of treatment.

Boceprevir in Null Responders

The results from another study using boceprevir in combination with PegIntron plus ribavirin yielded less promising outcomes.  However, this trial was more about establishing the most effective dose of boceprevir, treatment duration, safety issues and if ribavirin was needed to maximize treatment response rates. 

In the study there were 357 genotype 1 patients enrolled who were deemed prior null responders – defined as either less than a 2 log10 drop in HCV RNA after 12 weeks of therapy with pegylated interferon/ribavirin therapy or who did not achieve undetectable HCV RNA if treated longer than 12 weeks.  There were 7 arms in this study – with or without different doses of boceprevir (100, 200, 400, 800 mg), and with and without ribavirin. This study had a lead-in phase using PegIntron alone.    

The authors found that boceprevir is safe and well-tolerated.  The overall intent-to-treat sustained virological response rates were 2% in the group that only received PegIntron plus ribavirin and up to 14% in the groups that received triple combination of PegIntron, ribavirin and boceprevir.  It was found that the most effective dose of boceprevir was 800 mg TID and that the use of ribavirin would be required to optimize treatment outcome.  The treatment duration would include an additional 24 weeks after HCV RNA became undetectable. 

Bottom Line

It is hard to draw any concrete conclusions because of the small patient population and the many different treatment arms.  The group of patients in this study are some of the most difficult to treat and most did not receive the most effective dose of boceprevir.  The newly announced phase 3 studies will hopefully answer the question of the role of boceprevir in the retreatment of prior non-responders. 

R1626

R1626 is a polymerase inhibitor that is being developed by Roche, and in previous studies it has been shown to have potent antiviral activity against hepatitis C.  Prior treatment data has suggested that there was a lack of viral resistance to R1626.  At the AASLD 2007 Conference 4-week data that was presented was very encouraging.  At EASL 2008 more information was released that included the end-of-treatment response rates (total treatment duration = 48 weeks) of the entire Phase 2 clinical trial. 

All study participants were HCV genotype 1 treatment-naïve.  A total of 104 patients were randomized into 4 treatment arms:

Arm A:  R1626 (1500 mg bid-twice a day) plus Pegasys for 4 weeks followed by Pegasys plus ribavirin for an additional 44 weeks. (21 patients)

Arm B:  R1626 (3000 mg bid) plus Pegasys for 4 weeks followed by Pegasys and ribavirin for an additional 44 weeks.  (32 patients)

Arm C:  R1626 (1500 mg bid) plus Pegasys and ribavirin for 4 weeks followed by Pegasys plus ribavirin for an additional 44 weeks. (31 patients)

Arm D:  Pegasys plus ribavirin for 48 weeks (control arm) (20 patients)

The patient characteristics were fairly well-matched except that arm A had a higher percentage of males (81%) compared to the other arms (41%, 39% and 40% respectively).  The fibrosis scores were fairly well-matched and all fell within the F0-F2 range. 

The highest end-of-treatment response rates were in Arm C – 84% which is slightly higher than the treatment response rates reported after 4 weeks of treatment.  There were 7 patients who initially were HCV RNA negative after the 4-week lead-in, but became HCV RNA positive (rebounded) during therapy.  In all of the patients who rebounded, they rebounded after R1626 was discontinued.  As reported with the 4-week data at AASLD 2007, there was no drug resistance to R1626 found in this study.  The safety profile was similar between the arms with the exception of grade 4 neutropenia and other lab abnormalities in the R1626 arms.  After treatment was discontinued all lab values returned to normal.  

Bottom LIne

Even though this is a small patient population, the lack of drug resistance and very high end-of-treatment response rates are very encouraging.  Due to the high incidence of grade 4 neutropenia during the period that R1626 was taken, Roche has launched a phase 2b dose ranging study to determine the most optimal dose of R1626 that has lower rates of lab abnormalities.         

R7128

R7128 is an HCV polymerase inhibitor that is being developed by Pharmasset and Roche.  At AASLD 2007 it was reported that R7128 alone for treatment of HCV genotype 1 treatment-naïve patients for 4 weeks achieved an average of 2.7 log10 decline in HCV RNA with a maximum decline of 4.2 log10.  It was also found that twice a day dosing was the most effective.

At EASL 2008, Pharmasset presented results from another trial of R7128 in combination with Pegasys and ribavirin for 4 weeks.  In this trial, 50 HCV genotype 1, treatment-naïve patients were enrolled.  The treatment arms* and the results after 4 weeks of treatment are listed below.   

