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Use of PCR Signal and Therapeutic Drug Monitoring in a Switch Cohort Study to Tenofovir/Emtricitabine/Rilpivirine: A W96 Follow-Up.

Charpentier C, Lê MP, Joly V, Visseaux B, Lariven S, Phung B, Yéni P, Yazdanpanah Y, Descamps D, Peytavin G, Landman R - PLoS ONE (2015)

Bottom Line: PCRneg was defined as an undetected PCR signal.At W96, 17 (15%) discontinued STR due to adverse events.Median rilpivirine C24h was 91 ng/mL (57-141, n = 285), with 91% of rilpivirine C24h >50 ng/mL, the target effective concentration.

View Article: PubMed Central - PubMed

Affiliation: IAME, UMR 1137, Univ Paris Diderot, Sorbonne Paris Cité, F-75018, Paris, France; IAME, UMR 1137, INSERM, F-75018, Paris, France; AP-HP, Hôpital Bichat-Claude Bernard, Laboratoire de Virologie, F-75018, Paris, France.

ABSTRACT

Objective: To assess, in a clinical cohort, the efficacy of switching treatment in virologically-suppressed patients to tenofovir/emtricitabine/rilpivirine as a single-tablet regimen (STR) using the PCR signal of the viral load (VL) assay and plasma drug determination (C24h).

Patients and methods: An observational single-centre study enrolling patients with VL<50 copies/mL initiating rilpivirine-based STR. C24h and VL were performed until W48 and W96 of STR, respectively. PCRneg was defined as an undetected PCR signal. Medians (IQR) were presented.

Results: 116 patients were enrolled. At STR baseline, time since first antiretroviral therapy and time of virological suppression were 6 years (2-9) and 17 months (7-43), respectively. Before STR initiation, patients were receiving protease inhibitors and non-nucleoside reverse transcriptase inhibitors-based regimen in 44% and 47% of cases, respectively. Historical genotype showed virus resistant to one drug of the STR in 6 patients (5%). At W96, 17 (15%) discontinued STR due to adverse events. The proportion of patients maintaining VL <50 copies/mL on treatment was 98%, 99%, 100%, 100%, 100% and 100% at W12, W24, W36, W48, W72 and W96, respectively. Among them, 70%, 66%, 68%, 59%, 74%, 68% and 60% were PCRneg at baseline, W12, W24, W36, W48, W72 and W96, respectively. Median rilpivirine C24h was 91 ng/mL (57-141, n = 285), with 91% of rilpivirine C24h >50 ng/mL, the target effective concentration.

Conclusions: In this clinical cohort of virologically-suppressed patients switching to a new STR, most subjects had adequate rilpivirine C24h and displayed a high level of virological suppression with no residual viremia until W96.

No MeSH data available.


Related in: MedlinePlus

Distribution of plasma HIV-1 viral load at baseline (BL), Week (W)12, W24, W36, W48, W72 and W96.
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pone.0134430.g002: Distribution of plasma HIV-1 viral load at baseline (BL), Week (W)12, W24, W36, W48, W72 and W96.

Mentions: The number of patients still receiving tenofovir/emtricitabine/rilpivirine and maintaining plasma VL <50 copies/mL was 105 (98%), 85 (99%), 66 (100%), 81 (100%), 88 (100%) and 77 (100%) at W12, W24, W36, W48, W72 and W96, respectively (Fig 2). A total of 285 drug plasma concentrations were measured during the first year of STR. Overall, median tenofovir, emtricitabine and rilpivirine C24h were 56 ng/mL (IQR = 43–67), 132 ng/mL (IQR = 86–188) and 91 ng/mL (IQR = 57–141), respectively. During the first year of STR, 92%, 93% and 91% of tenofovir, emtricitabine and rilpivirine C24h were adequate or above the respective cut-offs (Fig 3). Inter-patient variability of tenofovir, emtricitabine and rilpivirine C24h was 44%, 69%, and 63%, respectively. Intra-patient variability of tenofovir, emtricitabine and rilpivirine C24h was 22%, 40% and 44%, respectively.


