Drugs

Peginterferon Alfa-2b (HIV)

Peginterferon Alfa-2b (HIV)

Other Names: PEG-interferon alfa 2b (HIV), PegIntron (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 III 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?

Peginterferon alfa-2b is being studied as an investigational HIV drug for the treatment of HIV infection.6–9 Peginterferon alfa-2b is currently approved by the U.S. Food and Drug Administration (FDA) to treat chronic hepatitis C virus infection (HCV) under the brand name PegIntron.3

As an HIV medicine, peginterferon alfa-2b is categorized as an immune modulator.2 Immune modulators (also called immunomodulators) are substances that help to activate, boost, or restore normal immune function. Peginterferon alfa-2b may have the ability to activate the immune systems of people living with HIV. Researchers are studying whether using peginterferon alfa-2b in combination with antiretroviral therapy (ART) can help control HIV infection.6–8

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

Which clinical trials are studying peginterferon alfa-2b?

Which clinical trials are studying peginterferon alfa-2b?

Study Name: NCT01295515
Phase: I/II
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to add peginterferon alfa-2b to a person’s antiretroviral therapy and look at the effect on residual HIV in participants with viral suppression.6

Study Name: NCT01935089
Phase: II
Status: This study has been completed.
Location: United States
Purpose:The purpose of this study was to see if peginterferon alfa-2b could reduce latent HIV in participants with viral suppression.7,10,11

Study Names: BEAT-HIV study; NCT02227277
Phase: II
Status: This study is ongoing, but not recruiting participants.
Location: United States
Purpose: The purpose of this study is to see if peginterferon alfa-2b can reduce latent HIV in participants with viral suppression on ART.8

Study Names: ANRS 112 INTERPRIM trial; NCT00196638
Phase: II/III
Status: This study has been completed.
Location: France
Purpose: The purpose of this study was to investigate how well 3 different treatment strategies could lower viral loads in participants with acute HIV infection. One of the strategies included treatment with peginterferon alfa-2b.12–14

Study Names: ANRS 105 INTERVAC trial; NCT00125814
Phase: III
Status: This study has been completed.
Location: France
Purpose: The purpose of this study was to see whether treatment with peginterferon alfa-2b during an analytical treatment interruption could postpone the need to restart HIV medicines. An analytical treatment interruption is a planned break from HIV medicines to evaluate how well an investigational drug can maintain control of a participant’s viral load during a clinical trial.4,15

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

Other HIV treatment studies involving peginterferon alfa-2b have also been completed. These include a Phase III study (NCT00035360) that looked at adding peginterferon alfa-2b to optimized background therapy in adults whose HIV had not been controlled by multiple attempts with ART.5

 

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 II pilot 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.10,11

ANRS 112 INTERPRIM (NCT00196638):
In this Phase II/III study, side effects associated with peginterferon alfa-2b included weakness, flu-like symptoms, neutropenia, and anemia. Most of these side effects were not severe. Some participants taking peginterferon alfa-2b had serious neuropsychiatric side effects, including 2 cases of suicide attempts, 1 case of depression, and 1 case of epilepsy.12,13

ANRS 105 INTERVAC (NCT00125814):
In this Phase III study, 2 participants taking peginterferon alfa-2b had severe neutropenia, and 1 participant had moderately high levels of triglycerides. Six participants taking peginterferon alfa-2b withdrew from the study before Week 48.15

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?

More information about research studies on peginterferon alfa-2b is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.

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 information, visit NIH Clinical Research Trials and You.

 

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced. https://chem.nlm.nih.gov/chemidplus/rn/215647-85-1. Accessed July 24, 2018.
  2.  World Health Organization (WHO). WHO drug information. 2000;14(4). http://apps.who.int/medicinedocs/pdf/s2201e/s2201e.pdf. Accessed July 24, 2018.
  3.  Merck Sharp & Dohme Corp. PegIntron - peginterferon alfa-2b: Full prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b70816bb-913a-467f-acb8-67ef62cf8dac. Published February 2017. Accessed July 24, 2018.
  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 July 24, 2018.
  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 July 24, 2018.
  6.  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 July 24, 2018.
  7.  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 July 24, 2018.
  8.  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 July 24, 2018.
  9.  Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed July 24, 2018.
  10.  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. http://pag.ias2015.org/PAGMaterial/eposters/2852.pdf. Accessed July 24, 2018.
  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. http://www.croiconference.org/sites/default/files/posters-2017/326_Azzoni.pdf. Accessed July 24, 2018.
  12.  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 July 24, 2018.
  13.  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
  14.  Adalid-Peralta L, Godot V, Colin C, et al. Stimulation of the primary anti-HIV antibody response by IFN-{alpha} in patients with acute HIV-1 infection. J Leukoc Biol. 2008;83(4):1060-1067. doi:10.1189/jlb.1007675
  15.  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: July 6, 2018