The effect of thymopentin add-on in hepatitis B e antigen positive chronic hepatitis B after virus suppression by peginterferon plus entecavir therapy.
Ma. Yanpin Y; Bao. Xuli X; Xiong. Fang F; Wang. Jinhuan J; Gu. Na N; Guo. Jia J; Wu. Huili H; Lu. Jun J
Key Findings
- TP5 combined with interferon reduced HBV cccDNA levels in liver cells in vitro.
- In a small clinical trial, TP5 add‑on did not change average HBsAg levels overall but showed a greater decline over time, particularly in patients with baseline HBsAg <1500 IU/ml.
- No additional side effects were observed with TP5 compared to standard therapy alone.
Practical Outcomes
- For people with chronic hepatitis B, a 24‑week course of TP5 alongside entecavir and peginterferon appears safe and may help the virus markers fall faster, especially if the starting antigen level is low. However, the benefit is modest and based on a small study, so it isn’t a proven protocol yet.
Summary
Adding the peptide thymopentin (TP5) to the usual hepatitis B drugs (entecavir and pegylated interferon) was safe and seemed to speed up the drop in the hepatitis B surface antigen in some patients, especially those who already had low levels of the antigen. In lab cells, TP5 worked together with interferon to cut down the virus's hidden DNA form.
Abstract
Hepatitis B virus (HBV) covalently closed circular DNA (cccDNA) was positively correlated with serological hepatitis B surface antigen (HBsAg) levels in hepatitis B e antigen (HBeAg) positive chronic hepatitis B (CHB) patients. We evaluated whether Thymopentin (TP5) and interferon (IFN-a) had a synergic effect on HBV cccDNA and the effect of TP5 addition therapy on HBsAg clearance in CHB patients. Real-time PCR experiments were performed to test cccDNA in HepG2.2.15 cells. 45 HBeAg-positive CHB patients had been distributed into two groups randomly. Treatment group: 23 patients were treated with a 24-week TP5 on the basis of the treatment entecavir (ETV) and peginterferon alfa-2a (PegIFN alpha-2a). Control group: 22 patients were treated with ETV and PegIFNa-2a. The study period was 72 weeks. In HepG2.2.15 cells, TP5 5ug/ml and 10ug/ml respectively combined with IFN-a 2ku/ml could potently inhibit cccDNA level at 72 hours (P&lt;0.05). In clinical study, mean HBsAg levels in two groups are not significantly different at different time points (p=0.112). However, changes of mean HBsAg levels in TP5 add-on group at different time points are significantly different (p&lt;0.05). Patients with HBsAg levels &lt;1500IU/ml in control group had higher HBsAg levels compared with patients with HBsAg levels &lt;1500IU/ml in TP5 add-on group (P=0.019). The latter had the most pronounced HBsAg reduction. TP5 and IFN had a synergic effect on inhibiting cccDNA levels in HepG2.2.15 cells; Patients in treatment group showed no extra side effects compared with the control group. 24 weeks TP5 add-on treatment was safe and had a tendency to accelerate the decline of HBsAg when HBV-DNA was undetectable.
Study Information
pubmed
2019
2019-02-28T00:00:00.000Z