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ribavirin + PEG-IFNalpha-2a (Copegus + Pegasys / Pegasys + Copegus / Pegasys/Copegus)

✓ Approved

Roche · IFNAR2 · Small Molecule

What is ribavirin + PEG-IFNalpha-2a?

ribavirin + PEG-IFNalpha-2a is a small molecule developed by Roche. It is approved for therapeutic indications via injectable (others) or oral (po) or subcutaneous injection.

Drug Profile

Brand NamesCopegus + Pegasys, Pegasys + Copegus, Pegasys/Copegus
CompanyRoche
Drug ClassSmall Molecule
Molecular TargetIFNAR2
RouteInjectable (Others), Oral (PO), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Roche

Mechanism of Action

Molecular Targets

ribavirin + PEG-IFNalpha-2a acts on 1 molecular target:

IFNAR2interferon alpha and beta receptor subunit 2 (IFNARB, IFN-alpha-REC)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

ribavirin + PEG-IFNalpha-2a is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis C✓ Approved

Related Research Articles

PubMedAnalytical chemistry2026-11-11

Deciphering the In Vivo Fate of PEGylated rhGH via a Molecular Ruler-Based MS Strategy.

Liu Kexin K, Zou Yuqing Y, Gu Qian Q, Song Shiwen S et al.

A growing number of long-acting protein therapeutics rely on high-molecular-weight (HMW) polyethylene glycol (PEG) conjugation to extend circulation time, yet the in vivo fate of PEG-derived species remains a critical blind spot for drug safety and regulatory evaluation. A key analytical challenge is that intact conjugates and PEG-derived species cannot be resolved by intact-protein or total-PEG measurements alone. Here we report a molecular ruler-based mass spectrometry strategy that integrates MSALL acquisition, PEG standard calibration anchors spanning broad molecular-weight ranges, and a self-built high-resolution mass spectral (HRMS) library to convert broad, overlapping PEG signal envelopes into temporally traceable, molecular-weight-referenced analytical targets. Applied to 40 kDa PEG-modified recombinant human growth hormone (PEG-rhGH) in rats, the workflow quantitatively traced the intact conjugate (plasma half-life t1/2 = 26.83 h) and concurrently resolved tissue-associated PEG 40 kDa and a PEG-related metabolite series. Intact PEG-rhGH remained below the validated tissue LLOQ, whereas PEG-derived components accumulated preferentially in the liver (peak at 48 h), with total urinary and fecal recovery of the quantitatively monitored intact PEG-rhGH and PEG 40 kDa below 10% by 144 hindicating profoundly delayed elimination. HRMS interrogation revealed low-molecular-weight PEG oligomers (PEG7-PEG21) together with carboxylic-acid- and aldehyde-terminated species in liver, consistent with in vivo chain shortening and end-group transformation. By linking intact-conjugate exposure, tissue accumulation, metabolite profiling, and excretion within a single transferable framework, this strategy provides a measurement-science tool for the systematic evaluation of HMW PEGylated protein therapeutics and other pharmaceutical polymer systems.

PMID 43010503
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PubMedThe Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology2026-11-11

Castor Oil Plus Polyethylene Glycol Electrolyte for Colonoscopic Bowel Preparation: A Prospective 3-Arm Randomized Controlled Trial.

Li Yanxia Y, Wang Wenjuan W, Jiang Xiaoda X, Huang Xu X et al.

The aim of this study was to compare 2 reduced-volume polyethylene glycol (PEG) electrolyte solution regimens combined with castor oil (CaO) with conventional 3-L PEG for bowel preparation before colonoscopy. This single-center, prospective, randomized, endoscopist-blinded trial enrolled 720 adults undergoing elective colonoscopy. Participants were assigned to receive 3-L PEG (group A), 2-L PEG plus 40 mL of CaO (group B), or 1-L PEG plus 40 mL of CaO (group C). The primary outcome was right-colon cleansing assessed using the Boston Bowel Preparation Scale (BBPS). Secondary outcomes included BBPS scores for other colonic segments and the total colon, Colon Endoscopic Bubble Scale (CEBuS) scores, adenoma detection rate (ADR), and preparation-related adverse events. Complete colonoscopy was achieved in 691 participants. Mean right-colon BBPS scores were 2.03 Å} 0.57, 2.45 Å} 0.53, and 2.31 Å} 0.27 in groups A, B, and C, respectively (overall P = .013). The score was higher in group B than in group A (P = .048), whereas the difference between groups B and C was not statistically significant (P = .096). Group B also had a lower CEBuS score than group A (1.02 Å} 0.42 vs. 1.73 Å} 0.16; P = .048). ADRs were 22.1%, 34.5%, and 29.9% in groups A, B, and C, respectively (overall P = .012), with a higher rate in group B than in group A (P = .038). Most pairwise differences in adverse events were not significant. No serious preparation-related adverse events occurred. The 2-L PEG plus CaO regimen improved right-colon cleansing and bubble clearance and was associated with a higher ADR compared with conventional 3-L PEG.