Group A:  R7128 500 mg BID plus Pegasys and ribavirin (20 patients).  30% were HCV RNA negative; mean HCV RNA reduction was -3.82 log10.

Group B:  R7128 1500 mg BID plus Pegasys and ribavirin (20 patients).  85% HCV RNA negative; mean HCV RNA reduction was -5.12 log10

Group C:  Placebo plus Pegasys and ribavirin (10 patients) – control arm.  10% were HCV RNA negative; mean HCV RNA reduction was -2.95 log10

*After initial treatment of R7128 (at various doses) combined with Pegasys and  ribavirin for 4 weeks, trial participants were then treated for another 4 weeks with Pegasys plus ribavirin – then all the study participants were rolled over to receive an additional 40 weeks with Pegasys plus ribavirin (total duration of treatment was 48 weeks). 

The safety and tolerability was similar between the 3 arms including the arm that did not include R7128. 

Bottom Line

The data is very impressive, but more long-term data is needed before any conclusions can be drawn.  It was announced at EASL that Pharmasset will conduct new studies to evaluate R7128 at 1500 mg BID in HCV genotype 2 & 3 patients who did not achieve a sustained virological response to a previous course of interferon based therapy, as well as testing R7128 at 1000 mg BID.   

In a related development, on May 19, 2008 Pharmasset announced that a new compound designated as PSI-7851 will be advanced into animal toxicity studies and that Pharmasset will apply to the Food and Drug Administration for an Investigational New Drug (IND) designation.  PSI-7851 is an HCV polymerase inhibitor that has demonstrated in vitro (test tube) a potency that is about 15- to 20 fold greater than R7128.  

More New Drugs in Development

There was more news from EASL on drugs in early development including the following studies:

VCH-916 is a HCV polymerase inhibitor being developed by ViroChem.  In a study of healthy volunteers who received up to a single dose of 600 mg, VCH-916 was found to be generally safe and well-tolerated and achieved plasma concentrations proportional to the dose given.  Based on these results a 14-day study of HCV genotype 1 treatment-naïve subjects is being planned. 

TMC435350 is an HCV protease inhibitor being developed by Medivir and Tibotec. In the study there were 52 healthy volunteers and 6 patients with HCV.  Once a day dosing with TMC435350 at 200 mg was given to all study participants.  The drug was found to be safe and well-tolerated in both the healthy and the HCV-positive participants.  In the 6 patients with HCV genotype 1, TMC435350 was found to have strong and rapid antiviral activity with a median viral load reduction of -3.9 log10.  Further studies are being planned.

Nitazoxanide is a broad spectrum antiviral that is being tested for the treatment of hepatitis C by Romark Laboratories.  In a previous study released at AASLD 2007, nitazoxanide used in combination with pegylated interferon and ribavirin for the treatment of HCV genotype 4 patients produced an SVR12 of 79% compared to 43% in the group that received pegylated interferon plus ribavirin but without nitazoxanide.  The prior study had a 12 week lead-in of nitazoxanide.  In this study a 4 week lead-in phase using nitazoxanide alone was studied.  The authors found that the SVR12 rates were similar between the different lead-in phases (80% for the 4-week lead-in vs. 79% for the 12-week).  This is one to keep track of since the potential for increased response rates by adding nitazoxanide to the current standard of care of pegylated interferon plus ribavirin is encouraging. 


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Chronic Hepatitis C in Children
Liz Highleyman

While much has been learned over the past decade about chronic hepatitis C virus (HCV) infection in adults – and treatment has improved dramatically – much remains to be learned about HCV in children.

Epidemiology of HCV in Children
Chronic hepatitis C is less common among children than adults – estimated at approximately 250,000 cases in the United States – largely because children are unlikely to contract the disease through parenteral transmission (for example, through shared use of drug injection equipment) or sexual intercourse.  A screening test for HCV in donated blood was developed in 1992, and the last children to be infected through this route are now in their teens.

While most children with hepatitis C today contracted the virus from their mothers during pregnancy or delivery, the mother-to-child HCV transmission rate remains low, in the range of 1% to 5% in most studies (though somewhat higher if the mother is coinfected with HIV).  Since many perinatally exposed infants spontaneously clear HCV within the first year, and because newborns still carry their mothers’ antibodies for several months after birth, HCV antibody testing is only recommended after 18 months of age (HCV RNA testing is accurate sooner).  Unfortunately, unlike hepatitis A and B, there is no vaccine or prophylactic therapy to prevent hepatitis C.

