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Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial.

Publication ,  Journal Article
Asmuth, DM; Murphy, RL; Rosenkranz, SL; Lertora, JJL; Kottilil, S; Cramer, Y; Chan, ES; Schooley, RT; Rinaldo, CR; Thielman, N; Li, X-D ...
Published in: J Infect Dis
June 1, 2010

BACKGROUND: To our knowledge, the antiviral activity of pegylated interferon alfa-2a has not been studied in participants with untreated human immunodeficiency virus type 1 (HIV-1) infection but without chronic hepatitis C virus (HCV) infection. METHODS: Untreated HIV-1-infected volunteers without HCV infection received 180 microg of pegylated interferon alfa-2a weekly for 12 weeks. Changes in plasma HIV-1 RNA load, CD4(+) T cell counts, pharmacokinetics, pharmacodynamic measurements of 2',5'-oligoadenylate synthetase (OAS) activity, and induction levels of interferon-inducible genes (IFIGs) were measured. Nonparametric statistical analysis was performed. RESULTS: Eleven participants completed 12 weeks of therapy. The median plasma viral load decrease and change in CD4(+) T cell counts at week 12 were 0.61 log(10) copies/mL (90% confidence interval [CI], 0.20-1.18 log(10) copies/mL) and -44 cells/microL (90% CI, -95 to 85 cells/microL), respectively. There was no correlation between plasma viral load decreases and concurrent pegylated interferon plasma concentrations. However, participants with larger increases in OAS level exhibited greater decreases in plasma viral load at weeks 1 and 2 (r = -0.75 [90% CI, -0.93 to -0.28] and r = -0.61 [90% CI, -0.87 to -0.09], respectively; estimated Spearman rank correlation). Participants with higher baseline IFIG levels had smaller week 12 decreases in plasma viral load (0.66 log(10) copies/mL [90% CI, 0.06-0.91 log(10) copies/mL]), whereas those with larger IFIG induction levels exhibited larger decreases in plasma viral load (-0.74 log(10) copies/mL [90% CI, -0.93 to -0.21 log(10) copies/mL]). CONCLUSION: Pegylated interferon alfa-2a was well tolerated and exhibited statistically significant anti-HIV-1 activity in HIV-1-monoinfected patients. The anti-HIV-1 effect correlated with OAS protein levels (weeks 1 and 2) and IFIG induction levels (week 12) but not with pegylated interferon concentrations.

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Published In

J Infect Dis

DOI

EISSN

1537-6613

Publication Date

June 1, 2010

Volume

201

Issue

11

Start / End Page

1686 / 1696

Location

United States

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Recombinant Proteins
  • RNA, Viral
  • Polyethylene Glycols
  • Middle Aged
  • Microbiology
  • Male
  • Interferon-alpha
  • Interferon alpha-2
 

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Asmuth, D. M., Murphy, R. L., Rosenkranz, S. L., Lertora, J. J. L., Kottilil, S., Cramer, Y., … AIDS Clinical Trials Group A5192 Team, . (2010). Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial. J Infect Dis, 201(11), 1686–1696. https://doi.org/10.1086/652420
Asmuth, David M., Robert L. Murphy, Susan L. Rosenkranz, Juan J. L. Lertora, Shyam Kottilil, Yoninah Cramer, Ellen S. Chan, et al. “Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial.J Infect Dis 201, no. 11 (June 1, 2010): 1686–96. https://doi.org/10.1086/652420.
Asmuth DM, Murphy RL, Rosenkranz SL, Lertora JJL, Kottilil S, Cramer Y, et al. Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial. J Infect Dis. 2010 Jun 1;201(11):1686–96.
Asmuth, David M., et al. “Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial.J Infect Dis, vol. 201, no. 11, June 2010, pp. 1686–96. Pubmed, doi:10.1086/652420.
Asmuth DM, Murphy RL, Rosenkranz SL, Lertora JJL, Kottilil S, Cramer Y, Chan ES, Schooley RT, Rinaldo CR, Thielman N, Li X-D, Wahl SM, Shore J, Janik J, Lempicki RA, Simpson Y, Pollard RB, AIDS Clinical Trials Group A5192 Team. Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial. J Infect Dis. 2010 Jun 1;201(11):1686–1696.
Journal cover image

Published In

J Infect Dis

DOI

EISSN

1537-6613

Publication Date

June 1, 2010

Volume

201

Issue

11

Start / End Page

1686 / 1696

Location

United States

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Recombinant Proteins
  • RNA, Viral
  • Polyethylene Glycols
  • Middle Aged
  • Microbiology
  • Male
  • Interferon-alpha
  • Interferon alpha-2