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March 2008 HCV Advocate

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Risk of Drug & Alcohol Relapse after Transplantation
Alan Franciscus, Editor-in-Chief

HCV Pipeline Update
Alan Franciscus, Editor-in-Chief

Report from the 2008 Retrovirus Conference (CROI)
Liz Highleyman

Healthwise: What the Heck is NHANES?
Lucinda Porter, RN

Extrahepatic Manifestations: Vitiligo
Alan Franciscus, Editor-in-Chief

Disability & Benefits: HCV Meets HMO
Jacques Chambers, CLU

Fast Food and ALT Levels
Alan Franciscus, Editor-in-Chief



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Risk of Drug & Alcohol Relapse after Transplantation
Alan Franciscus, Editor-in-Chief

A recently released study, “Meta-Analysis of Risk for Relapse to Substance Use after Transplantation of the Liver or Other Solid Organs,” by Dew et al., is shedding light on the incidence of drug and alcohol use after organ transplantation.  

Alcoholic liver disease and hepatitis C viral infection are the leading causes for liver transplantation in the United States and Europe.  Given the scarcity of available organs there has been concern in the transplant community about the appropriate use of organs for people with drug and alcohol addiction.  To compound the concern there has been very little data that has looked at the incidence of relapse after organ transplantation. 

In the study a total of 54 (50 liver, 3 kidney, 1 heart) transplant studies were included that met the authors’ inclusion criteria.  In total there were 3,651 people who received transplants (3,551 liver, 53 kidney, 47 heart) from the United States (28 studies) and Europe (26 studies) who were described as ‘substance abusers.’ 

In total the average rate for alcohol relapse was 5.6% for any given year and the average rate of relapse for heavy alcohol use was 2.5% for any given year.  The average rate of relapse to illicit drug use was 3.7% for any given year. 

Because of the amount of limited data available, the relapse risk factors could only be measured for alcohol use.   But for drug use relapse the authors found that the “demographics and most pretransplantation characteristics showed little correlation with relapse,” and that “poorer social support, family alcohol history, and pretransplantation abstinence of  less than or equal to 6 months showed small but significant associations with relapse. 

It was also noted by the authors that future prospective clinical trials are needed to help improve both the prediction of the risk for relapse as well as the strategies for abstinence after transplantation.  

An accompanying editorial raised concerns about limitations in the study.  For instance, the drug and alcohol use was self-reported and the data was collected by the transplant personnel; both of these factors could affect quality of post transplant medical care. 

Article: “Meta-analysis of risk for relapse to substance use after transplantation of the liver or other solid organs.” Dew et al. Liver Transplantation; February 2008.

Editorial: “Addictive behavior after solid organ transplantation: What do we know already and what do we need to know?” Lucey, Michael; Tome, S.; Said, Adnan. Liver Transplantation; February 2008.

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HCV Pipeline Update
Alan Franciscus, Editor-in-Chief

In January and February 2008 the amount of new information about HCV drugs in development was astounding!  This article will focus on the two top news stories: telaprevir and albuferon. 

Vertex Announces Phase III Studies
On January 23, 2008, Vertex announced that they are moving forward on clinical studies of telaprevir in combination with Pegasys (pegylated interferon-2a) and ribavirin in the United States, Europe and other unspecified countries.   

Primary Pivotal Study
The primary study is expected to begin recruitment of more than 1050 HCV patients in March 2008.  The study will recruit HCV treatment-naive (never been treated) genotype 1 patients from over 100 centers in the U.S., Europe and other countries.  The trial participants will be randomized into three treatment arms:

•    Arm 1: telaprevir dosed at 750 mg every eight hours for 12 weeks in combination with standard doses of Pegasys and ribavirin, then an additional treatment period of 12 weeks of standard doses of Pegasys plus ribavirin alone (without telaprevir).  (Total:  24 week treatment duration)

•    Arm 2: telaprevir dosed at 750 mg every eight hours for 8 weeks in combination with standard doses of Pegasys and ribavirin, with an additional  treatment period of 16 weeks with standard doses of Pegasys plus ribavirin alone.  (Total:  24 week treatment duration)

•    Arm 3:  Control arm of standard doses of Pegasys plus ribavirin.  (Total:  48 week treatment duration)

A key component of the study will be rapid virological response (RVR) – the patients in the telaprevir arms who achieve an RVR (HCV RNA less than 10 IU/mL) at week 4, and who are still undetectable at week 12 will receive a total of 24 weeks of treatment.  The patients in the telaprevir arms who do not achieve an RVR, but who are undetectable at week 24 will continue on standard doses of Pegasys plus ribavirin for a total treatment period of 48 weeks.

