Research & Treatment News
March 15, 2007
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While some chronic Hepatitis C patients maintain normal sexual function and a healthy interest in sex, many experience reduced libido, erectile dysfunction and diminished sexual satisfaction. Learn how Hepatitis C impacts the sex lives of both men and women and how opening up about these issues can help improve patients' quality of life.
by Nicole Cutler, L.Ac.
Hepatitis C is commonly accompanied by fatigue and depression, followed by a decreased interest in sex. Additionally, antiviral medications typically used to battle Hepatitis C may cause sexual dysfunction and decreased libido. Sexual dysfunction is the most frequently encountered side effect of many antidepressant medications used to treat the depression and anxiety associated with Hepatitis C combination treatment. When discontinued, the medication-induced sexual dysfunction typically vanishes. Due to its prevalence in chronic Hepatitis C patients, openly discussing sexual problems with a physician can help identify if the source is the disease, prescribed medications or some other condition.
Studies
Although no large-scale clinical trials have been conducted proving that the Hepatitis C virus (HCV) directly causes sexual dysfunction, many patients report an association between the two. The following two studies demonstrate a relationship between sexual dysfunction and Hepatitis C:
1. A study published in the June 2006 issue of American Journal of Gastroenterology investigated the prevalence of sexual dysfunction among men with chronic HCV infection and evaluated its impact on health-related quality of life. After evaluating 350 participants, researchers concluded “…Our study demonstrates a strong association between chronic HCV infection and sexual dysfunction among men in the United States. Men with chronic HCV infection had markedly reduced sexual function in all the five domains evaluated (sex drive, erectile function, ejaculation, sexual problem assessment and overall sexual satisfaction) compared to HCV-uninfected controls…”
2. A study published in the February 2005 edition of Journal of Endocrinology evaluated sexual dysfunction in men with chronic HCV on antiviral therapy. Researchers found that testosterone levels decreased significantly during antiviral therapy, closely correlating with decreased libido and sexual function. Additionally, depression increased during interferon therapy, a condition also associated with sexual dysfunction.
Hormone Changes
Hepatitis C infection also contributes to advanced liver disease which can alter levels of hormones. Approximately two percent of middle-aged men experience decreased sexual interest and erectile dysfunction. This percentage remains consistent both in men without liver disease and those in the early stages of liver disease. However, men with advanced liver disease are more likely to experience the following conditions related to changes in hormone levels:
· Testicular dysfunction
· Loss of body hair
· Gynecomastia (enlarged breasts)
· Redistribution of body fat
· A female configuration of pubic hair
· Decreased muscle mass
· Decreased sexual desire
· Erectile dysfunction
The male sex hormone (testosterone) is typically lowered with advanced liver disease, while the female sex hormone (estrogen) typically increases. Because alcohol abuse further lowers testosterone levels, alcoholic men with Hepatitis C who have progressed to advanced liver disease are particularly vulnerable to sexual dysfunction issues.
Women
Women with chronic Hepatitis C commonly complain of vaginal dryness, which typically results in decreased sexual interest. The majority of women with Hepatitis C who experience pain during intercourse, vaginal irritation, vaginal burning and itching are on interferon and ribavirin therapy. Discomfort may be severe when combined with atrophic vaginitis, a condition common when estrogen levels decline, such as in postmenopausal women. While a topical estrogen and progesterone cream can improve or alleviate the dryness, oral estrogen supplements should only be taken under a physician’s close supervision. Whether in the form of natural soy estrogen or oral estrogen supplements, estrogen supplementation carries the following risks to women with liver disease:
· Worsening jaundice
· Cholestasis
· Hepatitis
Regardless of your gender or whether or not you are undergoing combination therapy, living with Hepatitis C can spawn sexual dysfunction. Even though it is a subject that most of us prefer to avoid, speaking up on impaired sexual function or interest can prompt your physician to re-evaluate your liver management plan. Since a healthy sex life is one expression of physical, spiritual and emotional health, supporting this component can dramatically increase someone’s quality of life. By discussing this sensitive topic, people with Hepatitis C can get the help needed to reclaim this most basic part of being human.
References:
Jensen SB, Gluud C, Sexual dysfunction in men with alcoholic liver cirrhosis, Liver, April 1985.
M R Krauss, et al., Sexual dysfunction in males with chronic hepatitis C and antiviral
therapy: interferon-induced functional androgen deficiency or depression?, Journal of Endocrinology, February 2005.
www.liverdisease.com, Sex and Liver Disease, Melissa Palmer, MD, 2007.
www.natap.org, Sexual Dysfunction is Highly Prevalent Among Men with Chronic Hepatitis C Virus Infection and Negatively Impacts Health-Related Quality of Life, The American Journal of Gastroenterology, Ann Danoff, MD, et al, June 2006.
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Although most people with chronic Hepatitis C do not exhibit symptoms of the "silent" epidemic, a significant number will experience its impact in organs other than their liver. Learn how to recognize these lesser-known conditions to help in the early detection and treatment of Hepatitis C.
by Nicole Cutler, L.Ac.
