Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppression

Background: Dual antiretroviral regimens are attractive options to optimize the combination antiretroviral therapy in light of potential toxicities with long-term cumulative exposure to nucleos(t)ide reverse-transcriptase inhibitors (NRTIs). Methods: In this retrospective observational study, we inc...

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Main Authors: Tung-Che Hung, Guan-Jhou Chen, Shu-Hsing Cheng, Jhen-Hong Chen, Jheng-Lun Wei, Chien-Yu Cheng, Chien-Ching Hung
Format: Article
Language:English
Published: Elsevier 2019-12-01
Series:Journal of Microbiology, Immunology and Infection
Online Access:http://www.sciencedirect.com/science/article/pii/S1684118219300866
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author Tung-Che Hung
Guan-Jhou Chen
Shu-Hsing Cheng
Jhen-Hong Chen
Jheng-Lun Wei
Chien-Yu Cheng
Chien-Ching Hung
author_facet Tung-Che Hung
Guan-Jhou Chen
Shu-Hsing Cheng
Jhen-Hong Chen
Jheng-Lun Wei
Chien-Yu Cheng
Chien-Ching Hung
author_sort Tung-Che Hung
collection DOAJ
description Background: Dual antiretroviral regimens are attractive options to optimize the combination antiretroviral therapy in light of potential toxicities with long-term cumulative exposure to nucleos(t)ide reverse-transcriptase inhibitors (NRTIs). Methods: In this retrospective observational study, we included HIV-infected patients on suppressive antiretroviral therapy with plasma viral load (PVL) < 200 copies/mL for at least 6 months who were switched to dual regimens containing lamivudine (3TC) (150 mg twice daily or 300 mg once daily) plus lopinavir/ritonavir (LPV/r) 250/50 mg twice daily or darunavir/ritonavir (DRV/r) 800/100 mg once daily. Patients maintaining on suppressive triple therapy with DRV/r or LPV/r plus two NRTIs were included for comparisons. The primary endpoint was the proportion of patients with PVL <50 copies/mL after 48 weeks of follow-up. Results: In total, 364 patients were included with 93 (25.5%) switched to dual therapy After 48 weeks of observation, PVL <50 copies/mL was observed in 96.8% and 94.1% of dual-therapy and triple-therapy group, respectively, in per-protocol analysis (difference 2.7%; 95% CI -2.5%–7.9%). Nineteen patients (3 [3.2%] in dual-therapy and 16 [7.6%] in triple-therapy group) developed virologic failure, with none having emergent M184V resistance-associated mutation. A statistically significant increase of cholesterol level (13 mg/dL versus 2 mg/dL, p = 0.003) and high-density lipoprotein (3 mg/dL versus −2 mg/dL, p = 0.019) were observed in dual-therapy than in triple-therapy group. Changes of triglyceride, low-density lipoprotein and glycated hemoglobin levels were similar between the two groups. Conclusion: Dual therapy with DRV/r or LPV/r plus lamivudine demonstrated similar effectiveness in maintaining viral suppression to triple therapy. Keywords: Combination antiretroviral therapy, Stable switch, Simplification, Adverse effect, Mitochondrial toxicity
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spelling doaj.art-7b4021d0cd4d40ffbbcdc237484ca2492022-12-22T03:53:13ZengElsevierJournal of Microbiology, Immunology and Infection1684-11822019-12-01526865871Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppressionTung-Che Hung0Guan-Jhou Chen1Shu-Hsing Cheng2Jhen-Hong Chen3Jheng-Lun Wei4Chien-Yu Cheng5Chien-Ching Hung6Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital Yun-Lin Branch, Yun-Lin County, Taiwan; Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; School of Public Health, Taipei Medical University, Taipei, TaiwanDepartment of Pharmacy, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, TaiwanDepartment of Pharmacy, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, TaiwanDepartment of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; School of Public Health, National Yang-Ming University, Taipei, Taiwan; Corresponding author. Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. Fax: +886 3 3789127.Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; Department of Tropical Medicine and Parasitology, National Taiwan University College of Medicine, Taipei, TaiwanBackground: Dual antiretroviral regimens are attractive options to optimize the combination antiretroviral therapy in light of potential toxicities with long-term cumulative exposure to nucleos(t)ide reverse-transcriptase inhibitors (NRTIs). Methods: In this retrospective observational study, we included HIV-infected patients on suppressive antiretroviral therapy with plasma viral load (PVL) < 200 copies/mL for at least 6 months who were switched to dual regimens containing lamivudine (3TC) (150 mg twice daily or 300 mg once daily) plus lopinavir/ritonavir (LPV/r) 250/50 mg twice daily or darunavir/ritonavir (DRV/r) 800/100 mg once daily. Patients maintaining on suppressive triple therapy with DRV/r or LPV/r plus two NRTIs were included for comparisons. The primary endpoint was the proportion of patients with PVL <50 copies/mL after 48 weeks of follow-up. Results: In total, 364 patients were included with 93 (25.5%) switched to dual therapy After 48 weeks of observation, PVL <50 copies/mL was observed in 96.8% and 94.1% of dual-therapy and triple-therapy group, respectively, in per-protocol analysis (difference 2.7%; 95% CI -2.5%–7.9%). Nineteen patients (3 [3.2%] in dual-therapy and 16 [7.6%] in triple-therapy group) developed virologic failure, with none having emergent M184V resistance-associated mutation. A statistically significant increase of cholesterol level (13 mg/dL versus 2 mg/dL, p = 0.003) and high-density lipoprotein (3 mg/dL versus −2 mg/dL, p = 0.019) were observed in dual-therapy than in triple-therapy group. Changes of triglyceride, low-density lipoprotein and glycated hemoglobin levels were similar between the two groups. Conclusion: Dual therapy with DRV/r or LPV/r plus lamivudine demonstrated similar effectiveness in maintaining viral suppression to triple therapy. Keywords: Combination antiretroviral therapy, Stable switch, Simplification, Adverse effect, Mitochondrial toxicityhttp://www.sciencedirect.com/science/article/pii/S1684118219300866
spellingShingle Tung-Che Hung
Guan-Jhou Chen
Shu-Hsing Cheng
Jhen-Hong Chen
Jheng-Lun Wei
Chien-Yu Cheng
Chien-Ching Hung
Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppression
Journal of Microbiology, Immunology and Infection
title Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppression
title_full Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppression
title_fullStr Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppression
title_full_unstemmed Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppression
title_short Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppression
title_sort dual therapy with ritonavir boosted protease inhibitor pi plus lamivudine versus triple therapy with ritonavir boosted pi plus two nucleos t ide reverse transcriptase inhibitor in hiv infected patients with viral suppression
url http://www.sciencedirect.com/science/article/pii/S1684118219300866
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