Comparison of the long-term effects of treatment with oral and parenteral interferon alpha in chronic viral hepatitis patients.

This report presents the interferon alpha (IFN-alpha) treatment results for 75 patients with chronic hepatitis B virus (HBV) (51 cases) and hepatitis C virus (HCV) (24 cases) induced hepatitis in maximal 61 months follow-up. Among the group of 51 patients with chronic HBV hepatitis, 35 were treated orally with IFN-alpha in the form of lozenges in low daily doses (37.5-150 U). The treatment was completed in 32 cases. The remaining 16 patients with chronic HBV hepatitis completed the treatment with parenteral IFN-alpha (3 x 10(6) U, 3 times a week). Positive results measured by the use of seroconversion in the HBe-antigen system were obtained for 68.7% (5-61 months follow-up) and 56.2% (7-44 months follow-up) of the patients treated with oral and parenteral IFN-alpha, respectively. Among the group of 24 patients with chronic HCV hepatitis, the first 6 patients were initially treated with IFN-alpha in the form of lozenges, in low daily doses. Biochemical remission was not achieved in these patients; genotype 1b was documented in 4 of them. Both, the first 6 patients (after a break) and the remaining 18 were treated with IFN-alpha parenterally, as in HBV patients. Temporary clinical and biochemical remission was achieved in 62.5% of the cases during the treatment, however the durable remission observed during 6-29 months of follow-up was achieved in 20.4 of the cases only.

Treatment of six patients with chronic active HCV hepatitis, with low dose natural human interferon alpha administered orally.

Following the widely accepted therapeutic standard of treatment of HCV infection with parenteral interferon alpha, and encouraged by the author's won good experience with orally administered natural human interferon alpha in low doses (leuHuIFN alpha (ldou)), applied to chronic active HBV hepatitis patients, this form of interferon was given to six randomly selected HCV infected patients (2 women, 4 men) aged 34-62 years. The diagnosis was made based on a clinical and histological evaluation and confirmed by anti-HCV antibodies detection. In 2 out of 6 patients, leuHuIFN alpha (ldou) was employed immediately after steroid discontinuation. Patients were instructed to take one lozenge daily, in the morning, on an empty stomach, and keep it in the mouth until fully dissolved. Observation period varies from 19 to 69 weeks. In 3 patients the therapy concluded, after 19, 61 and 62 weeks, respectively. One patient after 4 weeks of treatment reported increasingly troublesome small joints pain and swelling, which forced leuHuIFN alpha (ldou) discontinuation after 19 weeks. In no patient transaminases normalization was seen during treatment; biochemical and clinical remission after the drug discontinuation was observed in only one patient, in whom the treatment was interrupted due to articular adverse symptoms. With HCV RNA levels assessment being unavailable at the moment, the treatment impact on the virus replication remains difficult to evaluate objectively. The treatment was well tolerated. All patients stressed significant increase of drive and appetite as well as improvement of the exercise tolerance.

Treatment of fourteen chronic active HBsAg+, HBeAg+ hepatitis patients with low dose natural human interferon alpha administered orally.

The therapy concept is based on a theory of the immunocorrective effect of orally administered natural human interferon alpha in low doses (leuHuIFN alpha (ldou)), manifolded by the logistic amplification system seated in the oral cavity. Fourteen randomly selected patients with chronic active type B hepatitis, aged 7-59 years, were assigned to treatment. All the patients had been treated for several months to several years with steroids, with no beneficial effect--clinical and biochemical symptoms of active liver disease, with histopathological progression (up to liver cirrhosis) had been permanently present. Treatment with leuHuIFN alpha (ldou) (doses: 50-100 U daily) was introduced immediately after the immunosuppression (steroids, steroids+azathioprine) discontinuation, and its influence on the course of the disease was monitored by means of hematological and biochemical tests, humoral and cellular immune response parameters, serological markers of HBV infection, HBV DNA concentration and immunohistochemical evaluation of liver biopsy specimens. The observation period ranges from 15 to 32 months. In all patients, within the first 3-6 weeks of treatment, transient deterioration of biochemical liver function tests was noted (e.g. 2-3 fold increase of ALAT), with no clinical symptoms of the disease exacerbation. The phenomenon lasted for 4-16 weeks. In all the treated patients, intensive immune system activation was seen, which lasted beyond the therapy period. Seven patients eliminated serum HBV DNA; all of them also eliminated HBeAg and seroconverted to HBeAb. Up to date, one person have lost serum HBsAg, in nine others its titre decreased significantly.

