Effects of peginterferon alfa-2b injection (sylatron): A Synthesis of Findings from 20 Studies

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Original Abstract of the Article

Major Research Findings

Peginterferon alfa-2b is a medication used to treat chronic hepatitis C. It is a formulation of interferon alfa-2b that has been attached to polyethylene glycol (PEG). 4 Peginterferon alfa-2b has a longer half-life than standard interferon alfa, meaning it stays in the body longer. This allows for once-weekly injections instead of three times a week. 11 When used in combination with ribavirin, peginterferon alfa-2b has been shown to be effective in reducing the amount of hepatitis C virus in the body. 6 Some studies have evaluated the use of peginterferon alfa-2b in children with chronic hepatitis C. 6 Peginterferon alfa-2b has also been studied in combination with ribavirin for the treatment of hepatitis C in people who are also infected with HIV. 13 Peginterferon alfa-2b has also been evaluated for its use in treating melanoma. 3 Peginterferon alfa-2b is not without risks, and side effects may include fever, fatigue, loss of appetite, muscle aches, nausea, chills, and injection site reactions. 12 In some cases, more serious side effects such as skin necrosis or tongue darkening have been reported. 11 , 19 People with kidney problems may need to be monitored closely, as their body may not process the medication as quickly. 7 Peginterferon alfa-2b can also interact with methadone, a medication used to treat opioid addiction, so those taking both medications should be monitored closely. 8

Benefits and Risks

Benefit Summary

Peginterferon alfa-2b can be effective in treating chronic hepatitis C. It has a longer half-life than standard interferon alfa, which means it stays in the body longer and allows for less frequent injections. It can also be used to treat melanoma.

Risk Summary

The most common side effects of peginterferon alfa-2b include fever, fatigue, loss of appetite, muscle aches, nausea, chills, and injection site reactions. In some cases, more serious side effects such as skin necrosis or tongue darkening have been reported. People with kidney problems may need to be monitored closely, as their body may not process the medication as quickly. Peginterferon alfa-2b can also interact with methadone, a medication used to treat opioid addiction.

Comparison of Studies

Commonalities

Many studies have found peginterferon alfa-2b to be effective in treating chronic hepatitis C. All studies agree that peginterferon alfa-2b has a longer half-life than standard interferon alfa, leading to less frequent injections, and that it is more effective in reducing the amount of hepatitis C virus in the body when used in combination with ribavirin.

Differences

Different studies have focused on various aspects of peginterferon alfa-2b treatment, including its efficacy for different genotypes of hepatitis C, its safety in patients with other health conditions, and its use in different patient populations, such as children or those co-infected with HIV. Results regarding the efficacy and side effects of peginterferon alfa-2b can vary depending on these factors.

Consistency and Contradictions

The majority of research suggests that peginterferon alfa-2b is an effective treatment for chronic hepatitis C, but some studies have shown less consistent results, indicating the need for further research. There are also inconsistencies in reported side effects across different studies.

Considerations for Real-Life Application

Peginterferon alfa-2b can be an effective treatment for chronic hepatitis C. However, it is important to be aware of the potential side effects and to discuss these risks with your doctor. If you are considering using peginterferon alfa-2b, it is important to talk to your doctor about your medical history and any other medications you are taking.

Limitations of Current Research

There are still many areas where research on peginterferon alfa-2b is limited. For example, more research is needed to understand the long-term effects of peginterferon alfa-2b, as well as the optimal dosing and treatment durations for different patient groups.

Future Research Directions

Future research should focus on long-term effects, optimal dosing regimens, and potential interactions with other medications. It would also be beneficial to conduct more studies in different patient populations and to investigate the use of peginterferon alfa-2b in combination with other treatments.

Conclusion

Peginterferon alfa-2b is a promising medication for treating chronic hepatitis C, offering a longer half-life and greater efficacy compared to standard interferon alfa. However, it is important to be aware of potential side effects and to discuss these risks with your doctor. Further research is needed to fully understand the long-term effects and optimal use of peginterferon alfa-2b.

