Advanced HIV Infection in Treatment-Naïve Individuals: Effectiveness and Persistence of Recommended 3-Drug Regimens

Mounzer, Karam; Brunet, Laurence; Fusco, Jennifer S; McNicholl, Ian R.; Cuervo, Helena Diaz; Sension, Michael; McCurdy, Lewis; Fusco, Gregory

doi:10.1093/ofid/ofac018

Cited by 20 publications

(23 citation statements)

References 40 publications

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“…To our knowledge, this is the rst study to evaluate the persistence of BIC/FTC/TAF and EFV + 3TC + TDF in real-world setting in China. Our study showed that after excluding the economic burden between ARTs, BIC/FTC/TAF had signi cant better persistence compared with EFV + 3TC + TDF, which is consistent with previous real-world studies in western countries [10,11]. The treatment discontinuation of EFV + 3TC + TDF group is mainly due to safety reason, which is also shown in other studies reporting the neuropsychiatric side effects related with EFV [14][15][16].…”

Section: Discussionsupporting

confidence: 91%

See 1 more Smart Citation

Treatment persistence of bictegravir/emtricitabine/tenofovir alafenamide and efavirenz+lamivudine+tenofovir disoproxil among HIV-1 patients newly starting treatment in China

Cao

Tang

Wang

et al. 2023

Preprint

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Background: Though bictegravir/emtricitabine/tenofovir (BIC/TAF/TAF) have been regulatory approved and included in the National Reimbursement Drug List in China, due to the affordability concern, generic version of efavirenz+lamivudine+tenofovir (EFV+3TC+TDF) is still recommended as the 1st-line therapy in the clinical guideline and widely used in clinical practice. The aim of the study is to assess the persistence with 1st-line BIC/TAF/TAF and EFV+3TC+TDF in newly treated HIV-1 patients in the real-world setting in China. Methods: A retrospective analysis of the medical records of HIV patients initiating 1st-line antiretroviral therapy in the First Hospital of Changsha in January 1st, 2021-July 31st, 2022 was conducted. Persistence was assessed as the number of days on the therapy from the index until treatment discontinuation or end of data availability. Kaplan-Meier Curves and Cox Proportional Hazard models were used to evaluate the discontinuation rates. Subgroup analysis was performed excluding BIC/FTC/TAF patients with treatment discontinuation due to economic reason, and EFV+3TC+TDF patients with a viral load >500,000 copies/mL. Results: A total of 310 eligible patients were included in the study, with 244 and 66 patients in the BIC/FTC/TAF group and EFV+3TC+TDF group, respectively. Compared with EFV+3TC+TDF patients, BIC/FTC/TAF patients were significantly younger and had significantly higher total cholesterol and low-density level (all p<0.05). No significant difference was shown in the time to discontinuation between BIC/FTC/TAF patients and EFV+3TC+TDF patients. After excluding BIC/FTC/TAF patients with treatment discontinuation due to economic reason, EFV+3TC+TDF group were shown to have a significantly higher risk of discontinuation than BIC/FTC/TAF group (hazard ratio [HR] = 9.6, 95% confidence interval [CI]=1.2-74.2). After further removing the EFV+3TC+TDF patients with a viral load>500,000 copies/mL, the analysis showed similar results (HR=9.7, 95% CI = 1.2 - 76.9). 79.4% of the EFV+3TC+TDF patients discontinued treatment due to clinical reasons, while 83.3% of the BIC/FTC/TAF patients discontinued treatment due to economic reasons. Conclusions: Compared with BIC/FTC/TAF, EFV+TDF+3TC patients were significantly more likely to discontinue the 1st-line treatment.

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Section: Discussionsupporting

confidence: 91%

“…Previous studies have shown that STRs had higher adherence and persistence compared with MTRs [10][11][12][13]. Nevertheless, limited studies have explored the persistence difference between STR and MTR in the real-world clinical practice in China.…”

Section: Introductionmentioning

confidence: 99%

Treatment persistence of bictegravir/emtricitabine/tenofovir alafenamide and efavirenz+lamivudine+tenofovir disoproxil among HIV-1 patients newly starting treatment in China

Cao

Tang

Wang

et al. 2023

Preprint

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“…Currently, there are limited data related to the selection, efficacy, and safety of ART regimens specifically for patients with advanced HIV infection. Three clinical trials (6)(7)(8) were designed to compare virological efficacy in ART-naïve PLWH with CD4 count < 200 cells/uL, such as the PRADAR study (7) which ART regimens contained abacavir/lamivudine (ABC/ 3TC) plus darunavir/ritonavir (DRV/r) or raltegravir (RAL), and real-world observational studies (9,10) mainly conducted in high-income countries. The common regimens used in PLWH were 3-drug regimens (3DRs) including efavirenz (EFV) or dolutegravir (DTG) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) between 2019 and 2021 in China, while data on the clinical efficacy and safety of common options in advanced ART-naïve PLWH have not been reported.…”

Section: Introductionmentioning

confidence: 99%

A retrospective clinical study of dolutegravir- versus efavirenz-based regimen in treatment-naïve patients with advanced HIV infection in Nanjing, China

Zhong

et al. 2023

Front. Immunol.

