Comparison of Virological Efficacy of DTG/ABC/3TG and B/F/TAF Regimens and Discontinuation Patterns in Persons Living with Advanced HIV in the Era of Rapid ART: A Retrospective Multicenter Cohort Study

Lee, Chun-Yuan; Lee, Chen‐Hsiang; Tang, Hung‐Jen; Tsai, Hung-Chin; Yang, Chen-Hsun; Lin, Yi-Pei; Wang, Sheng-Fan; Lu, Po‐Liang

doi:10.1007/s40121-022-00734-5

Cited by 6 publications

(5 citation statements)

References 38 publications

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“…This perpetuates an inflammatory vascular environment, raising the risk of non-HIV comorbidities. The multifactorial nature of leucopenia, including myelosuppressive drug use [ 10 15 ] and opportunistic infections [ 22 23 ], suggests a complex interplay. While our study does not dissect the mechanism behind paradoxical viral suppression without CD4+ T cell gain, it does propose a causal relationship between CD4+ T cell depletion, low viremia, and sustained immune activation.…”

Section: Discussionmentioning

confidence: 99%

“…Among these, anemia, leucopenia, and thrombocytopenia are notable clinical complications of HIV infection that frequently emerge early and persist irrespective of disease symptoms [ 2 8 ]. Importantly, these hematological complications significantly influence the efficacy of antiretroviral therapy (ART), contributing to accelerated disease progression, increased mortality, and a diminished quality of life [ 9 10 ].…”

Section: Introductionmentioning

confidence: 99%

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Prevalence of Cytopenia and its Correlation with Immunosuppression in Naïve HIV-1 Infected Patients Initiating First-Line Antiretroviral Therapy: A Pilot Study

Usman,

Balogun,

Shuaib

et al. 2023

Infect Chemother

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Background Cytopenias serve as common indicators and crucial predictive tools for evaluating disease progression and therapeutic outcomes in individuals with human immunodeficiency virus (HIV) infection. This study aimed to assess the prevalence of cytopenias and their correlation with the level of immunosuppression in treatment-naive HIV-infected participants after initiating highly active combined antiretroviral drug therapy (cART24). Materials and Methods This prospective study focused on evaluating cytopenia in 44 treatment-naive HIV-infected patients who consented to initiate cART and were consecutively enrolled. The research was conducted at the Nasara HIV Treatment & Care Centre of Ahmadu Bello University Teaching Hospital (ABUTH), Zaria, Nigeria, spanning from December 2016 to January 2018. Cytopenias, including anemia, leucopenia, lymphocytopenia, and thrombocytopenia, were defined and assessed according to World Health Organization guidelines. A combination of cross-sectional and longitudinal mixed-design two-step analysis was employed to validate our findings. Results The median time from enrollment to cART initiation was 7 days, following the universal test and treat protocol. The prevalence of cytopenia was 75% at the baseline before treatment and increased to 84% after cART24 administration. There were no statistically significant differences in the median values of immuno-hematological parameters between baseline and after cART24 initiation ( P >0.05). In terms of longitudinal assessment, the prevalence of anemia, leucopenia, lymphopenia, and thrombocytopenia at baseline were 66%, 23%, 0%, and 11%, respectively, and after cART24, the rates were 66%, 29%, 5%, and 20%. Notably, the prevalence of cytopenia correlated with declining CD4+ T cell counts. Among instances of unicytopenia, 58% exhibited isolated anemia, 6% had lone leucopenia, and 6% had solitary thrombocytopenia. Additionally, 27% demonstrated bi-cytopenia, and 3% exhibited pancytopenia. Interestingly, none of the study participants presented with lymphopenia. The most common combination was anemia and thrombocytopenia. Both longitudinal and cross-sectional analytical findings were consistent. Conclusion In treatment-naive HIV-infected individuals, the prevalence of cytopenias, particularly anemia and thrombocytopenia, was substantial and correlated with the degree of immunosuppression as indicated by CD4+ T cell counts. These cytopenias persisted despite initiation of cART24, highlighting the complexity of hematological manifestations in HIV infection. Our study underscores the significant hematopathological impact of HIV and antiretroviral therapy, highlighting the necessity for preventive strategies to mitigate these adverse effects.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Prevalence of Cytopenia and its Correlation with Immunosuppression in Naïve HIV-1 Infected Patients Initiating First-Line Antiretroviral Therapy: A Pilot Study

