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HCV Advocate Newsletter

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October 2008 HCV Advocate

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HCV Drug Pipeline Update
Alan Franciscus, Editor-in-Chief


Hearing Loss and Hepatitis C
C.D. Mazoff, PhD, Managing Editor

HealthWise: Hepatitis C and Liver Transplantation
Lucinda Porter, RN


Vaccine to Prevent HCV Remains Elusive
Liz Highleyman

Short Takes on HCV, Diabetes and Diet
Alan Franciscus, Editor-in-Chief

A Simple Way to Prevent Disease!
Alan Franciscus, Editor-in-Chief


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HCV Drug Pipeline Update
Alan Franciscus, Editor-in-Chief

In the last month there has been quite a bit of news about various new drugs in development including drugs being tested to treat hepatitis C, drugs being tested to prevent the recurrence of liver cancer, and the transfer of the clinical development of a HCV protease inhibitor from one pharmaceutical company to another one. 

The preliminary results from two studies of Pharmasset’s HCV polymerase inhibitor, R7128, for the treatment of HCV genotypes 1, 2, and 3 were recently released.  The first study included 25 HCV genotype 1 patients who received a dose of 1000 mg BID (twice a day) plus the standard dose of Pegasys plus ribavirin.  The control group consisted of 6 HCV genotype 1 patients who received the placebo drug plus the standard dose of Pegasys and ribavirin.  Eighty-eight percent of the patients who received the combination of R7128 / Pegasys / ribavirin  for 4 weeks achieved undetectable HCV RNA or viral load (less than 15 IU/mL).  The side effect profile in the group that received R7128 combination therapy was comparable to the group that received the placebo combination therapy.  Based on the safety, tolerance and efficacy of the 1000 mg BID dose of R7128, it was announced that this would be the dose that would be used in future trials. 

The second study reported on by Pharmasset on R7128 contained the preliminary results from a 4-week Proof-of-Concept study of HCV genotype 2 or 3 patients who did not achieve a sustained virological response (non-responders and relapsers) with a previous course of pegylated interferon plus ribavirin therapy.  In this study, 20 patients received the triple combination of R7128 1500 BID plus the standard dose of Pegasys and ribavirin; 5 patients received placebo plus the standard dose of Pegasys and ribavirin.  In the group that received the R7128 triple combination therapy, 90% achieved undetectable HCV RNA or viral load (less than 15 IU/mL) after 4 weeks of treatment.  The side effect profile in the group that received the R7128 combination therapy was comparable to the group that received the placebo combination therapy. 

Comments:  The preliminary results from these two studies of R7128 are very impressive – 88% and 90% of the study participants were HCV RNA negative after only 4 weeks of therapy and it appears that, so far, the side effect profile is good.  This is definitely the one to watch. 

ITMN-191 (R7227)
It was announced on September 2, 2008 that InterMune reached a milestone in the development of ITMN-191, an HCV protease inhibitor, being developed in collaboration with Roche.  In addition to a milestone payment of $15 million to InterMune, Roche will now be responsible for future clinical development.  In May 2008 InterMune started a 14-day study of ITMN-191 in combination with Pegasys and ribavirin.  The results from this study are expected towards the end of 2008. 

Nexavar
Bayer and Onyx announced that they have begun enrollment in a multi-international clinical trial called STORM to study Nexavar (sorafenib) to find out if Nexavar can prevent the recurrence of hepatocellular carcinoma (HCC), or liver cancer, following surgery or local radiation for patients with HCC or primary liver cancer.  The company expects to enroll about 1,100 patients.  The study participants will receive 400 mg of Nexavar twice daily (or placebo) for up to 4 years.  Nexavar is an oral multiple kinase inhibitor that is currently approved to treat liver and kidney cancer.  Visit www.clinicaltrials.gov for more information. 

IC31
The six month follow-up data from a study of IC31, a therapeutic HCV vaccine, in combination with the administration of a topical Toll-like receptor (TLR) agonist, imiquimod, used to treat 33 HCV genotype 1 treatment-naïve patients found that there was a viral load reduction of 0.46 log.  It was noted that this is the first therapeutic vaccine that was found to decrease HCV viral load up to 6 months post vaccination.  Although the viral load reductions were modest, IC31 in combination with imiquimod might have future uses as an add-on therapy with other HCV medications. 