Literature analysis of 20 papers
Positive Content
16
Neutral Content
2
Negative Content
2
Article Type
4
0
0
1
20
1.

Tolerance and biological activity of pentosan polysulfate after intramuscular or subcutaneous administration for ten days in human volunteers.

Author: SiéP, AlbaredeJ L, RobertM, BoulouxC, LansenJ, ChigotC, CorrellS, ThouvenotJ P, BoneuB

Good tolerance
Liver enzyme elevation
Platelet reduction

Pentosan polysulfate (PPS) is a drug that can be used to treat certain medical conditions. This study investigated the tolerance and pharmacological activity of PPS in 30 healthy volunteers. PPS was well tolerated, with the most common side effects being increased transaminase levels and decreased platelet counts. The study found that PPS significantly prolonged the activated partial thromboplastin time (APTT) and induced a weak but significant circulating anti-Xa activity.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Novel long-acting ropeginterferon alfa-2b: Pharmacokinetics, pharmacodynamics and safety in a phase I clinical trial.

Author: HuangYi-Wen, QinAlbert, FangJane, WangTing-Fang, TsaiChung-Wei, LinKo-Chung, TengChing-Leou, LaroucheRichard

Pharmacokinetic profile
Safety profile

Ropeginterferon alfa-2b, a novel long-acting pegylated interferon alfa-2b, was safe and well tolerated up to a dose of 270 μg. Ropeginterferon alfa-2b had higher drug exposures and a similar safety profile compared to pegylated IFN alfa-2a at the same dose level.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

U.S. Food and Drug Administration Approval: peginterferon-alfa-2b for the adjuvant treatment of patients with melanoma.

Author: HerndonThomas M, DemkoSuzanne G, JiangXiaoping, HeKun, GootenbergJoseph E, CohenMartin H, KeeganPatricia, PazdurRichard

Melanoma treatment
Relapse-free survival
Cardiovascular disease
Fatigue
Increased ALT/AST
Pyrexia

This study evaluated the efficacy and safety of peginterferon alfa-2b (PEG-IFN) for the adjuvant treatment of melanoma patients with microscopic or gross nodal involvement following definitive surgical resection. The study found that PEG-IFN significantly prolonged relapse-free survival, but did not significantly affect overall survival.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

4.

Comparison of peginterferon pharmacokinetic and pharmacodynamic profiles.

Author: BrunoR, SacchiP, CimaS, MaiocchiL, NovatiS, FiliceG, FagiuoliS

Hepatitis C treatment
Trough concentration

Peginterferon alfa-2a and peginterferon alfa-2b are pegylated interferons used to treat chronic hepatitis C. Peginterferon alfa-2a has a longer half-life in serum and maintains detectable trough concentrations during a 7-day dosing schedule. Peginterferon alfa-2b has a shorter half-life and may have trough concentrations below the limit of detection during the latter part of the 7-day dosing schedule. While the pharmacokinetic properties of the two drugs differ, their pharmacodynamic parameters appear to be similar.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Pegylated interferon alfa-2b pen device and ribavirin treatment for patients with chronic hepatitis C: an evaluation of patient satisfaction.

Author: Aggelopoulou-TigaParaskevi, DimitroulopoulosDimitrios, KaligerosKonstantinos, KoutsounasSotirios, KouroumalisElias, DiamantiHelen, IonnidouPanagiota, KountourasJannis, PapaioannouChristos, DimopoulouMaria, GiannoulisGrigoris, KetikoglouIoannis, ProtopapasAndreas, BassarisHarry, DelisVassilios, KaratapanisStylianos, ManolakopoulosSpilios, MimidisKonstantinos, NikolaouAntonios, ThomopoulosKonstantinos, TzelasGeorgios, TsianosEpameinodas, KardasiMaria, PerperasAntonios

Patient satisfaction
Adverse events

Patients are satisfied with the pegylated interferon α-2b pen device for the treatment of chronic hepatitis C, suggesting good treatment adherence.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin.

