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Early versus delayed antiretroviral therapy based on genotypic resistance test: Results from a large retrospective cohort study.

ABSTRACT: Rapid start of antiretroviral therapy (ART) pending genotypic resistance test (GRT) has been recently proposed, but the effectiveness of this strategy is still debated. The rate of virological success (VS), defined as HIV-RNA < 50 copies/ml, with and without GRT was compared in drug-naïve individuals enrolled in the Italian ARCA cohort who started ART between 2015 and 2018. 521 individuals started ART: 397 without GRT (pre-GRT group) and 124 following GRT (post-GRT group). Overall, 398 (76%) were males and 30 (6%) were diagnosed with AIDS. In the pre-GRT group, baseline CD4+ cell counts were lower (p < 0.001), and viral load was higher (p < 0.001) than in the post-GRT group. The estimated probability of VS in pre-GRT versus post-GRT group was 72.54% (CI₉₅ : 67.78-76.60) versus 66.94% (CI₉₅ : 57.53-74.26) at Week 24 and 92.40% (CI₉₅ : 89.26-94.62) versus 92.92% (CI₉₅ : 86.35-96.33) at Week 48, respectively (p = 0.434). At Week 48, VS was less frequent among individuals with baseline CD4+ cell counts <200 versus >500 (90.33% vs. 97.33%), log viral load <5.00 versus >5.70 log₁₀ cps/ml (97.17% vs 78.16%; p < 0.001), and those treated with protease inhibitors or non-nucleoside reverse transcriptase inhibitors versus those treated with integrase strand transfer inhibitors (p < 0.001). The rate of VS does not seem to be affected by an early ART initiation pending GRT results, but it could be influenced by the composition of the ART regimen, as well as immuno-virological parameters.

SUBMITTER: Bavaro DF

PROVIDER: S-EPMC9321101 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Early versus delayed antiretroviral therapy based on genotypic resistance test: Results from a large retrospective cohort study.

Bavaro Davide F DF De Vito Andrea A Pasculli Giuseppe G Bouba Yagai Y Magnasco Laura L Pincino Rachele R Saladini Francesco F Lattanzio Rossana R Corsini Romina R Arima Serena S Zazzi Maurizio M Incardona Francesca F Rossetti Barbara B Bezenchek Antonia A Vanni Borghi B Di Biagio Antonio A

Journal of medical virology 20220409 8

Rapid start of antiretroviral therapy (ART) pending genotypic resistance test (GRT) has been recently proposed, but the effectiveness of this strategy is still debated. The rate of virological success (VS), defined as HIV-RNA < 50 copies/ml, with and without GRT was compared in drug-naïve individuals enrolled in the Italian ARCA cohort who started ART between 2015 and 2018. 521 individuals started ART: 397 without GRT (pre-GRT group) and 124 following GRT (post-GRT group). Overall, 398 (76%) wer ...[more]

