Treatment initiation or switch to BIC/FTC/TAF – real-world safety and efficacy data from two HIV centers in Romania

Săndulescu, Oana; Irimia, Mădălina; Benea, Otilia Elisabeta; Mărdărescu, Mariana; Preoţescu, Liliana; Dorobăț, Carmen; Loghin, Isabela Ioana; Nicolau, I; Jipa, Raluca; Popescu, R.; Benea, Cristina Loredana; Cozma, Alina; Dărămuș, Ioana Andreea; Miron, Victor Daniel; Prisăcariu, Liviu Jany; Bahnă, Adriana Florina; Nistor, Irina; Secrieru, Oana Manuela; Silvaș, George; Bîrcă, Andreea; Dobrea, Loredana; Șogorescu, Alexandra-Ștefana; Viziteu, Ioana; Streinu-Cercel, Adrian

doi:10.18683/germs.2021.1286

Cited by 12 publications

(12 citation statements)

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“…After starting antiretroviral therapy, CD4 count increased while CD8 count decreased [16]. In this study, at week 24 of BIC + FTC + TAF treatment, CD4 count in patients increased, indicating improved immune function after ART with BIC + FTC + TAF, corroborating previous studies [12][13][14][15]17].…”

Section: Discussionsupporting

confidence: 90%

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Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered bicetivir, entatabine, and propofol tenofovir in southwest China

Kong

Xie

et al. 2023

Preprint

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Background: Prospective studies examining long-term therapeutic outcomes of the BIC+FTC+TAF regimen in human immunodeficiency virus (HIV) infection remain limited. This study assessed the actual efficacy and safety of BIC+FTC+TAF in HIV-infected individuals in southwest China. Methods: This was a single-center, prospective study enrolling treatment-naïve (n=32) and treatment-experienced (n=177) HIV-infected patients administered BIC+FTC+TAF treatment between March 2022 and August 2022. The data were collected until February 28, 2023. Virological reactions and adverse events to the treatment were recorded, and patient subjective feelings in the form of ePRO were collected. The primary endpoint was the rate of patients with HIV viral load <50 copies/mL at week 24. Results: At week 24, 87.5% and 95.5% of treatment-naïve and treatment-experienced HIV patients had a viral load <50 copies/mL, respectively. CD4 cell counts in treatment-naïve and treatment-experienced patients increased significantly by 163.5 cells/μL (P=0.002) and 55.0 cells/μL (P=0.022), respectively. By week 24, no patients had discontinued the BIC+FTC+TAF treatment due to adverse events. Based on ePRO data, treatment-naïve and treatment-experienced patients at week 24 had stable disease symptom burden, quality of life, and depression level after treatment with BIC+FTC+TAF. Conclusion: BIC+FTC+TAF reduces the viral load in treatment-naïve patients with high viral load as well as treatment-experienced patients with residual viremia. The patient's subjective experience was maintained stable after treatment with BIC+FTC+TAF. This study also revealed a very low incidence for BIC+FTC+TAF drug-related side effects.

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Section: Discussionsupporting

confidence: 90%

“…In this study, 3 treatment-naïve and 8 treatment-experienced patients had virological failure at week 24; 10 (31.3%) of the 32 treatment-naïve patients had a baseline viral load > 500000 copies/mL, and 7 had a VL < 50 copies/mL at week 24, consistent with previous ndings [12][13][14][15].…”

Section: Discussionsupporting

confidence: 88%

Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered bicetivir, entatabine, and propofol tenofovir in southwest China

Kong

Xie

et al. 2023

Preprint

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“…To a lesser extent, cases of tuberculosis (TB) (5.39%), syphilis (1.80%), toxoplasmosis (1.80%), Cryptococcus (0.60%), Cytomegalic virus (CMV) (1.20%), Herpes virus, and varicella-zoster virus (VZV) (2.40%) infections were recorded. The favorable evolution after ART was described in Romania, which used a single-pill regimen, also adapted to patient's comorbidities according to www.hiv-druginteractions.org [25,26].…”

