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AIDSinfo Drug Database

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FDA-approved

Investigational

Peginterferon Alfa-2b (HIV)  Audio icon

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 (ChemID)
Chemical Name: Monocarboxyinterferon alfa-2b, diesters with polyethylene glycol monomethyl ether
Chemical Class: Recombinant interferon
Company: Merck Sharp & Dohme Corp.
Phase of Development: III
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Chemical Image:
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peginterferon alfa-2b
peginterferon alfa-2b
Molecular Weight: 118.1112
(Compound details obtained from ChemIDplus Advanced,1,2 WHO Drug Information,2 PegIntron Full Prescribing Information,3 and ClinicalTrials.gov4,5)

What is an investigational drug?

An investigational drug is one that is under study and is not approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational drug. These research studies are also called clinical trials. Once an investigational drug has been proven safe and effective in clinical trials, FDA may approve the drug for sale in the United States.

To learn more about investigational drugs, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.

What is peginterferon alfa-2b?

Peginterferon alfa-2b (brand name: PegIntron) is a drug that has been approved by FDA for the treatment of chronic hepatitis C virus (HCV) infection. It is currently being studied to see if it can be effective as part of a strategy to cure HIV infection.3,6-9

Currently, there is no cure for HIV infection. One of the main obstacles to curing HIV infection is that the virus can remain hidden and inactive (latent) inside certain cells of the immune system (such as resting CD4 T cells) for many months or even years. While HIV is in this latent state, the immune system cannot recognize the virus, and antiretroviral therapy (ART) has no effect on it. (ART is the recommended treatment for HIV infection and involves using a combination of different antiretroviral [ARV] drugs to prevent HIV from replicating.)10,11

Peginterferon alfa-2b belongs to a class (group) of HIV drugs called immune modulators.2 Immune modulators (also called immunomodulators) are substances that help to activate, boost, or restore normal immune function. Interferon alfa is a protein that is made naturally in the body to help fight viral infections. Peginterferon alfa-2b is a synthetic version of interferon alfa.6,12

Peginterferon alfa-2b is being studied for its ability to help activate the immune systems of HIV-infected individuals. When used along with other drugs, peginterferon alfa-2b may help to clear the body of HIV that cannot be removed with ART alone.6,8

How are clinical trials of investigational drugs conducted?

Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.13

Phase I trials: Researchers test an investigational drug in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
Phase II trials: The investigational drug is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
Phase III trials: The investigational drug is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational drug to be used safely.13

In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States. Some drugs go through FDA’s accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by FDA and made available to the public, researchers track its safety in Phase IV trials to seek more information about the drug’s risks, benefits, and optimal use.13

In what phase of testing is peginterferon alfa-2b?

Peginterferon alfa-2b has been studied in Phase III clinical trials.4

What are some studies on peginterferon alfa-2b?

Study Name: NCT01295515
Phase: I/II
Location: United States
Participants: HIV-infected adults who had taken HIV medicines before starting the study (also called treatment-experienced) and were taking HIV medicines at the time of the study. Participants had:

  • viral load levels (the amount of HIV in a blood sample) that were less than 50 copies/mL for at least 12 months before the study.
  • CD4 counts of at least 300 cells/mm3. (A CD4 count is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function. The CD4 count of a healthy person ranges from 500 to 1,600 cells/mm3.)
  • HIV RNA levels of at least 5 copies/million in peripheral blood mononuclear cells (PBMCs). (Levels of HIV RNA in PBMCs is a measure of low levels of residual HIV in the body that cannot be detected by standard viral load tests.)

Purpose: The purpose of this study is to add peginterferon alfa-2b to ART and look at the effect on residual HIV in participants with viral suppression. (Viral suppression is when ART reduces a person’s viral load to an undetectable level.)6

For more details on this study, see the Health Professional version.

Study Name: NCT01935089
Phase: II
Location: United States
Participants: HIV-infected, treatment-experienced adults who were taking HIV medicines at the time of the study. Participants had viral load levels that were less than 50 copies/mL for at least 12 months before the study and CD4 counts that were greater than 450 cells/mm3.
Purpose: The purpose of this study was to see if peginterferon alfa-2b could reduce latent HIV in participants with viral suppression.7

For more details on this study, see the Health Professional version.

Study Name: BEAT-HIV study; NCT02227277
Phase: II
Location: United States
Participants: HIV-infected, treatment-experienced adults who were taking HIV medicines at the time of the study. Participants had viral load levels that were less than 50 copies/mL for at least 12 months before the study and CD4 counts that were greater than 450 cells/mm3.
Purpose: The purpose of this study is to see if peginterferon alfa-2b can reduce latent HIV in participants with viral suppression.8

For more details on this study, see the Health Professional version.