While as many as 80% of adults with acute hepatitis C develop chronic infection, the rate is lower in children, who are more likely to spontaneously clear the virus. For example, a retrospective study of 157 confirmed HCV RNA positive children in Canada (123 infected via blood transfusion and 20 via mother-to-child transmission) found that 28% cleared the virus without treatment after seven years of follow-up [Yeung 2007].  Other studies suggest that among infants infected at birth, the spontaneous clearance rate may be as high as 50%.  (This contrasts with hepatitis B, in which only about 10% of exposed adults, but 90% of infants infected at birth, develop chronic infection.)

Liver Disease Progression
Compared with adults, children with hepatitis C are more likely to be asymptomatic, more frequently have normal or only mildly elevated liver enzymes (ALT and AST), and tend to have slower liver disease progression.  In the ongoing Peds-C trial (described below), biopsies from 121 participants aged 2-16 years showed that 59% had minimal or mild liver inflammation and 90% had minimal or absent steatosis (fat accumulation) [Goodman 2008].

Over years or decades, however, HCV-infected pediatric patients are at risk of developing advanced liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC) during childhood, adolescence, or early adulthood. For example, Italian researchers following 332 untreated children with persistent HCV viremia for 10 years found that six (about 2%) progressed to decompensated cirrhosis [Bortolotti 2008].

In the aforementioned Peds-C cohort, five children (4%) had bridging fibrosis and two (less than 2%) had cirrhosis.  Liver inflammation was correlated with duration of infection and degree of fibrosis, and fibrosis was correlated with obesity, leading the investigators to suggest that “children with chronic hepatitis C will be at risk for progressive liver disease as they age and possibly acquire other comorbid risk factors.”

Hepatitis C Treatment in Children
Studies have shown that hepatitis C can be successfully treated in children.  In 2003, the U.S. Food and Drug Administration (FDA) approved combination therapy with conventional interferon plus ribavirin for children and adolescents aged 3-17 years.  Treatment is not recommended for children under 3 years. The newer pegylated interferons (Pegasys and PegIntron) are not yet approved for pediatric patients.  Drug doses should be adjusted based on a child’s weight.  A liquid formulation of ribavirin is available for children unable to swallow pills.

In general – using either conventional or pegylated interferon, alone or with ribavirin – sustained virological response (SVR) rates tend to be as good or better in children compared with adults.

A review of studies found that conventional interferon monotherapy produced sustained response in 26% of pediatric patients with HCV genotype 1 and 70% of those with non-1 genotypes.  Rates were higher in a study of 118 children treated with conventional interferon alfa-2b plus 15 mg/kg/day ribavirin, at 36% and 84%, respectively; this dose of ribavirin was more effective than 8 or 12 mg/kg/day [Gonzalez-Peralta 2005].  One study using this regimen found that children younger than 12 years were about twice as likely to respond as those aged 12-17 (57% vs 30%, respectively).

Though not yet approved for children, many experts prefer the longer-lasting pegylated interferon to conventional interferon based on its greater efficacy in adults and promising results from clinical trials in pediatric patients. Results from the randomized, controlled Phase III Peds-C trial – which is evaluating pegylated interferon alfa-2a (Pegasys), with or without ribavirin, for 48 weeks in more than 100 children and adolescents – are expected later this year.

Among smaller completed trials, an open-label pilot study included 62 children ages 2-17 years who were treated with the standard adult dose of 1.5 mcg/kg/week pegylated interferon alfa-2b (PegIntron) plus 15 mg/kg/day ribavirin for 48 weeks (those who did not respond by 24 weeks discontinued therapy).  SVR rates were 48% for genotype 1, 50% for genotype 4, and 100% for genotypes 2 or 3 [Wirth 2005].

In another pilot study, 10 adolescents aged 11-18 (nine with genotype 1; three prior nonresponders to conventional interferon) were treated with the same dose of PegIntron plus 800 mg/day ribavirin for 48 weeks. All but one attained undetectable HCV RNA during treatment, but only three went on to achieve SVR [Baker 2007].  In a more recent Spanish study of 30 children aged 3-16 years treated with 1.0 mcg/kg/week PegIntron plus 15 mg/kg/day ribavirin for 24 (genotypes 2/3) or 48 (genotype 1) weeks, all three genotype 3 patients and 44% of those with genotype 1 or 4 achieved SVR [Jara 2008].

