Drugs / Boceprevir
Boceprevir
also known as
BOC · Victrelis · Boceprevir: Victrelis · EBP 520 · SCH 503034 · Sch 50304 · Victrelis (Boceprevir) · Victrelis(r)
Small molecule targets CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Victrelis | — | 2018-06-29 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | VICTRELIS | — | 2013-02-13 – 2014-04-09 | fda.gov ↗ |
| Approved | EU (EMA) | Victrelis | — | 2011-07-18 | europa.eu ↗ |
| Approved | US (FDA) | VICTRELIS | — | 2011-05-13 | fda.gov ↗ |
Trials 40
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2013-04-23 | Merck Sharp & Dohme LLC | Results Merck to Present Updated Interim Data from Phase II Trial Evaluating Investigational NS3/4A Protease Inhibitor MK-5172 for Chronic Hepatitis C Virus Genotype 1 Infection at the International Liver Congress™ merck.com ↗
versus 54 percent (31/57) in the boceprevir plus PR active control arm. |
| 2013-04-08 | Merck Sharp & Dohme LLC | Results Merck to Present New Data on VICTRELIS® (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver CongressTM / 2013 EASL Annual Meeting merck.com ↗
Virologic Response Rates Are Similar In Previously Untreated And Previously Treated And Relapsed Patients Receiving Boceprevir Triple Therapy: A Retrospective Analysis. |
| 2012-11-10 | Merck Sharp & Dohme LLC | Results Merck Reports New Phase III Analyses on Anemia Management Strategies Used With VICTRELIS® (boceprevir) Combination Therapy, Including Cirrhotic Patients merck.com ↗
SVR rates were generally similar regardless of when patients began ribavirin dose reduction, the number of steps of ribavirin dose reduction, or the lowest ribavirin dose of 400 to 1,000 mg/day received for at least 14 days for anemia management. |
| 2012-11-10 | Merck Sharp & Dohme LLC | Results Interim Phase II Data of Merck’s Investigational MK-5172 in Combination Therapy in Chronic Hepatitis C Virus Genotype 1 Infection to be Presented at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting merck.com ↗
The MK-5172 regimens had rates of cEVR ranging from 82.8 to 93 percent, versus the control of 74.2 percent. |
| 2012-04-19 | Merck Sharp & Dohme LLC | Results Merck Reports Phase III Study Results Evaluating Anemia Management Strategies Used With VICTRELIS® (boceprevir) Combination Therapy merck.com ↗
The rates of SVR were 71 percent for both groups: those patients whose anemia was managed by ribavirin dose reduction (178/249) and those patients whose anemia was managed by the addition of erythropoietin (EPO) (178/251). |
| 2012-03-06 | Merck Sharp & Dohme LLC | Results Results from Investigational Studies with VICTRELIS™ (boceprevir) Presented at the Conference on Retroviruses and Opportunistic Infections to Understand Potential Use in Patients Coinfected with Chronic Hepatitis C and HIV-1 merck.com ↗
In this study, concomitant administration of VICTRELIS with ritonavir (Norvir ® ) in combination with atazanavir (Reyataz ® ) or darunavir (Prezista ® ), or with lopinavir/ritonavir (Kaletra ® ) resulted in reduced exposures of the HIV medicines and VICTRELIS. |
| 2011-11-05 | Merck Sharp & Dohme LLC | Results Interim Data for Merck’s VICTRELISTM (boceprevir) in Prior Null Responder Patients with Chronic Hepatitis C Genotype 1 to be Presented at The American Association for the Study of Liver Diseases 2011 Annual Meeting merck.com ↗
In this interim analysis, 38 percent (16/42) of prior null responders achieved a sustained virologic response (SVR)1 when treated with VICTRELIS in combination with P/R. |
| 2011-10-20 | Merck Sharp & Dohme LLC | Results Interim Phase IIb Data for Merck’s VICTRELIS™ (boceprevir) in Patients Coinfected with Chronic Hepatitis C and HIV-1 Presented at the Infectious Diseases Society of America (IDSA) 2011 Annual Meeting merck.com ↗
These interim results are being presented for the first time in a late-breaker oral presentation at the Infectious Diseases Society of America (IDSA) 2011 annual meeting in Boston. |
All press releases naming this drug 13 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 54 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | boceprevir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01396005 ↗ |
| Known as | BOC | “On day 15 the participants will attend for their 2nd long visit (10 hours) when they will be administered boceprevir (BOC) 800mg (4 capsules) with a standardised meal then have...” NCT01499498 ↗9“This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African...” NCT01446250 ↗ “Recent data show that adding an HCV serine protease inhibitor (such as boceprevir \[BOC\]) to peg-IFN and RBV results in HCV eradication rates of 70% to 80% among...” NCT01443923 ↗ “Boceprevir (BOC) is an Hepatitis C (HCV) NS3 serine protease inhibitor that has recently received FDA approval for the treatment of chronic HCV infection.” NCT01470690 ↗ “The addition of boceprevir(BOC) on atazanavir (ATV) or raltegravir (RAL) pharmacokinetic parameters in a subgroup of patients.” PMID 27077673 ↗ Feb 2016 “triple therapy with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver transplantation(LT)” NCT02160080 ↗ “Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.” NCT02204475 ↗ “Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400” NCT00160251 ↗ “Boceprevir (BOC)” NCT01482767 ↗ “Boceprevir (BOC)” NCT01390844 ↗ |
| Known as | Boceprevir: Victrelis | “Boceprevir: Victrelis” NCT01457937 ↗ |
| Known as | EBP 520 | ChEMBL registry synonym — accepted as the source's own label CHEMBL218394 ↗ |
| Known as | SCH 503034 | “Boceprevir (SCH 503034)” NCT00708500 ↗ |
| Known as | Sch 50304 | ChEMBL registry synonym — accepted as the source's own label CHEMBL218394 ↗ |
| Known as | Victrelis | “Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets)” NCT01949168 ↗ |
| Known as | Victrelis (Boceprevir) | “Victrelis (Boceprevir)” NCT02160080 ↗ |
| Known as | Victrelis(r) | “Boceprevir as Victrelis(r) 200mg capsules” NCT01663922 ↗ |
| Action | Inhibit | “boceprevir, an NS3 protease inhibitor” PMID 20692693 ↗ Aug 2010 |
| Modality | Small molecule | — CHEMBL218394 ↗ |
| Route | Oral | “100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID” NCT00160251 ↗ |
| Target | CYP3A4 | “Boceprevir is a strong inhibitor of CYP3A4/5.” NCT01663922 ↗ |