Usman,

Balogun,

Shuaib

et al. 2023

Infect Chemother

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“…Indeed, some studies included older PIs (i.e., atazanavir/ritonavir, lopinavir/ritonavir) or a first-generation InSTI (i.e., raltegravir, elvitegravir) [ 17 , 18 , 30 ], which, as of the last few years, is no longer recommended. Other studies included darunavir or a late-generation InSTI (i.e., dolutegravir and bictegravir), but had a limited follow-up which did not permit adequate investigation of the dynamics of TD in the long term [ 31 , 32 ]. Therefore, additional data are needed to guide the choice of antiretroviral regimens in late presenters.…”

Section: Discussionmentioning

confidence: 99%

“…Finally, no data on the use of bictegravir were available in our cohort, and this drug could have valuable characteristics in advanced naïve patients, since it is an integrase inhibitor with a high genetic barrier and is coformulated with an NRTI backbone in a single-tablet regimen. Recent data suggest that bictegravir could have good efficacy and provide durability data in this setting [ 31 , 32 , 50 ]. Thus, further studies should be performed to determine whether our findings could also be translated to this InSTI.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Durability of Dolutegravir- or Darunavir-Based Regimens in ART-Naïve AIDS- or Late-Presenting HIV-Infected Patients

Fabbiani

Masini

Rossetti

et al. 2023

Viruses

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Background: Since limited data are available, we aimed to compare the efficacy and durability of dolutegravir and darunavir in advanced naïve patients. Methods: Retrospective multicenter study including AIDS- or late-presenting (def. CD4 ≤ 200/µL) HIV-infected patients starting dolutegravir or ritonavir/cobicistat-boosted darunavir+2NRTIs. Patients were followed from the date of first-line therapy initiation (baseline, BL) to the discontinuation of darunavir or dolutegravir, or for a maximum of 36 months of follow-up. Results: Overall 308 patients (79.2% males, median age 43 years, 40.3% AIDS-presenters, median CD4 66 cells/µL) were enrolled; 181 (58.8%) and 127 (41.2%) were treated with dolutegravir and darunavir, respectively. Incidence of treatment discontinuation (TD), virological failure (VF, defined as a single HIV-RNA > 1000 cp/mL or two consecutive HIV-RNA > 50 cp/mL after 6 months of therapy or after virological suppression had been achieved), treatment failure (the first of TD or VF), and optimal immunological recovery (defined as CD4 ≥ 500/µL + CD4 ≥ 30% + CD4/CD8 ≥ 1) were 21.9, 5.2, 25.6 and 1.4 per 100 person-years of follow-up, respectively, without significant differences between dolutegravir and darunavir (p > 0.05 for all outcomes). However, a higher estimated probability of TD for central nervous system (CNS) toxicity (at 36 months: 11.7% vs. 0%, p = 0.002) was observed for dolutegravir, whereas darunavir showed a higher probability of TD for simplification (at 36 months: 21.3% vs. 5.7%, p = 0.046). Conclusions: Dolutegravir and darunavir showed similar efficacy in AIDS- and late-presenting patients. A higher risk of TD due to CNS toxicity was observed with dolutegravir, and a higher probability of treatment simplification with darunavir.

