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Viral kinetics in semen with different antiretroviral families in treatment-naïve HIV-infected patients: a randomized trial.

Viral kinetics in semen with different antiretroviral families in treatment-naïve HIV-infected patients: a randomized trial.
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Gutierrez-Valencia A, Benmarzouk-Hidalgo OJ, Rivas-Jeremías I, Espinosa N, Trujillo-Rodríguez M, Fernandez-Magdaleno T, Viciana P, López-Cortés LF,


Gutierrez-Valencia A, Benmarzouk-Hidalgo OJ, Rivas-Jeremías I, Espinosa N, Trujillo-Rodríguez M, Fernandez-Magdaleno T, Viciana P, López-Cortés LF, (click to view)

Gutierrez-Valencia A, Benmarzouk-Hidalgo OJ, Rivas-Jeremías I, Espinosa N, Trujillo-Rodríguez M, Fernandez-Magdaleno T, Viciana P, López-Cortés LF,

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Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2017 04 25() doi 10.1093/cid/cix358

Abstract
Background
There are several regimens for starting antiretroviral treatment, but it remains unknown whether either of them is more advantageous regarding the time course and magnitude of HIV-RNA decay in semen.

Objective
To evaluate the differential effect of different antiretroviral drug families on viral kinetics in seminal plasma of treatment-naïve HIV-infected patients.

Methods
Phase II, randomized, open-label study in which participants were randomized 1:1:1 to receive tenofovir-DF plus emtricitabine, and either cobicistat-boosted elvitegravir (EVGcobi), rilpivirine (RPV), or ritonavir-boosted darunavir (DRVrtv). The primary endpoint was the proportion of participants with undetectable HIV-RNA in seminal plasma (SP) at week 12. HIV-1 RNA was measured in paired SP and blood plasma (BP) at baseline and after 1, 2, 4, 6, 8, 12, 18, and 24 weeks. EVG, RPV and DRV concentrations were quantified by the liquid chromatography-tandem mass spectrometry method.

Results
In SP, the HIV-RNA decay rate with RPV was as fast as with EVGcobi; by week 12, all participants in the RPV and the EVGcobi groups reached an undetectable viral load, but only 58.3% in the DRVrtv arm (p= 0.003). The highest SP/BP drug concentration ratio was for EVG (0.43), followed-up by RPV (0.19) and DRV (0.10). For both EVG and RPV, the SP concentrations exceeded >2-fold the protein binding-adjusted EC90 for wild-type HIV-1; for DRV, only 33.7% of the SP showed concentrations above the protein binding-adjusted EC90.

Conclusions
In SP, both RPV and EVGcobi, associated to tenofovir-DF and emtricitabine, behave similarly and achieve and undetectable viral load much faster than DRVrtv.

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