Second Study
An additional study is being planned with telaprevir in combination with pegylated interferon plus ribavirin therapy that will be conducted simultaneously with the above study to gather more information on the effectiveness of telaprevir/pegylated interferon/ribavirin therapy to compare the 48-week treatment period to the 24-week treatment period in HCV genotype 1 treatment-naïve patients.  The main reason for this study is to further validate the 24 week treatment period to make sure it is as effective as the current standard 48-week treatment period. 

The primary end point of the telaprevir clinical trials is sustained virological response (SVR), which means that HCV RNA is undetectable (less than 10 IU/mL) 24 weeks after the completion of therapy. 

Additional Studies 
Vertex and its partner Tibotec are also conducting many additional clinical trials in the U.S. and Europe.  The one that is the most eagerly awaited is the Prove 3 clinical trial that is studying the use of telaprevir in combination with pegylated interferon plus ribavirin in HCV genotype 1 patients who have not achieved an SVR with a previous course of pegylated interferon-based therapy.   The results of this study are expected around mid-2008.

Another study that Tibotec is conducting uses a different dosing schedule of telaprevir (every 8 hours vs. every 12 hours) in combination with pegylated interferon plus ribavirin.  Interim 12 week data is expected mid-2008.  Tibotec is also conducting studies on people with genotypes 2 and 3, and in December 2007 Tibotec began a Phase II study on people infected with HCV genotype 4. 

Bottom Line
The results from the Phase III pivotal study of telaprevir in combination with pegylated interferon plus ribavirin therapy in HCV genotype 1 treatment-naïve patients along with the results of the Phase II treatment duration study (48 weeks vs. 24 weeks) will be submitted to the FDA for marketing approval.  Vertex has stated that the clinical trial data should be available in mid-2010 and that they expect to file an application to the Food and Drug Administration for marketing approval of the combination of telaprevir, pegylated interferon and ribavirin by the end of 2010. 

This is encouraging news because the combination of telaprevir, pegylated interferon plus ribavirin might be approved for the treatment of genotype 1 treatment-naïve patients by the FDA and available to the general hepatitis C population by mid-to-end 2011. 

Albuferon Dosing Adjusted
Albuferon in combination with ribavirin is currently in Phase III clinical studies.  In January 2008 Human Genome Sciences announced that, based on the recommendations of an independent Data Monitoring Committee (DMC), the arm in which the patients were receiving the highest dose (1200-mcg dose) will be closed out and that the people in the 1200-mcg dose arm will be moved over to the 900-mcg dose arm group.  The reason the 1200-mcg dose arm is being discontinued is due to safety concerns regarding pulmonary (lung) adverse events.  In a company press release, Human Genome Sciences (HGS) stated that the closing of the 1200-mcg dosing arm will not affect the scheduled completion of the study and subsequent filing to the FDA for marketing approval, which is expected in late 2009.  It was also stated in the HGS press release that the DMC did not express any safety concerns about the 900-mcg dose of Albuferon. 

Albuferon is a form of long-acting interferon that is being tested to find out if an injection of Albuferon once every two weeks is as effective as the once weekly dose of pegylated interferon alfa-2a (Pegasys).  Both drugs are being given in combination with ribavirin.  Originally HGS was testing Albuferon as a once every 4 week injection, but there hasn’t been any data that would support further development of this therapeutic approach.

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Report from the 2008 Retrovirus Conference (CROI)
Liz Highleyman

The 15th Conference on Retroviruses and Opportunistic Infections (CROI) took place February 3-6 in Boston. As the major annual U.S. conference on HIV/AIDS and its treatment, CROI featured numerous reports on HIV/HCV coinfection.

