Suspected pharmacokinetic interaction between raltegravir and the 3D regimen of ombitasvir, dasabuvir and paritaprevir/ritonavir in an HIV-HCV liver transplant recipient

Cattaneo, Dario; Sollima, Salvatore; Charbe, Nitin; Resnati, Chiara; Clementi, Emilio; Gervasoni, Cristina

doi:10.1007/s00228-015-1936-6

Cited by 3 publications

(2 citation statements)

References 15 publications

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“…In a study of healthy adults, raltegravir area under the plasma concentration–time curve (AUC τ ) and trough concentration increased by an average of 134% and 100%, respectively, during coadministration with OBV/PTV/r + DSV . Similarly, a case report of an adult liver transplant patient with HIV/HCV coinfection reported a 265% increase in raltegravir AUC τ during treatment with OBV/PTV/r + DSV . In contrast, a single‐centre observational study of HIV/HCV coinfected adults reported no significant differences in raltegravir trough concentrations either with or without OBV/PTV/r ± DSV …”

Section: Introductionmentioning

confidence: 97%

“…The impact of OBV/PTV/r + DSV coadministration on raltegravir exposures is not clear. There have been some reports demonstrating increases in exposures of raltegravir when administered with OBV/PTV/r + DSV . In a study of healthy adults, raltegravir area under the plasma concentration–time curve (AUC τ ) and trough concentration increased by an average of 134% and 100%, respectively, during coadministration with OBV/PTV/r + DSV .…”

Section: Introductionmentioning

confidence: 99%

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Raltegravir pharmacokinetics before and during treatment with ombitasvir, paritaprevir/ritonavir plus dasabuvir in adults with human immunodeficiency virus‐1 and hepatitis C virus coinfection: AIDS Clinical Trials Group sub‐study A5334s

Venuto

Cramer

Rosenkranz

et al. 2019

Brit J Clinical Pharma

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Aims: AIDS Clinical Trials Group study A5334s evaluated the pharmacokinetics of raltegravir before and during combined administration of ombitasvir, paritaprevir/ritonavir, plus dasabuvir (OBV/PTV/r + DSV) and weight-based ribavirin in human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfected adults.The pharmacokinetics of OBV/PTV/r + DSV during raltegravir coadministration were also characterized. Methods:Adults living with HIV/HCV coinfection receiving steady-state raltegravir (400 mg twice daily) with 2 nucleos(t)ide analogues were enrolled. Pharmacokinetics of raltegravir were assessed prior to HCV therapy, and 4 weeks later following initiation of OBV/PTV/r (25/150/100 mg) once daily + DSV (250 mg) twice daily. Geometric mean ratios (GMRs) and 90% confidence intervals (CIs) were used to compare the following: raltegravir pharmacokinetics with HCV therapy (week 4) vs before HCV therapy (week 0); OBV/PTV/r and DSV pharmacokinetics vs historical healthy controls; raltegravir pharmacokinetics at week 0 vs historical control adults living with HIV. Results: Eight of 11 participants had decreased raltegravir exposures after initiation of HCV therapy. The GMRs (90% CI) for maximum concentration and area under the concentration-time curve of raltegravir with vs without HCV therapy were 0.68 (0.38-1.19) and 0.82 (0.58-1.17), respectively. Comparing OBV/PTV/r pharmacokinetics in healthy controls, A5334s study participants demonstrated generally lower maximum concentration and area under the concentration-time curve values by 41-82% and 4-73%, respectively. Raltegravir exposures tended to be higher in A5334s study participants compared to adults living with HIV.

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Section: Introductionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%