Integrase strand-transfer inhibitors for treatment of early HIV infection: A case series.

This study evaluated whether the interval from the first clinic visit until the start of antiretroviral treatment (ART) was correlated with common parameters of immunological recovery among patients with early HIV infection (EHI).We reviewed the medical records of patients with EHI who started ART using integrase strand-transfer inhibitors (ISTIs) within the first 6 months after diagnosis. Simple linear regression analyses were performed to determine whether the interval from the first visit to the start of ART was correlated with 1-year changes in CD4+ cell count, CD8+ cell count, CD4+ percentage, and CD4+/CD8+ ratio.Fifty-three patients with probable or definite EHI started ART using ISTIs between April 2014 and August 2016. Forty-nine patients completed 1 year of follow-up, including 48 men. The routes of HIV transmission were 1 case of needle sharing, 5 cases of heterosexual activity, and 43 cases of men who had sex with men. None of the immunological recovery parameters were correlated with time to the start of ART (CD4+ cell count: R = .12, P = .42; CD8+ cell count: R = .107, P = .5; CD4+ percentage: R = .14, P = .34; CD4+/CD8+ ratio: R = .23, P = .14). Furthermore, subgroup sensitivity analyses failed to detect significant correlations based on definite or probable diagnoses, treatment using elvitegravir or dolutegravir, or the time from HIV diagnosis to ART initiation.This series of EHI cases indicate that using ART with ISTI-based regimens is efficacious and well-tolerated. However, earlier initiation of treatment was not significantly correlated with common parameters of immunological recovery.

Safety of Switching Nevirapine Twice Daily to Nevirapine Once Daily in Virologically Suppressed Patients.

BACKGROUND: The strategy of switching nevirapine (NVP) twice daily to once daily was evaluated. METHODS: Forty-eight-week randomized, open, multicenter trial. Stable HIV-infected patients on NVP twice daily for >12-18 weeks with alanine aminotransferase (ALT) <2.5, the upper normal limit were randomized to continue their regimen or switch to NVP 400 mg once daily. Primary end point was the proportion of ALT/aspartate transaminase (AST) > or =grade 3. RESULTS: Two hundred eighty-nine patients were included, mean CD4 620 cells per microliter. Noninferiority was demonstrated in the per protocol analysis, with 97.9% (once daily) and 99.3% (twice daily) of patients event free (difference, 1.4%; 95% confidence interval, -1.95% to 5.4%), whereas 81.8% vs. 93.8% were event free by intent-to-treat switch = toxicity analysis (difference, 12%; 95% confidence interval, 4.6% to 19.4%). Only 4 patients (3 once daily, 1 twice daily) had NVP-related grade 3/4 ALT/AST increases, but in 2 of them (once daily), transaminases decreased despite continuation with NVP. Two other once daily patients presented grade 3/4 ALT/AST increase due to well-documented acute hepatitis A virus or hepatitis C virus infection. Grade 2 ALT/AST increases occurred in 11.2% (once daily) vs. 10.3% (twice daily) of patients (P = 0.80). A larger number of once daily patients were lost to follow-up/violated protocol (15% vs. 5%). CONCLUSIONS: In patients on standard twice daily NVP-containing regimens for at least 12-18 weeks, per protocol analysis showed that switching to once daily NVP was not inferior to continued twice daily NVP in terms of the predefined noninferiority margin of 10% for hepatotoxicity.

[Changing trends in HIV epidemics: recent diagnoses in the Spanish VACH cohort (2000-2002)]. / Patrón epidemiológico de la infección por el VIH en 15 hospitales españoles: casos de nuevo diagnóstico incluidos en la cohorte VACH en 2001 y 2002.