Study Name: ANRS 112 INTERPRIM trial; NCT00196638
Phase: II/III
Location: France
Participants: HIV-infected adults who had never taken HIV medicines before the study (also called treatment-naive). Participants had acute HIV infection, which is an early stage of HIV infection that extends about 1 to 4 weeks from the initial infection.
Purpose: The purpose of this study was to look at the ability of three different ways to lower viral loads in participants with acute HIV infection. One of the ways included treatment with peginterferon alfa-2b.14

For more details on this study, see the Health Professional version.

Study Name: ANRS 105 INTERVAC trial; NCT00125814
Phase: III
Location: France
Participants: HIV-infected, treatment-experienced adults who had been on the same HIV medicines for at least 6 months before the study. Participants had viral loads that were less than 400 copies/mL for at least 6 months and CD4 counts that were greater 350 cells/mm3.
Purpose: The purpose of this study was to see whether treatment with peginterferon alfa-2b during a treatment interruption could postpone the need to restart HIV medicines. (A 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

For more details on this study, see the Health Professional version.

What side effects might peginterferon alfa-2b cause?

In the Phase II pilot study (NCT01935089) discussed under the previous question, the most common side effect was neutropenia, which is a lower-than-normal number of neutrophils (a type of white blood cell) in the blood. 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.15

In the Phase II/III ANRS 112 INTERPRIM study, common 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 two cases of suicide attempt, one case of depression, and one case of epilepsy.16

In the Phase III ANRS 105 INTERVAC trial, two participants taking peginterferon alfa-2b had severe neutropenia, and one participant had moderately high levels of triglycerides (a type of fat in the blood). Six participants taking peginterferon alfa-2b withdrew from the study before the 48th week.17

Because peginterferon alfa-2b is still being studied, 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?

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.

How can I find more information about participating in a clinical trial?

Participating in a clinical trial can provide benefits. For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals. However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied.13

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.

References

  1. United States National Library of Medicine. ChemIDplus Advanced. Available at: http://chem.sis.nlm.nih.gov/chemidplus/rn/215647-85-1. Last accessed on May 2, 2016.
  2. World Health Organization (WHO). WHO Drug Information. 2000; 14(4): 211-288. Available at: http://apps.who.int/medicinedocs/pdf/s2201e/s2201e.pdf. Last accessed on May 2, 2016.
  3. Merck Sharp & Dohme Corp. PEGINTRON - peginterferon alfa-2b: Full Prescribing Information, February 2016. DailyMed. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b70816bb-913a-467f-acb8-67ef62cf8dac. Last accessed on May 2, 2016.
  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. Available at: https://clinicaltrials.gov/ct2/show/NCT00125814. Last accessed on May 2, 2016.
  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. Available at: https://clinicaltrials.gov/ct2/show/NCT00035360. Last accessed on May 2, 2016.
  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. Available at: https://clinicaltrials.gov/ct2/show/NCT01295515. Last accessed on May 2, 2016.
  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. Available at: https://clinicaltrials.gov/ct2/show/NCT01935089. Last accessed on May 2, 2016.
  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. Available at: https://clinicaltrials.gov/ct2/show/NCT02227277. Last accessed on May 2, 2016.
  9. Treatment Action Group website. Research Toward a Cure Trials. Available at: http://www.treatmentactiongroup.org/cure/trials. Last accessed on May 2, 2016.
  10. National Institute of Allergy and Infectious Diseases (NIAID): News Release, dated June 16, 2009. NIAID Invites Applications to Conduct Basic Research on HIV Persistence. Available at: http://www.niaid.nih.gov/news/newsreleases/Archive/2009/Pages/HIV_persistence.aspx. Last accessed on May 2, 2016.
  11. Siliciano RF, Greene WC. HIV Latency. Cold Spring Harb Perspect Med. 2011 Sep; 1(1): a007096. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234450/. Last accessed on May 2, 2016.
  12. Gibbert K, Schlaak JF, Yang D, and Dittmer U. IFN-α subtypes: distinct biological activities in anti-viral therapy. Br J Pharmacol. 2013 Mar; 168(5): 1048–1058. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3594665/. Last accessed on May 2, 2016.
  13. National Institutes of Health (NIH). NIH Clinical Research Trials and You. Available at: http://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on May 2, 2016.
  14. 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. Available at: https://clinicaltrials.gov/ct2/show/NCT00196638. Last accessed on May 2, 2016.
  15. 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. Poster presented at: 8th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment & Prevention. July 19 -22, 2015; Vancouver, Canada. Poster TUPEB297. Available at: http://pag.ias2015.org/PAGMaterial/eposters/2852.pdf. Last accessed on May 2, 2016.
  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 Sep 24; 26(15): 1895-905. Available at: http://journals.lww.com/aidsonline/Fulltext/2012/09240/Continuous_versus_intermittent_treatment.6.aspx. Last accessed on May 2, 2016.
  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 Jan 2; 25(1): 115-8. Available at: http://journals.lww.com/aidsonline/Fulltext/2011/01020/Alpha_interferon_administration_during_structured.14.aspx. Last accessed on May 2, 2016.


Last Reviewed: May 2, 2016

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