Author: WirthStefan, Ribes-KoninckxCarmen, CalzadoMaria Angeles, BortolottiFlavia, ZancanLucia, JaraPaloma, SheltonMark, KerkarNanda, GaloppoMarcela, PedreiraAlejandra, Rodriguez-BaezNorberto, CioccaMirta, LachauxAlain, LacailleFlorence, LangThomas, KullmerUlrike, HuberWolf Dietrich, GonzalezTeresita, PollackHenry, AlonsoEstella, BrouePierre, RamakrishnaJyoti, NeigutDeborah, Valle-SegarraAntonio Del, HunterBessie, GoodmanZachery, XuChristine R, ZhengHanzhe, NovielloStephanie, SniukieneVilma, BrassClifford, AlbrechtJanice K

PEG-IFN effective hepatitis C
PEG-IFN safe children

Pegylated interferon (PEG-IFN) alfa-2b plus ribavirin (RBV) was effective in treating children and adolescents with chronic hepatitis C, achieving sustained virologic response (SVR) rates similar to those in adults. The treatment was generally well tolerated, with mild or moderate side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Multiple-dose pharmacokinetics of peginterferon alfa-2b in patients with renal insufficiency.

Author: GuptaSamir K, SwanSuzanne K, MarburyThomas, SmithWilliam, SchwartzSherwyn, KolzKaren, CutlerDavid L

Increased exposure

PEG-IFN alfa-2b exposure was increased in patients with renal insufficiency, suggesting that doses should be reduced for those with moderate or severe renal impairment.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Effects of pegylated interferon alfa-2b on the pharmacokinetic and pharmacodynamic properties of methadone: a prospective, nonrandomized, crossover study in patients coinfected with hepatitis C and HIV receiving methadone maintenance treatment.

Author: BerkSteven I, LitwinAlain H, ArnstenJulia H, DuEvelyn, SolowayIrene, GourevitchMarc N

Methadone confusion
Opioid withdrawal

Pegylated interferon (pegIFN) used in combination with ribavirin is conventional treatment for HCV. However, pegIFN has been associated with adverse effects that may simulate opioid withdrawal and be confused with insufficient methadone dosage.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

9.

Suppressive anti-HCV therapy for prevention of donor to recipient transmission in stem cell transplantation.

Author: SurapaneniSri Naveen, HariParameswaran, KnoxJosh, DanielJack, SaeianKia

Prevented HCV transmission

This case report describes a successful allogeneic hematopoietic stem cell transplantation from an HCV-positive donor to an HCV-negative recipient. The donor was treated with pegylated interferon alfa-2b and ribavirin, resulting in negative HCV PCR prior to transplantation.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Cost-efficacy analysis of peginterferon alfa-2b plus ribavirin compared with peginterferon alfa-2a plus ribavirin for the treatment of chronic hepatitis C.

Author: MaloneDaniel C, TranTram T, PoordadF Fred

HCV treatment cost-efficacy

This analysis compares the cost-effectiveness of pegylated interferon alfa-2b plus ribavirin with pegylated interferon alfa-2a plus ribavirin in treating chronic hepatitis C virus infection.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Cutaneous necrosis after injection of polyethylene glycol-modified interferon alfa.

Author: DalmauJoan, PimentelCarmen Lucia, PuigLuis, PeramiquelLaura, RoéEsther, AlomarAgustin

Longer half-life
Superior antiviral efficacy
Cutaneous necrosis
Dose modification required
Local cutaneous reactions

Pegylated interferon alfa-2b can cause local cutaneous reactions at sites of injection. These reactions can range from mild to severe and may require dose modification or treatment withdrawal.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for treatment of HIV/HCV co-infected patients.

Author: LagunoMontserrat, MurillasJavier, BlancoJosé Luis, MartínezEsteban, MiquelRosa, Sánchez-TapiasJosé M, BargalloXavier, García-CriadoAngeles, de LazzariElisa, LarrousseMaría, LeónAgathe, LoncáMontserrat, MilinkovicAna, GatellJosep M, MallolasJosep

Improved SVR rate
Side effects
Treatment discontinuation

Pegylated interferon alfa-2b (PEG-INF) + ribavirin (RBV) was significantly more effective than interferon alfa-2b (IFN) + RBV for the treatment of chronic hepatitis C in HIV co-infected patients, especially those with genotype 1 or 4.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Pegylated interferon alfa-2b treatment for patients with solid tumors: a phase I/II study.

