Drugs / Pegalyted interferon
Pegalyted interferon
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT01589952 | Mar 2012 → Feb 2013 | chronic hepatitis B virus infection | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 55
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | Brii Biosciences Limited | Results Brii Bio Presents Late-Breaking Data from Its Phase 2 ENSURE Study at EASL Congress 2026, Further Supporting the Potential Role of BRII-179 in Achieving Durable Immunological Control of HBV briibio.com ↗
Final results from the ENSURE study demonstrate that the addition of elebsiran resulted in a higher functional cure rate compared with pegylated interferon alfa ( PEG-IFNα ) alone |
| 2026-04-26 | Brii Biosciences Limited | Results Brii Bio Presents Cross-Study Analysis of Post-Treatment HBsAg Rebound at APASL 2026 briibio.com ↗
Participants achieving HBsAg loss with pegylated interferon alfa ( PEG -IFNα) ± elebsiran or BRII-179 demonstrated favorable off-treatment clinical outcomes, with most HBsAg rebounds <10 IU/mL and HBV DNA rebound infrequent and not associated with clinically significant ALT elevation. |
| 2025-11-10 | Brii Biosciences Limited | Results Brii Biosciences Presents Late-Breaking Data from Ongoing Phase 2 ENSURE Study at AASLD 2025, Reinforcing BRII-179’s Potential as a Curative Treatment for Chronic Hepatitis B briibio.com ↗
Cohort 4 follow-up confirms durable h epatitis B surface antigen ( HBsAg ) loss at 24 weeks post end of treatment (EOT) in BRII-179 anti-HBs respon ders treated with elebsiran plus pegylated interferon alfa (PEG-IFNα) |
| 2025-11-07 | GlaxoSmithKline | Results GSK presents data from its advancing liver pipeline at AASLD 2025 gsk.com ↗
Phase II B-Sure study sub-analysis shows durability of functional cure in chronic hepatitis B (CHB) patients treated with bepirovirsen and pegylated interferon (Peg-IFN) |
| 2025-11-07 | Brii Biosciences Limited | Results Brii Biosciences Announces Publication of Phase 2 ENSURE Study Results in Nature Medicine briibio.com ↗ |
| 2025-05-09 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces Preliminary 24-Week Post-End of Treatment Data for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B From the MARCH Study vir.bio ↗
HBsAg loss 24 weeks post-end of treatment achieved in 17% and 21% of participants with low baseline HBsAg receiving tobevibart + elebsiran without or with PEG-IFNα, respectively |
| 2025-05-08 | Brii Biosciences Limited | Results Brii Bio Presents Late-Breaking Data from Its Ongoing Phase 2 ENSURE Study at EASL Congress 2025, Suggesting BRII-179’s Role in Advancing Higher HBsAg Loss briibio.com ↗
24 Week follow-up results from Cohorts 1-3 of the ENSURE study demonstrated sustained off-treatment benefits of elebsiran + PEG-IFNα combination therapy vs PEG-IFNα alone |
| 2025-04-24 | Brii Biosciences Limited | Results Brii Bio to Present Late-Breaking Data from Its Ongoing Phase 2 ENSURE Study in Participants with Chronic Hepatitis B Virus Infection at EASL 2025 briibio.com ↗
Chronic hepatitis B virus infected participants responding to prior BRII-179 treatment achieved faster and higher rate of hepatitis B virus surface antigen seroclearance on elebsiran plus peginterferon-alfa: end of treatment data from ENSURE study |
| 2025-03-30 | Brii Biosciences Limited | Results Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179’s Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification briibio.com ↗
48-week EOT data from Cohort 1-3 of the ENSURE study clearly suggests the added benefits of elebsiran towards achieving a higher rate of HBsAg loss in combination with PEG-IFNα |
| 2024-11-19 | Brii Biosciences Limited | Results Brii Bio Delivers First Head-to-Head Comparison of siRNA (Elebsiran) and PEG-IFNα Combination versus PEG-IFNα Alone at AASLD’s The Liver Meeting ® 2024, Demonstrating Higher Loss of HBV Surface Antigen by Combining with siRNA briibio.com ↗
The ENSURE 48-week end-of-treatment (EOT) data demonstrated that 26.3% (5/19) or 33.3% (6/18) of participants receiving 200 mg or 100 mg elebsiran in combination with PEG-IFNα versus 5.6% (1/18) receiving PEG-IFNα alone achieved HBsAg seroclearance at EOT. |