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Hearing Loss and Hepatitis C
C.D. Mazoff, PhD, Managing Editor

If you keep up with the Hep C online support groups, chances are, sooner or later, you will hear somebody talking about “tinnitus,” or ringing in the ears, and other hearing problems.  Tinnitus and hearing loss can be caused by many things – certain medications, pressure on the auditory nerve, blood flow problems, obstructions to the inner ear, and autoimmune activity.   A quick search through PubMed or Google reveals a few scholarly articles on tinnitus and/or hearing loss caused by interferon treatment; however, hearing loss and/or tinnitus caused by interferon usually subsides soon after treatment ends.

Unfortunately some people with hepatitis C report that their hearing problems did not go away after they stopped treatment; so if the interferon didn’t cause it, what did?

There are quite a few autoimmune-related conditions that have tinnitus, and/or hearing loss as part of the symptoms.  Some of these are: fibromyalgia, thyroid disorders, depression, and Meniere’s disease, which can be autoimmune, genetic or idiopathic (cause unknown).

Meniere’s disease also causes episodes of vertigo, where you may feel that you are falling even when lying down and that the world is spinning so quickly that it makes you want to vomit.  A search on Google for “Interferon and Vertigo” produces quite a few hits.

Vertigo can also be caused by an unknown virus (viral labyrinthitis), which inflames the part of the inner ear that controls balance, or it can be caused by herpes simplex virus type 1 (HSV-1) in the vestibular ganglion, where information on linear acceleration and the influence of gravitational pull is processed.   

Sometimes a visit to your doctor can help you if your vertigo is caused by particles floating in the inner ear chamber.  The doctor may use the canalith repositioning procedure.  This is a series of movements performed in your doctor’s office to move particles from the fluid-filled canals of your inner ear into the utricle (a small sac in the labyrinth).

In some people, the vertigo becomes so bad that surgery is necessary; however the upshot of the surgery is usually permanent hearing loss in the affected ear.

In any case, if you have ringing in your ears that doesn’t go away, try picking up the phone . . . and if that doesn’t work, go see your doctor.


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HealthWise: Hepatitis C and Liver Transplantation
Lucinda Porter, RN

In 1963, the first human liver transplant was attempted in Denver, Colorado by a team headed by Thomas Starzl, MD.  Four years later, the procedure was performed successfully.  Survival rates have been steadily improving, particularly with the introduction of anti-rejection medications.  The five-year survival rate is roughly 75%.

In the past twenty years, there have been more than 90,000 liver transplant surgeries.  Most liver transplants use deceased donors.  However, the liver’s remarkable ability to regenerate allows us to use partial livers from living donors.  Approximately 3,600 of these have been transplanted. 

According to the American Liver Foundation, the number of liver transplants has been increasing every year.  Unfortunately, there are far more people who need livers than there are donors.  In order to deal with the fair distribution of organs, the U.S.  Congress passed the National Organ Transplant Act in 1984.  A national registry for organ matching was established and is maintained by the Organ Procurement and Transplantation Network (OPTN).  The OPTN contract was awarded to the United Network for Organ Sharing (UNOS).

UNOS is a non-profit, scientific and educational organization with a broad agenda.  This organization regulates distribution as well as promotes increasing the supply of organs.  UNOS collects, analyzes and publishes organ transplant data, educates in the professional and public domains, develops policy, and interfaces with all aspects in the organ donor/transplant arena.

Some interesting facts gleaned from the OPTN/UNOS data (as of July 2008):
• There are over 99,000 people on an organ transplant list.  The majority (more than 76,000) are waiting for kidney transplantation.  Second place on the list are those waiting for livers – more than 16,000.  Third place are people listed for heart transplantation at around 2,600.
• The median waiting time for a liver transplant is 458 days for those with blood type O and 75 days for those with blood type AB.
• Of those with blood type O who are waiting for a liver, close to 50% will receive a transplant; blood type AB have about a 75% chance.  (See sidebar)

“Blood type is essential when matching donor livers with recipients. The most common blood type in the U.S. is O+ (37%), followed by A+ (36%), B+ (8.5%) AB+ (3%), O- (7%), A- (6%), B- (1.5%), AB- (1%).  Type O is the universal donor, so all of the blood groups may receive blood and tissue from Type O donors. TypeAB is a universal recipient and may receive blood from all blood groups.’’

