Drug information

Audio
Other Names:
PegIntron (brand product for the treatment of chronic hepatitis C), Sylatron (brand product for the treatment of melanoma), PEG-interferon alfa 2b (HIV), pegIFN alfa-2b (HIV), pegylated-interferon alfa 2b (HIV)
Drug Class:
Immune Modulators
Registry Number:
215647-85-1 (CAS)
Chemical Name:

Monocarboxyinterferon alfa-2b, diesters with polyethylene glycol monomethyl ether

Chemical Class:
Recombinant interferon
Organization:
Merck Sharp & Dohme Corp.
Phase of Development:

Peginterferon alfa-2b is in Phase 3 development for HIV treatment.

(Compound details obtained from ChemIDplus Advanced,1 WHO Drug Information,2 PegIntron Full Prescribing Information,3 and ClinicalTrials.gov4,5)

 
What is peginterferon alfa-2b?What is peginterferon alfa-2b?

What is peginterferon alfa-2b?

Peginterferon alfa-2b is a drug that has been approved by the U.S. Food and Drug Administration (FDA) under the brand name PegIntron to treat chronic hepatitis C virus infection and under the brand name Sylatron for the treatment of melanoma.3,6 It is also being studied as an investigational drug to treat HIV infection.7

As an investigational HIV drug, peginterferon alfa-2b belongs to a group of drugs called immune modulators.2 Immune modulators (also called immunomodulators) are substances that help to activate, boost, or restore normal immune function. Researchers are currently studying whether using peginterferon alfa-2b in combination with other drugs can help control HIV infection.8

To learn how investigational drugs are tested during clinical trials, read the HIVinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

Select clinical trials of peginterferon alfa-2bSelect clinical trials of peginterferon alfa-2b

Select clinical trials of peginterferon alfa-2b

Study Name: NCT01295515
Phase: 1/2
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the effect of peginterferon alfa-2b on the latent HIV reservoir in participants with viral suppression who used the drug in addition to ART.9

Study Name: NCT01935089
Phase: 2
Status: This study has been completed.
Location: United States
Purpose:The purpose of this study was to see if peginterferon alfa-2b could reduce the latent HIV reservoir in participants who were virally suppressed.
Selected Study Results: Results were presented at CROI 2017 and published in the AIDS Research and Human Retroviruses journal. During 20 weeks of peginterferon alfa-2b plus ART treatment (with a 4-week structured treatment interruption of ART), there was a trend toward a decrease in HIV persistence and latent reservoir size, as measured by a change in integrated HIV DNA in the blood and total HIV DNA and cell-associated RNA in gut-associated lymphoid tissue.10–12

Study Names: BEAT-HIV study; NCT02227277
Phase: 2
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to see if peginterferon alfa-2b could reduce the latent HIV reservoir in participants who were virally suppressed on ART.
Selected Study Results: Results presented at CROI 2019 found that both peginterferon alfa-2b plus a structured treatment interruption of ART and peginterferon alfa-2b plus ART had no substantial effect on latent HIV reservoir size, as measured by a change in integrated HIV DNA during 20 weeks of treatment. However, treatment with peginterferon alfa-2b reduced other measurements of HIV persistence (inducible HIV p24 levels).13,14

Study Names: ANRS 112 INTERPRIM trial; NCT00196638
Phase: 2/3
Status: This study has been completed.
Location: France
Purpose: The purpose of this study was to investigate how well three different treatment strategies could lower viral loads in participants with acute HIV infection. One of the strategies included treatment with peginterferon alfa-2b.
Selected Study Results: Results published in the AIDS journal showed that fixed-cycles of ART treatment interruption with and without peginterferon alfa-2b had no effect on viral load levels when compared to ART alone.15,16

Study Names: ANRS 105 INTERVAC trial; NCT00125814
Phase: 3
Status: This study has been completed.
Location: France
Purpose: The purpose of this study was to determine whether the use of peginterferon alfa-2b during structured treatment interruptions of ART could postpone the need for resumption of ART.
Selected Study Results: Results published in the AIDS journal demonstrated that peginterferon alfa-2b given during structured treatment interruptions of ART is not beneficial in postponing the need for resuming ART.4,17

For more details on the studies listed above, see the Health Professional version of this drug summary.