| 2024-11-15 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at AASLD The Liver Meeting vir.bio ↗
The study demonstrated promising rates of hepatitis B surface antigen (HBsAg) loss (seroclearance) in participants with low baseline HBsAg (<1000 IU/mL) in both combination regimens. |
| 2024-06-07 | Brii Biosciences Limited | Results Brii Bio Presents New Data from Its Ongoing Phase 2 Chronic Hepatitis B Trials at EASL™ Congress 2024 briibio.com ↗
BRII-179 as add-on therapy induces functional antibody responses and contributes to improved sustained HBsAg loss in PEG-IFN a -treated participants with chronic HBV infection |
| 2023-11-14 | Brii Biosciences Limited | Results Brii Bio Presents New Data Highlighting Progress Towards Achieving HBV Functional Cure at AASLD’s The Liver Meeting ® 2023 briibio.com ↗
At Week 36 (12 weeks after end-of-treatment [EOT]), BRII-179 + PEG-IFNα combination group achieved higher HBsAg loss rate compared to Placebo + PEG-IFNα group (Full Analysis Set (FAS): 24.6% vs.14.0%, Per Protocol Set (PPS): 31.8% vs.14.9%). |
| 2023-11-13 | Vir Biotechnology, Inc. | Results Vir Biotechnology to Present New Data from Its Ongoing Phase 2 Chronic Hepatitis Delta and B Trials Today at AASLD’s The Liver Meeting® 2023 vir.bio ↗
Specifically, at 24 weeks, 15.0% and 14.3% of participants achieved HBsAg loss at EOT for VIR-3434 + VIR-2218 and VIR-2218 + VIR-3434 + PEG-IFN-α, respectively. |
| 2023-10-11 | GlaxoSmithKline | Results GSK presents scientific advances to improve patient outcomes at the American Association for the Study of Liver Diseases’ The Liver Meeting® 2023 gsk.com ↗
All patients that met the primary endpoint had a baseline surface antigen ≤3000 IU/mL, reinforcing the previously announced results from the B-Clear phase IIb trial which showed that treatment with bepirovirsen resulted in sustained clearance of HBsAg and HBV DNA both in patients on concurrent nucleosid |
| 2023-09-06 | VBI Vaccines Inc. | Results VBI Vaccines Partner Brii Biosciences Announces Topline Interim Results of Phase 2 Study Evaluating BRII-179 (VBI-2601) in Combination With PEG-IFNα for the Treatment of Chronic Hepatitis B vbivaccines.com ↗
BRII-179 (VBI-2601) as an add-on therapy to standard of care PEG-IFNα increases HBsAg loss rate at the end of treatment and 12 weeks follow up |
| 2023-09-06 | Brii Biosciences Limited | Results Brii Biosciences Announces Topline Interim Results of Phase 2 Study Evaluating BRII-179 (VBI-2601) in Combination with PEG-IFNα for the Treatment of Chronic Hepatitis B briibio.com ↗
BRII-179 (VBI-2601) as an add-on therapy to standard of care PEG-IFN α increases HBsAg loss rate at the end of treatment and 12 weeks follow up |
| 2023-06-26 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Poster Presentation of Phase II Study of ASC42 FXR Agonist for Functional Cure of Chronic Hepatitis B at EASL CONGRESS 2023 ascletis.com ↗
In total, 122, 119, and 107 adverse events (AEs) were reported in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively, and most AEs (94.3%) were mild (grade 1) or moderate (grade 2) in severity. |
| 2023-06-25 | Brii Biosciences Limited | Results Brii Bio Announces New Data from Partners Underscoring Potential for HBV Functional Cure at EASL™ Congress 2023 briibio.com ↗
16% (5/31) of participants demonstrated sustained HBsAg loss 24 weeks after end of treatment; Two of the five participants had baseline HBsAg levels greater than 1,000 IU/mL. |
| 2023-06-24 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 as Therapies for Chronic Hepatitis B and Hepatitis D vir.bio ↗
16% (5/31) achieved sustained HBsAg loss 24 weeks following the end of treatment. |
| 2023-06-21 | Assembly Biosciences | Results Assembly Biosciences Presents New Data Highlighting Entry Inhibitor and Core Inhibitor Programs at EASL’s International Liver Congress™ 2023 assemblybio.com ↗
The first-generation core inhibitor candidate, VBR, was evaluated in a Phase 2 study in combination with entecavir (ETV) and pegylated interferon alpha (Peg-IFNα) in patients with hepatitis B e antigen positive cHBV infection. |