The most common reason for liver transplantation in the U.S.  is chronic hepatitis C virus (HCV) infection.  Since transplantation is reserved for end-stage liver failure, the majority with HCV will never suffer enough damage to require this procedure.  Thank goodness.  Organ transplantation is a complicated surgery, requiring lifelong follow-up care.   It is preferable to keep our diseased liver, even with advanced HCV, for as long as possible.

Although you may not need a liver transplant, you may be referred for a transplant evaluation.  This is an extensive process, conducted by a transplant team.  Eligibility is determined on a case-by-case basis, but there are general guidelines.  Some of these criteria are absolute and some are relative, depending on specific transplant centers’ practices.

Potential disqualifications for liver transplantation:
• Active alcohol or substance abuse – this one is black and white AND can be changed by patient participation
• Metastatic cancer and active septic infections are absolute contraindications
• Age – Less likely over age 70
• Other serious health issues, advanced heart, lung or kidney disease, severe infection, other terminal conditions; some centers are transplanting patients living with HIV
• Liver failure that is too massive and complicated to respond favorably to transplantation
• Morbid obesity or advanced malnutrition
• Inability to follow medical instructions
• Lack of support to help manage post-surgical medication regimen

Liver disease and alcohol are incompatible.  It is understandable why active alcohol abuse disqualifies a person from being considered for a liver transplant, since someone who will keep drinking may injure their transplanted organ.  Occasionally I’ll hear about patients hospitalized with liver failure due to alcohol abuse.  They can’t receive a liver transplant without at least six months of sobriety.  The transplant team guides them towards alcohol recovery resources.  Six alcohol-free months later, their liver has regenerated and they don’t need a transplant at all.

New from
“The Medical  Writers’  Circle”:

Increasing the Chance of
Receiving Liver Transplantation by Multiple Listing,
by Lorenzo Rossaro, M.D., F.A.C.P.
http://www.hcvadvocate.org/hcsp/articles
/Multiple_listing.html

A huge area of debate is tobacco and marijuana use.  Tobacco-related health risks are well-documented.  If all risk factors are equal, it makes sense that a non-smoker would be a better candidate for an organ transplant than a smoker.  The research regarding cannabis use is less conclusive.  However, since available organs are scarce, there is merit to the argument of transplanting the candidate with the fewest risk factors.

The reality is not just that there is a scarcity of livers, but that some will die as a result of this shortage.  The responsibility for selecting suitable candidates is an enormous one.  As guardians over precious organs, it seems fair to give a patient the choice between an organ and continued tobacco or marijuana use.

Whether transplant eligibility is a reality or a distant possibility, consider embracing those criteria over which you have control.  Although alcohol and other substance use sometimes make us feel good, they are not health-enhancing, particularly for those living with HCV.  If abstaining from substances is a problem, you may need help.

Obesity is another selection criterion that patients are better off addressing now rather than later. Liver transplant survival rates decrease with morbid obesity.  Body weight is a significant factor for liver health, whether or not you are hoping to keep your own liver or preparing for possible transplantation.  (For more on obesity, see sidebar)

“Body Mass Index (BMI) is an indicator of healthy weight. Obesity is a BMI > 25; morbid obesity is >35. To calculate BMI: (1) multiply your weight (in pounds) by 703, (2) multiply your height in inches by itself, then divide the answer in (1) by the answer in (2). You can find BMI calculators and other fitness tools and tips at  www.healthfinder.gov ’’

Liver transplantation does not cure HCV.  In fact, post-transplant HCV recurrence rate is nearly 100%.  Despite recurrence, long-term post-transplant survival rates are nearly identical to those of other diseases.  Management of HCV after surgery is a hot issue in liver disease research and clinical practice.  Post-transplant treatment uses the same medications as those used for general HCV treatment – peginterferon and ribavirin.  As more evidence is being collected, treatment protocols are being fine tuned.