Treatment of HIV/HCV Coinfected Patients
Juan Berenguer and colleagues with the Spanish GESIDA 3603 study presented data on long-term outcomes in HIV/HCV coinfected patients (abstract 60). On the whole, research has shown that coinfected individuals respond less well to interferon-based therapy than people with HCV alone. In HCV monoinfected patients, sustained response to anti-HCV treatment can slow or halt liver fibrosis progression, but this has not yet been extensively studied in the coinfected population.

GESIDA 3603 included 711 coinfected participants treated for hepatitis C between January 2000 and December 2005. Nearly three-quarters were men, the median age was 41 years, 63% had HCV genotype 1 or 4, and 2% also had hepatitis B; 39% already had advanced fibrosis or cirrhosis (stage F3-F4) at study entry. Overall, they had well-controlled HIV disease, with a median CD4 count of 544 cells/mm3 and half with an undetectable HIV viral load under 50 copies/mL.

Most study participants (80%) received pegylated interferon – about evenly split between alfa-2a (Pegasys) and alfa-2b (PegIntron) – while the rest received conventional interferon; everyone also received ribavirin. Sustained virological response (SVR) rates were 14% for genotype 1 and 4 patients and 46% for those with genotypes 2 and 3. Participants who did not respond initially or who relapsed after treatment were classified as nonresponders.

Sustained responders and nonresponders were followed for a median duration of about 20 months. Patients who achieved SVR were significantly less likely to develop hepatocellular carcinoma (HCC), to progress to decompensated liver disease (indicated by ascites, gastrointestinal bleeding, or hepatic encephalopathy), or to require a liver transplant; in fact, none of the sustained responders developed liver cancer or needed a transplant. Looking at all these events combined, nonresponders had nearly a nine-fold higher risk compared with sustained responders. Individuals who achieved SVR not only had a significantly lower rate of liver-related death, but also of all-cause mortality.

In a related report, Juan Gonzalez-Garcia and the GESIDA 50/06 Study Group presented data from a retrospective analysis of the effect of anti-HIV drugs on response to hepatitis C in about 700 coinfected patients (abstract 1076). They found that individuals who used tenofovir (Viread) as part of their combination HAART regimen were significantly more likely to achieve sustained response to pegylated interferon plus ribavirin than those who used AZT (Retrovir), d4T (Zerit), or abacavir (Ziagen). Conversely, those who used AZT had a 40% lower SVR rate, attributable to a greater likelihood of adverse events such as anemia.

Pegylated  Interferon Maintenance
Since about half of all hepatitis C patients do not achieve sustained response with current standard therapy – a rate that is even higher among HIV/HCV coinfected people – researchers have explored whether interferon maintenance therapy might reduce the risk of long-term liver complications even without HCV clearance.

Kenneth Sherman and colleagues presented results from the SLAM-C study (ACTG 5178), which assessed full-dose pegylated interferon maintenance therapy in HIV/HCV coinfected patients in the U.S. (abstract 59). Among the 329 coinfected participants, 83% were men, 43% were white, 37% were black, the median age was 48 years, 84% had HCV genotype 1, all had at least mild (F1) fibrosis, and 13% had cirrhosis (stage F4). These patients, too, mostly had well-controlled HIV disease, with a median CD4 cell count of 498 cells/mm3, and about 75% had undetectable HIV viral load.

Participants were first treated with 180 mcg once-weekly Pegasys plus 1,000-1,200 mg/day weight-based ribavirin. Just over half (56%) demonstrated early virological response at Week 12. Among the remainder, 86 nonresponders were randomly assigned to either receive maintenance monotherapy with the same dose of pegylated interferon for 72 weeks or to undergo observation without further treatment.

Paired liver biopsies were compared for evidence of fibrosis. At an interim analysis in early 2007, 62 participants had completed 72 weeks of follow-up and 45 paired biopsies were available. Among these patients, there was no significant change in fibrosis in either the maintenance arm or the untreated observation arm. Necroinflammation remained stable in the interferon maintenance group while worsening in the observation group, but this was not correlated with fibrosis progression. The maintenance arm was halted in April 2007 since it failed to show any benefit. Indeed, it was unable to demonstrate any benefit because the progression rate in the untreated group was unexpectedly low, explained co-investigator Raymond Chung.

