Drug information
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Interferon alphaA (human leukocyte), mono(N2,N6-dicarboxy-L-lysyl)deriv., diester with alpha-methyl-omega-hydroxypoly(oxy-1,2-ethanediyl)
Peginterferon alfa-2a is in Phase 2 development for HIV treatment.
(Compound details obtained from PubChem,1 NIAID Therapeutics Database,2 Pegasys Full Prescribing Information,3 and ClinicalTrials.gov4)
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.5
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-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 monotherapy in participants with HIV who were not receiving antiretroviral therapy (ART).7
Selected Study Results: Results published in the Journal of Infectious Diseases (210) 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
Additional Published Material:
- J Infect Dis article, 2012: Host gene expression changes correlating with anti–HIV-1 effects in human subjects after treatment with peginterferon alfa-2a
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 in participants with HIV who had viral suppression on ART.4
Selected Study Results: Results published in the Journal of Infectious Diseases (2013) showed that the administration of peginterferon alfa-2a (given at either of two doses) led to sustained viral control in 45% of participants after analytical treatment interruption of ART. The proportion of participants maintaining viral load control during ART treatment interruption was greater than what investigators had anticipated.9
Study Name: NCT02767193
Phase: 2a
Status: This study has been completed.
Location: Spain
Purpose: The purpose of this study was to evaluate the safety and virological effects of a therapeutic HIV vaccine in combination with peginterferon alfa-2a in participants with HIV who had viral suppression on ART.10,11
Selected Study Results: Findings published in Frontiers in Immunology (2021) showed that the combination of a therapeutic HIV vaccine with peginterferon alfa-2a was safe. Only one severe or life-threatening treatment-related side effect was reported. However, the combination treatment had minimal impact on the main viral outcome measure. All participants experienced viral rebound prior to completing a 12-week analytical treatment interruption of ART.11
Study Names: ACTIVATE; NCT02471430
Phase: 1/2
Status: This study is ongoing, but not 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: Results published at CROI 2022 showed that although panobinostat reactivated latent HIV and interferon alfa-2a induced immune activation in participants with viral suppression on ART, the combination regimen was ineffective in reducing latent HIV reservoir size.12
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?
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. One participant experienced moderately severe treatment-related depression.7,8
In this Phase 2 study, which evaluated peginterferon alfa-2a at two different doses, participants' CD4 counts 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
In this Phase 2a study, the study interventions were generally safe, and the majority of side effects were mild in severity. The most common side effect related to subcutaneously administered peginterferon alfa-2a was weakness or lack of energy and strength. One participant had an allergic reaction (mild rash) that was related to peginterferon alfa-2a treatment. Another participant who received the therapeutic HIV vaccine plus peginterferon alfa-2a experienced a severe or life-threatening side effect—reactivation of pneumonia during analytical treatment interruption—which may have been related to study interventions.11
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?
More information about peginterferon alfa-2a-related research studies 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.
References
- National Center for Biotechnology Information. PubChem Substance Record for SID 135347948, Peginterferon Alfa-2a, Source: ChemIDplus. https://pubchem.ncbi.nlm.nih.gov/substance/135347948. Accessed March 9, 2023
- National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed October 14, 2022
- Genentech, Inc. Pegasys: full prescribing information, November 8, 2019. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de61685e-2b8c-4e22-84bb-869e13600440. Accessed October 14, 2022
- 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 14, 2022
- Treatment Action Group website. Research toward a cure trials. https://www.treatmentactiongroup.org/cure/trials/. Accessed October 14, 2022
- 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 14, 2022
- 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 14, 2022
- 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.
- 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
- Judit Pich Martínez. Safety and immunogenicity of a vaccine dendritic cell-based pulsed with autologous heat-inactivated HIV in HIV-1 infected patients. Prospective, randomized, partially blinded study. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 22, 2016. NLM Identifier: NCT02767193. https://clinicaltrials.gov/ct2/show/NCT02767193. Accessed October 14, 2022
- Leal L, Couto E, Sánchez-Palomino S, et al. Effect of intranodally administered dendritic cell-based HIV vaccine in combination with pegylated interferon α-2a on viral control following ART discontinuation: a Phase 2A randomized clinical trial. Front Immunol. 2021;12:767370. doi:10.3389/fimmu.2021.767370
- Armani-Tourret M, Hartana CA, Rassadkina Y, et al. HIV-1 viral reservoir disruption with panobinostat and IFN-⍺. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI)); February 12-16, 2022; Virtual. Poster 357. https://www.croiconference.org/wp-content/uploads/sites/2/posters/2022/CROI2022_Poster_357.pdf. Accessed October 14, 2022
Last Reviewed: October 14, 2022