Safety and Efficacy of Nucleic Acid Polymers in Monotherapy and Combined with Immunotherapy in Treatment-Naive Bangladeshi Patients with HBeAg+ Chronic Hepatitis B Infection.

Al-Mahtab M, Bazinet M, Vaillant A

PloS one3 Jun 2016Cited by 144 (Europe PMC)

PMID27257978PMCIDPMC4892580DOI10.1371/journal.pone.0156667PepBankPUB-27257978

Summary

UnlabelledPrevious in vivo studies have suggested that nucleic acid polymers (NAPs) may reduce circulating levels of HBsAg in the blood by blocking its release from infected hepatocytes and that this effect may have clinical benefit. NAP treatment, was evaluated in two clinical studies in patients with HBeAg positive chronic HBV infection. The REP 101 study examined REP 2055 monotherapy in 8 patients and the REP 102 study examined REP 2139-Ca, in monotherapy in 12 patients, 9 of which transitioned to short term combined treatment with pegylated interferon alpha 2a or thymosin alpha 1. In both studies NAP monotherapy was accompanied by 2-7 log reductions of serum HBsAg, 3-9 log reductions in serum HBV DNA and the appearance of serum anti-HBsAg antibodies (10-1712 mIU / ml). Eight of the 9 patients transitioning to combined treatment with immunotherapy (pegylated interferon or thymosin alpha 1) in the REP 102 study experienced HBsAg loss and all 9 patients experienced substantial increases in serum anti-HBsAg antibody titers before withdrawal of therapy. For 52 weeks after removal of REP 2055 therapy, rebound of serum viremia (HBV DNA > 1000 copies / ml, HBsAg > 1IU / ml) was not observed in 3 / 8 patients. Suppression of serum virema was further maintained for 290 and 231 weeks in 2 of these patients. After withdrawal of all therapy in the 9 patients that transitioned to combination therapy in the REP 102 study, 8 patients achieved HBV DNA < 116 copies / ml after treatment withdrawal. Viral rebound occurred over a period of 12 to 123 weeks in 7 patients but was still absent in two patients at 135 and 137 weeks of follow-up. Administration tolerability issues observed with REP 2055 were rare with REP 2139-Ca but REP 2139-Ca therapy was accompanied by hair loss, dysphagia and dysgeusia which were considered related to heavy metal exposure endemic at the trial site. These preliminary studies suggest that NAP can elicit important antiviral responses during treatment which may improve the effect of immunotherapy. NAPs may be a potentially useful component of future combination therapies for the treatment of chronic hepatitis B.Trial registrationClinicalTrials.gov NCT02646163 and NCT02646189.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone4

In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Thymosin alpha-1.

01HumanNot a test of Thymosin alpha-1 aloneNon-randomized trialEfficacy outcome
In HBeAg-positive chronic hepatitis B, eight of 9 patients given a nucleic acid polymer then immunotherapy (pegylated interferon or thymosin α1) had HBsAg loss.
In plain wordsIn people with hepatitis B, 8 of 9 given a nucleic acid polymer, then interferon or thymosin α1, lost HBsAg; drugs not separated.
Peptide
Thymosin alpha-1
Outcome
DecreaseHBsAg loss
Study
n = 9
Outcome group
Antiviral activity · Infection
Source sentences
Summary
Eight of the 9 patients transitioning to combined treatment with immunotherapy (pegylated interferon or thymosin alpha 1) in the REP 102 study experienced HBsAg loss and all 9 patients experienced substantial increases in serum anti-HBsAg antibody titers before withdrawal of therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
The REP 101 study examined REP 2055 monotherapy in 8 patients and the REP 102 study examined REP 2139-Ca, in monotherapy in 12 patients, 9 of which transitioned to short term combined treatment with pegylated interferon alpha 2a or thymosin alpha 1.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2725797801
02HumanNot a test of Thymosin alpha-1 aloneNon-randomized trialEfficacy outcome
In HBeAg-positive chronic hepatitis B, all 9 patients given a nucleic acid polymer then immunotherapy (pegylated interferon or thymosin α1) had substantial increases in anti-HBsAg antibody titers.
In plain wordsIn people with hepatitis B, all 9 given a nucleic acid polymer, then interferon or thymosin α1, had higher antibody levels; drugs not separated.
Peptide
Thymosin alpha-1
Outcome
IncreaseAnti-HBsAg antibody titers
Study
n = 9
Outcome group
Immune response · Infection
Source sentences
Summary
Eight of the 9 patients transitioning to combined treatment with immunotherapy (pegylated interferon or thymosin alpha 1) in the REP 102 study experienced HBsAg loss and all 9 patients experienced substantial increases in serum anti-HBsAg antibody titers before withdrawal of therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
The REP 101 study examined REP 2055 monotherapy in 8 patients and the REP 102 study examined REP 2139-Ca, in monotherapy in 12 patients, 9 of which transitioned to short term combined treatment with pegylated interferon alpha 2a or thymosin alpha 1.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2725797802
03HumanNot a test of Thymosin alpha-1 aloneNon-randomized trialEfficacy outcome
In HBeAg-positive chronic hepatitis B, 8 of the 9 patients on combination therapy reached HBV DNA below 116 copies/ml after treatment withdrawal.
In plain wordsIn people with hepatitis B, 8 of 9 given a nucleic acid polymer plus interferon or thymosin α1 reached very low virus levels after stopping.
Peptide
Thymosin alpha-1
Outcome
DecreaseHBV DNA below 116 copies/ml after withdrawal
Study
n = 9
Outcome group
Antiviral activity · Infection
Measurements
HBV DNA
< 116 copies / ml
after withdrawal
Source sentences
Summary
After withdrawal of all therapy in the 9 patients that transitioned to combination therapy in the REP 102 study, 8 patients achieved HBV DNA < 116 copies / ml after treatment withdrawal.
1 context sentence(design, population, supporting numbers)
Summary · context
The REP 101 study examined REP 2055 monotherapy in 8 patients and the REP 102 study examined REP 2139-Ca, in monotherapy in 12 patients, 9 of which transitioned to short term combined treatment with pegylated interferon alpha 2a or thymosin alpha 1.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2725797803
04HumanNot a test of Thymosin alpha-1 aloneNon-randomized trialEfficacy outcome
In HBeAg-positive chronic hepatitis B, viral rebound occurred over 12 to 123 weeks in 7 patients on combination therapy but was absent in two at 135 and 137 weeks.
In plain wordsIn people with hepatitis B, the virus returned in 7 patients given a nucleic acid polymer plus interferon or thymosin α1, not in two.
Peptide
Thymosin alpha-1
Outcome
IncreaseViral rebound after withdrawal
Study
n = 9
Outcome group
Antiviral activity · Infection
Source sentences
Summary
Viral rebound occurred over a period of 12 to 123 weeks in 7 patients but was still absent in two patients at 135 and 137 weeks of follow-up.
1 context sentence(design, population, supporting numbers)
Summary · context
The REP 101 study examined REP 2055 monotherapy in 8 patients and the REP 102 study examined REP 2139-Ca, in monotherapy in 12 patients, 9 of which transitioned to short term combined treatment with pegylated interferon alpha 2a or thymosin alpha 1.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2725797804

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1/2NCT02646189

Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

Replicor Inc.n = 12Aug 2011 to Aug 2013

Hepatitis B, Chronic

Trial page ClinicalTrials.govUpdated 5 Jan 2016

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 2
9 Oct 2026, 03:03 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:02 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.