Long-term outcomes of thymosin-α1 and interferon α-2b combination therapy in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B

Murat Saruc, Nuri Ozden, Nurten Turkel, Semin Ayhan, Lynette M Smith, Isil Tuzcuoglu, Hakan Yuceyar

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Hepatitis B e antibody (HbeAb) and hepatitis B virus (HBV) DNA positive chronic hepatitis is a clinical entity, distinct from classical hepatitis B e antigen (HbeAg) positive chronic hepatitis B. Our aim was to evaluate the long-term therapeutic efficacy of the combination of interferon α-2b and thymosin-α1 compared with lamivudine plus interferon α-2b and interferon α-2b alone. Fifty-two patients with HbeAg-negative chronic hepatitis B were assigned to three different groups in a nonrandomized manner. Group 1 (n = 27) received thymosin-α1 [1.6 mg subcutaneously (sc), twice a week] and interferon α-2b (10 MIU sc, three times per week) for 26 weeks, subsequently followed by interferon α-2b monotherapy at the same dosage for an additional 26 weeks. Group 2 (n = 10) received interferon α-2b (10 MIU sc, three times per week) for 52 weeks. Group 3 (n = 15) received interferon α-2b (10 MIU sc, three times per week) and lamivudine [100 mg orally (po), q.d.] for 52 weeks, followed by continuous lamivudine (100 mg po, q.d.) therapy. By the end of 78 weeks, a sustained response (SR-6 mo) was seen in 74% (20/27) of the patients within Group 1. On the contrary, Groups 2 and 3 had sustained response rates of 40 (4/10) and 53.3% (8/15), respectively (p = 0.13). At the end of 12 months post-treatment in Group 1, a virological and biochemical response rate was seen in 70.3% of patients (19/27); in contrast, Groups 2 and 3 had response rates of 20 (2/10) and 26.6% (4/15), respectively (p = 0036). At the end of the 18-month post-treatment follow-up period, 71.4% (19/27) of patients in Group 1, 10% of patients in Group 2 (1/10), and 20% of patients in Group 3(3/15) preserved their sustained response (p = 0.0003). Interferon α-2b and thymosin-α1 combination therapy results in significant virological and biochemical response rates compared with standard therapeutic regimens and is well tolerated.

Original languageEnglish (US)
Pages (from-to)1386-1395
Number of pages10
JournalJournal of Pharmaceutical Sciences
Volume92
Issue number7
DOIs
StatePublished - Jul 1 2003

Fingerprint

Thymosin
Hepatitis B e Antigens
Chronic Hepatitis B
Interferons
Lamivudine
Therapeutics
Hepatitis B Antibodies
Chronic Hepatitis
Hepatitis B virus
DNA

Keywords

  • Chronic hepatitis B
  • Hepatitis B e antigen (HBeAg) negative
  • Interferon α-2b
  • Thymosin-α1

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Long-term outcomes of thymosin-α1 and interferon α-2b combination therapy in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B. / Saruc, Murat; Ozden, Nuri; Turkel, Nurten; Ayhan, Semin; Smith, Lynette M; Tuzcuoglu, Isil; Yuceyar, Hakan.

In: Journal of Pharmaceutical Sciences, Vol. 92, No. 7, 01.07.2003, p. 1386-1395.