Organs are not disposable body parts.  Replacement organs are difficult to obtain and are not 100% guaranteed.  If your liver is still functioning, then do the best you can to keep it.  Making healthy choices might not keep you completely out of the hands of surgeons, but it may help you heal faster if you go down that road.    

Resources
• American Association for the Study of Liver Diseases – For clear in-depth information about liver transplantation, read AASLD Practice guidelines Evaluation of the Patient for Liver Transplantation by Karen Murray and Robert Carithers, Jr.     Hepatology Nov.6, 2005 www.aasld.org/practiceguidelines

• Donate Life America donatelife.net

HCV Disease Progression: Liver Transplantation, by Liz Highleyman www.hcvadvocate.org/hepatitis/
factsheets_pdf /transplant.pdf

• OrganDonor.gov www.organdonor.gov

• United Network for Organ Sharing www.unos.org


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Vote Health!
Absentee ballot voting is a convenient way to vote. If you choose this option, you must:

• Request an absentee ballot application

• Complete the request application correctly and mail it in

• When you receive your ballot, follow instructions

• Take the ballot in or mail it with sufficient postage Check out the Internet or call your local voter registrar’s office for more information.

www.longdistancevoter.org

 

Organ and Tissue Donor Registry: Tennessee
Being an organ donor transforms death into life.  In the case of kidneys and livers, some donate organs while still alive.  More than 3,600 liver transplants used organs from living donors.  Living donors meet stringent requirements.  They must pass medical and psychological testing.  They must have compatible blood types.  They cannot have liver disease, alcohol or substance abuse, be obese or pregnant.  Living donors face serious risks, including death, when donating livers, and it is not something to be entered into lightly.

Tennessee boasts more than a million people who signed up on their organ donor website. For more information, visit www.tndonorregistry.org/index.aspx  

Note: Residents of Tennessee must check “yes” when renewing or changing their driver’s license.  Failure to do so means removal from the registry.


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Vaccine to Prevent HCV Remains Elusive
Liz Highleyman

Ever since hepatitis C virus (HCV) was identified in 1989, investigators have sought to develop a vaccine to prevent infection.  Over the past two decades, however, an effective hepatitis C vaccine has proven more elusive than vaccines for hepatitis A and B.

This article focuses on vaccines that prevent HCV infection, but researchers are also working on therapeutic vaccines that improve the immune system’s ability to control HCV – and ideally slow or prevent liver disease progression – in people who are already infected.

Immune Response to HCV
Much of the difficulty in developing a preventive hepatitis C vaccine is attributable to incomplete understanding of how the immune system naturally fends off the virus.  HCV is highly variable – with at least six major genotypes, numerous subtypes, and countless quasispecies – and it mutates rapidly to evade immune detection.  An effective vaccine would have to protect against a wide range of HCV variants, leading researchers to search for viral epitopes (antigens) that remain constant, or “conserved,” across strains.

The immune response to HCV involves both antibodies (humoral immunity) and T-cell activity (cell-mediated immunity).  Most people produce antibodies against HCV several months after initial infection, but this typically is not sufficient to eradicate the virus.  Likewise – in contrast to hepatitis A and B – injected antibodies (immunoglobulins) generally do not prevent chronic infection.

Furthermore, while many people exhibit CD4 “helper” and CD8 “killer” T-cell activity against HCV, this is usually not enough to control the virus.  Only about one-quarter to one-third of acutely-infected individuals spontaneously clear the virus without treatment, while the rest develop chronic infection.

The host factors – likely genetic – that contribute to effective immune response to HCV remain poorly understood, though vigorous T-cell activity seems to play an important role.  One recent study, for example, found that people who cleared the virus mounted stronger killer T-cell responses against a wider range of epitopes of the HCV NS3 protein.