These surprising results – along with those of the HALT-C trial (see the February 2008 HCV Advocate), which failed to show a benefit of low-dose interferon maintenance therapy in HCV monoinfected patients – suggest that this may not be a worthwhile strategy to pursue.

Fibrosis Progession
The issue of fibrosis progression in HIV/HCV coinfected individuals remains controversial. Several prior observational studies have shown more rapid progression in coinfected patients, many of whom had advanced HIV disease and low CD4 counts. The SLAM-C findings support a smaller body of evidence suggesting that coinfected people with well-controlled HIV disease and well-preserved immune function may fare as well as HCV monoinfected individuals. Most of the coinfection data reported at CROI, however, came down on the side of faster progression.

Juan Macias and colleagues, for example, evaluated fibrosis progression in HIV positive individuals in Spain with chronic hepatitis C (abstract 1055). This retrospective analysis included 83 coinfected patients who underwent two liver biopsies separated by at least one year (median separation 40 months); those with pre-existing cirrhosis were excluded. Most (81%) were on combination anti-HIV therapy and 76% had undetectable HIV viral load. The patients had no identifiable causes of liver disease other than hepatitis C. About half received interferon-based therapy, and 50% of these achieved an end-of-treatment response.

Between the two biopsies, 13 patients (16%) experienced fibrosis regression by one stage or more and 36 (43%) experienced no change. However, 34 participants (41%) progressed by at least one stage. Factors associated with progression were moderate-to-severe lobular inflammation and lack of end-of-treatment or sustained virological response to therapy. The researchers concluded that while fibrosis progression is frequently observed in coinfected patients on HAART over a period of three years, response to anti-HCV treatment can prevent progression.

Progression during Acute HCV Infection
Outbreaks of apparently sexually transmitted acute hepatitis C have recently been reported among mostly HIV positive gay and bisexual men in several cities in Europe and Australia. At last year’s CROI, Daniel Fierer and colleagues from Mt. Sinai School of Medicine in New York City presented early findings from a prospective study of HIV positive men infected with HCV within the past six months. Among the first five enrolled participants, four already had moderate portal fibrosis during the acute phase of infection.

At this year’s conference, the researchers presented further data from additional patients (abstract 1050). Among 11 men who underwent liver biopsy (most within five months of ALT elevation suggesting acute infection), nine (82%) had stage F2 fibrosis and one had stage F1, despite the short duration of infection. The mean fibrosis progression rate was 4.5 units per year. Here, too, no potential causes of liver damage other than HCV infection were identified. The investigators concluded that, “Acute HCV infection of [men who have sex with men] with underlying HIV infection resulted in early and rapid progression of liver fibrosis, with [fibrosis progression rates] far in excess of other settings of HCV infection.” Similar findings have not been widely reported by other investigators studying HIV positive patients with acute hepatitis C, so further research is indicated.

Finally, another research team from Mt. Sinai offered a possible explanation for the more extensive fibrosis widely reported in HIV/HCV coinfected individuals (abstract 57). Ana Tuyama and colleagues performed a laboratory study to examine whether HIV enters and replicates in hepatic stellate cells. These cells, which produce collagen and other material that makes up the scar tissue of fibrosis, express the CCR5 and CXCR4 molecules that serve as co-receptors allowing HIV to enter cells.

Mechanism for Accelerated Fibrosis
The investigators assessed the ability of CCR5-using and CXCR4-using strains of HIV to infect cultured hepatic stellate cells. They found that HIV entered the cells and actively replicated, indicated by the presence of the p24 antigen. The HIV IIIB strain was able to enter stellate cells without using the CD4 receptor (which is present on the immune system T-cells that are the major target of the virus). They further demonstrated that HIV infection promoted stellate cell activation, resulting in a 1.6-fold increase in collagen I and a 1.5-fold increase in alpha-SMA mRNA (two markers of fibrosis). Incubation of stellate cells with HIV’s gp120 envelope protein led to a 2.1-fold increase in collagen I. “HIV enters and actively replicates within hepatic stellate cells independent of CD4,” the researchers concluded, adding that both viral entry and exposure to HIV envelope proteins can “promote activation and collagen induction in hepatic stellate cells.”

