Treatment of chronic hepatitis D with thymus-derived polypeptide thymic humoral factor-gamma 2: a pilot study.
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.


OBJECTIVE
To evaluate tolerability and efficacy of thymic humoral factor-gamma 2 in chronic hepatitis D.


METHODS
Intramuscular thymic humoral factor-gamma 2, 40 microg, 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.


CONCLUSIONS
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.
Rosina
F
F
Department of Gastroenterology, University of Torino, Molinette Hospital, Italy. flrosina@venturanet.it
Conoscitore
P
P
Smedile
A
A
Mangia
A
A
Borghesio
E
E
Martinotti
R
R
Andriulli
A
A
Rizzetto
M
M
D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D005260:Female; D003699:Hepatitis D / Q000276:immunology; D019701:Hepatitis D, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D010865:Pilot Projects; D012367:RNA, Viral / Q000032:analysis; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D009842:Oligopeptides; D012367:RNA, Viral; C064563:thymic humoral factor gamma 2; D000410:Alanine Transaminase