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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 (ChemID) 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 an investigational drug?

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?

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.3 It is also being studied as an investigational drug for the treatment of HIV infection.6-9 As an HIV treatment, 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.

HIV infection can make a person’s immune system not work properly over the course of the viral infection. When this happens:

  • CD4 counts can drop and HIV infection can worsen.
    (A CD4 count is a laboratory test that measures the number of CD4 cells—a type of immune cell—in a sample of blood and is an important indicator of immune function.)
  • Other immune system cells or proteins may not be produced in normal amounts and may not work normally.
  • A person may not respond well to antiretroviral therapy (ART). 
    (ART is the recommended treatment for HIV infection and involves using a combination of different antiretroviral [ARV] drugs to prevent HIV from multiplying.)
  • Latent HIV reservoirs can form and persist in the body.
    (Latent HIV reservoirs are “resting” CD4 cells or other cells that are infected with HIV but not actively producing HIV in the body. Because ART does not work against HIV that’s hidden in latent reservoirs, these reservoirs are one of the main obstacles to curing HIV infection.)10-14
Peginterferon alfa-2b is being studied for its ability to help activate the immune systems of HIV-infected individuals. Interferon alfa is a protein that is made naturally in the body to help fight viral infections. Peginterferon alfa-2b is a manufactured version of interferon alfa.6,15 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?

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.16

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.16

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.16 (Some clinical trials are categorized as “a” or “b,” such as “Phase Ia” or “Phase IIb.” These different subphases typically mean that a study is researching certain types of information or using a certain type of participant population.)

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

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

The use of peginterferon alfa-2b in HIV treatment has been studied in Phase III clinical trials.4,5

What are some studies on peginterferon alfa-2b?

What are some studies on peginterferon alfa-2b?

Study Name: NCT01295515
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Phase: I/II
Location: United States
Participants:

  • Participants were HIV-infected adults who had taken HIV medicines before starting the study 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.
  • Participants had CD4 counts of at least 300 cells/mm3 within 2 weeks of starting the study.
  • Participants had viral load levels of at least 5 copies/million in peripheral blood mononuclear cells (PBMCs) at the start of the study. (Viral load levels in PBMCs are 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 was 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

Study Name: NCT01935089
Sponsor: The Wistar Institute
Phase: II
Location: United States
Participants:

  • Participants are HIV-infected adults who are taking HIV medicines at the time of the study and have been taking HIV medicines for more than 1 year before the study.
  • Participants have viral load levels of less than 50 copies/mL at the start of the study, and they have not had viral loads greater than 50 copies/mL for at least 1 year before the study.
  • Participants have CD4 counts that are greater than 450 cells/mm3 at the start of the study.

Purpose: The purpose of this study is to see if peginterferon alfa-2b can reduce latent HIV in participants with viral suppression.7

*This study is ongoing, but not recruiting participants.

Study Name: BEAT-HIV study; NCT02227277
Sponsor: The Wistar Institute
Phase: II
Location: United States
Participants:

  • Participants are HIV-infected adults who are taking HIV medicines at the time of the study and had been taking HIV medicines for at least 1 year before the study.
  • Participants have viral load levels of less than 50 copies/mL at the start of the study, and they have not had viral loads greater than 50 copies/mL for at least 1 year before the study.
  • Participants have CD4 counts that are greater than 450 cells/mm3 at the start of the study.

Purpose: The purpose of this study is to see if peginterferon alfa-2b can reduce latent HIV in participants with viral suppression.8

*This study is currently recruiting participants.

Study Name: ANRS 112 INTERPRIM trial; NCT00196638
Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Phase: II/III
Location: France
Participants:

  • Participants were HIV-infected adults who had never taken HIV medicines before the study.
  • 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 3 different ways to lower viral loads in participants with acute HIV infection. One of the ways included treatment with peginterferon alfa-2b.17,18

Study Name: ANRS 105 INTERVAC trial; NCT00125814
Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Phase: III
Location: France
Participants:

  • Participants were HIV-infected 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 before the start of the study.
  • Participants had CD4 counts that were greater 350 cells/mm3. A participant's lowest ever CD4 count was 100 cells/mm3 or above.

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.)4,19

For more details on the studies listed above, see the Health Professional version.

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 an optimized background ART regimen in adults whose HIV had not been controlled by multiple attempts with ART. (An optimized background regimen is a combination of drugs, chosen on the basis of a person’s resistance test results and treatment history, that are not being studied as the investigational drug[s] in the clinical trial, but are given to help control a participant’s HIV infection.)5

What side effects might peginterferon alfa-2b cause?

What side effects might peginterferon alfa-2b cause?

In the Phase II 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.7,20

In the Phase II/III ANRS 112 INTERPRIM study (NCT00196638), 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 attempt, 1 case of depression, and 1 case of epilepsy.17,21

In the Phase III ANRS 105 INTERVAC trial (NCT00125814), 2 participants taking peginterferon alfa-2b had severe neutropenia, and 1 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.22

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?

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?

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.16

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

References

  1. United States National Library of Medicine. ChemIDplus Advanced. Available at: https://chem.sis.nlm.nih.gov/chemidplus/rn/215647-85-1. Last accessed on June 2, 2017.
  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 June 2, 2017.
  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 June 2, 2017.
  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 June 2, 2017.
  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 June 2, 2017.
  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 June 2, 2017.
  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 June 2, 2017.
  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 June 2, 2017.
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  14. Savarino A, Shytaj IL. Chloroquine and beyond: exploring anti-rheumatic drugs to reduce immune hyperactivation in HIV/AIDS. Retrovirology. 2015; 12: 51. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4472405/. Last accessed on June 2, 2017.
  15. 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 June 2, 2017.
  16. 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 June 2, 2017.
  17. 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 June 2, 2017.
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Last Reviewed: June 2, 2017