| 2022-11-06 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 to Achieve a Functional Cure for Chronic Hepatitis B Virus (HBV) Infection vir.bio ↗
Additionally, 48 weeks of VIR-2218 plus PEG-IFN-α provided greater reductions in hepatitis B surface antigen (HBsAg) (mean decrease of -2.9 log10 IU/mL) compared to VIR-2218 alone or with shorter regimens of the combination. |
| 2021-11-12 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 to Achieve a Functional Cure for Chronic Hepatitis B Virus (HBV) Infection at AASLD The Liver Meeting® vir.bio ↗
New findings also demonstrate that concurrent initiation of VIR-2218 and pegylated interferon alpha (PEG-IFN-α) therapy resulted in substantial HBsAg reductions compared to VIR-2218 alone or with PEG-IFN-α following a VIR-2218 lead-in. |
| 2021-06-25 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents New Clinical Data from Ongoing Trials of VIR-2218 and VIR-3434 in Patients with Chronic Hepatitis B Virus Infection at the International Liver Congress 2021 vir.bio ↗
In a separate analysis evaluating VIR-2218 in combination with pegylated interferon alfa (PEG-IFN-α) for 12 weeks, a more rapid and substantial HBsAg decline was observed in the co-administration cohort compared to VIR-2218 alone. |
| 2019-02-11 | Replicor Inc. | Results Replicor to update analysis of high rates of functional cure of HBV at APASL 2019 replicor.com ↗
demonstrating further treatment is no longer required in 85% of patients completing therapy |
| 2018-11-06 | Replicor Inc. | Results Replicor to disclose achievement of high rates of functional cure of HBV at AASLD 2018 replicor.com ↗
Replicor’s poster presentation (Poster 393), to be presented on Friday, November 9, 2018, will showcase the on-going follow-up analysis after removal of all treatment (now beyond 24 weeks in most patients) indicating normalization of liver function |
| 2017-10-23 | Replicor Inc. | Results Replicor discloses the persistence of functional control off-therapy in 80% of patients with chronic hepatitis B from the REP 401 study at AASLD 2017 replicor.com ↗
This functional control is persisting in all patients (80%) after removal of all therapy with data available for 24 weeks in 4 patients, 12 weeks in 3 patients and 4 weeks in 1 patient. |
| 2017-10-10 | Replicor Inc. | Results Replicor to disclose late-breaking follow-up data from its REP 401 study at AASLD 2017 replicor.com ↗
control of HBV infection (HBsAg, anti-HBs and HBV DNA) and normalization of liver function is currently persisting for up to 24 weeks after withdrawal of all therapy |
| 2017-02-20 | Replicor Inc. | Results Replicor discloses high rates of HBsAg loss with NAP combination therapy at APASL 2017 replicor.com ↗
In patients receiving NAPs in combination with TDF and peg-IFN, 8/9 patients receiving REP 2139 have experienced HBsAg reductions > 4 logs with HBsAg loss (HBsAg ≤ 0.01 IU / ml) in 7 of these patients. |
| 2016-11-15 | Replicor Inc. | Results Replicor discloses late breaking HBV and follow-up HBV / HDV clinical data at AASLD 2016 replicor.com ↗
After 24 weeks of follow-up, despite the use of a suboptimal combination regimen, 5/12 patients had no detectable HBsAg and 7/12 patients had no detectable HDV RNA, indicating that functional control of infection has been established in these patients. |
| 2015-03-16 | Medivir | Results New data on Simeprevir presented at the Conference of the Asian Pacific Association for the Study of the Liver medivir.com ↗
89-91% were cured with simeprevir in combination with pegylated interferon (P) and ribavirin (R) |
| 2014-04-11 | Gilead Sciences | Results Gilead’s Sovaldi® Demonstrates Efficacy and Safety Among Chronic Hepatitis C Patients with Advanced Liver Disease gilead.com ↗
Overall, 62 percent of patients achieved SVR12. |
| 2014-04-10 | Gilead Sciences | Results Gilead Announces Results from Study of Sovaldi® for Retreatment of Chronic Hepatitis C in Patients Not Cured with Prior Antiviral Therapy gilead.com ↗
Among the 50 patients for whom sustained virologic response data was available 12 weeks after the end of treatment (SVR12), 74 percent (n=37/50) achieved SVR12. |