Many people infected with the Hepatitis C virus have no symptoms. Even if the person has been infected with Hepatitis C for a long time, no symptoms of the disease may present themselves until cirrhosis has developed. When symptoms are present, they can range from mild to severe. The most common symptom of chronic Hepatitis C is fatigue. Additional common symptoms of Hepatitis C include:
· Intermittent abdominal pain
· Reduced appetite and weight loss
· Nausea or vomiting
· Depression
· Jaundice – yellowing of the skin or whites of the eyes
· Low-grade fever
· Muscle aches
· Pale or grey colored stool
· Dark urine
· Generalized itching
· Ascites
· Bleeding varices – dilated veins in the esophagus
Extrahepatic Manifestations
People with Hepatitis C may exhibit symptoms and signs of infection that manifest in organs other than the liver. Known as extrahepatic manifestations, or immune-complex mediated diseases, these symptoms arise from the immune system’s effort to fight off the infection. Chronic Hepatitis C infection leaves people vulnerable to the development of diseases involving the kidneys, the skin, eyes, joints, immune system and the nervous system. The occurrence of an extrahepatic manifestation does not correlate with the severity of the underlying liver disease. The following associated conditions are the most commonly seen as a result of liver disease:
1. Cryoglobulinemia – This condition is due to the presence of abnormal antibodies (called cryoglobulins) that come from Hepatitis C virus stimulation of lymphocytes (white blood cells). These antibodies can deposit in small blood vessels, thereby causing inflammation of the vessels (vasculitis) in tissues throughout the body. The skin, joints and kidneys (glomerulonephritis) are often targets of the vasculitis.
People with cryoglobulinemia can present a variety of symptoms, including weakness, joint pain or swelling (arthralgia or arthritis), and a raised, purple skin rash (palpable purpura) usually in the lower portion of the legs. As well, people may experience swelling of the legs and feet due to loss of protein in the urine from the kidney involvement and nerve pain (neuropathy). What is more, this vascular condition can spawn Raynaud’s phenomenon, in which the fingers and toes turn color (white, then purple, then red) and become painful in cold temperatures.
2. B-cell non-Hodgkin's lymphoma – This cancer of the lymph tissue is associated with the chronic Hepatitis C virus. Its cause is believed to be excessive stimulation by the Hepatitis C virus of B-lymphocytes, resulting in the abnormal reproduction of the lymphocytes. Most individuals with Hepatitis C virus-associated non-Hodgkin’s lymphoma will require standard anti-cancer therapies.
3. Porphyria cutanea tarda (PCT) – PCT is a skin condition characterized by the overproduction of enzymes involved in the manufacturing of blood. People with PCT often have blisters and vesicles form on the back of the hands, forearms and neck, as well as the face. Lesions develop in areas exposed to the sun or have sustained minor trauma. Increased facial hair and pigmentation changes are also common. Major risk factors for the development of PCT include excessive iron exposure, heavy alcohol use, and the use of estrogens.
4. Lichen planus – A skin condition, Lichen planus appears as shiny, flat-topped bumps that often have an angular shape. This rash can occur anywhere on the skin, but often favors the inside of the wrists and ankles, the lower legs, back and neck. The mouth, genital region, hair and nails are affected in some individuals. Thick patches may occur, especially on the shins. About 20 percent of those affected with lichen planus of the skin experience minimal symptoms and need no treatment. However, in many cases the itching can be constant and intense.
5. Diabetes mellitus – An increasingly common metabolic disorder, diabetes mellitus is characterized by resistance to insulin, the hormone that regulates the amount of sugar in your blood. The accompaniment of Hepatitis C with diabetes is strongly associated with advanced liver fibrosis or cirrhosis. People with cirrhosis are believed to have decreased hepatic uptake of glucose, along with reduced hepatic clearance of insulin, leading to high levels of insulin and, therefore, insulin resistance syndrome.
Other conditions noted to be associated with Hepatitis C infection, include:
· Thyroid disease
· Kidney disease, especially Membranoproliferative Glomerulonephritis (MPGN)
· Vitiligo
· Arthritis
· Sjogren’s syndrome
· Mooren’s ulcer
· Neuropathy
While Hepatitis C is perceived as a virus attacking only the liver, clinical practice proves that its ramifications extend beyond solitary hepatic involvement. Perhaps due to the liver’s involvement in nearly every aspect of health, Hepatitis C is a systemic problem. The wide range of possible manifestations of this virus should signal increased public education for earlier diagnosis and treatment of Hepatitis C. Additionally, understanding the commonality between conditions associated with Hepatitis C can help a person suffering with multiple ailments recognize the likely origin of their extrahepatic manifestations.
References:
www.aocd.org, Lichen Planus, American Osteopathic College of Dermatology, 2006.
www.ccjm.org, Hepatitis C Infection: A Systemic Disease with extrahepatic manifestations, Aman Ali, MD, Nizar N Zein MD, Cleveland Clinic Journal of Medicine, November 2005.
www.hcvadvocate.org, Extrahepatic Manifestations of Chronic Hepatitis C, Roderick Remoroza, MD, Herbert Bonkovsky, MD, Hepatitis C Support Project, 2003.
www.idph.state.il.us, Health Beat: Hepatitis C, Illinois Department of Public Health, 2006.
www.medicinenet.com, What Conditions Outside the Liver are Associated with Hepatitis C?, Tse-Ling Fong, MD, MedicineNet, Inc, 2006.