With many diseases, once a person has recovered, they remain protected against future reinfection with the same pathogen.  Though results in animal and human studies have been inconsistent, reinfection with the same pathogen does not reliably occur in the case of hepatitis C.  In one recent study, for example, investigators re-challenged two chimps with resolved infection using the same genotype 1a HCV strain about a year later (Bukh).  One animal developed chronic infection with the first rechallenge, and the other did so after seven rechallenges using various genotypes.   The researchers concluded that viral persistence was seen “even in the best-case scenario” when rechallenging with the exact same virus.

Vaccine Candidates
Studies have produced conflicting data about whether antibodies alone can neutralize HCV and prevent chronic infection.  Most current vaccine candidates aim to stimulate anti-HCV T-cell responses, either alone or in conjunction with increased antibody production.   Many of these use HCV E1 and/or E2 envelope proteins (which appear to be a major target of anti-HCV antibodies) or the relatively conserved nonstructural (NS) core proteins.

Various vaccine strategies are under investigation.  Synthetic subunit vaccines contain strings of HCV peptides or proteins.  Many recombinant vaccines consist of viral vectors such as vaccinia that have been genetically engineered to express HCV proteins.  DNA vaccines consist of pieces of viral genetic material selected to trigger an immune response.  Other vaccines use dendritic cells to deliver DNA or messenger RNA encoding HCV proteins, or else the proteins themselves.  Most HCV preventive vaccine candidates are still in preclinical laboratory or animal studies; a few therapeutic vaccines have been tested in early trials in humans.

In the August 2008 Journal of Virology, researchers with Novartis described a study of various HCV vaccine strategies in mice (Lin).  Replication-defective alphavirus particles carrying genes for either E1/E2 envelope proteins or NS 3, 4, and 5 nonstructural proteins elicited strong CD8 T-cell responses, but low CD4 cell responses.  Conversely, recombinant polyprotein vaccines consisting of E1/E2 or NS3/4/5 plus a Th1 adjuvant elicited strong CD4 responses, but no CD8 responses.  The investigators were able to elicit both CD4 and CD8 responses to E1/E2 and NS3/4/5 with a prime-boost approach using HCV proteins plus a Th1 adjuvant followed by boosting with alphaviruses expressing these HCV genes.  This regimen also induced production of antibodies against E1/E2 that neutralized a variety of HCV isolates in vitro.

In related research, Australian researchers demonstrated that vaccines containing the Th1 adjuvants CpG ODN and Montanide ISA 720 – agents that promote interferon-gamma production and stimulate cell-mediated immunity – induced stronger antibody and T-cell responses against HCV core, NS3, and NS5b antigens in mice compared with a formulation that contained HCV proteins without the adjuvants (Qiu).  

In another recent study, Cuban researchers found that mice and vervet monkeys immunized with a recombinant fowlpox vector vaccine called FPCoE1 expressing a truncated HCV core/E1 polyprotein generally failed to elicit an antibody response.  It did, however, stimulate interferon-gamma secretion and lymphoproliferative responses, and led to virological suppression when the animals were subsequently challenged with a recombinant vaccinia virus expressing HCV structural proteins (Alvarez-Lajonchere).  

Given prior suboptimal results using replication-defective vectors (viruses that have been altered so they cannot reproduce), an international research team tested a replication-competent vaccinia virus vector expressing HCV genes in four chimpanzees, while two control chimps received a placebo (vaccinia without HCV genes).  When challenged with HCV, both control animals developed chronic infection,while all four immunized chimps experienced resolution of infection.  The immunized animals exhibited vigorous interferon-gamma responses and moderate proliferative responses.  When the immunized chimpanzees were challenged a second time with a combination of all six major HCV genotypes, they exhibited high viral loads during the acute phase of infection, but then viral load fell to undetectable or consistently very low HCV levels (Youn).  

Taking a different approach, another team showed that a DNA vaccine encoding genotype 1a/1b consensus HCV NS3/NS4A proteins induced strong T-cell responses in both mice and Rhesus macaque monkey (Lang).

Given the challenges of eliciting a strong and long-lasting immune response against multiple strains of HCV, many experts expect that a successful vaccine will employ a combined approach to stimulate both antibody production and T-cell activity.

