Drug information

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Other Names
Pegasys (brand product for the treatment of chronic hepatitis C and chronic hepatitis B), PEG-interferon alfa-2a (HIV), pegIFN alfa-2a (HIV), pegylated-interferon alfa 2a (HIV)
Drug Class
Immune Modulators
Registry Number
198153-51-4 (CAS)
Chemical Name

Interferon alphaA (human leukocyte), mono(N2,N6-dicarboxy-L-lysyl)deriv., diester with alpha-methyl-omega-hydroxypoly(oxy-1,2-ethanediyl)

Chemical Class
Recombinant interferon
Organization
Hoffman-La Roche
Phase of Development

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

(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 Pegasys Full Prescribing Information,3 and ClinicalTrials.gov4

 
What is peginterferon alfa-2a?What is peginterferon alfa-2a?

What is peginterferon alfa-2a?

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

As an investigational HIV drug, peginterferon alfa-2a 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 trying to find out whether using peginterferon alfa-2a in combination with other drugs can help reduce the latent HIV reservoir.6

To learn about 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-2aSelect clinical trials of peginterferon alfa-2a

Select clinical trials of peginterferon alfa-2a

Study Names: ACTG A5192; NCT00078442
Phase: 2
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety and antiviral activity of peginterferon alfa-2a when this drug is taken without any other HIV medicines (also called monotherapy).7
Selected Study Results: Results were published in the Journal of Infectious Diseases and showed that monotherapy with peginterferon alfa-2a over 12 weeks led to significant reductions in participants’ viral load levels. Treatment-related side effects included depression, fatigue, and decreased neutrophils (a type of white blood cell).8

Study Name: NCT00594880
Phase: 2
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety and antiviral activity of two different doses of peginterferon alfa-2a.4
Selected Study Results: Results published in the Journal of Infectious Diseases showed that in participants with viral suppression on antiretroviral therapy (ART), the administration of peginterferon alfa-2a (given at either of two doses) was capable of sustaining viral control after participants underwent an analytical treatment interruption of ART. The proportion of participants maintaining viral load control during the ART treatment interruption was greater than what investigators had anticipated.9

Study Names: ACTIVATE; NCT02471430
Phase: 1/2
Status: This study is currently recruiting participants.
Location: United States
Purpose: The purpose of this study is to evaluate whether using a combination of the latency-reversing agent panobinostat and the immune modulator peginterferon alfa-2a can reduce the latent HIV reservoir.6
Selected Study Results: First results from this ongoing study were presented at CROI 2020 and found that the administration of panobinostat in combination with peginterferon alfa-2a had no effect on reducing the latent HIV reservoir. Thus far, there have been no unexpected or severe side effects reported.10

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

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

What side effects might peginterferon alfa-2a 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-2a listed above.

ACTG A5192 (NCT00078442):

In this Phase 2 study, the most common side effects that were related (or possibly related) to peginterferon alfa-2a were fatigue and mild to moderate decreases in the number of neutrophils, a type of infection-fighting immune cell. One participant experienced moderately severe treatment-related depression.7,8

NCT00594880:

In this Phase 2 study, which evaluated peginterferon alfa-2a at two different doses, participants' CD4 count levels decreased during the first 5 weeks of peginterferon alfa-2a treatment, but then remained stable throughout the rest of the study. No participants stopped peginterferon alfa-2a treatment because of a drop in CD4 count.9

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

Additional information on side effects known to be associated with peginterferon alfa-2a can be found in the FDA-approved Full Prescribing Information for Pegasys.

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

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

More information about peginterferon alfa-2a-related research studies 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-2a. https://chem.nlm.nih.gov/chemidplus/rn/198153-51-4. Accessed October 1, 2021 
  2. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed October 1, 2021
  3. Genentech, Inc. Pegasys: full prescribing information, March 31, 2021. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de61685e-2b8c-4e22-84bb-869e13600440. Accessed October 1, 2021
  4. The Wistar Institute. Antiviral activity of peg-IFN-alpha-2A in chronic HIV-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 4, 2008. NLM Identifier: NCT00594880. https://www.clinicaltrials.gov/ct2/show/NCT00594880. Accessed October 1, 2021
  5. Treatment Action Group website. Research toward a cure trials. https://www.treatmentactiongroup.org/cure/trials/. Accessed October 1, 2021
  6. Massachusetts General Hospital. A Phase I-II pilot study to assess the safety and efficacy of combined administration with pegylated interferon-alpha2a and the histone deacetylase inhibitor (HDACi) panobinostat for reducing the residual reservoir of HIV-1 infected cells in cART-treated HIV-1 positive individuals. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 11, 2015. NLM Identifier: NCT02471430. https://www.clinicaltrials.gov/ct2/show/NCT02471430. Accessed October 1, 2021
  7. National Institute of Allergy and Infectious Diseases (NIAID). A Phase II open-label pilot trial of the antiretroviral activity, safety, and tolerability of pegylated interferon alfa-2a (40KD) [PegasysTM] in HIV-1 infected subjects. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 25, 2004. NLM Identifier: NCT00078442. https://www.clinicaltrials.gov/ct2/show/NCT00078442. Accessed October 1, 2021
  8. Asmuth DM, Murphy RL, Rosenkranz SL, et al. Safety, tolerability and mechanisms of antiretroviral activity of peginterferon alfa-2a in HIV-1-mono-infected subjects: a Phase II clinical trial. J Infect Dis. 2010;201(11):1686–1696.
  9. Azzoni L, Foulkes AS, Papasavvas E, et al. Pegylated interferon alfa-2a monotherapy results in suppression of HIV type 1 replication and decreased cell-associated HIV DNA integration. J Infect Dis. 2013;207(2):213-222. doi:10.1093/infdis/jis663
  10. Hartana CA, Flynn T, Sbrolla A, et al. Viral reservoir disruption with panobinostat and IFN-α: first results. Abstract presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 8-11, 2020; Boston, MA. Abstract 341. https://www.croiconference.org/abstract/viral-reservoir-disruption-with-panobinostat-and-ifn-α-first-results/. Accessed October 1, 2021
 

Last Reviewed: October 1, 2021