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Currently, there are limited data related to the efficacy and safety of ART regimens, as well as factors influencing immune recovery in antiretroviral therapy (ART)-naïve patients with advanced HIV infection, especially in China. We designed a single-center, retrospective cohort study from March 1, 2019, to May 31, 2022, at The Second Hospital of Nanjing, China. ART-naïve adults with advanced HIV infection (CD4+ T-cell count < 200 cells/μL) who met the study criteria were included. The plasma viral load (VL), CD4+ T-cell count, CD4/CD8 ratio, treatment discontinuation, and immune reconstitution inflammatory syndrome (IRIS) events were collected to compare the efficacy and safety of the dolutegravir (DTG) and the efavirenz (EFV) regimens. Factors of immune recovery were analyzed using the Cox regression model. Study enrolled 285 ART-naïve adults with advanced HIV-1 infection, of which 95 (33.3%) started regimens including DTG and 190 (66.7%) were treated with EFV. After ART initiation, the proportion of patients with HIV-1 RNA < 50 copies/mL was higher (22.5% versus 6.5%, P < 0.001) in those on DTG-based regimens at month 1, but no significant difference at other follow-up points. Compared to the baseline, the median CD4+ T-cell count and CD4/CD8 ratio increased significantly during follow-up both in the EFV and the DTG groups. However, the CD4+ T-cell count increased greater in patients on DTG-based regimens at months 6, 12, 24, and 36 (P < 0.05). A total of 52 (18.2%) patients discontinued treatment, with no significant difference between ART regimens in treatment discontinuation rates. Only 7 patients reported IRIS, without significant difference between ART regimens (P=0.224). Overall, 34.0% (97/285) achieved a CD4+ T-cell count ≥ 350 cells/μL during follow-up. Age (P < 0.001), baseline CD4+ T-cell count (P < 0.001), baseline VL (P < 0.001) and ART regimens (P = 0.019) were associated with the CD4+ T-cell count ≥ 350 cells/μL after adjusting for potential confounders. Among ART-naïve adults with advanced HIV infection, it appeared that DTG-based regimens were better options for initial therapy compared to regimens including EFV; in addition, ART regimens, age, baseline VL and CD4+ T-cell count were associated with immune recovery.

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“…The study showed that those initiating B/F/TAF were less likely to discontinue their regimen than those on any other regimen and were more likely to achieve virological suppression than those on bDRV but not those on other INSTIs. However, no adjusted analysis of immunological outcomes was performed [29].…”

Section: Introductionmentioning

confidence: 99%

Immune response to ART initiation in advanced HIV infection

Mounzer

Brunet²,

Fusco³

et al. 2023

HIV Medicine

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Objectives Our objective was to compare the immunological responses to commonly used antiretroviral therapy (ART) regimens among people with advanced HIV in the USA and to assess virological outcomes and regimen persistence. Methods This study included ART‐naïve adults with advanced HIV infection (CD4 cell count <200 cells/μL) initiating ART with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), boosted darunavir (bDRV), dolutegravir (DTG), or elvitegravir (EVG/c)‐containing regimens between 1 January 2018 and 31 December 2020 in the Observational Pharmaco‐Epidemiology Research and Analysis (OPERA) cohort. Cox proportional hazards models and linear mixed models with random intercept were fit with inverse probability of treatment weighting. Results Overall, 1349 people with advanced HIV (816 B/F/TAF, 253 DTG, 146 EVG/c, 134 bDRV) were followed for a median of 22 months. Compared with B/F/TAF, a lower likelihood of achieving a CD4 cell count ≥200 cells/μL was observed with bDRV (hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.60–0.96), DTG (HR 0.82; 95% CI 0.69–0.98), and EVG/c (HR 0.73; 95% CI 0.57–0.93). All groups had a similar pattern of CD4:CD8 ratio changes: a rapid increase in the first 6 months (ranging from +0.15 to +0.16 units), followed by a slower increase thereafter. Only 40 individuals (4%) achieved CD4:CD8 ratio normalization (≥1). B/F/TAF was associated with a faster time to virological suppression (viral load <200 copies/mL) and a slower time to discontinuation compared with other regimens. Conclusions Among people with advanced HIV infection, B/F/TAF initiation was associated with faster CD4 cell count recovery and favourable virological outcomes compared with bDRV‐, DTG‐, and EVG/c‐based regimens, although no difference was observed in CD4:CD8 ratio changes over time across regimens.

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Advanced HIV Infection in Treatment-Naïve Individuals: Effectiveness and Persistence of Recommended 3-Drug Regimens

Cited by 20 publications

References 40 publications

Treatment persistence of bictegravir/emtricitabine/tenofovir alafenamide and efavirenz+lamivudine+tenofovir disoproxil among HIV-1 patients newly starting treatment in China

Treatment persistence of bictegravir/emtricitabine/tenofovir alafenamide and efavirenz+lamivudine+tenofovir disoproxil among HIV-1 patients newly starting treatment in China

A retrospective clinical study of dolutegravir- versus efavirenz-based regimen in treatment-naïve patients with advanced HIV infection in Nanjing, China

Immune response to ART initiation in advanced HIV infection

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