The higher treatment success rate in children compared with adults may be related to the fact that they typically have mild pre-existing liver damage.  Studies to date suggest that, as is the case with adults, black children do not respond as well as whites (though numbers have been small), and that rapid (week 4) and early (week 12) virological response predict sustained response.

Several studies indicate that side effects associated with interferon and ribavirin are of similar types, but tend to be less frequent and severe, in children versus adults.  However, neutropenia (low white blood cell count) may be a treatment-limiting toxicity.  Further, children may experience inhibited growth while taking interferon, though they tend to catch up after completing treatment.

Continuing Challenges
As is true for adults, it can be difficult to determine which pediatric patients should receive treatment, given that interferon-based therapy often causes side effects and many patients will not develop severe liver disease even without treatment.

Since treatment is traditionally delayed until there is evidence of liver disease progression – for example, elevated liver enzymes or a biopsy showing fibrosis – a majority of children with hepatitis C may not require treatment until they reach adulthood. Some experts, however, favor earlier therapy for children, since the effects of lifelong HCV infection are not well understood.  Some clinicians recommend a lower threshold for treatment of patients with the easier-to-treat genotypes 2 or 3, since the odds of a cure are high.

Current American Association for the Study of Liver Diseases (AASLD) practice guidelines, last updated in 2004, recommend that monitoring of children with HCV “should proceed as with adults.”  In addition to liver biopsies, pediatric patients should receive regular ALT and AST monitoring and liver cancer screening (e.g., alpha-fetoprotein assays and abdominal ultrasound).

Newer directly-targeted antiviral therapies, such as HCV protease and polymerase inhibitors, have not yet been tested in children and adolescents.  However, if their promise is confirmed and they are approved for adults, doctors will be able to prescribe them “off label” if this seems advisable for individual pediatric patients.

In addition to the challenges of treatment and lifelong monitoring of a chronic disease, children and adolescents may have difficulty understanding what having hepatitis C means for them, as well as dealing with the stigma associated with the disease.  For help explaining hepatitis C to children, see the Hepatitis C Support Project’s fact sheet How to Tell Children They Have Hepatitis.

References

  • Baker, R.D. et al. Response to pegylated interferon alpha 2b and ribavirin in children with chronic hepatitis C. Journal of Clinical Gastroenterology 41(1): 111-114. January 2007.

  • Bortolotti, F. et al. Long-term course of chronic hepatitis C in children: from viral clearance to end-stage liver disease. Gastroenterology. March 2, 2008 [Epub ahead of print].

  • Gonzalez-Peralta, R.P. et al. Interferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics. Hepatology 42(5): 1010-1018. November 2005.

  • Goodman, Z.D. et al. Pathology of chronic hepatitis C in children: Liver biopsy findings in the Peds-C Trial. Hepatology 47(3): 836-843. March 2008.

  • Jara, P. et al. Efficacy and safety of peginterferon-alpha2b and ribavirin combination therapy in children with chronic hepatitis C infection. Pediatr Infect Dis J. 27(2): 142-148. February 2008.

  • Rosenthal, P. Hepatitis C in Children: Update 2006. Hepatitis C Support Project Medical Writers Circle. www.hcvadvocate.org/hcsp/articles
    /hcv_children_2006.html
    .

  • Wirth, S. et al. Peginterferon alfa-2b plus ribavirin treatment in children and adolescents with chronic hepatitis C. Hepatology 41(5): 1013-1018. May 2005.

  • Yeung, L. et al. Spontaneous clearance of childhood hepatitis C virus infection. Journal of Viral Hepatitis 14(11): 797-805. November 2007.



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HealthWise: Health and Money
Lucinda Porter, RN

This year, some of us have received, or will receive, an economic stimulus payment from the United States Internal Revenue Service.  To collect this money, you must file an income tax return – even if you are not required to for tax purposes. Checks typically range from $300 to $600.  Extra money is always welcome, but what can $600 buy for your health?

According to the National Coalition on Health Care (NCHC), medical costs rose by nearly 7% last year.  This is double the rate of inflation.  Our rebate checks will not buy much.  This is a good time to take stock of our finances before those dollars burn up in rising fuel costs.

Preventing illness actually increases our bank balance.  For instance, smoking is costly because it increases health risks while simultaneously decreasing our bank accounts.1  Furthermore, how we spend our money says a lot about our priorities.  Would you prefer a big screen TV or a treadmill?  Rather go to the movies or play golf?  Go hiking or go to the mall?  Choose a giant sugar laden triple mocha with whipped cream or a cup of green tea?