Other HIV treatment studies that are looking at peginterferon alfa-2b  have been completed or are ongoing:

What side effects might peginterferon alfa-2b cause?What side effects might peginterferon alfa-2b cause?

What side effects might peginterferon alfa-2b cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of peginterferon alfa-2b listed above.

NCT01935089:
In this Phase 2 study, the most common side effect was neutropenia. Six serious cases of neutropenia were managed with treatment or by stopping peginterferon alfa-2b. One person withdrew from the study because of continued depression that was moderate in severity.11,18

BEAT-HIV study (NCT02227277):
In this Phase 2 study, participants were assigned to one of the following groups: peginterferon alfa-2b plus structured treatment interruption, peginterferon alfa-2b plus ART, or only ART. In each of the peginterferon alfa-2b groups, two participants had a severe or life-threatening side effect that was related to treatment.14

ANRS 112 INTERPRIM (NCT00196638):
In this Phase 2/3 study, side effects that were associated with taking peginterferon alfa-2b included weakness, flu-like symptoms, neutropenia, and anemia. Most of these side effects were not severe. Some participants who were taking peginterferon alfa-2b had serious neuropsychiatric side effects, including suicide attempts, depression, and epilepsy.15,16 

ANRS 105 INTERVAC (NCT00125814):
In this Phase 3 study, two participants who were taking peginterferon alfa-2b had severe neutropenia, and one participant had moderately high levels of triglycerides. Six participants who were taking peginterferon alfa-2b withdrew from the study before Week 48.17

Because peginterferon alfa-2b is still being studied in people with HIV, information on possible side effects of the drug is not complete. As testing of peginterferon alfa-2b continues, additional information on possible side effects will be gathered.

Additional information on side effects that are known to be associated with peginterferon alfa-2b can be found in the FDA-approved Full Prescribing Information for PegIntron and Sylatron.

Where can I get more information about clinical trials studying peginterferon alfa-2b?Where can I get more information about clinical trials studying peginterferon alfa-2b?

Where can I get more information about clinical trials studying peginterferon alfa-2b?

More information about research studies related to peginterferon alfa-2b is available from ClinicalTrials.gov.

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.

 
ReferencesReferences

References

 

