Drug intelligence / Profile preview

peginterferon alfa-2a + tenofovir disoproxil fumarate

Development stage
Phase 4
Lead developer
National Institute of Diabetes and Digestive and Kidney Diseases
Modality
Cytokines & Interferons → Recombinant Proteins and Enzymes, Small Molecules
Administration
Subcutaneous, Oral
01

Overview

This combination therapy regimen consists of peginterferon alfa-2a, a pegylated interferon biologic, and tenofovir disoproxil fumarate (TDF), a nucleoside analog small molecule. It was evaluated in a randomized, open-label Phase 3 clinical trial (NCT01369212) sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through the Hepatitis B Research Network (HBRN). The regimen involves 24 weeks of combination therapy followed by tenofovir monotherapy. Tenofovir acts by inhibiting HBV reverse transcriptase/DNA polymerase, while peginterferon alfa-2a provides direct antiviral effects and modulates the host immune response to enhance viral clearance. The primary goal is to achieve sustained hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B.

Other names
peginterferon alfa-2a + tenofovirpeginterferon alfa-2a + TDFPegasys + Viread
02

Targets

HBV Pol (Hepatitis B virus polymerase)IFNAR (Immune system modulation via type I interferon receptor)IFNAR1 (Interferon alpha/beta receptor 1)IFNAR2 (Interferon alpha/beta receptor subunit 2)

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