Conclusion
In a review article on HCV vaccine development in the June 2008 issue of Lancet Infectious Diseases, G.T.  Strickland and colleagues discussed the challenges of hepatitis C vaccine development beyond the difficult aspects of HCV itself.   These include the cost and logistical difficulties of conducting clinical trials and making a successful vaccine widely accessible to the high-risk individuals who need it most, such as injection drug users and healthcare providers in high-prevalence areas.

Over time, chronic hepatitis C can lead to liver cirrhosis, hepatocellular carcinoma, and end-stage liver failure requiring transplantation.  As such, an effective preventive vaccine would have major public health benefits – and would likely prove cost-effective – as has been the case with the widespread adoption of the hepatitis B vaccine since the early 1980s.

References

  • Alvarez-Lajonchere, L. et al.  Immunization with a recombinant fowlpox virus expressing a hepatitis C virus core-E1 polyprotein variant, protects mice and African green monkeys (Chlorocebus aethiops sabaeus) against challenge with a surrogate vaccinia virus.  Biotechnol Appl Biochem 51(Pt 2): 97-105.  October 2008.  
  • Bukh, J., et al.  Previously infected chimpanzees are not consistently protected from reinfection or persistent infection following reexposure to the identical hepatitis C virus strain. J.  Virology 82(16): 8183-8195.  August 2008.
  • Lang, K.A. et al.  Strong HCV NS3- and NS4A-specific cellular immune responses induced in mice and Rhesus macaques by a novel HCV genotype 1a/1b consensus DNA vaccine.  Vaccine August 8, 2008 [Epub ahead of print].
  • Lin, Y.  et al.  The induction of broad CD4+ and CD8+ T cell responses and cross-neutralizing antibodies against the hepatitis C virus (HCV) by vaccinating with Th1-adjuvanted polypeptides followed by defective alphaviral particles expressing envelope glycoproteins gpE1/gpE2 and nonstructural proteins 3, 4 & 5.  J. Virology. 82(15): 7492-7503.   August 2008.
  • Qiu, Q. et al.  Induction of multispecific Th-1 type immune response against HCV in mice by protein immunization using CpG and Montanide ISA 720 as adjuvants.  Vaccine.  September 1, 2008 [Epub ahead of print].
  • Strickland, G.T. et al.  Hepatitis C vaccine: supply and demand.  Lancet Infectious Diseases 8(6): 379-386.  June 2008.
  • Youn, J.W., et al. Evidence for protection against chronic hepatitis C virus infection in chimpanzees by immunization with replicating recombinant vaccinia virus.  J. Virology.  August 27, 2008 [Epub ahead of print].



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Short Takes on HCV, Diabetes and Diet
Alan Franciscus, Editor-in-Chief

Diabetes
The incidence of diabetes is almost twice as high in people with hepatitis C, according to a study by Yu and colleagues.1  The study compared the prevalence of glucose abnormalities between 683 chronic hepatitis C patients and 515 patients without hepatitis C (matched by sex and age).  An oral glucose tolerance test was performed on 522 chronic hepatitis C patients and 447 in the control group without diagnosed diabetes. 

The results reported found that in the group with HCV:

•    27.7% had normal glucose levels,
•    34.6% had impaired glucose tolerance and,
•    37.8% had diabetes. 

In addition, the authors found that there was an increase in the prevalence of glucose abnormalities in people with chronic hepatitis C (65.8%) compared to the control group (35.3%). 

The authors stated that the study results would suggest that people with chronic hepatitis C should be screened for diabetes.

The results from another study on diabetes in people with hepatitis C showed a marked increase in the rates of liver cancer in people infected with hepatitis C who also had diabetes.  Researchers headed up by Bart Veldt2 and Harry Janssen of the Erasmus MC University Medical Center in the Netherlands analyzed data from five large hepatology centers throughout Europe that included 541 patients (mean age 50 yo) of whom 85 had diabetes. 

The percentage of people who were infected with HCV and who also had diabetes increased based on the severity of fibrosis:   

•    10.5% - Ishak score 4*
•    12.5% - Ishak score 5
•    19.1% - Ishak score 6

*The scoring system for the degree of fibrosis used was the Ishak – with 0 as no fibrosis to 6 as cirrhosis.  