Behaviour of chosen acute phase proteins in acute viral type B hepatitis as a predictive factor of further evolution of the infection.

The study was aimed at the assessment of the immune system function of a large group of patients with early phase of acute viral type B hepatitis, who were subsequently follow-up in order to select those developing chronic forms of the infection. It was assumed that re-assessment of their initial immunological status with regard to further evolution of the infection would show some factors predictive of chronic active hepatitis development. Chosen immunological parameters: circulating blood lymphocyte sets and subsets, immunoglobulin concentrations, presence of non-specific immune complexes and concentrations of randomly chosen acute phase proteins (ceruloplasmin, transferrin, haptoglobin, alpha-acid glycoprotein, C3 and C4 complement components) were evaluated in 104 acute viral type B hepatitis patients, aged 18-50, on the days 8, 10, 15, 30, 40, 60, 80 and 130 of the illness. After mean of 744 days, 56 patients reported to final follow-up examination, 15 of whom presented with symptoms of chronic sequelae of acute HBV infection (elimination phase of chronic aggressive hepatitis, chronic persistent hepatitis, or integration phase of HBV infection). Behaviour of cellular immunity parameters, immunoglobulin concentrations, presence of immune complexes or non-specific antibodies, however varied in individual patients, showed no correlation predictive of chronic sequelae of the infection. Significant differences between patients who subsequently developed chronic active or chronic persistent hepatitis were found, however, with regard to all the acute phase proteins tested, most prominent in case of C3 and C4 complement components, haptoglobin, transferrin and ceruloplasmin.(ABSTRACT TRUNCATED AT 250 WORDS)

[Preliminary results of the treatment of patients with chronic active hepatitis (CAH) HBsAg+,HBeAg+ with low oral doses of human interferon-alpha]. / Wstepne wyniki leczenia chorych z przewleklym czynnym zapaleniem watroby (p. c. z. w.) HBsAg+, HBeAg+ niskimi doustnymi dawkami ludzkiego interferonu alfa.

The treatment conception was based on the theory of immunocorrective activity function of low doses of human interferon alpha (HuIFN alpha) multi-played by logistic amplifier system included in oral cavity. Twelve patients with chronic hepatitis, HBV infected, aged 7-59, were randomly chosen for treatment. Previously they underwent immunosuppression without success. All of them revealed clinical and biochemical symptoms of steel active disease with morphological progression including active cirrhosis (3 cases). HuIFN alpha therapy was started just after withdrawal of immunosuppression (steroids, steroids and azathioprine). Effects of 50-100 U/d dose of HUIFN alpha were monitored by examination of hematological, biochemical parametres and indicators of humoral and cellular immune response and HBV markers in control liver biopsy specimens too. The HBVDNA serum level was measured besides, using the method of molecular hybridisation. Observation period is from 5 to 17 month, now. Among all patients during 1-2 months from the treatment beginning, transient increase of biochemical parametres of liver function (f. ex: 2-3 times ALAT increase) were observed without any clinical signs of disease exacerbation. All patients revealed immune system activation that lasted longer than incipiens intensive stimulation. Four from twelve patients that finished therapy, eliminated HBVDNA from blood serum. One of them eliminated HBsAg too. Three further confirmed decrease of HBsAg with e system seroconversion. Three from 8 patients treated 6-9 months reveal decrease of HBVDNA concentration in blood serum.

[HBV, HCV and HIV infections among drug addicts-residents of rehabilitation and social adjustment centers in the Gdansk district]. / Zakazenie HBV, HCV i HIV wsród narkomanów, mieszkanców osrodków rehabilitacji i resocjalizacji w województwie gdanskim.

Among 46 i.v. drug abusers we revealed HBV infection in 36, presence of anti-HCV antibodies in 33, and HIV infection in 21. Prevalence of HBV markers and anti-HCV antibodies increased with a period of time of i.v. drug abuse. The course of HBV and HCV infection was often subclinical. IgG levels turned out to be higher in HBV infected persons, with or without HIV infection.