Lege Artis Medicinae

[Efficacy of peginterferon alfa-2a and -2b plus ribavirin in the routine treatment of patients with chronic hepatitis C]

TUSNÁDI Anna, SZABÓ Anna

JANUARY 27, 2009

Lege Artis Medicinae - 2009;19(01)

[INTRODUCTION - Combination of peginterferon plus ribavirin is the standard treatment for chronic hepatitis C virus (HCV) infection. Two types of peginterferon are available. The aim of this retrospective study was to find out whether the choice of peginterferon influenced the patient’s chance of recovery. PATIENTS AND METHODS - Between 2004 and 2007, 142 patients with HCV genotype 1 hepatitis with or without cirrhosis (107 treatmentnaive, 35 previously treated) were treated with 180 ug/week peginterferon alfa-2a (Group A) or 1.5 ug/kg/week peginterferon alfa-2b (Group B) plus ribavirin. Examination and treatment of patients followed the rules of the national guideline. Patients were not randomized in any way. Group A consisted of 78 patients and Group B included 64 patients. Eight patients dropped out for various reasons (5 from Group A, 3 from Group B). There was no statistically significant difference in the baseline characteristics and the cumulative doses of the drugs between Group A and B, so the treatment results were comparable. RESULTS - Sustained virological response (undetectable HCV ribonucleic acid serum levels 24 weeks after the end of treatment) occurred in 42.5% of patients from Group A and 37.7% from Group B. When focusing on treatment-naive patients only, sustained virological response was found in 48.2% of patients in Group A and 46.7% in Group B. Result of the treatment was better if the patient was treatment-naive, if there was no cirrhosis, and if early virological response at 12 weeks was achieved. CONCLUSION - Patients treated with peginterferon alfa-2a plus ribavirin achieved sustained virological response at a higher rate than those with peginterferon alfa-2b plus ribavirin, however, the difference was not statistically significant.]

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[Relationships in recovery, recovery in relationships]

SZABÓ József, GEREVICH József

[INTRODUCTION - Some of the recent researches based on analyses of autobiographies pointed out, that the quality and the quantity of our social relations are in connection with our life longevity, and the frequency of words referring social roles and integration gives a respective measurement possibility of it. Conception of the term “social words” had been introduced. The influence of the degree of social support to the recovery from alcohol addiction is also a well-known phenomenon. Based on the above we supposed that examining their autobiography vocabularies we find special differences which can show the distinction between the social support of the relapsed and recovering addicted persons. We planned to prove the being of these special differences via revealing bias of the frequency and pattern of social word usage. PATIENTS AND METHODS - Two separate groups were created for purpose of the examination. The first consisted of relapsed alcohol dependent persons, who were treated in hospital (department of addiction psychiatry) diagnosed alcohol-dependent (F 10.2) (and nothing else) at least twice within a year (N=30). We chose earlier treated (because of alcohol-dependency, and nothing else mental disease) persons who had been being abstinent for at least 2 years into the second group (N=20). Beside the earlier diagnosis we used the parts of the ASI test to sreen any other mental diseases. We created similar groups with regards to gender, age and qualification. We collected autobiographies from the persons, and made two common documents of them. Afterwards we compared these documents by the Atlas.ti 5.0 (trial free version) content analysing software. We defined the frequency of the found social words in the rate of these words and the sum of the words in the whole text. We found the most prominent difference between the frequency of social words referring to the family and relatives, opposite the words dealing with friendship. RESULTS - In the latter case we could not detect any difference between the two groups. We got results confirming our hypothesis in the frequency of such words as “help”, “love”, “give” and “get”. We experienced in connection with the pattern that the words referring to social organisations, for example “team”, “community”, “company”, “club”, “meeting”, “collective” and the word “guest” practically did not appear (R<0.001) in the texts of relapsed persons, while they could be detected in the case of the recovering group (R=0.023). We did khisquare test to compare the frequency in the mentioned categories and we experienced significant differences between the social word usage of the two groups. CONCLUSION - Our results confirmed that the recovery from alcohol addiction was related to the quality and quantity of person's social relations, what we can get relevant information from the frequency of social words in the autobiographies about, so the high frequency of the social words can be considered as a good predictor of recovery.]

