Cargando…

1582. Dolutegravir/Rilpivirine STR Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life

BACKGROUND: Single tablet regimens (STRs) are widely utilized in HIV treatment in the Western world largely because they improve convenience of oral regimens and eliminate differential adherence. US Blacks are disproportionately impacted by HIV, and are also disproportionately affected by chronic ki...

Descripción completa

Detalles Bibliográficos
Autores principales: Kwakwa, Helena, Stokes, Tawanaha, Gebreselassie, Millen, Maslankowski, Lisa, Chernak, Esther
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10677703/
http://dx.doi.org/10.1093/ofid/ofad500.1417
_version_ 1785150192821993472
author Kwakwa, Helena
Stokes, Tawanaha
Gebreselassie, Millen
Maslankowski, Lisa
Chernak, Esther
author_facet Kwakwa, Helena
Stokes, Tawanaha
Gebreselassie, Millen
Maslankowski, Lisa
Chernak, Esther
author_sort Kwakwa, Helena
collection PubMed
description BACKGROUND: Single tablet regimens (STRs) are widely utilized in HIV treatment in the Western world largely because they improve convenience of oral regimens and eliminate differential adherence. US Blacks are disproportionately impacted by HIV, and are also disproportionately affected by chronic kidney disease (CKD) for a variety of reasons, especially in their later years. For PWH and CKD, STR options are limited due to pharmacokinetic considerations. We evaluate the impact on viral suppression, adherence, treatment satisfaction and quality of life (QOL) of switching to DTG/RPV STR for a largely Black aging US cohort with HIV and CKD. METHODS: In this 48-week open label single arm switch study conducted in a community health center setting, adults with HIV, a GFR< 60 mL/min/1.73m(2), an HIV RNA < 50 copies/mL and no known prior resistance to DTG or RPV were switched to DTG/RPV STR. HIV RNA and CD4 were monitored per standard national clinical guidance following switch. Standardized tools for medication adherence, treatment satisfaction and QOL were administered at baseline, 24 weeks and 48 weeks. We present final 48-week data. RESULTS: Between August 2019 and December 2021, 35 participants were enrolled. One dropped out after 19 weeks and one after 22 weeks due to drug-drug interaction concerns following renal transplantation. 94% of participants were Black, 57% were female and 43% were 65 years and older. At baseline, 20% had a GFR < 30 mL/min/1.73m(2) per race-based calculation (36% per race-free calculation). At 48 weeks, 97% of participants maintained viral suppression with an HIV RNA < 50 copies/mL in a per protocol analysis (91% in an intent-to-treat analysis). One participant with an HIV RNA of 62 copies/mL at 48 weeks subsequently re-suppressed on DTG/RPV. 69% reported an improvement in adherence, 77% noted an improvement in treatment satisfaction and 66% reported an improvement in QOL. The only adverse event reported in >5% of participants was nausea (5.7%). There were no serious adverse events. CONCLUSION: For this diverse aging cohort with HIV and CKD in a real-life community health center setting, DTG/RPV STR was efficacious, well-tolerated and associated with improvements in adherence, treatment satisfaction and QOL, sustained over 48 weeks. DTG/RPV is a feasible oral ARV option for PWH and CKD. DISCLOSURES: Helena Kwakwa, MD, MPH, ViiV Healthcare: Grant/Research Support
format Online
Article
Text
id pubmed-10677703
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-106777032023-11-27 1582. Dolutegravir/Rilpivirine STR Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life Kwakwa, Helena Stokes, Tawanaha Gebreselassie, Millen Maslankowski, Lisa Chernak, Esther Open Forum Infect Dis Abstract BACKGROUND: Single tablet regimens (STRs) are widely utilized in HIV treatment in the Western world largely because they improve convenience of oral regimens and eliminate differential adherence. US Blacks are disproportionately impacted by HIV, and are also disproportionately affected by chronic kidney disease (CKD) for a variety of reasons, especially in their later