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Clinical Trial
. 2014 Mar;58(6):873-9.
doi: 10.1093/cid/cit799. Epub 2013 Dec 13.

Telaprevir in the treatment of acute hepatitis C virus infection in HIV-infected men

Collaborators, Affiliations
Clinical Trial

Telaprevir in the treatment of acute hepatitis C virus infection in HIV-infected men

Daniel S Fierer et al. Clin Infect Dis. 2014 Mar.

Abstract

Background: There is an international epidemic of hepatitis C virus (HCV) infection among human immunodeficiency virus (HIV)-infected men who have sex with men. Sustained virologic response (SVR) rates with pegylated interferon and ribavirin treatment are higher in these men during acute HCV than during chronic HCV, but treatment is still lengthy and SVR rates are suboptimal.

Methods: We performed a pilot study of combination therapy with telaprevir, pegylated interferon, and ribavirin in acute genotype 1 HCV infection in HIV-infected men. Men who were treated prior to the availability of, or ineligible for, telaprevir were the comparator group. The primary endpoint was SVR12, defined as an HCV viral load <5 IU/mL at least 12 weeks after completing treatment.

Results: In the telaprevir group, 84% (16/19) of men achieved SVR12 vs 63% (30/48) in the comparator group. Among men with SVR, median time to undetectable viral load was week 2 in the telaprevir group vs week 4 in the comparator group, and 94% vs 53% had undetectable viral loads at week 4. Most patients (81%) who achieved SVR in the telaprevir group received ≤12 weeks of treatment and there were no relapses after treatment. The overall safety profile was similar to that known for telaprevir-based regimens.

Conclusions: Incorporating telaprevir into treatment of acute genotype 1 HCV in HIV-infected men halved the treatment duration and increased the SVR rate. Larger studies should be done to confirm these findings. Clinicians should be alert to detect acute HCV infection of HIV-infected men to take advantage of this effective therapy and decrease further transmission in this epidemic.

Keywords: HIV infection; acute HCV; men who have sex with men; telaprevir; treatment.

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Figures

Figure 1.
Figure 1.
Flowchart of disposition of human immunodeficiency virus–infected men with acute hepatitis C infection after enrollment. *All 7 men who were unable to receive telaprevir were treated as part of the comparator group. Abbreviations: HCV, hepatitis C virus; TVR, telaprevir.
Figure 2.
Figure 2.
Duration of treatment in men with sustained virologic response at 12 weeks after treatment (SVR12) treated with telaprevir (n = 16; dashed line) or without telaprevir (pegylated interferon plus ribavirin only; n = 30; solid line). The cumulative percentage of men with SVR12 is shown by duration of treatment for each treatment group. Abbreviations: SVR, sustained virologic response; TVR, telaprevir.
Figure 3.
Figure 3.
Time to undetectable (target not detected) hepatitis C virus (HCV) viral load (VL) among men with sustained virologic response at 12 weeks after treatment (SVR12) comparing transcription-mediated amplification (TMA; dashed line) and real-time polymerase chain reaction (PCR; solid line) assays. Thirteen of the 16 men who had SVR12 had weekly HCV VL measurements using both TMA and real-time PCR assays. The cumulative percentage of men with undetectable HCV VL is shown by time for the 2 assays. Abbreviations: HCV VL, hepatitis C virus viral load; PCR, polymerase chain reaction; TMA, transcription-mediated amplification; UTND, unquantifiable, target not detected.
Figure 4.
Figure 4.
Time to undetectable (target not detected) hepatitis C virus (HCV) viral load (VL) among men with sustained virologic response at 12 weeks after treatment (SVR12) treated with telaprevir (n = 16; dashed line) or without telaprevir (pegylated interferon plus ribavirin only; n = 30; solid line). The cumulative percentage of men with SVR12 who had undetectable HCV VL (transcription-mediated amplification assay, <5 IU/mL) is shown by time for each treatment group. Abbreviations: HCV VL, hepatitis C virus viral load; TVR, telaprevir.

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