Effectiveness and Risk Factors for Virological Outcome of Raltegravir-Based Therapy for Treatment-Experienced HIV-Infected Patients

Mata‐Marín, José Antonio; Smeke, Ariane Estrella Weiser; Rodriguez, Mariana Rotzinger; Chavez-García, Marcelino; Banda-Lara, Marco Isaac; Ríos, Alma Minerva Pérez; Nuñez-Rodríguez, Nohemí; Domínguez-Hermosillo, Juan Carlos; Sánchez, Alberto Chaparro; Juárez-Kasusky, Irene; Herrera, Javier Enrique Cruz; Ramírez, Jorge Luis Sandoval; Gaytán-Martı́nez, Jesús

doi:10.1007/s40268-017-0174-z

Cited by 8 publications

(8 citation statements)

References 13 publications

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“…Phase 3 trials showed that baseline plasma HIV-RNA did not affect DTG-based therapy; for raltegravir, the impact of baseline viral load is discussed controversially [ 8 , 11 ]. Smaller clinical studies that encompassed drug-naive and treatment-experienced patients suggested that older age [ 12 , 13 ], lack of adherence [ 14 ], origin from a high-prevalence country, injection drug use, and a low CD4 count at baseline [ 13 ] increased the risk for failure of InSTI-based therapy.…”

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confidence: 99%

Predictors of Virological Failure and Time to Viral Suppression of First-Line Integrase Inhibitor–Based Antiretroviral Treatment

Pyngottu

Scherrer

Kouyos

et al. 2020

Clinical Infectious Diseases

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Background Integrase strand transfer inhibitors (InSTIs) are recommended for first-line treatment of HIV-infection. We identified risk factors, including baseline minor InSTI resistance mutations, for treatment failure of InSTI-based regimens. Methods We studied time to treatment failure and time to viral suppression among 1419 drug-naive patients in the Swiss HIV Cohort Study. We performed Cox regression models adjusted for demographic factors, baseline HIV RNA/CD4 cell counts, AIDS defining events and the type of InSTI. In 646 patients with a baseline genotypic resistance test of the integrase, we studied the impact of minor integrase resistance mutations. Results We observed 121 virological failures during 18’447 person-years of follow-up. A baseline viral load ≥100’000 cps/mL (multivariable Hazard Ratio (mHR): 2.2, 95% CI: 1.3-3.6) and an AIDS defining event (mHR: 1.8, 95% CI: 1.1-3.0) were associated with treatment failure. CD4 counts between 200-500 cells/µL (mHR: 0.5, 95% CI: 0.3-0.8) and >500 cells/µL (mHR: 0.4, 95% CI: 0.2-0.7) were protective. Median [IQR] time to viral suppression was 50 [29,107] days. Time to suppression was shorter in lower viral load strata (mHR: 0.7, 95% CI: 0.6-0.8) and in dolutegravir-based therapy (mHR: 1.2, 95% CI: 1.0-1.4). Minor resistance mutations were found at baseline in 104/646 (16%) patients with no effect on treatment outcome. Conclusion Among drug-naïve HIV-infected individuals treated with InSTI-based regimens, factors associated with treatment failure, in particular high viral load and low CD4 counts remain similar to older treatments. Minor InSTI resistance mutations had no impact in this large observational cohort.

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confidence: 99%

Predictors of Virological Failure and Time to Viral Suppression of First-Line Integrase Inhibitor–Based Antiretroviral Treatment

Pyngottu

Scherrer

Kouyos

et al. 2020

Clinical Infectious Diseases

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“…Los esquemas de TARGA basados en Raltegravir incluidos en el estudio presentan un importante efecto antirretroviral, que se refleja en la importante reducción de la carga viral a los 6 meses de tratamiento. En concordancia, diversos estudios que han evaluado la eficacia de los esquemas basados en este medicamento en condiciones clínicas reales han demostrado una alta eficacia para el control del virus (4,6,7) . Sin embargo, los datos siguen siendo aún limitados, sobre todo, en nuestra población (8) .…”

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“…Se encontraron altas tasas de supresión virológicas a las 48 semanas de tratamiento similares al nuestro. Por otro lado, la edad mayor de 40 años se asoció a un buen resultado virológico con importante tamaño del efecto (Odds Ratio [OR]: 5,61; Intervalo de confianza al 95% [IC-95%]: 1,61-18,84), sin embargo, el uso de Tenofovir dentro del régimen se asoció a un mal resultado virológico (OR:0,16; IC-95%: 0,03-0,80) (7) .…”

