Journal of Gastrointestinal & Digestive System
Open Access

Abstract

Introduction: Monotherapy with PEG-interferon (PEG-IFN-�?±) or nucleotide analogues (NA) are largely ineffective in chronic hepatitis B (CHB) patients. A sequential combination therapy may have better therapeutic effects by sustained viral suppression combined with immunomodulation. Aim: To Study the high efficacy of sequential therapy with pegylated interferon-alpha 2b and tenofovir compared to tenofovir monotherapy in HBeAg positive chronic hepatitis B patients. Methods: One hundred twenty six treated naive HBeAg (+) CHB patients with moderately elevated alanine aminotransferase (ALT) (48-200 IU/mL) received tenofovir 300 mg/day for 72 weeks with PEG-IFN-a2b 1.5 mcg/kg per week added after first 12 weeks (lead-in-period) for 24 weeks (sequential combination therapy; ST) or tenofovir monotherapy; 300 mg/day for 72 weeks (TM). Primary end point was rate of HBeAg loss. Biochemical and virological responses were assessed at weeks 12, 36, 48 and 72 weeks. Combined virological response (CVR) [HBeAg loss and HBV DNA<2000 IU/ml at week 72] was also determined. Results: At week 72, HBeAg loss occurred in 35.8% in ST group and 17% in TM group (P=0.028; OR: 2.73, 95% CI: 1.09 to 6.79). Combined virological response (CVR) was seen in 20.8% and 11.3% (P<0.05), respectively. No patients on ST group had HBeAg seroreversion at last follow up. At week 72, undetectable HBV DNA was seen in 77.4% (ST group) vs. 71.7% (TM group); (p=0.51) and normal ALT was seen in 62.3% and 52.8% (p=0.32), respectively. Significantly more patients on ST group had >3Log HBV DNA reduction at week 36 (92.5%) compared to TM group (66%) (P=0.001). Four (7.5%) patients on ST achieved HBsAg loss compared with MT (1 patient, 1.8%) by week 72. No patient had treatment related major adverse effect requiring discontinuation of therapy. Conclusion: 24 weeks of PEG-IFNa2b as add-on sequential regimen to TDF is safe and resulted in more HBeAg and HBsAg loss, when compared to TDF monotherapy in selected HBeAg (+) chronic hepatitis B patients. Long-term follow-up trials are needed to assess for sustained durable response.

Biography

Email: ankur.jindal3@gmail.com