PMID: 35355293

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Project description:BackgroundUse of antiretroviral treatment for HIV-1 infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-1. However, the best time to initiate antiretroviral treatment to reduce progression of HIV-1 infection or non-AIDS clinical events is unknown. We reported previously that early antiretroviral treatment reduced HIV-1 transmission by 96%. We aimed to compare the effects of early and delayed initiation of antiretroviral treatment on clinical outcomes.MethodsThe HPTN 052 trial is a randomised controlled trial done at 13 sites in nine countries. We enrolled HIV-1-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation, stratified by site. Random assignment was unblinded. The HIV-1-infected member of every couple initiated antiretroviral treatment either on entry into the study (early treatment group) or after a decline in CD4 count or with onset of an AIDS-related illness (delayed treatment group). Primary events were AIDS clinical events (WHO stage 4 HIV-1 disease, tuberculosis, and severe bacterial infections) and the following serious medical conditions unrelated to AIDS: serious cardiovascular or vascular disease, serious liver disease, end-stage renal disease, new-onset diabetes mellitus, and non-AIDS malignant disease. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00074581.Findings1763 people with HIV-1 infection and a serodiscordant partner were enrolled in the study; 886 were assigned early antiretroviral treatment and 877 to the delayed treatment group (two individuals were excluded from this group after randomisation). Median CD4 counts at randomisation were 442 (IQR 373-522) cells per μL in patients assigned to the early treatment group and 428 (357-522) cells per μL in those allocated delayed antiretroviral treatment. In the delayed group, antiretroviral treatment was initiated at a median CD4 count of 230 (IQR 197-249) cells per μL. Primary clinical events were reported in 57 individuals assigned to early treatment initiation versus 77 people allocated to delayed antiretroviral treatment (hazard ratio 0·73, 95% CI 0·52-1·03; p=0·074). New-onset AIDS events were recorded in 40 participants assigned to early antiretroviral treatment versus 61 allocated delayed initiation (0·64, 0·43-0·96; p=0·031), tuberculosis developed in 17 versus 34 patients, respectively (0·49, 0·28-0·89, p=0·018), and primary non-AIDS events were rare (12 in the early group vs nine with delayed treatment). In total, 498 primary and secondary outcomes occurred in the early treatment group (incidence 24·9 per 100 person-years, 95% CI 22·5-27·5) versus 585 in the delayed treatment group (29·2 per 100 person-years, 26·5-32·1; p=0·025). 26 people died, 11 who were allocated to early antiretroviral treatment and 15 who were assigned to the delayed treatment group.InterpretationEarly initiation of antiretroviral treatment delayed the time to AIDS events and decreased the incidence of primary and secondary outcomes. The clinical benefits recorded, combined with the striking reduction in HIV-1 transmission risk previously reported, provides strong support for earlier initiation of antiretroviral treatment.FundingUS National Institute of Allergy and Infectious Diseases.

Project description:Common bile duct injury is a severe complication. It is related to increased rates of morbidity and mortality. Early recognition and on-time diagnosis plus multidisciplinary management of this disease led by a hepatobiliary surgeon show fewer complications rate and best postoperative outcomes. However, no guidelines exist about the proper time of reconstruction. This study aims to describe the experience of a specialized Hepato-Pancreatic-Biliary (HPB) group and to analyze the outcomes regarding the time of bile duct injury (BDI) repair. A multicenter retrospective review of a prospective database was conducted. All the patients older than 18 years old that underwent common bile duct reconstruction between January 2014 and December 2021 were included. Analysis and description of preoperative characteristics and postoperative outcomes were performed. A reconstruction time-based group differentiation was made and analyzed. 44 patients underwent common bile duct reconstruction between January 2014 and December 2021. 56.82% of the patients were female. The mean age was 53.27 years ± 20.7 years. The most common injury was type E2 (29.55%). Hepaticojejunostomy was performed in 81.81% (of the patients. Delayed reconstruction (> 72 h) was performed in the majority of the cases (75.00%) due to delays in the referral centers or poor condition. No statistically significant difference regarding complications in early or delayed BDI reconstruction. The mortality rate was 2.7% (n = 1). 2-year follow-up bilioenteric stenosis was observed in 7 patients. Biloma showed a statistical relationship with complex bile duct injuries (p = 0.02). Bile duct injury is a severe and complex postoperative complication that increases morbidity and mortality rates in the short and long term in patients undergoing cholecystectomy. In our study, there were no statistical differences between the timing of bile duct reconstruction and the postoperative outcomes; we identified the presence of biloma as a statistically related factor associated with complex bile duct injury; however, further prospective or studies with an increased sample size are required to prove our results.

Dataset Information

Early versus delayed antiretroviral therapy based on genotypic resistance test: Results from a large retrospective cohort study.

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Early versus delayed antiretroviral therapy based on genotypic resistance test: Results from a large retrospective cohort study.

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