Use of PCR Signal and Therapeutic Drug Monitoring in a Switch Cohort Study to Tenofovir/Emtricitabine/Rilpivirine: A W96 Follow-Up.

Charpentier C, Lê MP, Joly V, Visseaux B, Lariven S, Phung B, Yéni P, Yazdanpanah Y, Descamps D, Peytavin G, Landman R - PLoS ONE (2015)

Distribution of plasma HIV-1 viral load at baseline (BL), Week (W)12, W24, W36, W48, W72 and W96.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4520481&req=5

pone.0134430.g002: Distribution of plasma HIV-1 viral load at baseline (BL), Week (W)12, W24, W36, W48, W72 and W96.
Mentions: The number of patients still receiving tenofovir/emtricitabine/rilpivirine and maintaining plasma VL <50 copies/mL was 105 (98%), 85 (99%), 66 (100%), 81 (100%), 88 (100%) and 77 (100%) at W12, W24, W36, W48, W72 and W96, respectively (Fig 2). A total of 285 drug plasma concentrations were measured during the first year of STR. Overall, median tenofovir, emtricitabine and rilpivirine C24h were 56 ng/mL (IQR = 43–67), 132 ng/mL (IQR = 86–188) and 91 ng/mL (IQR = 57–141), respectively. During the first year of STR, 92%, 93% and 91% of tenofovir, emtricitabine and rilpivirine C24h were adequate or above the respective cut-offs (Fig 3). Inter-patient variability of tenofovir, emtricitabine and rilpivirine C24h was 44%, 69%, and 63%, respectively. Intra-patient variability of tenofovir, emtricitabine and rilpivirine C24h was 22%, 40% and 44%, respectively.

Bottom Line: PCRneg was defined as an undetected PCR signal.At W96, 17 (15%) discontinued STR due to adverse events.Median rilpivirine C24h was 91 ng/mL (57-141, n = 285), with 91% of rilpivirine C24h >50 ng/mL, the target effective concentration.

View Article: PubMed Central - PubMed

Affiliation: IAME, UMR 1137, Univ Paris Diderot, Sorbonne Paris Cité, F-75018, Paris, France; IAME, UMR 1137, INSERM, F-75018, Paris, France; AP-HP, Hôpital Bichat-Claude Bernard, Laboratoire de Virologie, F-75018, Paris, France.

ABSTRACT

Objective: To assess, in a clinical cohort, the efficacy of switching treatment in virologically-suppressed patients to tenofovir/emtricitabine/rilpivirine as a single-tablet regimen (STR) using the PCR signal of the viral load (VL) assay and plasma drug determination (C24h).

Patients and methods: An observational single-centre study enrolling patients with VL<50 copies/mL initiating rilpivirine-based STR. C24h and VL were performed until W48 and W96 of STR, respectively. PCRneg was defined as an undetected PCR signal. Medians (IQR) were presented.

Results: 116 patients were enrolled. At STR baseline, time since first antiretroviral therapy and time of virological suppression were 6 years (2-9) and 17 months (7-43), respectively. Before STR initiation, patients were receiving protease inhibitors and non-nucleoside reverse transcriptase inhibitors-based regimen in 44% and 47% of cases, respectively. Historical genotype showed virus resistant to one drug of the STR in 6 patients (5%). At W96, 17 (15%) discontinued STR due to adverse events. The proportion of patients maintaining VL <50 copies/mL on treatment was 98%, 99%, 100%, 100%, 100% and 100% at W12, W24, W36, W48, W72 and W96, respectively. Among them, 70%, 66%, 68%, 59%, 74%, 68% and 60% were PCRneg at baseline, W12, W24, W36, W48, W72 and W96, respectively. Median rilpivirine C24h was 91 ng/mL (57-141, n = 285), with 91% of rilpivirine C24h >50 ng/mL, the target effective concentration.

Conclusions: In this clinical cohort of virologically-suppressed patients switching to a new STR, most subjects had adequate rilpivirine C24h and displayed a high level of virological suppression with no residual viremia until W96.

No MeSH data available.


Related in: MedlinePlus