| 2013-11-02 | Gilead Sciences | Results Gilead Announces New Sustained Viral Response Data for Sofosbuvir-Based Regimens in Genotype 3-Infected Hepatitis C Patients gilead.com ↗
Additionally, the Phase 2 LONESTAR-2 study evaluated 12 weeks of sofosbuvir, RBV and pegylated interferon (peg-IFN) among patients who had previously failed treatment with peg-IFN/RBV, approximately half of whom had cirrhosis. |
| 2013-04-23 | Gilead Sciences | Results Data from Phase 3 Studies of Gilead’s Sofosbuvir for Hepatitis C To Be Presented at 48th Annual EASL Meeting; Findings Published Online Today in The New England Journal of Medicine gilead.com ↗
Overall SVR12 rates (sustained viral response 12 weeks after completing therapy) from 50 to 90 percent were observed. |
| 2013-02-04 | Gilead Sciences | Results Gilead Announces Sustained Virologic Response Rates from Two Phase 3 Studies of Sofosbuvir for Hepatitis C gilead.com ↗
All common adverse events (≥10 percent in any group) occurred more frequently in subjects receiving peg-IFN and RBV as compared to sofosbuvir and RBV. |
| 2012-11-11 | Scynexis, Inc. | Results SCYNEXIS’ Oral SCY-635 Shows Potential as an Immune Acting Antiviral to Augment Current HCV Treatments scynexis.com ↗
The Phase 2a study found that SCY-635 administered for only four weeks restored sensitivity to Peg-IFN/RBV therapy in a difficult to treat, HCV genotype 1 infected population. |
| 2012-04-19 | Gilead Sciences | Results Gilead Announces Sustained Virologic Response Data for 12-Week Regimen of GS-7977 Plus Pegylated Interferon and Ribavirin in Genotype 1 Hepatitis C Patients gilead.com ↗
At the end of treatment, 51/51 patients (100 percent) were HCV RNA undetectable. |
| 2011-03-07 | Bristol-Myers Squibb | Results New Data on Multiple Bristol-Myers Squibb Investigational Hepatitis C Compounds to be Presented at The International Liver Congress 2011 bms.com ↗
Quadruple therapy with BMS-790052, BMS-650032 and PEG-IFN/RBV for 24 weeks results in 100% SVR12 in HCV Genotype 1 null responders |
| 2010-09-07 | Vertex Pharmaceuticals Incorporated | Results 65% of People Whose Prior Treatment for Hepatitis C Was Unsuccessful Achieved SVR (Viral Cure) with Telaprevir-Based Therapy in Phase 3 REALIZE Study vrtx.com ↗ |
| 2009-04-25 | Vertex Pharmaceuticals Incorporated | Results Telaprevir Data Presented at EASL Show Unprecedented SVR Rates in HCV Treatment-Failure Patients in PROVE 3 Study vrtx.com ↗
In comparison, SVR rates were achieved by 14% of patients randomized to receive 48 weeks of peg-IFN and RBV alone. |
| 2009-04-21 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals to Present Data at EASL Suggesting Telaprevir's Potential for Use in a Broad Range of HCV Patients and Highlighting the Company's Expanded STAT-C Portfolio vrtx.com ↗
Interim data from two Phase 2 studies (C209 and C210) in treatment-naïve HCV patients show substantial antiviral activity against HCV genotypes 2 and 4 when telaprevir is combined with the standard of care compared with standard of care alone. |
| 2008-11-01 | Vertex Pharmaceuticals Incorporated | Results New Clinical Data Support Broad Profile for Telaprevir in Patients with Genotype 1 Hepatitis C Virus (HCV) Infection vrtx.com ↗
The PROVE 3 data show a 52% SVR12 in HCV treatment-failure patients, with a 24-week treatment duration. |
| 2008-06-09 | Vertex Pharmaceuticals Incorporated | Results Vertex Reports 52% SVR 12 Rate for a 24-week Telaprevir-based Regimen in Genotype 1 Hepatitis C Patients Who Failed Prior Treatment vrtx.com ↗ |
| 2008-04-28 | Debiopharm International SA | Results Clinical Update – Debio025 in Hepatitis C – Presentation of Phase IIa Efficacy Results debiopharm.com ↗
Data indicates that Debio025 shows an important additive anti-HCV effect when co-administered with pegylated Interferon (Peg-IFN) alpha-2a to treatment- naïve HCV patients. |
| 2008-04-24 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Positive Interim Results with Telaprevir-based Therapy in Genotype 1 Chronic Hepatitis C Patients who Failed to Achieve SVR with Previous Pegylated Interferon & Ribavirin Treatment vrtx.com ↗