Author: BukowskiRonald, ErnstoffMarc S, GoreMartin E, NemunaitisJohn J, AmatoRobert, GuptaSamir K, TendlerCraig L

Treats RCC
Treats melanoma
Safety
Tolerability

Pegylated interferon alfa-2b, a treatment for advanced melanoma and renal cell carcinoma, was investigated for safety, tolerability, and effectiveness in a phase I/II study.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

16.

A Phase 1 trial of autologous monocytes stimulated ex vivo with Sylatron<sup>&#174;</sup> (Peginterferon alfa-2b) and Actimmune<sup>&#174;</sup> (Interferon gamma-1b) for intra-peritoneal administration in recurrent ovarian cancer.

Author: GreenDaniel S, NunesAna T, David-OcampoVirginia, EkwedeIrene B, HoustonNicole D, HighfillSteven L, KhuuHanh, StroncekDavid F, SteinbergSeth M, ZoonKathryn C, AnnunziataChristina M

Ovarian cancer treatment
Ovarian cancer recurrence

This study proposes a novel approach to treating ovarian cancer using locoregional immune therapy with interferons and monocytes. The method aims to create a pro-inflammatory environment at the site of disease to kill malignant cells.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., IntramuralFunding provided by the NIH for research projects within the NIH.

Language : English

17.

Efficacy of response-guided directly observed pegylated interferon and self-administered ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: The ACTIVATE study.

Author: GrebelyJason, DalgardOlav, CunninghamEvan B, HajarizadehBehzad, FosterGraham R, BruggmannPhilip, ConwayBrian, BackmundMarkus, RobaeysGeert, SwanTracy, AminJanaki, MarksPhilippa S, QuieneSophie, ApplegateTanya L, WeltmanMartin, ShawDavid, DunlopAdrian, HellardMargaret, BruneauJulie, MidgardHåvard, BourgeoisStefan, StaehelinCornelia, DoreGregory J,

Effective treatment
None mentioned

This study examines the efficacy of response-guided therapy for chronic hepatitis C virus (HCV) infection among people with ongoing injecting drug use or receiving opioid substitution therapy (OST). The study aims to identify predictors of treatment response and address the limited data available on HCV treatment in this population.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

18.

A preliminary study on the efficacy and influencing factors of interferon for the treatment of genotype 1 chronic hepatitis C with different dosage forms.

Author: MaPing, YangJi-Ming, HouWei, SongShi-Duo, WangLei, LuWei

Improved hepatitis C treatment

Peginterferon alfa-2a plus ribavirin was more effective than interferon alfa-2b plus ribavirin in the treatment of genotype 1 chronic hepatitis C with similar safety.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

19.

Tongue hyperpigmentation resulting from peginterferon alfa-2b and ribavirin treatment in a patient with chronic hepatitis C.

Author: GhoshSouvik, DusejaAjay, DhimanRadha Krishan, ChawlaYogesh Kumar

Tongue hyperpigmentation

Tongue hyperpigmentation has been reported as a side effect of combination therapy with peginterferon alfa (PEG-INF) and ribavirin in patients with hepatitis C virus (HCV) infection.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

20.

Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases.

Author: MelikyanA L, SubortsevaI N, GilyazitdinovaE A, KoloshejnovaT I, PustovayaE I, EgorovaE K, KovriginaA M, SudarikovA B, AbdullaevA O, LomaiaE G, SiordiyaN T, ZaritskeyA Yu, SavchenkoV G

Clinical responses
ET treatment
PV treatment
Hair loss
Hematologic adverse events
Local reactions
Pulmonary embolism
Skin toxicity

Treatment with ce-pegiterferone alpha-2b (ce-pegalpha-INF-α-2b) was highly effective in patients with polycythemia vera (PV) and essential thrombocythemia (ET), with most patients achieving clinical and hematological responses. The safety profile was acceptable.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

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