Natural interferon alpha(BioPharm Solutions, Inc.)

The aim of the study was to evaluate the efficacy and safety of combined treatment with natural leukocyte interferon alpha (Alfaferone) plus ribavirin in patients with HCV-related cirrhosis.

Twenty-three patients (15 women, 8 men) aged 17-68 years hospitalized in 2005-2008 were included in the study. Seventeen patients who qualified for treatment were Child-Pugh class A patients and 6 others were class B. Seventeen patients had genotype 1b and 6 genotype 3a infection. Thirteen patients were naïve, retherapy concerned 8 patients, and in two cases the continuation of treatment had been stopped because of adverse events following the use of pegylated interferons. The treatment was continued for 48 weeks regardless of HCV genotype. Normalized AlAT activity (<40 U/l) was the measure of biochemical efficacy of the treatment, while virological efficacy was reflected by an undetectable viral load in plasma. Both measurements were conducted immediately after the end of treatment (EOT) and after a 6-month follow-up period (SVR). Therapeutic safety was evaluated by the monitoring of the adverse events of the treatment.

Abnormal AlAT levels prior to treatment were detected in 20/23 patients. During therapy normalized levels were achieved in 50% of them, and after 6 months they were sustained in 9/20. EOT was achieved in 6/19 patients and SVR in 3 patients. Mild psychiatric disorders were the most frequently detected adverse events (12 patients). Thrombocytopenia and leucopenia existing prior to treatment did not intensify during the treatment. Severe adverse events caused by the drug resulted in the discontinuation of treatment in three patients (urinary tract infections, depression, myasthenia gravis), of whom two patients were Child-Pugh class A and one was class B. In one patient treatment was discontinued because of HCC.

Natural leukocyte interferon alpha is well tolerated by patients with HCV-related cirrhosis and coexisting thrombocytopenia and leucopenia.

We experienced a case of advanced renal carcinoma that showed complete remission to interferon-alpha therapy. A 76-year-old male underwent radical nephrectomy for left renal cell carcinoma (pT3b pN0 M0, stage III). Two and a half months later, chest X-ray, computed tomographic (CT) scan and ultrasonography revealed multiple lung metastases and a hepatic metastasis simultaneously. We started the intramuscular administration of natural interferon-alpha (OIF, 5 MIU) combined with cimetidine everyday. It caused leukopenia, a possible side-effect of interferon-alpha. We reduced the dose to three times a week. The lung metastases and hepatic metastases disappeared after 5 and 12 months, respectively. After we reduced the dose to once a week, there was no evidence of disease for 21 months.