In the interim analysis, patients treated with telaprevir in combination with peg-IFN and RBV demonstrated a high rate of viral response at week 4 (49 of 60 patients achieved HCV RNA 25 IU/mL). |
| 2007-07-24 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports Second Quarter 2007 Financial Results and Provides Development Pipeline Update vrtx.com ↗
Among the patients who completed 24 weeks of therapy and had undetectable HCV RNA (less than 10 IU/mL) at the end of treatment, fewer than 10 percent had relapsed by the end of 12 weeks post-treatment follow-up. |
| 2007-06-12 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports 2007 Pipeline Progress vrtx.com ↗
At this time, Vertex is reporting that the preliminary results are consistent with findings reported for PROVE 1. |
| 2006-05-21 | Vertex Pharmaceuticals Incorporated | Results Researchers Report Results for 28-day Phase II Study of VX-950 in Combination with Pegylated Interferon and Ribavirin in Hepatitis C Patients vrtx.com ↗
Researchers reported for the first time today that 11 of these patients (92%) continue to have no detectable virus in their blood at the end of 12 additional weeks of follow-on peg-IFN+RBV dosing. |
| 2006-04-29 | Vertex Pharmaceuticals Incorporated | Results Researchers Report Initial Results for 14-day Phase Ib Study of VX-950, and Pegylated Interferon, Showing Anti-HCV Activity in Combination in Hepatitis C Patients vrtx.com ↗
Researchers reported for the first time today that 8 of 8 patients who received VX-950 and peg-IFN in combination for 14 days have no detectable virus in their blood at the end of 12 additional weeks of peg-IFN+RBV dosing. |
| 2006-02-07 | Vertex Pharmaceuticals Incorporated | Results Vertex Successfully Completes Key Studies with VX-950 to Prepare for Next Steps in Clinical Program vrtx.com ↗
Plasma HCV RNA levels are less than 10 IU/mL in 12 of 12 patients after 28 days of dosing with VX-950/peg-IFN/RBV in Phase II study |
| 2006-01-09 | Vertex Pharmaceuticals Incorporated | Results VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid and Dramatic Reduction in Viral Levels in Combination with Pegylated Interferon vrtx.com ↗
The antiviral activity of the combination through 14 days was significantly greater than the activity of VX-950 administered as a single agent, and much greater than peg-IFN alone. |
| 2006-01-09 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Announces Key Business Objectives for 2006 at 24th Annual JPMorgan Healthcare Conference vrtx.com ↗
In this study, patients receiving a combination of VX-950 dosed with peg-IFN achieved a median 5.5 log10 reduction in HCV RNA at 14 days. |
| 2006-01-09 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Announces Key Business Objectives for 2006 at 24th Annual JPMorgan Healthcare Conference vrtx.com ↗
In this study, patients receiving a combination of VX-950 dosed with peg-IFN achieved a median 5.5 log10 reduction in HCV RNA at 14 days. |
| 2004-04-16 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports Data on Investigational Hepatitis C Therapies Suggesting Potential for Novel Treatment Approaches vrtx.com ↗
results for patients enrolled in the extension phase of a pilot Phase IIa study designed to evaluate the safety and tolerability of merimepodib in combination with peg-IFN and ribavirin |
All press releases naming this drug 55 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pegalyted interferon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01589952 ↗ |
| Known as | Peg-IFN | “According to published literature, treatment with pegylated interferon (Peg-IFN) is associated with end of treatment response in treatment naive patients with chronic hepatitis B (CHB).” NCT01589952 ↗ |
| Known as | Pegylated interferon | “According to published literature, treatment with pegylated interferon (Peg-IFN) is associated with end of treatment response in treatment naive patients with chronic hepatitis B (CHB).” NCT01589952 ↗ |
| Route | Subcutaneous | “Pegalyted interferon: 90 micro gms subcutaneously once weekly for 24 weeks” NCT01589952 ↗ |