Dolutegravir Plus Rilpivirine as a Switch Option in cART-Experienced Patients

96-Week Data

Amedeo Ferdinando Capetti, Maria Vittoria Cossu, Gaetana Sterrantino, Giorgio Barbarini, Simona Di Giambenedetto, Giuseppe Vittorio De Socio, GianCarlo Orofino, Antonio Di Biagio, Benedetto M Celesia, Stefano Rusconi, Barbara Argenteri, Giuliano Rizzardini

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Data from clinical studies confirm the efficacy of switching to dolutegravir (DTG) plus rilpivirine (RPV) in selected patients.

OBJECTIVE: The primary objective is to report the 96-week virological suppression in our cohort, assessing the durability of this strategy in complicated situations. The secondary objective is to describe the safety and metabolic profile.

METHODS: All patients who had switched to DTG plus RPV between October 1, 2014, and September 30, 2015, were analyzed using a retrospective-prospective design, approved by ethics committees. Routine metabolic, immunological, and virological data were regularly sent to the coordinating center. Viral control was classified as HIV-1 RNA ≥50 copies/mL, 1 to 49 copies/mL, or undetectable (no virus detected [NVD]).

RESULTS: We followed 145 patients for a median of 101 weeks. The median age was 52 years; 31.7% were women, and 9.6% non-Caucasian; 50.3% had failed at least 1 antiretroviral regimen; and 15% had ≥50 copies/mL at baseline. The reasons for switching were as follows: simplification (51.7%), toxicity (36.5%), drug-drug interactions (6.9%), persistent low-level viremia (3.0%), nonadherence (2.1%), and viral failure (1.4%). By week 96, seven patients dropped out. At week 96, none had ≥50 HIV-1 RNA copies/mL, 138 (95.2%) had <50 copies/mL, and 123 (84.8%) had NVD. The low- to high-density lipoprotein cholesterol (LDL-C/HDL-C) ratio decreased significantly ( P = 0.04). Of the 287 baseline altered laboratory parameters, 32.7% normalized by week 96. Serum glucose and total- and LDL-cholesterol normalization were statistically significant.

CONCLUSIONS: Switching to DTG plus RPV improved viral suppression and LDL-C/HDL-C ratio.

Original languageEnglish
Pages (from-to)740-746
Number of pages7
JournalAnnals of Pharmacotherapy
Volume52
Issue number8
DOIs
Publication statusPublished - Aug 2018

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Rilpivirine
HIV-1
RNA
Viruses
Ethics Committees
Metabolome
Viremia
Drug-Related Side Effects and Adverse Reactions
Drug Interactions
LDL Cholesterol
HDL Cholesterol
Safety
Glucose
dolutegravir
Serum

Cite this

Capetti, A. F., Cossu, M. V., Sterrantino, G., Barbarini, G., Di Giambenedetto, S., De Socio, G. V., ... Rizzardini, G. (2018). Dolutegravir Plus Rilpivirine as a Switch Option in cART-Experienced Patients: 96-Week Data. Annals of Pharmacotherapy, 52(8), 740-746. https://doi.org/10.1177/1060028018761600

Dolutegravir Plus Rilpivirine as a Switch Option in cART-Experienced Patients : 96-Week Data. / Capetti, Amedeo Ferdinando; Cossu, Maria Vittoria; Sterrantino, Gaetana; Barbarini, Giorgio; Di Giambenedetto, Simona; De Socio, Giuseppe Vittorio; Orofino, GianCarlo; Di Biagio, Antonio; Celesia, Benedetto M; Rusconi, Stefano; Argenteri, Barbara; Rizzardini, Giuliano.

In: Annals of Pharmacotherapy, Vol. 52, No. 8, 08.2018, p. 740-746.

Research output: Contribution to journalArticle

Capetti, AF, Cossu, MV, Sterrantino, G, Barbarini, G, Di Giambenedetto, S, De Socio, GV, Orofino, G, Di Biagio, A, Celesia, BM, Rusconi, S, Argenteri, B & Rizzardini, G 2018, 'Dolutegravir Plus Rilpivirine as a Switch Option in cART-Experienced Patients: 96-Week Data', Annals of Pharmacotherapy, vol. 52, no. 8, pp. 740-746. https://doi.org/10.1177/1060028018761600
Capetti, Amedeo Ferdinando ; Cossu, Maria Vittoria ; Sterrantino, Gaetana ; Barbarini, Giorgio ; Di Giambenedetto, Simona ; De Socio, Giuseppe Vittorio ; Orofino, GianCarlo ; Di Biagio, Antonio ; Celesia, Benedetto M ; Rusconi, Stefano ; Argenteri, Barbara ; Rizzardini, Giuliano. / Dolutegravir Plus Rilpivirine as a Switch Option in cART-Experienced Patients : 96-Week Data. In: Annals of Pharmacotherapy. 2018 ; Vol. 52, No. 8. pp. 740-746.
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AU - Capetti, Amedeo Ferdinando

AU - Cossu, Maria Vittoria

AU - Sterrantino, Gaetana

AU - Barbarini, Giorgio

AU - Di Giambenedetto, Simona

AU - De Socio, Giuseppe Vittorio

AU - Orofino, GianCarlo

AU - Di Biagio, Antonio

AU - Celesia, Benedetto M

AU - Rusconi, Stefano

AU - Argenteri, Barbara

AU - Rizzardini, Giuliano

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N2 - BACKGROUND: Data from clinical studies confirm the efficacy of switching to dolutegravir (DTG) plus rilpivirine (RPV) in selected patients.OBJECTIVE: The primary objective is to report the 96-week virological suppression in our cohort, assessing the durability of this strategy in complicated situations. The secondary objective is to describe the safety and metabolic profile.METHODS: All patients who had switched to DTG plus RPV between October 1, 2014, and September 30, 2015, were analyzed using a retrospective-prospective design, approved by ethics committees. Routine metabolic, immunological, and virological data were regularly sent to the coordinating center. Viral control was classified as HIV-1 RNA ≥50 copies/mL, 1 to 49 copies/mL, or undetectable (no virus detected [NVD]).RESULTS: We followed 145 patients for a median of 101 weeks. The median age was 52 years; 31.7% were women, and 9.6% non-Caucasian; 50.3% had failed at least 1 antiretroviral regimen; and 15% had ≥50 copies/mL at baseline. The reasons for switching were as follows: simplification (51.7%), toxicity (36.5%), drug-drug interactions (6.9%), persistent low-level viremia (3.0%), nonadherence (2.1%), and viral failure (1.4%). By week 96, seven patients dropped out. At week 96, none had ≥50 HIV-1 RNA copies/mL, 138 (95.2%) had <50 copies/mL, and 123 (84.8%) had NVD. The low- to high-density lipoprotein cholesterol (LDL-C/HDL-C) ratio decreased significantly ( P = 0.04). Of the 287 baseline altered laboratory parameters, 32.7% normalized by week 96. Serum glucose and total- and LDL-cholesterol normalization were statistically significant.CONCLUSIONS: Switching to DTG plus RPV improved viral suppression and LDL-C/HDL-C ratio.

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DO - 10.1177/1060028018761600

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