التفاصيل البيبلوغرافية
| العنوان: |
Treatment of chronic hepatitis B naïve patients with a therapeutic vaccine containing HBs and HBc antigens (a randomized, open and treatment controlled phase III clinical trial). |
| المؤلفون: |
Al Mahtab, Mamun1, Akbar, Sheikh Mohammad Fazle2 sheikh.akbar_mohammad_fazle@m.ehime-u.ac.jp, Aguilar, Julio Cesar3, Guillen, Gerardo3, Penton, Euduaro3, Tuero, Angela3, Yoshida, Osamu4, Hiasa, Yoichi4, Onji, Morikazu5 |
| المصدر: |
PLoS ONE. 8/22/2018, Vol. 13 Issue 8, p1-14. 14p. |
| مصطلحات موضوعية: |
*DRUG efficacy, *CHRONIC hepatitis B, *TREATMENT effectiveness, *CHRONIC hepatitis C, *CIRRHOSIS of the liver, *PATIENTS, *THERAPEUTICS |
| مستخلص: |
Context: Current drugs for chronic hepatitis B therapy have a poor efficacy in terms of post-treatment sustained viral suppression and generate important side effects during and after therapy. Therapeutic vaccination with HBV antigens is an attractive alternative to test. Objective: Evaluating the efficacy of a therapeutic vaccine candidate (designated NASVAC) containing both hepatitis B surface antigen (HBsAg) and core antigen (HBcAg) versus pegylated interferon (Peg-IFN) in naïve chronic hepatitis B patients. Design, setting, participants: An open phase III, randomised and treatment controlled clinical trial was conducted in a total of 160 CHB patients, allocated into two groups of 80 patients each to receive NASVAC or Peg-IFN. The vaccine formulation comprised 100 μg of each HBsAg and HBcAg, and was administered in 2 cycles of 5 doses. The control group received 48 subcutaneous injections of Peg-IFN alfa 2b, 180 μg per dose, every week, for 48 consecutive weeks. Main outcome measure: The primary outcome measure was in relation with the proportion of patients showing reduction of the viral load under the limit of detection (250 copies/mL) after 24 weeks of treatment completion. Results: Sustained control of HBV DNA was significantly more common in NASVAC group (p<0.05) at 24 weeks of follow up. NASVAC-induced increases of alanine aminotransferases (ALT) were detected in 85% patients after 5 nasal vaccinations, although seen in only 30% of patients receiving Peg-IFN. At the end of treatment (EOT) antiviral effect was comparable in both NASVAC and Peg-IFN groups. Clearance of Hepatitis B e antigen (HBeAg) was also more frequent in NASVAC group compared to Peg-IFN recipients. A lower progression to cirrhosis was found in NASVAC group compared to Peg-IFN group. Conclusion: Nasvac induced a superior reduction of the viral load under the limit of detection compared to Peg-IFN treatment. It is a safe and efficacious finite alternative of antiviral treatment for CHB patients. Trial registration: ClinicalTrials.gov . [ABSTRACT FROM AUTHOR] |
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