years. For PWH and CKD, STR options are limited due to pharmacokinetic considerations. We evaluate the impact on viral suppression, adherence, treatment satisfaction and quality of life (QOL) of switching to DTG/RPV STR for a largely Black aging US cohort with HIV and CKD. METHODS: In this 48-week open label single arm switch study conducted in a community health center setting, adults with HIV, a GFR< 60 mL/min/1.73m(2), an HIV RNA < 50 copies/mL and no known prior resistance to DTG or RPV were switched to DTG/RPV STR. HIV RNA and CD4 were monitored per standard national clinical guidance following switch. Standardized tools for medication adherence, treatment satisfaction and QOL were administered at baseline, 24 weeks and 48 weeks. We present final 48-week data. RESULTS: Between August 2019 and December 2021, 35 participants were enrolled. One dropped out after 19 weeks and one after 22 weeks due to drug-drug interaction concerns following renal transplantation. 94% of participants were Black, 57% were female and 43% were 65 years and older. At baseline, 20% had a GFR < 30 mL/min/1.73m(2) per race-based calculation (36% per race-free calculation). At 48 weeks, 97% of participants maintained viral suppression with an HIV RNA < 50 copies/mL in a per protocol analysis (91% in an intent-to-treat analysis). One participant with an HIV RNA of 62 copies/mL at 48 weeks subsequently re-suppressed on DTG/RPV. 69% reported an improvement in adherence, 77% noted an improvement in treatment satisfaction and 66% reported an improvement in QOL. The only adverse event reported in >5% of participants was nausea (5.7%). There were no serious adverse events. CONCLUSION: For this diverse aging cohort with HIV and CKD in a real-life community health center setting, DTG/RPV STR was efficacious, well-tolerated and associated with improvements in adherence, treatment satisfaction and QOL, sustained over 48 weeks. DTG/RPV is a feasible oral ARV option for PWH and CKD. DISCLOSURES: Helena Kwakwa, MD, MPH, ViiV Healthcare: Grant/Research Support Oxford University Press 2023-11-27 /pmc/articles/PMC10677703/ http://dx.doi.org/10.1093/ofid/ofad500.1417 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Abstract
Kwakwa, Helena
Stokes, Tawanaha
Gebreselassie, Millen
Maslankowski, Lisa
Chernak, Esther
1582. Dolutegravir/Rilpivirine STR Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life
title 1582. Dolutegravir/Rilpivirine STR Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life
title_full 1582. Dolutegravir/Rilpivirine STR Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life
title_fullStr 1582. Dolutegravir/Rilpivirine STR Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life
title_full_unstemmed 1582. Dolutegravir/Rilpivirine STR Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life
title_short 1582. Dolutegravir/Rilpivirine STR Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life
title_sort 1582. dolutegravir/rilpivirine str switch study in persons with hiv-1 and chronic kidney disease: 48-week assessment of viral suppression, treatment adherence and quality of life
topic Abstract
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10677703/
http://dx.doi.org/10.1093/ofid/ofad500.1417
work_keys_str_mv AT kwakwahelena 1582dolutegravirrilpivirinestrswitchstudyinpersonswithhiv1andchronickidneydisease48weekassessmentofviralsuppressiontreatmentadherenceandqualityoflife
AT stokestawanaha 1582dolutegravirrilpivirinestrswitchstudyinpersonswithhiv1andchronickidneydisease48weekassessmentofviralsuppressiontreatmentadherenceandqualityoflife
AT gebreselassiemillen 1582dolutegravirrilpivirinestrswitchstudyinpersonswithhiv1andchronickidneydisease48weekassessmentofviralsuppressiontreatmentadherenceandqualityoflife
AT maslankowskilisa 1582dolutegravirrilpivirinestrswitchstudyinpersonswithhiv1andchronickidneydisease48weekassessmentofviralsuppressiontreatmentadherenceandqualityoflife
AT chernakesther 1582dolutegravirrilpivirinestrswitchstudyinpersonswithhiv1andchronickidneydisease48weekassessmentofviralsuppressiontreatmentadherenceandqualityoflife