Drug information

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Other Names
PegIntron (brand product for the treatment of chronic hepatitis C [discontinued]), Sylatron (brand product for the treatment of melanoma [discontinued]), 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 was previously 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 to treat melanoma; both products are no longer marketed in the United States3,6-9 Peginterferon alfa-2b is also being studied as an investigational drug to treat HIV infection.10

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.11

To learn how investigational drugs are tested during clinical trials, read the HIVinfo What is an Investigational HIV Drug? and HIV and 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 low-level persistent viremia and latent HIV reservoir size in participants with viral suppression who added peginterferon alfa-2b to ART.12

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.13,14
Selected Study Results: Results presented at CROI 2017 and published in AIDS Research and Human Retroviruses (2021) demonstrated that 20 weeks of treatment with peginterferon alfa-2b plus ART (with a 4-week analytical treatment interruption of ART), led to a reduction in measures of HIV persistence and latent reservoir size. Specifically, there was a trend toward a decrease in the latent HIV reservoir, as measured by a change in integrated HIV DNA in circulating CD4 cells. In gut-associated lymphoid tissue (GALT), there was a significant reduction in the number of HIV RNA-positive cells. (Gut-associated lymphoid tissue consists of immune cells in the lining of the gut and is a major site of the body where HIV establishes infection and persists long-term.)14,15

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.16,17
Selected Study Results: Results presented at CROI 2019 found that both peginterferon alfa-2b plus an analytical 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).17

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.18,19
Selected Study Results: Results published in the journal AIDS (2012) 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.19

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 analytical treatment interruptions of ART could postpone the need for resumption of ART.4,20
Selected Study Results: Results published in the journal AIDS (2011) demonstrated that peginterferon alfa-2b given during analytical treatment interruptions of ART is not beneficial in postponing the need for resuming ART.20

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, 20 participants enrolled to receive a 20-week course of weekly peginterferon alfa-2b. One participant experienced moderate depression, and seven participants had severe or potentially life-threatening neutropenia. Three participants stopped peginterferon alfa-2b treatment — two discontinuations were due to life-threatening neutropenia and one discontinuation was due to depression.13,14

BEAT-HIV study (NCT02227277):
In this Phase 2 study, participants were assigned to one of the following groups: peginterferon alfa-2b plus analytical 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.17

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.18,19

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 48.20

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.

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. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)

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 22,2022
  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 22, 2022
  3. Merck Sharp & Dohme Corp. PegIntron: full prescribing information, September 2021 [archived drug label]. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid = b70816bb-913a-467f-acb8-67ef62cf8dac. Accessed August 22, 2022
  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 22, 2022
  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 22, 2022
  6. Merck Sharp & Dohme Corp. Sylatron: full prescribing information, September 2021 [archived drug label]. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3874c95c-092e-4cd5-b104-6ed2bc391b0e. Accessed August 22, 2022
  7. U.S. Food and Drug Administration (FDA) website. Dear health care professional letter, dated March 2015. Merck voluntarily discontinuing all doses of PEGINTRON® (peginterferon alfa-2b) REDIPEN® single-use pre-filled pen. https://www.fda.gov/media/91283/download. Accessed August 22, 2022
  8. U.S. Food and Drug Administration (FDA) website. Dear pharmaceutical purchaser letter, dated August 2015. Merck voluntarily discontinuing all doses of PEGINTRON® (peginterferon alfa-2b) vials. https://www.fda.gov/media/93466/download. Accessed August 22, 2022
  9. U.S. Food and Drug Administration (FDA) website. FDA drug shortages: current and resolved drug shortages and discontinuations reported to FDA. Peginterferon alfa-2b (Sylatron) (Discontinuation). https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Peginterferon alfa-2b (Sylatron)&st=d. Accessed August 22, 2022
  10. Treatment Action Group website. Research toward a cure trials. https://www.treatmentactiongroup.org/cure/trials/. Accessed August 22, 2022
  11. 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 22, 2022
  12. 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 22, 2022
  13. 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 22, 2022
  14. 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
  15. 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 22, 2022
  16. 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 22, 2022
  17. 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 22, 2022
  18. 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 22, 2022
  19. 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
  20. 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.
 

Last Reviewed: August 22, 2022