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“…Indeed, the median time to reach virological suppression (VL <50 copies/mL) observed in other retrospective studies of Asian populations was similar to that in our findings, 184 days in the DTG + 3TC group and 90 days in the B/F/TAF group. [ 21 , 22 ] Differences in baseline characteristics may contribute to mixed results of RCTs and real-life studies. Both the prevalence of comorbidities and higher baseline VL characteristic of the study populations may explain why HIV-1 RNA decay with DTG + 3TC during initial treatment was slow in the present real-life study than in the GEMINI study.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety profiles of dolutegravir plus lamivudine vs. bictegravir/emtricitabine/tenofovir alafenamide in therapy-naïve adults with HIV-1

Wei,

Li,

et al. 2023

Chinese Medical Journal

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Background: Dual regimen dolutegravir (DTG) plus lamivudine (3TC) has demonstrated non-inferior efficacy compared to DTG-based three-drug regimens (3DRs), yet directly comparative data regarding the efficacy and safety of DTG + 3TC and bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for therapy-naïve people with human immunodeficiency virus (HIV)-1 (PWH) are still limited. We aimed to assess the antiviral potency and safety profiles of DTG + 3TC vs. B/F/TAF based on antiretroviral therapy (ART)-naïve PWH in China. Methods: This retrospective multicenter study enrolled PWH initiating ART with DTG + 3TC or B/F/TAF from 2020 to 2022 in Guangdong and Guangxi. We analyzed response rates based on target not detected (TND) status using intention-to-treat (ITT) analysis. Subgroups were formed based on baseline viral load (VL) (<100,000 vs. ≥100,000 copies/mL) and CD4+ cell count (<200 vs. ≥200 cell/µL). Median time to TND VL was assessed by Kaplan–Meier method. We also measured changes from baseline in CD4+ cell counts, CD4/CD8 ratio, lipid parameters, weight, creatinine (Cr), estimated glomerular filtration rate (eGFR), and drug-related adverse effects (DRAEs). Results: We enrolled 280 participants, including 137 (48.9%) on DTG + 3TC and 143 (51.1%) on B/F/TAF. At week 48, 96.4% (132/137) on DTG+3TC and 100% (143/143) on B/F/TAF achieved TND (P = 0.064). At week 12, TND responses were higher with B/F/TAF (78.3% [112/143]) than DTG+3TC (30.7% [42/137]) (P <0.001). This trend held across subgroups. B/F/TAF achieved TND faster (12 weeks) than DTG+3TC (24 weeks) (P <0.001). No differences were seen in CD4+ cell count and CD4/CD8 ratio, except in the high-VL subgroup, where B/F/TAF showed better recovery. DRAEs were significantly lower with B/F/TAF (4.9% [7/143]) than with DTG + 3TC (13.1% [18/137]) (P = 0.016). Lipid parameters, body weight, and Cr increased in both groups over 48 weeks, with DTG+3TC showing a more favorable effect on triglycerides, high-density lipoprotein (HDL) cholesterol, and weight gain. Conclusions: In this real-life study, B/F/TAF led to a faster viral decline and fewer DRAEs compared to DTG+3TC. No significant difference was observed in the TND rate at week 48, regardless of baseline VL and CD4+ cell count. CD4+ recovery was superior for B/F/TAF in participants with high VL. The DTG + 3TC regimen had less impact on metabolic changes than B/F/TAF.

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Comparison of Virological Efficacy of DTG/ABC/3TG and B/F/TAF Regimens and Discontinuation Patterns in Persons Living with Advanced HIV in the Era of Rapid ART: A Retrospective Multicenter Cohort Study

Cited by 6 publications

References 38 publications

Prevalence of Cytopenia and its Correlation with Immunosuppression in Naïve HIV-1 Infected Patients Initiating First-Line Antiretroviral Therapy: A Pilot Study

Prevalence of Cytopenia and its Correlation with Immunosuppression in Naïve HIV-1 Infected Patients Initiating First-Line Antiretroviral Therapy: A Pilot Study

Efficacy and Durability of Dolutegravir- or Darunavir-Based Regimens in ART-Naïve AIDS- or Late-Presenting HIV-Infected Patients

Efficacy and safety profiles of dolutegravir plus lamivudine vs. bictegravir/emtricitabine/tenofovir alafenamide in therapy-naïve adults with HIV-1

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