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Eficacia y seguridad en condiciones clínicas reales del raltegravir en un hospital de referencia del seguro social peruano

et al. 2021

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Introducción: El Rategravir pertenece a los inhibidores de integrasas, quedando demostrado y aprobado por diversos ensayos clínicos como un potente antirretroviral seguro y eficaz para el tratamiento de pacientes infectados con el virus de inmunodeficiencia humana (VIH), con buena tolerancia y baja toxicidad, incluyéndose en el esquema de tercera línea o rescate y se inicia cuando los esquemas de primera y segunda línea han fracasado.Objetivo: Evaluar la eficacia y seguridad en condiciones clínicas reales del uso de Raltegravir dentro de los esquemas de la Terapia Antiretroviral de Gran Actividad (TARGA) en pacientes con infección por VIH en un hospital de referencia del seguro social en Perú.Métodos: Se realizó un estudio observacional retrospectivo en pacientes con diagnóstico de infección por VIH que iniciaron tratamiento dentro del esquema TARGA basados en Raltegravir con seguimiento y control a los 6 meses. Se presentaron medidas de resumen de frecuencias y porcentajes para las variables cualitativas, así como medias y desviación estándar para las variables cuantitativas en base a los resultados de las pruebas de normalidad. Los datos fueron procesados y analizados en el software estadístico SPSS versión 22.Resultados: El género masculino fue el más afectado con un 76%(n=119) del total. El rango de edad más frecuente fue el comprendido entre los 45 a 55 años (25,4%; n=40). Las comorbilidades más frecuentes fueron Diabetes mellitus e Hipertensión arterial, con reducción exponencial de la carga viral y elevación de los niveles de linfocitos CD4.Conclusión: El Raltegravir es eficaz para el tratamiento de pacientes VIH. Introduction: Rategravir belongs to integrase inhibitors, being demonstrated and approved by several clinical trials as a powerful and safe antiretroviral drug for the treatment of patients infected with human immunodeficiency virus (HIV), with good tolerance and low toxicity, including in the third line or rescue scheme and it starts when the first and second lineas schemes have failed.Objective: To evaluate the efficacy and safety in real clinical conditions of the use of Raltegravir within the HAART schemes in patients with HIV infection in a reference hospital of social insurance in Peru.Methods: A retrospective observational study was performed in patients with a diagnosis of HIV infection who started treatment within the TARGA scheme based on Raltegravir with follow-up and control at 6 months. We presented summary measures of frequencies and percentages for the qualitative variables, as well as means and standard deviation for the quantitative variables based on the results of the normality tests. The data was processed and analyzed in the statistical software SPSS version 22.Results: The male gender was the most affected with 76% (n = 119) of the total. The most frequent age range was between 45 to 55 years (25.4%, n = 40). The most frequent comorbidities were Diabetes mellitus and arterial hypertension, with exponential reduction in viral load and elevation of CD4 lymphocyte levels.Conclusion: Raltegravir is effective for the treatment of HIV patients.

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“…6,7 Patients in our study who had previously failed several regimens, including potent ones initiated in recent years, may have been non-adherent to the new INSTI-based treatment. Two observational studies reporting 48-week outcomes of switching from a failing regimen to RAL found failure rates of 15% and 35%, 17,24 while another two studies found a failure rate of 20% at 24 weeks. 18,25 Only one study of RAL reported high suppression rates after 2 years in patients switching from a failing regimen.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of integrase strand transfer inhibitors among treatment-experienced patients in a clinical setting

Davy-Méndez

Napravnik

Zakharova³

et al. 2019

Aids

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Objective: Characterize virologic and immunologic outcomes of INSTI-based antiretroviral therapy (ART) in experienced patients with and without virologic failure. Design: Prospective clinical cohort. Methods: ART-experienced, INSTI-naïve participants in the University of North Carolina Center for AIDS Research HIV Clinical Cohort (UCHCC) initiating an INSTI-containing regimen 2007-2016 were followed from INSTI initiation (baseline) to the earliest of: outcome of interest, loss to follow-up (LTFU, one year without clinical visit), or death. Outcomes of interest were virologic failure (VF, first of two consecutive viral loads [VL] ≥200 copies/mL >2 weeks apart, or one VL≥200 before LTFU) and immune recovery (first CD4≥500 cells/μL). Patients with baseline VL≥50 were given 24 weeks before meeting VF criteria. Kaplan Meier curves and Cox proportional hazards models compared INSTI regimens and patient characteristics. Results: Of 773 patients, 32% were women, 59% African-American, and 42% had a VL≥50 at INSTI initiation. After two years, 5% of patients with baseline VL<50 experienced VF, compared to 35% of patients with baseline VL≥50 (P<0.01). Among patients with baseline VL<50, dolutegravir/NRTIs was associated with longer time to VF (adjusted hazard ratio [aHR] 0.11, 95% confidence interval [CI] 0.01, 0.80), while among patients with baseline VL≥50, raltegravir/NRTIs was associated with longer time to VF (aHR 0.35, 95% CI 0.18, 0.68), both compared to elvitegravir/NRTIs. After five years suppressed, irrespective of baseline VL, 61% of patients experienced immune recovery. Conclusions: In this cohort, INSTI-containing regimens led to low VF rates in patients switching ART while suppressed. Viremic patients initiating INSTIs were at high risk of VF during follow-up.

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Effectiveness and Risk Factors for Virological Outcome of Raltegravir-Based Therapy for Treatment-Experienced HIV-Infected Patients

Cited by 8 publications

References 13 publications

Predictors of Virological Failure and Time to Viral Suppression of First-Line Integrase Inhibitor–Based Antiretroviral Treatment

Predictors of Virological Failure and Time to Viral Suppression of First-Line Integrase Inhibitor–Based Antiretroviral Treatment

Eficacia y seguridad en condiciones clínicas reales del raltegravir en un hospital de referencia del seguro social peruano

Effectiveness of integrase strand transfer inhibitors among treatment-experienced patients in a clinical setting

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