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The percentage of liver transplant patients who experience Hepatitis C recurrence is extremely high. The Mayo Clinic Transplant Center is currently conducting research on Civacir, a potential drug therapy that could inhibit the return of HCV.
www.allamericanpatriots.com
Mayo Clinic Tests New Drug to Prevent Hepatitis C Recurrence after Liver Transplant
March 08, 2007 -- ROCHESTER, Minn. -- The Mayo Clinic Transplant Center is studying whether Hepatitis C Immune Globulin (Human), an investigational drug candidate known as Civacir, prevents the recurrence of hepatitis C-related liver disease in liver transplant patients.
Mayo Clinic sites in Arizona, Florida and Minnesota are looking for adults to participate in this study. Eligible participants must have hepatitis C and need a liver transplant. Individuals who have liver cancer may participate.
Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). Each year approximately 6,000 liver transplants are performed in the United States, and more than 2,000 of those are due to HCV. There are no approved or effective treatments for HCV-positive liver transplant patients or patients who receive HCV-positive livers.
"The clinical need for hepatitis C prevention in liver transplant patients is great," says Michael Charlton, M.D., medical director of the liver transplant program at Mayo Clinic's campus in Rochester, Minn. "HCV recurrence for liver transplant patients is nearly 100 percent. Five years after transplantation, one-third of re-infected patients either pass away, get re-transplanted or experience cirrhosis from HCV."
Civacir is a human-pooled antibody product created from blood and serum donated by individuals who have HCV antibodies. The idea for this potential therapy for hepatitis C came from an unexpected result of a similar human antibody drug for hepatitis B, known as HBIG.
"Prior to the discovery of hepatitis C in 1988, HBIG unknowingly included hepatitis C antibodies," says Dr. Charlton. "A retrospective study of approximately 200 patients who received HBIG found that in addition to preventing hepatitis B, it also prevented hepatitis C in about half of the cases."
The Mayo Clinic study will test whether Civacir can prevent HCV recurrence after liver transplant.
More than 400 patients receive liver transplants at Mayo Clinic's three sites each year. Mayo Clinic is the most experienced liver transplant center in the nation, with some of the highest survival rates in the world.
For more information on eligibility requirements and the screening process for this study, contact Kristin Eggebraaten, Mayo Clinic liver transplant referral coordinator at 1-507-538-5908.
Civacir is a product of NABI Biopharmaceuticals and Kedrion S.p.A.
Source: Mayo Clinic
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March 12, 2007
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Preliminary results assessing Pharmasset's R7128 treatment for Hepatitis C genotype 1 are encouraging. This well-tolerated polymerase inhibitor will now be evaluated on an ascending dose schedule. Due to current therapies for genotype 1 having a low HCV eradication rate, R7128's development is worthy of attention.
Pharmasset Initiates Multiple Ascending Dose Study of R7128 in Patients Chronically Infected With HCV Genotype 1
PR Newswire Europe (inc. UK Disclose) - Feb. 28, 2007
PRINCETON, New Jersey, February 28 /PRNewswire/ --
http://www.therapeuticsdaily.com
Pharmasset initiated the multiple ascending dose portion of an on-going Phase 1 clinical trial evaluating R7128 in up to 40 patients chronically infected with hepatitis C virus (HCV) genotype 1. The primary objective of this part of the study, being conducted in collaboration with Roche, is to assess the safety, tolerability and pharmacokinetics of multiple doses of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy of R7128 by measuring the decrease in HCV viral load. As a result of the initiation of the multiple ascending dose portion of this study, Pharmasset triggered a US$5.0 million milestone payment from Roche.
Pharmasset and Roche recently completed part 1 of this Phase 1 study in 38 healthy volunteers who received single ascending doses of R7128. The effect of food on R7128 was also assessed. Preliminary data from the single ascending dose portion of the study indicate:
- All doses of R7128 studied were generally well-tolerated.
- All patients completed the study, and none experienced gastrointestinal adverse events or serious adverse events during the study.
- No hematological or laboratory abnormalities of clinical significance were noted.
The preliminary safety and pharmacokinetic data from part 1 of the study supported progression of R7128 into part 2 of the study in patients chronically infected with HCV genotype 1.
About R7128
R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated excellent potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase I clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This study is comprised of two parts:
- Part 1 is a single ascending dose study being conducted in up to 38
healthy volunteers. The primary objective of Part 1 is to assess the
safety, tolerability and pharmacokinetics of R7128 following single
ascending doses under fasting conditions. The secondary objective of
Part 1 is to explore the effect of food on the pharmacokinetics of
R7128.
- Part 2 is a multiple ascending dose study being conducted in up to 40 patients chronically infected with HCV genotype 1. The primary
objective of Part 2 is to assess the safety, tolerability and
pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy by
measuring the decrease in HCV viral load.
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