PMID 43012342
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PubMedBMC pediatrics2026-11-11

Comparison of long-acting versus short-acting growth hormone therapy in children with idiopathic short stature: a retrospective cohort study with advanced causal inference methods.

Hou Yanfang Y

To compare the efficacy and safety of polyethylene glycol-modified recombinant human growth hormone (PEG-rhGH) versus daily rhGH in children with idiopathic short stature (ISS) during 12-24 months of follow-up and to propose individualised treatment strategies incorporating mid-parental height standard deviation score (MPH-SDS) correction for genetic potential. This single-centre retrospective cohort study enrolled patients aged 4-14 years with ISS consecutively between January 2018 and December 2024. Treatment assignment reflected real-world physician-guardian shared decision-making after counselling regarding observation, daily rhGH and PEG-rhGH, and prescribed starting doses averaged 0.17 ± 0.03 mg/kg/week for PEG-rhGH and 0.23 ± 0.04 mg/kg/week for daily rhGH. Propensity score matching (1:1, calliper = 0.2) and inverse probability treatment weighting controlled for confounding. Linear mixed-effects models estimated treatment × time interactions, and marginal structural models adjusted for time-dependent confounding. Multiple sensitivity analyses, including E-value calculation, negative control outcomes and sex-stratified subgroup analyses, were conducted. Among 596 patients (187 PEG-rhGH, 213 daily rhGH and 196 controls), 12-month height SDS changes were 0.82 ± 0.31, 0.65 ± 0.28 and 0.18 ± 0.21, respectively. Adjusted mean differences versus controls were 0.64 SDS (95% confidence interval [CI]: 0.58-0.70) for PEG-rhGH and 0.47 SDS (95% CI: 0.41-0.53) for daily rhGH (both p < 0.001). Direct comparison showed PEG-rhGH superior by 0.17 SDS, increasing to 0.31 SDS after MPH-SDS adjustment (95% CI: 0.24-0.38, p < 0.001), exceeding the preset minimal clinically important difference of 0.3 SDS. At 24 months, height SDS improvements were 1.38 ± 0.42, 1.09 ± 0.38 and 0.31 ± 0.27, respectively. Sex-stratified analyses confirmed consistent effects in boys and girls (interaction p = 0.72). Children with lower MPH-SDS showed greater benefit from PEG-rhGH. Safety profiles were comparable. Growth hormone treatment significantly improved height SDS in children with ISS, and PEG-rhGH demonstrated marginal superiority over daily rhGH that reached clinical significance after MPH-SDS correction. Children with lower genetic height potential preferentially benefit from long-acting formulations.

PMID 43009862
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PubMedLiver international : official journal of the International Association for the Study of the Liver2026-11-11

The Nucleoside Analogue NITD008, Alone or Combined With Ribavirin, Potently Reduces Hepatitis E Virus Infection in Humanised Mice.

Volmari Annika A, Hinte Florian F, Volz Tassilo T, Chen Junfei J et al.

Hepatitis E virus (HEV) infection is becoming increasingly clinically relevant worldwide, but no approved antiviral therapy currently exists. Ribavirin (RBV) is used off-label for immunosuppressed patients with chronic hepatitis E, although it is effective in only 80% of patients and linked to side effects. The nucleoside analogue NITD008 was shown to be effective against a broad range of RNA viruses. We aimed to evaluate the efficacy of NITD008, alone or in combination with RBV, in humanised mice stably infected with HEV. Mice received either NITD008 alone (20 mg/Kg/day) by oral gavage for up to 2 weeks, or 5 mg/Kg NITD008 alone or in combination with RBV (50 mg/Kg). Viral changes were determined in faeces, blood and intrahepatically. NITD008 efficiently reduced HEV loads to undetectable levels in serum and by > 4log10 in faeces within 1 week. Intrahepatic analysis showed a ∆log10: 2.5 reduction in HEV RNA levels in treated mice compared to controls after 2 weeks. Imaging showed fewer HEV-RNA-positive human hepatocytes in treated mice. NITD008 did not increase serum markers of hepatocyte death. Combination therapy induced stronger suppression of HEV RNA in faeces (∆log10: 5.02) than RBV monotherapy (∆log10: 1.08), despite lower NITD008 doses. This study demonstrates the non-toxicity of NITD008 towards human hepatocytes and more potent antiviral activity compared to RBV in HEV-infected mice. Combination regimens with RBV showed strong additive activity. The study suggests that HEV clearance may be achieved in immunosuppressed patients by using and further developing this class of direct antiviral drugs.