These findings may help explain why coinfected individuals tend to experience more rapid fibrosis progression, and why this may be less of a problem for patients whose HIV is well-controlled with antiretroviral therapy.

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HealthWise:  What the Heck is NHANES?
Lucinda Porter, RN

How many people in the United States are living with chronic hepatitis C viral infection (HCV)?  The answer is nearly always traceable back to the acronym NHANES – the National Health and Nutrition Examination Survey.

Look at any article, and if it discusses the number of people who test positive for HCV, the figure will likely be around 4 million. Subtracting those who spontaneously clear the virus, this leaves 2.7 million people with chronic HCV infection. Look at the source documentation. The source will likely be the National Institutes of Health HCV Consensus Statement (2002), which got its data from the 1988-1994 NHANES III. If another source is cited, trace it back. It will probably lead to the NHANES.

The NHANES is sponsored by the National Center for Health Statistics (NCHS) under the umbrella of the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC). No additional acronyms for the rest of this article, I promise. The NCHS started collecting health data in 1959. The first NHANES was in 1971. There were three specific NHANES, but since 1999 data is collected continuously. The NHANES data released this year was collected in 2005-2006. There is also a version of the survey that collects Latino health data.

The purpose of the NHANES is to survey the health of the U.S. adult and child population. Among other things, the NHANES tracks diseases, health risks, and the relationship between diet and health.  Information is collected using questionnaires, lab tests and physical exams.

Participants are selected based on a formula intended to represent the entire country. The U.S. population is over 303 million. Astonishingly, only 5,000 people participate in the NHANES. That is less than the population of Truth or Consequences, New Mexico. One person represents 50,000 citizens, although if you do the math, that calculates to 250 million.

Taking part in the NHANES is a big deal. Candidates are given ample time to consider if they want to take part in the survey.  After giving consent, the NHANES begins with an extensive questionnaire and in-home interview. The answers to questions about sexual behavior, drug use and other sensitive issues are recorded by participants, rather than the interviewer. A week or two after the interview, participants are given an extensive physical exam. A health team performs the exam in a well-equipped mobile unit. Laboratory and diagnostic tests are included.

Virtually every aspect of health is examined. This includes hearing, vision, occupational risks, sleep habits, pesticide exposure, sexual behavior, diet, mental health, dental health, drug, tobacco and alcohol use. Bone density and cardio fitness are measured. The lab portion analyzes over 100 variables. These include the usual blood tests we are accustomed to, along with less common ones.  Examples of lab tests are vitamin levels, allergens, poisons, and markers for various diseases, including hepatitis A, B, C, and D.

Participants receive a report within 12 weeks of the exam. If something abnormal turns up, participants are notified immediately by mail. They are referred to their medical provider or local health department. Test results for sexually transmitted diseases and HIV are handled differently. To insure privacy and counseling, participants are given a toll-free phone number and password. If they do not call, a reminder letter is sent. And yes, I lied about no more acronyms, but I hope you’ll cut me some slack about using HIV.

If someone tests positive for the HCV antibody, they will receive a letter, followed by a twenty minute telephone survey. Participants are asked if they had prior knowledge about their HCV status and if so, what they knew about it.  Most of the questions are about the participant’s knowledge of HCV and its treatment.

One of the criticisms of the NHANES is that since it is a household survey, some of the populations with higher HCV rates are left out of the equation. NHANES does not count people who are in the military, homeless, incarcerated, hospitalized, or institutionalized. Brian Edlin, M.D., associate professor of medicine at Cornell University, believes that the NHANES data underestimates HCV prevalence. Looking at the rates of those who weren’t counted, Edlin concluded that those testing positive for HCV are closer to 5 million with a chronic infection rate of 3.4 million.

The benefits resulting from NHANES outweigh the criticism. The survey contributed to our awareness of the increasing obesity and osteoporosis trends. One of the reasons we have lead-free gas followed the NHANES discovery of lead in the blood. Recommendations about folate and other vitamins came from the survey. Whether it is 4 million or 5 million people who were exposed to HCV, the NHANES has grabbed our attention.