More importantly, in a mean follow-up period of 4 years, 11 (13%) patients with diabetes developed hepatocellular carcinoma, or liver cancer, compared to only 27 (5.9%) patients in the HCV non-diabetic group.  After 5 years, the incidence of liver cancer was 11.4% in the diabetic group compared to 5.0% in the non-diabetic group. 

The authors concluded that “in patients with chronic hepatitis C and advanced cirrhosis, diabetes mellitus increases the risk of developing HCC.”

Diet
Although the two studies listed below do not specifically address hepatitis C, they do deal with issues related to metabolic disorders which are important factors in maintaining overall health, and specifically influence HCV disease progression and management as well as HCV treatment outcome.  The last study specifically addresses the affect of diet on HCV disease progression and treatment outcome. 

The first study, by Sahi et al.,3 compared the safety and effectiveness of various diets.  The trial included 322 moderately obese people who followed the Mediterranean (restricted calories), low fat (restricted calories) and the low-carbohydrate (non-restricted calories) over a period of 2 years.  The mean weight loss by diet was:

  • Mediterranean-diet group:  4.4 kg (9.68 lbs),
  • Low-Fat diet group:  2.9 kg (6.38 lbs)
  • Low-carbohydrate group:  4.7 kg (10.34 lbs)

Of the 272 people who were able to complete the study, the mean weight loss by diet was:

  • Mediterranean-diet group:  4.6 kg (10.12 lbs),
  • Low-fat diet group:  3.3 kg (7.26 lbs),
  • Low-carbohydrate diet group:  5.5 kg (12.1 lbs)

The authors concluded that the low-carbohydrate diet was favorable for lowering lipids (fats) and the Mediterranean-diet was more favorable towards glycemic (blood sugar) control and they suggested that “personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions.”

The second study, by Sofi et al.,4 reviewed 12 studies that included a total of 1,574,299 patients to evaluate the association between adherence to a Mediterranean diet, death and incidence of disease.  The participants were followed for a time period ranging from 3 to 18 years from 1966 to June 30, 2008.  On a nine-point scale, the authors found that a two-point increase in adherence to the Mediterranean-like diet was associated with a significant reduction in:

  • Overall death (9%)
  • Cardiovascular diseases (9%)
  • Death from cancer (6%)
  • The incidence of Alzheimer’s or Parkinson’s disease (13%)

The authors concluded that “[These] results seem to be clinically relevant for public health, in particular for encouraging a Mediterranean-like dietary pattern for primary prevention of major chronic diseases.” 

The Mediterranean diet in this study varied but was generally a diet rich in legumes, cereals, fruits/nuts, vegetables, fish, olive oil, and low in the consumption of meat, meat products, dairy products, and alcohol.   

Can we take the information from the two general studies and apply the outcomes to people with hepatitis C?  That’s exactly what researchers Loguercio, C et. al5 in Italy attempted to answer in a prospective clinical trial of over 1,084 patients with chronic hepatitis C (432 treated with interferon/ribavirin) and 2,326 people without hepatitis C (control group).  The participants’ dietary and alcohol consumption was evaluated with a questionnaire.  Body mass index was measured and various laboratory tests, including blood glucose, cholesterol, triglycerides, nitrogen, and creatinine as well as routine liver function tests, were done.  All of the study subjects were well-matched for weight (50% overweight), alcohol consumption (60% consumed alcohol), and dietary habits.  The results found that “alcohol intake differed significantly between treatment responders and non-responders to interferon therapy,” and that “dietary composition was related to the extent of liver damage.”  The authors commented that, “This suggests that HCV patients may benefit from instructions regarding their diet.”

References
1Yu, et al.  Reappraisal of the Characteristics of Glucose Abnormalities in Patients With Chronic Hepatitis C Infection. Am J Gastroenterol 2008;103:1933–1940

2Veldt, et al.  Increased risk of hepatocellular carcinoma among patients with hepatitis C cirrhosis and diabetes mellitus.  Hepatology  2008;47:1856-1862  DOI: 10.1002/hep.22251. 