Here is what $600 will buy:

  • Depending on where you live, $600 will likely cover the cost of a medical appointment and basic lab tests, such as a complete blood count and liver panel.
  • Although it will not cover the cost of a liver biopsy, it will likely cover the cost of an abdominal ultrasound.
  • Will barely cover the cost of one week of hepatitis C treatment.
  • Will cover the cost of most immunizations, particularly if purchased through the public health department, local store or senior center.
  • Depending on your age and health, may buy one or two months of health insurance.
  • A one-year fitness program or gym membership.
  • Exercise equipment, such as a stationary bike, hand weights, heart monitor, fitness books or exercise tapes. 
  • A blood pressure monitor, health magazines, medical reference books.

Here are other ways to spend extra money:

  • Add additional daily fruit and vegetables to your diet.
  • Switch to organic foods from local growers or grow your own – cherry tomatoes grow nicely in planters.
  • Buy a water filtration system, such as BRITA®.  Buy a stainless-steel water bottle.2
  • Donate money to a favorite non-profit.
  • Send money to a political candidate who proposes or supports health care reform.

There are other ways to improve the business side of your health.  Did you know that health costs are negotiable?  Yes, you can haggle over the price of a procedure or hospital charges.  Your best bet is to do this up front, before incurring the cost.  However, you can still do this even after the bills have arrived, as long as it doesn’t violate insurance regulations.  Talk to the business office of your medical facility.  Ask if there are ways to bring down costs.  Will the physician give you a discount if you pay upfront and with cash?

If your medical provider orders labs and procedures, you can choose where to have the tests done.  Shop around for the cheapest labs.  Diagnostic tests performed in a hospital are usually more expensive than those done in a stand-alone facility.

Choose the right provider for the right occasion.  Emergency room visits are expensive and should be reserved for true emergencies. You don’t need a plastic surgeon to remove a splinter unless it is a two-by-four across your face.

Some insurance companies keep price information on hand. Check out the company website or call and discuss how you can reduce your medical bills.  For those fifty-five and over, visit the National Council on Aging’s Benefits Check-Up website www.benefitscheckup.org

Don’t forget to check medical bills. Request itemized hospital bills, ask questions and challenge any charges that may be incorrect. Hospital billing departments do make mistakes.

Understand the terms of your medical insurance.  Do you need prior authorization for any procedures?  My insurance company denied a claim for a $1200 MRI because I did not get prior authorization.  I wrote a letter arguing that the procedure was an emergency and they reversed their decision. Ultimately it is your responsibility to pay the bills, so do not assume that your medical provider will verify coverage.

Check to see if you are eligible for any services provided by your local public health department: www.fda.gov/oca/sthealth.htm  

Do you live near a dental, chiropractry or podiatry school?  You may be able to get basic care for little or no cost.

See if there is a clinical trial that offers free treatment for what you are looking for.  I know someone who got her eyelids lifted for free by a famous plastic surgeon.  The catch was that one eye was done with traditional surgery and the other using experimental tape.  If the experimental side didn’t look as good as the surgical side, she would get the second lid done for free.

For the past 25 years, a friend of mine has been participating in a study on aging.  Every year he gets a free extensive medical exam.  This spring he spent an all-expense paid weekend at UCLA undergoing every possible non-invasive diagnostic procedure known to medicine. A month later, he and his regular physician received a one-inch thick report telling him he was healthy.

There are ways to reduce the cost of prescription and over-the-counter drugs.  Ask your doctor for free samples to try before committing to a new medication. See if there is generic version or a cheaper substitute for a drug.  Scan the Internet for drug manufacturers’ coupons.  For more information, see the Hepatitis C Support Project’s fact sheet, Tips for Lowering Prescription Drug Costs

A popular trend for cutting medical costs involves travel. In recent years, approximately 500,000 U.S. residents travel abroad annually seeking medical and dental treatment.  For example, hip replacement surgery costs around $50,000 or more in the U.S. The same procedure at a state-of-the-art hospital in India may be purchased for roughly $15,000.  This includes all travel expenses, a recovery stay in a lovely guesthouse and a trip to the Taj Mahal.  Medical travel is not for everyone and it does have some downsides, particularly if there are complications.  However, if you are considering it, really do your research.

In addition to saving money, you can make money on health. During college I picked up extra cash by volunteering for medical research. I made a few hundred dollars by agreeing to some nearly painless skin biopsies. This was good money back then.  I found my limit when I could have made $500 if I agreed to have a tube put down my throat.  My minimum gagging fee is $1000.