 

Everyone in the U.S. is affected by health policy. This is true whether you are a Democrat, Green Party, Libertarian, Republican, or a member of one of the many other political parties. Do you know what your party’s position is on health policy? Do you know what your position is? Do you know which candidates’ views are closest to yours? Take the time to find out.

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Extrahepatic Manifestations: Vitiligo
Alan Franciscus, Editor-in-Chief

Vitiligo is a specific type of dermatological condition that is characterized by loss of pigment of the skin that can affect almost any part of the body, including premature graying of hair.  The exact cause of vitiligo is unknown but it is believed to be an autoimmune disease that can be caused by genetic and/or environmental factors.  The relationship between HCV and vitiligo is controversial.  Most studies have not been able to find a direct link between HCV and vitiligo, but some smaller studies have suggested a causal link.  Still other studies have found a link between vitiligo and interferon therapy.     

Symptoms
The most common symptoms include white patches of skin that itch.  It can affect any area of the body but it is usually seen on the extremities, face or neck, and skin folds.  It can also affect the areas around the lips, genitals, gums, nipples, and the colored skin that surrounds the nipple. Vitiligo generally strikes people between the ages of 10-30 years old, and it is common in females and males alike.           

Causes
The exact cause of vitiligo is not known.  It is an autoimmune disease that is believed to be hereditary.  The proposed theories are that stress, thyroid dysfunction, skin injury, severe sunburns, chemicals, and medicines combined with the genetic tendency towards vitiligo can all contribute to the condition.  However, these are theories that have not yet been substantiated.   

Diagnosis
The diagnosis of vitiligo is usually made based on a combination of tests, including physical examination, blood tests for autoimmune markers, skin biopsy, and obtaining a medical history of the individual’s family.

Treatment
There is no standardized treatment for vitiligo.  Treatment is usually individualized and can include phototherapy (light therapy), steroids, and various topical ointments.  In severe cases of vitiligo skin grafts have been found to help as well as tattooing the skin in people with dark skin.  The skin can also be dyed or artificially tanned although it is difficult to match the dyed or tanned area to the pigmentation of the surrounding or healthy skin. 

Other strategies to help manage vitiligo include wearing sunscreen and sun-protecting clothing, and avoiding the use of hair dyes and bleaches that can damage the skin.  

Dealing with Vitiligo
In people with moderate to severe vitiligo the emotional toll can be enormous especially if it affects the skin on specific parts of the body that are visible, such as the face, arms hands, and legs.  Finding a medical provider who is well-versed in treating the physical and emotional issues of vitiligo is important.  Peer support in the form of a support group for discussing the condition and receiving emotional support is critical. 

Resources:
http://www.vitiligosupport.org/

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Disability & Benefits: HCV Meets HMO
Jacques Chambers, CLU

Although they are not as popular as they once were, Health Maintenance Organizations (HMOs) and their close relatives, Exclusive Provider Organizations (EPOs) and Point of Service (POS) Plans, still provide coverage to the majority of people with health insurance.

While these plans have worked well for people who are generally healthy and have only temporary or minor medical problems, they can be a real challenge for persons dealing with chronic or catastrophic medical conditions, such as HCV.

The basic principle of HMOs is that, in return for a flat fee called capitation or premium, as well as nominal co-pays for services, they will provide all your medical needs. However, to make sure you get the “quality of care you need,” and, coincidentally avoid “unnecessary” and expensive “over-utilization,” a Primary Care Physician (PCP) must coordinate all your treatment. Regardless of what treatment you may need, you must first go to your PCP, who will usually be a general practitioner, possibly an Internist or Family Practice specialist.

This Primary Care Physician is also called the “Gatekeeper” – an extremely descriptive title. If you believe you should see a specialist, it is the Gatekeeper who decides whether or not you get to see the specialist, and, if so, which specialist you will see.

Remember the game of “Simon Says?” In the HMO world, it is “PCP Says.” Unless the PCP says you need a specialist, you will have to rely on the PCP to provide your care, whether it is something he/she is familiar with or not. Keep in mind that the fewer doctor visits, tests, and treatment you undergo, the bigger an HMO’s profits and the more the doctor/clinic will earn.

