Re: Re: Medscape/Pegasys - HCV Treatment Therapy

[Guest guest]

Hi, About the interferon/ribaviran tx. when Jeff started the program, his Dr. gave him 10% chance of clearing , since he was on the suppressant drugs. He reads all the literature that comes with the medicine. Some of the side effects are death. Pretty bad in a way, but, he takes the drugs because he has too, his regular Dr. knows all meds. he is on. which means if he has too give him something for his thyroid, he knows what he is taking. I would say make sure you get a Dr. that you are comfortable with, knows what you are taking, and wants to help you if you develope something else down the way. Sue

Subject: Re: Medscape/Pegasys - HCV Treatment TherapyTo: hepatitiscsupportgroupfordummies Date: Wednesday, November 5, 2008, 11:49 PM

Yes it is all very confusing and by whom and by the #'s stats are just #'s easily manipulated to 1's favor and from whom done by whom. Is stats from reliable controlled non-biased medical research with strict controls or from co's in the industry for profit of medical products.

Are Dr's and their practice of medicine for pt's guided by their medical education and keeping up to date on all the latest medical research and developments more reliable controlled trials by medical non-biased means - following the natural medical history pattern progressions of a disease as in HCV/Liver disease or relying on stats and #'s from independent or for profit co's and the drug reps.

Our Dr's are trying their best and the interferon/ribaviri n on the market or us in trials is all they have to offer us as this time until new forms of tx probably inhibitors hit the market.

Everyday you can pull up different stats #'s and conflicting with each other or in complete opposite of each other. How many bad stats reports have we seen from these same pharm. co's.

The specific wording is very well carefully done. Showed improvement - efficiency - define this in more specif terms in late cirrhosis stages or decompensated - was the stats non-bias done by whom using a wide variety large # of pt's in late cirrhosis stages - geno's etc........

There are no long term medical studies stats on HCV pt's based on the new forms of interferon and ribavirin tx's and for pt's in late cirrhosis decompensated stages. It is too early and we are in the forefront of these studies and medical practices.

If you noticed that info was from the pharm. co and in very small print - Information from Industry - from their site.

All tx's on the market are all interferon alpha A - B combo's under brand or generic names. Ribavirin the pills the same. Pegasys is short for Peg interferon 2a and because it is pegylated in the form of a slower release drug.

We need to ask our Dr's specific ?'s for us for our stage/grade and their honest medical outcomes per pt's similar to us in stage/grade and based on what and what medical findings. What are my own risk factors ?????

HCV tx meds are very powerful and toxic meds and pt's should be under very careful and strict follow-up and testings preferable from Hep Dr's familiar and trained in that field.

Also per FDA rulings - Safety - Warnings - Contraindications were also posted.

How many of us on tx have read or were told it all know the safety - warnings - contraindications what severe complications to look for report to our Dr's ASAP and more listed with complete drug instructions sheets.

Hepatic = liver

CHC = Chronic Hep C

Deb

Important Safety Information for PEGASYS® (Peginterferon alpha-2a) for Injection

PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy). PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

Alpha interferons, including PEGASYS® (Peginterferon alfa-2a), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information) .

Use with Ribavirin. Ribavirin, including COPEGUS®, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information) .

CONTRAINDICATIONS

PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity

to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).

Exacerbations of hepatitis during hepatitis B therapy are not uncommon and are characterized by transient and potentially severe increases in serum ALT. Patients experiencing ALT flares should receive more frequent monitoring of liver function. PEGASYS dose reduction should be considered in patients experiencing transaminase flares. If ALT increases are progressive despite reduction of PEGASYS dose or are accompanied by increased bilirubin or evidence of hepatic decompensation, PEGASYS should be immediately discontinued.

ADDITIONAL SAFETY CONCERNS

Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients’ clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score ≥6) is observed. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS. Events occurred in patients with few or no reported risk factors for stroke,

including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish.

INCIDENCE OF ADVERSE EVENTS

The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/ anxiety/nervousn ess (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection-site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%). The adverse event profile of coinfected patients treated with PEGASYS and COPEGUS was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%) and mood alteration (9%). In clinical trials of 48-week treatment duration, the adverse event profile of PEGASYS in chronic hepatitis B was similar to that seen in chronic hepatitis C PEGASYS monotherapy use,

except for exacerbations of hepatitis. The most common adverse events reported for PEGASYS, observed in clinical studies, were pyrexia (54%), headache (27%), myalgia (26%), fatigue (24%), alopecia (18%) and anorexia (16%).

Serious adverse events in hepatitis B and hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt, suicide, psychotic disorder and hallucinations) , serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis) , endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis) , colitis (ulcerative and hemorrhagic/ ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of

vision, retinopathy including macular edema and retinal thrombosis/hemorrha ges, optic neuritis and papilledema) . Adverse reactions reported during post-approval use of PEGASYS therapy, with and without ribavirin, include hearing impairment, hearing loss, serious skin reactions, including erythema multiforme major, and infections (bacterial, viral and fungal).

Please see complete Prescribing Information.

References

Osterberg L et al. Adherence to medication. N Engl J Med. 2005;353(5): 487-497.

Ammassari A, Trotta MP, Murri R, Castelli F, et al. Correlates and Predictors of Adherence to Highly Active Antiretroviral Therapy: Overview of Published Literature. JAIDS. 2002;31:S123- S127.

Stone VE et al. Antiretroviral regimen complexity, self-reported adherence, and HIV patients’ understanding of their regimens: survey of women in the HER study. J Acquir Immune Defic Syndr. 2001;28(2):124- 131.

PEGASYS [Package Insert], Hoffmann-La Roche, Inc. Nutley, New Jersey. January 2004.

Janisch HD et al. Economic evaluation of standard-therapy (ST) for chronic hepatitis C (CHC) with peginterferon alfa-2a (40KD) plus ribavirin versus pegylated interferon alfa-2b (12KD) plus ribavirin: ready-to-use syringe (SYR) versus injector (INJ) (SPRINT). Presented at: 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); November 11-15, 2005; San Francisco, CA.