  1. United States National Library of Medicine. ChemIDplus Advanced: Peginterferon Alfa-2b. https://chem.nlm.nih.gov/chemidplus/rn/215647-85-1. Accessed August 9, 2021
  2. World Health Organization (WHO). WHO drug information. 2000;14(4). http://whqlibdoc.who.int/druginfo/DRUG_INFO_14_4_2000_INN-84.pdf. Accessed August 9, 2021
  3. Merck Sharp & Dohme Corp. PegIntron: full prescribing information, November 2, 2020. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid = b70816bb-913a-467f-acb8-67ef62cf8dac. Accessed August 9, 2021
  4. French National Agency for Research on AIDS and Viral Hepatitis. Multi-Center trial to evaluate the efficacy and safety of structured treatment interruptions with or without pegylated interferon alpha for HIV-infected patients after prolonged viral suppression (ANRS 105 INTERVAC). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 1, 2005. NLM Identifier: NCT00125814. https://clinicaltrials.gov/ct2/show/NCT00125814. Accessed August 9, 2021
  5. Merck Sharp & Dohme Corp. Phase 3 study of PEG-intron in heavily treatment-experienced, HIV-infected patients. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 2, 2002. NLM Identifier: NCT00035360. https://clinicaltrials.gov/ct2/show/NCT00035360. Accessed August 9, 2021
  6. Merck Sharp & Dohme Corp. Sylatron: full prescribing information, November 2, 2020. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3874c95c-092e-4cd5-b104-6ed2bc391b0e. Accessed August 9, 2021
  7. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed August 9, 2021
  8. Luis Montaner. Pilot study on innate activation and viral control in HIV-infected adults undergoing an analytical treatment interruption after administration of pegylated interferon alpha 2b with broadly HIV-1 neutralizing antibodies (3BNC117, 10-1074). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 17, 20185. NLM Identifier: NCT03588715. https://clinicaltrials.gov/ct2/show/NCT03588715. Accessed August 9, 2021
  9. National Institute of Allergy and Infectious Diseases (NIAID). Effect of interferon alpha 2b intensification on HIV-1 residual viremia in individuals suppressed on antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 11, 2011. NLM Identifier: NCT01295515. https://clinicaltrials.gov/ct2/show/NCT01295515. Accessed August 9, 2021
  10. The Wistar Institute. Pilot study: single arm, multi-site, open-label study to assess the effectiveness of peg-IFN-a2b in decreasing the levels of cell-associated integrated viral DNA in HIV chronic infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 27, 2013. NLM Identifier: NCT01935089. https://clinicaltrials.gov/ct2/show/NCT01935089. Accessed August 9, 2021
  11. Azzoni L, Papasavvas E, Chomont N, et al. Pegylated IFNa-2b decreases latent HIV measures in ART-suppressed subjects. Presented at the: 23rd Conference on Retroviruses and Opportunistic Infections (CROI). February 13-16, 2017; Seattle, WA. Poster 326. https://2jg4quetidw2blbbq2ixwziw-wpengine.netdna-ssl.com/wp-content/uploads/sites/2/posters/2017/326_Azzoni.pdf. Accessed August 9, 2021
  12. Papasavvas E, Azzoni L, Pagliuzza A, et al. Safety, Immune, and Antiviral Effects of Pegylated Interferon Alpha 2b Administration in Antiretroviral Therapy-Suppressed Individuals: Results of Pilot Clinical Trial. AIDS Res Hum Retroviruses. 2021;37(6):433-443. doi:10.1089/AID.2020.0243
  13. The Wistar Institute. Towards eradication: reducing proviral HIV DNA with interferon-a immunotherapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 25, 2014. NLM Identifier: NCT02227277. https://clinicaltrials.gov/ct2/show/NCT02227277. Accessed August 9, 2021
  14. Azzoni L. Interferon-α2b reduces inducible CD4-associated HIV in ART-suppressed individuals. Webcast presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2019; Seattle, WA. http://www.croiwebcasts.org/console/player/41302?mediaType = slideVideo&. Accessed August 9, 2021
  15. French National Agency for Research on AIDS and Viral Hepatitis. Multicentric trial comparing three therapeutical strategies in patients with acute primary HIV infection. ANRS 112 INTERPRIM. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 12, 2005. NLM Identifier: NCT00196638. https://clinicaltrials.gov/ct2/show/NCT00196638. Accessed August 9, 2021
  16. Goujard C, Emilie D, Roussillon C, et al. Continuous versus intermittent treatment strategies during primary HIV-1 infection: the randomized ANRS INTERPRIM Trial. AIDS. 2012;26(15):1895. doi:10.1097/QAD.0b013e32835844d9
  17. Boué F, Reynes J, Rouzioux C, et al. Alpha interferon administration during structured interruptions of combination antiretroviral therapy in patients with chronic HIV-1 infection: INTERVAC ANRS 105 trial. AIDS. 2011;25(1):115-118.
  18. Azzoni L, Papasavvas E, Lynn K, et al. A feasibility study of weight-based pegylated IFN-α2b immunotherapy to target persistent HIV-1 on ART. Presented at the: 8th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment & Prevention. July 19-22, 2015; Vancouver, Canada. Poster TUPEB297. https://www.webcitation.org/6zbdh4Y2I. Accessed August 9, 2021
 

Last Reviewed: August 9, 2021