With a set-up like this, it makes you wonder if anyone ever gets good care from an HMO. Health care from an HMO does not have to be inferior. Thanks to the public outcry about HMOs skimping on care to increase their profits, Congress and many state legislatures have tightened regulation of this industry. Publicity by the media of problems with care from HMOs and the frequency of large jury awards have forced HMOs to make an effort to improve the quality of their care, or at least improve the image of their quality of care.

In fact, medical care can be excellent in an HMO. This is due in part to stricter oversight and regulation. It is also due to the doctors and other medical providers actually treating patients who still care about providing quality care to people who need it. However, the key to the quality of the care you receive is you and how actively you participate in the decisions about your healthcare.

There are a lot of excellent and caring medical providers working with HMOs, but you will have to seek them out. You will also have to make sure they continue to focus on your medical care, despite the bureaucratic barriers built into the HMO system.

In reality, the HMO is not that different from any other type of healthcare delivery system. You are the person who is ultimately responsible for seeing to it that you get the best care available. It is up to you to know the level of care you are actually receiving and to determine what quality of care you should be receiving.

It is up to you to take control of your medical care, and, to do that, you need to become more knowledgeable about all areas of your medical condition and its treatment.

Know your medical condition. Thanks to sites like the HCV Advocate and others on the web, there is a lot of information about hepatitis C and its treatment. Thanks to the Internet, you can stay current on new treatments, clinical trials, and new diagnostic methods.

HCV is a relatively recent discovery. There is a lot of information available about it, and there is a lot of research being done to learn more. It would be nice if everyone could find a physician whose practice consisted only of HCV patients, but that is not possible. You can become one of your physician’s sources of new information about HCV treatments and trials.

You should feel free to print out information, cut out articles and take them to your physician. Hopefully, he/she is already current, but you may be providing new information. If your doctor is not the type that welcomes such input from the patient, you may be seeing the wrong doctor.

Find a knowledgeable Primary Care Physician. The Centers for Disease Control states: “Any physician who manages a person with hepatitis C should be knowledgeable and current on all aspects of the care of a person with hepatitis C.”  Following this statement means that in an HMO, your Primary Care  Physician should be “knowledgeable and current” in HCV and its treatment.

Within virtually all HMO networks, you are able to select your own Primary Care Physician. Your selection of a PCP will determine not only who provides the majority of your care, but will also determine which specialists will be utilized when needed.

However, the HMO directory will give you only minimal information about your choices, and it won’t tell you which PCPs frequently treat patients with HCV or stay current about it. Clearly, you will need to do some research.

If you attempt to call the HMO itself, it will not provide much information, as they are prohibited from “steering” patients to particular clinics or doctors, even if it would mean better health care. You may have to call several doctors’ offices to learn more. Keep in mind the chances that you will actually get to speak to the doctor are very slim, but his nurse should be able to handle the questions as well. Some questions you may want to ask include:

   •  What is the doctor’s specialty? Is he/she board-certified? Many PCPs are internists, which may give them more experience with HCV.

   •  What chronic medical conditions does the doctor treat most frequently?

   •  Does the doctor treat other patients with HCV? How many? What percentage of their practice is HCV?

   •  What has been the doctor’s experience with HCV treatment? Do not hesitate to ask very specific questions, referring to treatments and using terms you have learned in your research on HCV. If they don’t know what you’re talking about, scratch them off your list and move on.

   •  Who are the gastroenterologists, hepatologists, infectious disease specialists, or other HCV knowledgeable specialists that the doctor works with and refers patients to? You may want to talk to their offices as well.

   •  How long does it take to get a referral once the PCP requests one?

Some PCPs even have the ability to permanently refer you to a specialist for treatment of chronic conditions such as HCV. In those cases, the specialist effectively becomes your PCP.  Ask your prospective PCPs if this is a possibility. This is particularly important if you can’t find a PCP knowledgeable in the treatment of HCV.

These are a lot of questions, I realize. However, neither the HMO nor your physician has as much at stake as you do in your medical care. This is your health and your life you are protecting, so spending some time and energy on this now can give you piece of mind and better healthcare later.