PMID 43012094
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PubMedClinical pharmacology and therapeutics2026-11-11

Antiviral Activity and Safety of Molnupiravir in Healthy Participants Inoculated With Influenza Virus: A Phase 2a, Randomized, Human Challenge Trial.

Nussbaum Jesse J, Mann Alex J AJ, Liao Laura E LE, Zhao Tian T et al.

Influenza viruses cause substantial global morbidity and mortality. Molnupiravir, an orally administered prodrug of β-D-N4-hydroxycytidine, has broad activity against RNA viruses, including influenza. A phase 2a, randomized, two-part human challenge trial in healthy adults (NCT05818124) was conducted to evaluate molnupiravir for influenza infection. In Part 1, 20 participants were inoculated with 106.26TCID50 of A/France/759/21 (H1N1) to establish infectivity, pathogenicity, and safety. After assessment of Part 1, a 10-fold lower virus dose was selected for Part 2 to delay time to peak viral load (PVL). In Part 2, 141 participants were randomized 1:1:1:1 to receive molnupiravir (5 days, 800 mg twice daily) postexposure prophylaxis (PEP; initiated 12 hours after inoculation), molnupiravir treatment (initiated 48 hours after inoculation), oseltamivir treatment (5 days, 75 mg twice daily, initiated 48 hours after inoculation), or placebo. Primary endpoints, assessed by quantitative viral culture, were PVL in all participants for PEP and viral load area under the curve (VL-AUC) in participants with confirmed infection for treatment. Lowering the viral inoculum delayed PVL by ~12 hours, although infection rates in the Part 2 placebo arm (40%) were lower than in Part 1 (75%). Molnupiravir PEP did not significantly reduce PVL compared with placebo but was associated with lower viral burden (difference in mean log10 VL-AUC -2.21 day*log10TCID50/mL; P = 0.03). No significant antiviral effect was observed with molnupiravir or oseltamivir treatment compared with placebo. Molnupiravir was well tolerated, with an adverse event profile similar to placebo. Although primary endpoints were not met, early administration of molnupiravir showed antiviral activity.

PMID 43010566
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PubMedAntimicrobial agents and chemotherapy2026-11-11

Rosmarinic acid exerts anti-CVB3 effects by inducing HO-1 via the SIRT1/AMPKα/Nrf2 pathway.

Huang Junbo J, Song Qing Q, Di Yanjun Y, Cheng Zhiyun Z et al.

Coxsackievirus B3 (CVB3) is the primary pathogen of viral myocarditis (VMC), and there is no specific therapy. Rosmarinic acid (RA) has anti-inflammatory and antioxidant properties, but its anti-CVB3 activity and mechanism remain unclear. This study examined the inhibitory effect of RA on CVB3 replication and VMC, and the underlying mechanism. In CVB3-infected HeLa cells and a mouse VMC model, RA blocked viral replication dose-dependently, with an EC50 of 26.49 μM and a selectivity index of 21.72, which was more effective than ribavirin. Time-of-addition experiments showed that RA interfered with the post-entry replication stage. Mechanistically, RA directly bound sirtuin 1 (SIRT1), with an affinity of -10.2 kcal/mol, increasing its conformational stability and inhibiting ubiquitin-proteasome degradation, thereby reversing CVB3-induced SIRT1 downregulation. Antiviral and anti-inflammatory effects of RA were abolished by SIRT1 knockdown. RA activated the AMPK/Nrf2/HO-1 cascade in a SIRT1-dependent manner. Notably, the HO-1 metabolite biliverdin (BV) stimulated STAT1/2 phosphorylation and interferon-stimulated gene expression. In vivo, RA effectively ameliorated CVB3-induced myocardial injury and restored SIRT1/AMPK/Nrf2/HO-1 expression. In conclusion, RA prevents CVB3 replication and VMC via direct binding and stabilization of SIRT1, activation of the SIRT1/AMPK/Nrf2/HO-1/BV signaling pathway, and stimulation of interferon response through STAT1/2.

PMID 43012511
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