Background. Thymic humoral factor-gamma 2 is a thymus-derived synthetic octapeptide, shown to be effective in chronic hepatitis B virus infection; as the latter is needed to support hepatitis D virus, thymic humoral factor-gamma 2 may have a therapeutic role in hepatitis D. Aim. To evaluate tolerability and efficacy of thymic humoral factor-gamma 2 in chronic hepatitis D. Methods. Intramuscular thymic humoral factor-gamma 2, 40 μg, was given for 15 consecutive days and twice weekly for 22 additional weeks to adult patients with chronic hepatitis D virus hepatitis. Results. A total of 11 patients (male/female 9/2, mean age 45.9 years) completed the treatment period, 10 the 6-month follow-up. At baseline, hepatitis D virus-RNA was positive in 8/11 (73%) patients. During treatment, hepatitis D virus-RNA became undetectable in 3/8 (37%), decreased in 1/8 (13%), remained unchanged in 4/8 (50%) and persisted undetectable in 3 patients, negative at baseline. During follow-up hepatitis D-viraemia relapsed in all patients but 2, one already negative at baseline. No changes in hepatitis B virus markers occurred. Mean serum alanine aminotransferase levels did not change significantly. None of the patients reached normal serum alanine aminotransferase levels. Conclusion. At the doses given, thymic humoral factor-gamma 2 has been of limited efficacy. A possible role of thymic humoral factor-gamma 2 in the treatment of chronic hepatitis D requires further dose-finding studies and/or combination with other antivirals.
- Chronic hepatitis
- Hepatitis D virus
- Thymic humoral factor-gamma 2
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