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[TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C, USING PEGYLATED INTERFERON ALFA-2A AND RIBAVIRIN - THE FIRST EXPERIENCES IN HUNGARY BASED UPON A MULTICENTRIC, OPEN, PROSPECTIVE STUDY]

TORNAI István, DALMI Lajos, GERVAIN Judit, HORVÁTH Gábor, NAGY István, NEMESÁNSZKY Elemér, RIBICZEY Pál, TELEGDY László, VÁRKONYI Tibor, WERLING Klára

[INTRODUCTION - The treatment of patients with hepatitis C virus infection is one of the most challenging tasks in hepatology nowadays. PATIENTS AND METHODS - Between 2001 and 2004, during a phase III, prospective, multicentric, international open trial 69 patients (35 naive and 34 non-responder or relapser) with chronic hepatitis C were treated, using 180 μg pegylated interferon alfa-2a once weekly and 800-1200 mg daily ribavirin. The inclusion and exclusion criteria were the same as in the normal daily practice. Five patients were treated for 24 weeks and 54 were treated for 48 weeks. The treatment was stopped in 10 additional patients. Sustained virological response was the main end-point of the trial, after 24 weeks of follow-up. RESULTS - The mean age of the patients was 46 years. In all the patients virus genotype 1 could be detected. In none of the patients, treated for 24 weeks, sustained remission could be obtained. In patients, treated for 48 weeks, the overall sustained virological remission was 48%. The outcome of the treatment was better, if the patient was naive to the treatment, could receive the full dosage of drugs and had no liver cirrhosis. The best result could be obtained if the patient was naive to the therapy and younger than age 40. Viral load, however, did not show any effect on viral remission in our patients. At week 24, a negative HCV RNA had a positive predictive value of 68%, while a positive virus test had a negative predictive value of 93%, regarding sustained remission. CONCLUSION - Considering the high rate of genotype 1, pegylated interferon alfa-2a and ribavirin proved to be a very effective therapy in Hungarian chronic hepatitis C patients.]

Lege Artis Medicinae

[Successful treatment of chronic hepatitis C infection accompanied by rare but reversible adverse effects]

ERŐSS Bálint Mihály, NEMESÁNSZKY Elemér

[INTRODUCTION - In absence of signs and symptoms characteristic of chronic hepatic disease caused by hepatitis C viral infection, its diagnosis is generally suggested by abnormal liver function tests. If viral serological activity is confirmed, combined antiviral treatment (pegylated interferon plus ribavirin) has to be considered. Antiviral treatment is accompanied by several, usually reversible adverse effects. CASE REPORT - The 62 year-old woman has had waveringly abnormal liver function results for decades. Her anamnesis included transfusions for polytraumatization that resulted in a hepatitis C virus infection. We started treatment with interferon alpha-2a plus ribavirin. At week 4 of therapy, a significant decrease in virulence and at week 12, viral negativity was confirmed, accompanied by a normalization of hepatic function markers. Because of a gradually developing anemia, beginning from month 4, the former optimal dose of ribavirin had to be reduced. At the end of week 42, severe dermatitis with fever, muscle weakness and malaise (Sweetsyndrome) developed, and antiviral therapy had to be discontinued and steroids had to be given. During a short travel abroad, the patient suffered a collaptiform episode caused by extremely high blood glucose (28.0 mmol/l). She received temporarily fractioned insulin and then combined oral antidiabetic treatment. Then, dermatosis symptoms rapidly resolved, glycemic status gradually improved, and could be controlled by low-dose metformin. Liver function tests were normal. At the end of antiretroviral treatment and 6 months later, HCV-RNA by PCR proved negative, meaning that hepatitis C virus has been eradicated successfully. CONCLUSION - Treatment with pegylated interferon alpha-2a plus ribavirin rendered viral replication undetectable at 3 months, which is - together with the normalization of abnormal liver function tests - the strongest predictor of a good outcome. The patient’s exemplary good compliance contributed to successful treatment of hepatitis C and control of these rare but reversible adverse effects.]

Lege Artis Medicinae

[THE SAFETY OF TREATMENT WITH PEGYLATED INTERFERON-ALPHA-2A AND RIBAVIRIN IN PATIENTS WITH CHRONIC HEPATITIS C INFECTION, BASED ON HUNGARIAN EXPERIENCE]

WERLING Klára, DALMI Lajos, GERVAIN Judit, HORVÁTH Gábor, NAGY István, NEMESÁNSZKY Elemér, RIBICZEY Pál, TELEGDY László, VARGA Márta, TORNAI István, TULASSAY Zsolt