3Shai, et al.  Weight Loss with a Low-Carbohydrate, Mediterranean, or Low-Fat Diet.  N Engl Med 2008;359:229-41

4 Sofi, et al.  Adherence to Mediterranean diet and health status:  meta-analysis.  BMJ 2008;337:a1344 doi:10.ll36/bmj.a1344

5 C Loguercio, A Federico, M Masarone, and others. The impact of diet on liver fibrosis and on response to interferon therapy in patients with HCV-related chronic hepatitis. American Journal of Gastroenterology. September 11, 2008 [Epub ahead of print].


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A Simple Way to Prevent Disease!
Alan Franciscus, Editor-in-Chief

What is the best disease prevention strategy available?  If you were to say handwashing – you would be right!  It is easy to understand how handwashing can prevent disease transmission, but this wasn’t always the case.  In fact, it wasn’t until 1847 that handwashing was proven to prevent disease.  In the first study of its kind, Dr. Ignatz Semmelweis was able to demonstrate that puerperal fever, also called “childbed fever,” transmission could be greatly reduced from 13% to 2% by hand washing.  Over the years, hand washing has become standard practice to prevent many diseases. 

Two of the most common types of food-borne illnesses that can be prevented by handwashing are salmonella and E coli.  The Centers for Disease Control (CDC) estimate that every year about 76 million Americans will come down with and 5,000 Americans will die from a food-borne illness.  It is also possible to get the flu, common cold, gastrointestinal disorders and even hepatitis A from a hand that has not been washed after exposure. 

After all the research over the years and many public health campaigns to teach people why, how and when to wash their hands you would think that every American would wash their hands especially after using the toilet – right?  Wrong– a surprising number of Americans especially men don’t regularly wash their hands after using the toilet. 

A study conducted in 2007 by the American Society for Microbiology and The Soap and Detergent Association found that 92% Americans interviewed via the telephone self-reported that they washed in public restrooms.  But, as usual, direct observation paints a much different picture.   

In the direct observational part of the study, conducted in public restrooms in 4 cities – Atlanta, Chicago, New York City, and San Francisco – attendants were stationed in the restrooms to observe the hand washing habits of  6,076 adults who used the toilets.  The researchers found that 88% of women actually washed their hands compared to only 66% of men.  Breaking it down by city – Chicago was the best at handwashing with 81%, followed by New York City (79%), Atlanta (75%) and San Francisco (73%).

When to wash your hands:

•    After using the toilet
•    After changing a diaper
•    After petting or touching an animal or any animal waste
•    Before preparing food
•    Before and after handling raw meat, poultry or fish
•    Prior to eating
•    After blowing the nose
•    After coughing or sneezing into the hands
•    Before and after treating wounds or cuts
•    Before and after touching a person who is sick or injured
•    After handling garbage
•    Before touching the eyes, such as when inserting or removing contact lens
•    When using any public restroom
•    Whenever there is a risk of transmitting an illness

Soap and Water:

Use soap and water or an alcohol-based hand sanitizer.  Avoid or reduce the use of antibacterial soaps because overuse could potentially lead to the development of bacteria that are resistant to these cleaning agents.

•    Wash your hands thoroughly by rubbing hands and fingers together for at least 20 seconds – make sure that you get the backs of the hands, wrists, fingernails, and between the fingers.  In other words, make sure that the entire hand is rubbed, scrubbed and cleaned. (See illustration)
•    Rinse your hands in water
•    Dry your hands with a clean towel and use the same towel to turn off the faucet or open the door.  You can also use cloth towels and an automatic warm air hand dryer

 

 

Alcohol-based hand sanitizers that don’t require water:

•    Squeeze about ½ teaspoon into the palm of the hand
•    Rub your hands together to make sure all surfaces are covered

Use sanitizer that contains at least 60% alcohol.  Don’t forget to use hand moisturizer regularly since frequent hand washing can leave the hands dry and irritated.  

Sources:
•    Centers for Disease Control, and hand washing recommendations from the Mayo Clinic.
•    Illustration: La Crosse County, Wisconsin, Department of Health
http://www.co.la-crosse.wi.us/Health/Environmental/
Images/Handwashing/handwashing
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