Medical office personnel are not always as helpful to prospective patients as you may think. One alternative is to learn as much as you can about your PCP choices, select one and schedule an appointment. Then you can ask the doctor directly and decide whether you want to stay with that PCP or switch to another. This will give you an excellent idea of how well they listen to you, how much time they are willing to spend with you, and their general “bedside” manner as well as their knowledge and experience of HCV.

Know your plan and your rights. You should spend some time with your Plan Document, the booklet that describes the provisions of your HMO coverage. While it is important to have a good idea of what is and isn’t covered, it is even more important to understand your rights under the plan. Not everything you need to know about your plan will be in the document. You may have to talk to a representative at the HMO itself or at the state regulatory agency, either your state’s Department of Insurance or Department of Managed Health Care, for information. Things you should know about your plan include:

   •  How do you change your PCP and how often can you do it? Be aware that if you are totally dissatisfied with your PCP, an HMO will often accommodate your request for a change regardless of their “rules.”

   •  What right do you have to appeal the denial of a referral or of a particular course of treatment? What are the time limits on such appeals? How does the appeal process work?

   •  What is the timeline for an expedited appeal if medical treatment is being withheld pending the appeal? Many states have enacted laws which require such appeals to be handled within 24 or 48 hours.

   •  Does the HMO offer Nurse Case Management for patients with chronic diseases such as HCV? Case Managers have an underlying purpose of saving the HMO money, but most of these case managers are trained nurses, and can be a valuable source of information about the HMO’s policies and rules and may even be an ally for you when “fighting the system.”

The days are long gone in any healthcare delivery system when patients could put themselves in the doctor’s hands and rest assured that they were getting the best and latest treatment. However, in the HMO system of healthcare, where the providers can increase profits by withholding care, it becomes even more important that you stay actively involved in your medical care. To do that, you must find knowledgeable medical providers who not only know about HCV, but who will listen to you and answer questions candidly about the input of the HMO in determining the direction of your care.

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Fast Food and ALT Levels
Alan Franciscus, Editor-in-Chief

Elevated liver enzymes are an indication that there is damage or inflammation occurring in the liver.  The liver enzyme that is measured most commonly is alanine aminotransferase (ALT).  The usual cause of elevated ALT levels is consumption of large quantities of alcohol, HCV infection and the presence of steatosis (fatty liver).  However, after eliminating these risk factors, there are still many people who have elevated ALT levels with no known risk factor.   

A small study from Sweden, “Fast-food-based hyper-alimentation can induce rapid and profound elevations of serum alanine aminotransferase in healthy subjects,” by S. Kechagias and colleagues, may help to explain some of the causes of elevated ALT levels in healthy adults who have no other risk factors.  In the study, the effects of 4 weeks of consuming fast food (combination of fast food consumed at home and at well-known fast-food restaurants) with a physical activity level limited to 5000 steps per day was examined.  Study participants were given physical exams and were found to be free from conditions that could influence elevated ALT levels such as hepatitis B and C.  Alcohol consumption was limited to under 140 g/week.   A total of 12 men and six women volunteered and all but one of the study participants were students.  There was also a well-matched control group in which the subjects continued to follow their regular diet and exercise routines. 

At week four, 17 of the 18 adults recruited for the study met a goal of a 5-15% increase in body weight with an average weight gain of 14 pounds.  A total of 13 study participants on the high fast-food diet developed elevated ALT levels and in most of the study participants the elevation was seen within the first week and continued until end of the study.  In contrast, all of the ALT levels in the people in the control group remained in the normal range. 

The authors concluded that the cause of the elevated ALT levels “may be the sudden increased supply of metabolic substrates, to the liver, in particular monosaccharides.”

The authors stated, “We suggest that in the clinical evaluation of subjects with elevated ALT physicians should include not only questions about alcohol intake, but also explore whether recent excessive food intake has occurred.” 

The information presented in this study is important because it links poor nutrition with liver inflammation or damage in healthy adults.  It also supports the notion that good nutrition and exercise are some of the most important components in the management of hepatitis C. 

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