1. HBsAg clearance in chronic hepatitis B patients with add-on pegylated interferon alfa-2a to ongoing tenofovir treatment: A randomized controlled study.
- Author
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Al Ashgar H, Peedikayil MC, Al Quaiz M, Al Sohaibani F, Al Fadda A, Khan MQ, Thoralsson E, Al Thawadi S, Al Jedai A, and Al Kahtani K
- Subjects
- Adult, Antiviral Agents administration & dosage, Antiviral Agents therapeutic use, DNA, Viral blood, Drug Therapy, Combination adverse effects, Drug Therapy, Combination methods, Female, Hepatitis B Antibodies blood, Hepatitis B Antibodies immunology, Hepatitis B Surface Antigens blood, Humans, Injections, Subcutaneous, Interferon-alpha administration & dosage, Male, Middle Aged, Polyethylene Glycols administration & dosage, Recombinant Proteins administration & dosage, Recombinant Proteins therapeutic use, Tenofovir administration & dosage, Viral Load drug effects, Hepatitis B Surface Antigens drug effects, Hepatitis B, Chronic drug therapy, Interferon-alpha therapeutic use, Polyethylene Glycols therapeutic use, Tenofovir therapeutic use
- Abstract
Background/aims: The ideal end point of treatment for chronic hepatitis B virus (HBV) infection is sustained off-therapy hepatitis B surface antigen (HBsAg) loss with or even without seroconversion to anti-HBs. We investigated the role of adding PEGylated interferon (PEG IFN) to ongoing tenofovir treatment in chronic HBV patients for achieving HBsAg clearance., Patients and Methods: In this randomized controlled trial, chronic HBV patients who have been receiving tenofovir for >6 months with HBV viral load <2000 IU/ml were randomized into two groups. One group (add-on therapy) was given subcutaneous PEG IFN 180 mcg weekly for 12 months in addition to tenofovir. Patients in the other group received only tenofovir 300 mg orally on a daily basis. Patients in both groups were followed up for a total of two years, and patients in both groups were given tenofovir 300 mg daily indefinitely until they developed HBsAg clearance., Results: Twenty-three patients were allocated to the PEG IFN and tenofovir (add-on therapy) group, and another 25 patients were recruited to the tenofovir monotherapy group. Before randomization, patients had received tenofovir for 1135 mean days (range203 to 1542 days). One patient (4.3%) in add-on therapy lost HBsAg and seroconverted. Within two years, mean HBsAg decreased significantly with add-on therapy (from 4753 IU/ml to 2402; P= 0.03); and it decreased from 5957 IU/ml to 4198; P= 0.09 in tenofovir monotherapy group. More patients in the add-on group developed serious side effects, with treatment discontinuation, and dose reductions (P = 0.3)., Conclusion: PEG IFN and tenofovir add-on therapy was successful in achieving HBsAg clearance and seroconversion in 4.3% of the patients. Add-on therapy patients had a significant decrease in HBsAg levels in two years; and no significant decrease in HBsAg levels with the tenofovir monotherapy. With no significant HBsAg clearance, the utility of this combination regimen is questionable.
- Published
- 2017
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