Common sense makes cents. Proverbs such as “An apple a day keeps the doctor away” and “A penny saved is a penny earned” are as true today as when they were first uttered.  An updated version might be “A dollar saved by purchasing an organic apple rather than a soft drink, keeps the nurse practitioner away, which is a dollar earned plus compound interest in both money and health.”  I doubt this saying will catch on as well Benjamin Franklins’ did.  However, if it does, you read it here first.

Additional Reading

HCV Advocate newsletter: www.hcvadvocate.org and contributor Jacques Chambers, CLU’s Help with Benefits www.helpwithbenefits.com  

Kaiser Family Foundation:
www.kff.org/insurance/index.cfm

National Coalition on Health Care:
http://nchc.org/facts-resources/quick-facts

U.S. Department of Health and Human Services - Agency for Healthcare Research and Quality:
www.ahrq.gov/research/costix.htm

1This is not entirely true. Smoking is expensive and smokers do incur more medical costs. But in the end, living longer costs more than dying younger. However, living longer increases the opportunity to earn more.

2If you prefer plastic, choose #2 high-density polyethylene (HDPE) or #4 low-density polyethylene (LDPE). Wash plastic by hand in warm sudsy water and not in the dishwasher.

Political Action
In 1776, the United States of America was born. The Founders believed that we are endowed with certain rights that cannot be taken away, including the right to the pursuit of happiness. For many, health and happiness are linked.  Protecting and participating in a democracy is more than just voting – it invites us to be informed and to be involved.  Donate your time and money to support a cause, a candidate, and to keep our democracy healthy.


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Latinos and HCV Treatment
Alan Franciscus, Editor-in-Chief

The Digestive Disease Week Conference was held in San Diego, CA on May 17th to 22nd, 2008.  This year one of the largest and most important studies was released: “Virological Responses to Peginterferon Alfa-2A/Ribavirin in Treatment-Naïve Latino vs. Non-Latino Whites Infected with HCV Genotype 1:  The Latino Study, by Rodriguez-Torres and colleagues. 

The “Latino Study” is the first large study to look at treatment response in Latinos vs. non-Latino whites.  This is important because Latinos are the fastest growing group in this county.  In 2000 (the last census) there were an estimated 35.3 million Americans who were Latino, which accounted for 12.5% of the population.  By 2010 it is estimated that there will be 47.8 million Latinos in the U.S. which will account for 15.5% of the U.S. population. 

The main objective of the study was to evaluate the effectiveness of Pegasys plus ribavirin in Latino and non-Latino whites in treatment-naïve patients with HCV genotype 1.

Latino patients were defined as those patients from Mexico, Puerto Rico, Cuba, the Dominican Republic, Central America (Costa Rica, Guatemala, Honduras, Nicaragua, Panama, and El Salvador), and South America (Argentina, Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru, Uruguay, and Venezuela).  The majority of Latino patients came from Mexico (51%), Puerto Rico (32%), Cuba (9%); all other countries account for 8%.  Indian, Asiatic, or black Latinos were excluded from the study. 

All patients were treated with 180 ug/week Pegasys plus 1000 or 1200 mg/day ribavirin for a treatment duration of 48 weeks.  The study enrolled 269 Latino whites and 300 non-Latino whites.  The patient characteristics were well matched between the study groups except that the there were more Latinos £ 40 years old (27.9% vs. 16.3%), and who had a higher body mass index (BMI) than the non-Latino group (40.1% vs. 25.0%).  The Latino group also had higher ALT levels defined as 3 times the upper limit (24.5% vs. 16.7%) and more Latinos were cirrhotic (13.4% vs. 9.7%). 

The sustained virological response rates (HCV RNA less than 28 IU/mL) were lower in the Latino group 33.5% compared to 49% in the non-Latino white group.  Overall the treatment discontinuation rates based on side effects and non-safety issues were similar between the two groups—29% in the Latino group compared to 25% in the non-Latino group.

The factors that were associated with achieving an SVR among Latino patients were low baseline levels of alanine aminotrasferease (ALT), low baseline HCV RNA (£ 400,000 IU/mL), and non-cirrhosis classification. The factors associated with achieving an SVR in non-Latino whites included male sex, high ALT, and low baseline HCV RNA levels.

Given the lower treatment response in Latinos, the authors noted that there needs to be additional strategies to help improve the SVR in Latinos.

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