[INTRODUCTION - Adverse effects of treatment for chronic C virus hepatitis present an important problem both for the patient and the clinician. The reduction of drug doses or the suspension of therapy lessen the likelihood of recovery. PATIENTS, METHODS - Between 2001 and 2004, 66 patients with chronic hepatitis C received 180 μg pegylated interferon-alpha-2a per week and 800-1200 mg ribavirin per day, 6 of whom for 24 weeks and 60 patients for 48 weeks. During treatment, patients were closely followed in order to recognize any adverse effects early. RESULTS - Of the patients treated for 48 weeks, 48.3% developed adverse effects, with changes in the differential in 41.7%, and anaemia, low platelet count, neutropenia in similar rates. Further side effects included cardiac complications, skin symptoms, persisting high fever, autoimmune thyroiditis and liver failure, altogether in 9 cases. Dose reduction or temporary suspension of pegylated interferon-alpha-2a was necessary in 21 cases (31.7%), while complete cessation of this treatment was decided in 7 cases, most of them because of blood count changes. The 1000 to 1200 mg per day ribavirin had to be reduced in 30.8% of patients, while treatment was stopped in 3 cases. Long-term virological remission occurred in 48% of patients who received treatment for 48 weeks, whereas no such result was observed among any of those treated for 24 weeks. CONCLUSION - Adverse effects of variable severity developed in nearly half of the patients with chronic hepatitis C infection who received antiviral treatment for 48 weeks, but treatment had to be stopped in only a small proportion of this group. Early treatment of adverse effects can prevent the need to cease therapy and may improve its efficiency.]

Lege Artis Medicinae

[Treatment of hungarian chronic hepatitis C genotype 1 patients with severe fibrosis or compensated cirrhosis in the international telaprevir Early Access Program: Interim analysis of the week 16 results]

TORNAI István, BÁNYAI Tivadar, GERVAIN Judit, HORVÁTH Gábor, MAKARA Mihály, MARTYIN Tibor, NEMES Zsuzsanna, PÁR Alajos, PÁR Gabriella, PÉTERFI Zoltán, SZALAY Ferenc, SZINKU Zsolt, TÓTH Tamás, VINCZE Áron, ISABELLE Lonj

[The approval of the first two direct acting antiviral agents, boceprevir and telaprevir, has been a major step forward in the treatment of chronic hepatitis C. Both protease inhibitors must be added to the dual peginterferon and ribavirin combination therapy. The triple combination therapy resulted in significantly higher rates of recovery both in naive patients and in those previously unresponsive to therapy. Following the approval of telaprevir, an Early Access Program has been initiated in 16 countries. In Hungary 132 patients were enrolled into this program. In the first interim analysis, data from the first 16 weeks of treatment of 92 patients are included. Liver cirrhosis (F4) was detected in 70% of the patients and severe fibrosis (F3) was found in the other 30%, on the basis of either liver biopsy or transient elastography. During their previous antiviral treatment, 64% of the patients were non-responders (partial and nullresponders), 26% were relapsers, and only 10% were treatment naives. The efficacy of the triple combination was excellent, as 82% of the patients had undetectable HCV RNA at week 12. Further - more, 48% had negative HCV RNA at week 4 as well as at week 12. Cessation of i.e. negative HCV RNA at week 4 through week 12. Only 5.4% of the patients had virologic failure and needed to stop therapy prematurely. The most frequent adverse event was anemia, hemoglobin level decreased below 100 g/l in 40% of the patients. In the majority of these patients ribavirin dose reduction was sufficient to treat anemia, only 16% needed blood transfusion. The rate of severe rash was 6%. Although this group of patients represents a difficult-to-treat population, both efficacy and safety data are similar to published data in international clinical trials. A very effective, triple combination therapy with telaprevir, peginterferon and ribavirin can be provided for patients with advanced liver disease, to reduce the risk of liver failure and hepatocellular carcinoma.]

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[TREATMENT APPROACHES OF CHRONIC HEPATITIS B IN HUNGARY]

TORNAI István, NEMESÁNSZKY Elemér

[Today, there are less patients with active chronic hepatitis B requiring treatment than patients with chronic hepatitis C. However, the course and outcome of chronic hepatitis B is usually more severe, therefore, the disease has not lost importance. The most dangerous risks are the development of liver cirrhosis and hepatocellular carcinoma. The disease may present in various forms. Symptom-free carriers only need follow-up and hepatologic care. In the active stages with elevated liver enzymes and high level of viral nucleic acid (either HBeAg negative or positive), however, antiviral treatment is strongly indicated. There are two main forms of treatment. Alfa-interferon-based therapy, which is applied for a defined period of time, has a direct antiviral and immunomodulatory effect, but has several adverse effects. Long-term nucleoside analogue treatment represent the other treatment modality. These drugs are administered orally, have minimal side effects, but after some time resistant mutants may develop. Traditional interferon has recently been replaced by pegylated interferon alfa-2a with much better pharmacokinetic properties. Lamivudine has been in use for the longest time of the nucleoside analogues. Its efficacy is high, but after 3 to 4 years of treatment, resistant mutants appear in about 70% of cases. Of the most recent compounds, adefovir dipivoxil has recently become available in Hungary; it is primarily recommended in cases with lamivudine resistant mutants. There are promising new drugs in the stages of clinical trial; of these, entecavir has already been approved in the United States.]