Research output: Contribution to journalArticle

Saruc, Murat ; Ozden, Nuri ; Turkel, Nurten ; Ayhan, Semin ; Smith, Lynette M ; Tuzcuoglu, Isil ; Yuceyar, Hakan. / Long-term outcomes of thymosin-α1 and interferon α-2b combination therapy in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B. In: Journal of Pharmaceutical Sciences. 2003 ; Vol. 92, No. 7. pp. 1386-1395.
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abstract = "Hepatitis B e antibody (HbeAb) and hepatitis B virus (HBV) DNA positive chronic hepatitis is a clinical entity, distinct from classical hepatitis B e antigen (HbeAg) positive chronic hepatitis B. Our aim was to evaluate the long-term therapeutic efficacy of the combination of interferon α-2b and thymosin-α1 compared with lamivudine plus interferon α-2b and interferon α-2b alone. Fifty-two patients with HbeAg-negative chronic hepatitis B were assigned to three different groups in a nonrandomized manner. Group 1 (n = 27) received thymosin-α1 [1.6 mg subcutaneously (sc), twice a week] and interferon α-2b (10 MIU sc, three times per week) for 26 weeks, subsequently followed by interferon α-2b monotherapy at the same dosage for an additional 26 weeks. Group 2 (n = 10) received interferon α-2b (10 MIU sc, three times per week) for 52 weeks. Group 3 (n = 15) received interferon α-2b (10 MIU sc, three times per week) and lamivudine [100 mg orally (po), q.d.] for 52 weeks, followed by continuous lamivudine (100 mg po, q.d.) therapy. By the end of 78 weeks, a sustained response (SR-6 mo) was seen in 74{\%} (20/27) of the patients within Group 1. On the contrary, Groups 2 and 3 had sustained response rates of 40 (4/10) and 53.3{\%} (8/15), respectively (p = 0.13). At the end of 12 months post-treatment in Group 1, a virological and biochemical response rate was seen in 70.3{\%} of patients (19/27); in contrast, Groups 2 and 3 had response rates of 20 (2/10) and 26.6{\%} (4/15), respectively (p = 0036). At the end of the 18-month post-treatment follow-up period, 71.4{\%} (19/27) of patients in Group 1, 10{\%} of patients in Group 2 (1/10), and 20{\%} of patients in Group 3(3/15) preserved their sustained response (p = 0.0003). Interferon α-2b and thymosin-α1 combination therapy results in significant virological and biochemical response rates compared with standard therapeutic regimens and is well tolerated.",
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N2 - Hepatitis B e antibody (HbeAb) and hepatitis B virus (HBV) DNA positive chronic hepatitis is a clinical entity, distinct from classical hepatitis B e antigen (HbeAg) positive chronic hepatitis B. Our aim was to evaluate the long-term therapeutic efficacy of the combination of interferon α-2b and thymosin-α1 compared with lamivudine plus interferon α-2b and interferon α-2b alone. Fifty-two patients with HbeAg-negative chronic hepatitis B were assigned to three different groups in a nonrandomized manner. Group 1 (n = 27) received thymosin-α1 [1.6 mg subcutaneously (sc), twice a week] and interferon α-2b (10 MIU sc, three times per week) for 26 weeks, subsequently followed by interferon α-2b monotherapy at the same dosage for an additional 26 weeks. Group 2 (n = 10) received interferon α-2b (10 MIU sc, three times per week) for 52 weeks. Group 3 (n = 15) received interferon α-2b (10 MIU sc, three times per week) and lamivudine [100 mg orally (po), q.d.] for 52 weeks, followed by continuous lamivudine (100 mg po, q.d.) therapy. By the end of 78 weeks, a sustained response (SR-6 mo) was seen in 74% (20/27) of the patients within Group 1. On the contrary, Groups 2 and 3 had sustained response rates of 40 (4/10) and 53.3% (8/15), respectively (p = 0.13). At the end of 12 months post-treatment in Group 1, a virological and biochemical response rate was seen in 70.3% of patients (19/27); in contrast, Groups 2 and 3 had response rates of 20 (2/10) and 26.6% (4/15), respectively (p = 0036). At the end of the 18-month post-treatment follow-up period, 71.4% (19/27) of patients in Group 1, 10% of patients in Group 2 (1/10), and 20% of patients in Group 3(3/15) preserved their sustained response (p = 0.0003). Interferon α-2b and thymosin-α1 combination therapy results in significant virological and biochemical response rates compared with standard therapeutic regimens and is well tolerated.

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