Section: Discussionmentioning

confidence: 99%

Profile of Newly Diagnosed Patients with HIV Infection in North-Eastern Romania

et al. 2023

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Background and Objectives: Human immunodeficiency virus infection and the acquired immunodeficiency syndrome (HIV/AIDS) pandemic are unquestionably the most serious public crisis of our time. Identifying, preventing, and treating HIV-associated comorbidities remains a challenge that must be addressed even in the era of antiretroviral therapy. Materials and Methods: In this study, we aimed to characterize the aspects of newly diagnosed patients with HIV/AIDS, during 2021–2022 in Northeastern Romania. We reviewed the frequency and associated comorbidities of these patients in correspondence with national and global results. Results: Our study found that of all newly diagnosed HIV cases (167 cases—74 cases in 2021 and 98 cases in 2022), 49.70% were diagnosed with HIV infection and 50.30% had AIDS. Based on sex correlated with the CD4+ T-lymphocyte level, the most affected were males, with a lower CD4+ T-lymphocyte level overall. The average HIV viral load was 944,689.55 copies/mL. Half of males had an abnormal ALT or AST (39.53% and 49.61%); as for the females, less than a quarter had an increased value of ALT or AST, respectively (18% and 26%). The most frequent co-infections were as follows: oral candidiasis (34.73% of patients), hepatitis B (17.37% of patients), and SARS-CoV-2 infection (8.38%), followed by hepatitis C (6.39%), tuberculosis (TB), syphilis, toxoplasmosis, Cryptococcus, Cytomegalovirus infections. Males were more affected than females, with a higher percentage of co-infections. The prescribed antiretroviral treatment focused on a single-pill regimen (79.04%) to ensure adherence, effectiveness, and safety. Therefore, 20.96% had been prescribed a regimen according to their comorbidities. Conclusions: Our study found a concerning rise in the incidence of HIV in 2022 compared to that in 2021 in Northeastern Romania, because of the rise in post-SARS-CoV-2 pandemic addressability. Advanced immunodeficiency and the burden of opportunistic infections characterize newly diagnosed HIV patients. The physicians should keep in mind that these patients may have more than one clinical condition at presentation.

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“…11 In this study, three ART-naïve and eight ARTexperienced patients had virological failure at Week 24; 10 (31.3%) of the 32 ART-naïve patients had a baseline viral load >500,000 copies/mL, and 7 had a VL < 50 copies/mL at Week 24, consistent with previous findings. [12][13][14][15] After starting ART, CD4 count increased while CD8 count decreased. 16 In this study, at Week 24 of BIC/FTC/ TAF treatment, CD4 count in patients increased, indicating improved immune function after ART with BIC/FTC/TAF, corroborating previous studies.…”

Section: Discussionmentioning

confidence: 99%

“…16 In this study, at Week 24 of BIC/FTC/ TAF treatment, CD4 count in patients increased, indicating improved immune function after ART with BIC/FTC/TAF, corroborating previous studies. [12][13][14][15]17 In patients with HIV and associated comorbidities, simplified medication regimens can reduce drug interactions and decrease the risk of renal dysfunction. In this study, 84.4% of patients with no previous ART and 78.5% of those with ART experience were younger than 45 years old.…”

Section: Discussionmentioning

confidence: 99%

Clinical efficacy, safety, and subjective experience based on ePRO in HIV‐infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China

Kong,

Xie,

et al. 2023

Immunity Inflam & Disease

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BackgroundProspective studies examining long‐term therapeutic outcomes of the Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) regimen in human immunodeficiency virus (HIV) infection remain limited. This study assessed the actual efficacy and safety of BIC/FTC/TAF in HIV‐infected individuals in southwest China.MethodsThis was a single‐center, prospective study enrolling ART‐naïve (n = 32) and ART‐experienced (n = 177) HIV‐infected patients administered BIC/FTC/TAF treatment between March 2022 and August 2022. The data were collected until February 28, 2023. Virological reactions and adverse events to the treatment were recorded, and patient subjective feelings in the form of Electronic Patient Reporting Outcome (ePRO) were collected. The primary endpoint was the rate of patients with HIV viral load <50 copies/mL at Week 24.ResultsAt Week 24, 87.5% and 95.5% of ART‐naïve and ART‐experienced HIV patients had a viral load <50 copies/mL, respectively. CD4 cell counts in ART‐naïve and ART‐experienced patients increased significantly by 163.5 cells/μL (p = .002) and 55.0 cells/μL (p = .022), respectively. By Week 24, no patients had discontinued the BIC/FTC/TAF treatment due to adverse events. Based on ePRO data, ART‐naïve and ART‐experienced patients at Week 24 had stable disease symptom burden, quality of life, and depression level after treatment with BIC/FTC/TAF.ConclusionBIC/FTC/TAF reduces the viral load in ART‐naïve patients with high viral load as well as ART‐experienced patients with residual viremia. The patient's subjective experience was maintained stable after treatment with BIC/FTC/TAF. This study also revealed a very low incidence for BIC/FTC/TAF drug‐related side effects.

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Treatment initiation or switch to BIC/FTC/TAF – real-world safety and efficacy data from two HIV centers in Romania

Cited by 12 publications

References 0 publications

Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered bicetivir, entatabine, and propofol tenofovir in southwest China

Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered bicetivir, entatabine, and propofol tenofovir in southwest China

Profile of Newly Diagnosed Patients with HIV Infection in North-Eastern Romania

Clinical efficacy, safety, and subjective experience based on ePRO in HIV‐infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China

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