BACKGROUND: Studying the changing trends of HIV epidemics is a useful means of evaluating the results of current preventive plans as well as of defining future needs and objectives. METHODS: We performed a cross-sectional study of the newly-diagnosed cases of HIV infection included in the Spanish VACH cohort. New HIV cases were defined as those diagnosed between January 2001 and December 2002. Their epidemiologic characteristics were compared with those of patients included in the same cohort who had been diagnosed between January 1998 and December 2000. RESULTS: We studied 603 new cases (27% women). In 146 (24.4%) HIV infection had been acquired by sharing material for intravenous drug use (IVDU), 171 (28,6%) were men who had had sex with other men (MSM) and 247 (41.3%) acknowledged some risk for heterosexual HIV transmission. The median age was 36 years (range: 18-80). Only 1.5% of the patients were younger than 20 years while 32.1% were older than 40 years. This percentage was significantly higher than that corresponding to 1998-2000 (27.5%; p < 0,05). HIV infection was diagnosed simultaneously with an AIDS-defining condition in 13.3% of patients and an AIDS-defining disease was diagnosed in the first month after HIV-diagnosis in another 40 patients (6.6%). CONCLUSIONS: We confirm the trends observed in previous studies: a growing proportion of newly diagnosed cases among women, a decreasing proportion of IVDU, a growth of MSM, and a trend toward diagnosis at a later age.

Patrón epidemiológico de la infección por el VIH en 15 hospitales españoles: casos de nuevo diagnóstico incluidos en la cohorte VACH en 2001 y 2002 / Changing trends in HIV epidemics: recent diagnoses in the Spanish VACH cohort (2000-2002)

ANTECEDENTES. El estudio de los cambios en las tendencias de la epidemia del virus de la inmunodeficiencia humana(VIH) constituye un método útil para evaluar los resultados de los planes preventivos actuales, así como para definir futuras necesidades y objetivos de los próximos. MÉTODOS. Estudio descriptivo transversal de los casos nuevos incluidos en la cohorte VACH. Definimos “caso nuevo” a los sujetos cuyo diagnóstico de infección por el VIH se realizó entre enero de 2001 y diciembre de 2002. Comparamos sus características epidemiológicas con las de los sujetos incluidos en la misma cohorte diagnosticados de infección por el VIH entre enero de 1998 y diciembre de 2000. RESULTADOS. Estudiamos 603 nuevos casos (27% mujeres).En 146 (24,4%) el riesgo de transmisión había sido el uso de drogas (usuarios de drogas por vía parenteral, UDVP),171 (28,6%) eran hombres que tuvieron relaciones sexuales con otros hombres (HSH) y 247 (41,3%) reconocían alguna exposición heterosexual de riesgo. La mediana de edad fue 36 años (límites: 16-80). Solamente 1,5% tenían menos de 20 años y 32,1% superaban 40 años. Este porcentaje fue significativamente superior al correspondiente al trienio 98-00 (27,5%; p < 0,05). La infección por VIH se diagnosticó simultáneamente con alguna complicación definitoria de sida en 13,3% casos y otros 40 pacientes (6,6%) la desarrollaron durante el primer mes tras el diagnóstico. CONCLUSIONES. Confirmamos las tendencias observadas en estudios previos: crecimiento de la proporción de mujeres con diagnóstico reciente de VIH, progresiva disminución de la proporción de UDVP y aumento de HSH y tendencia al diagnóstico en edades más avanzadas (AU)

BACKGROUND. Studying the changing trends of HIV epidemics is a useful means of evaluating the results of current preventive plans as well as of defining future needs and objectives. METHODS. We performed a cross-sectional study of the newly-diagnosed cases of HIV infection included in the Spanish VACH cohort. New HIV cases were defined as those diagnosed between January 2001 and December 2002. Their epidemiologic characteristics were compared with those of patients included in the same cohort who had been diagnosed between January 1998 and December 2000. RESULTS. We studied 603 new cases (27% women). In 146 (24.4%) HIV infection had been acquired by sharing material for intravenous drug use (IVDU), 171 (28,6%) were men who had had sex with other men (MSM) and 247 (41.3%) acknowledged some risk for heterosexual HIV transmission. The median age was 36 years (range: 18-80).Only 1.5% of the patients were younger than 20 years while 32.1% were older than 40 years. This percentage was significantly higher than that corresponding to 1998-2000 (27.5%; p < 0,05). HIV infection was diagnosed simultaneously with an AIDS-defining condition in 13.3% of patients and an AIDS-defining disease was diagnosed in the first month after HIV-diagnosis in another 40 patients (6.6%). CONCLUSIONS. We confirm the trends observed in previous studies: a growing proportion of newly diagnosed cases among women, a decreasing proportion of IVDU, a growth of MSM, and a trend toward diagnosis at a later age (AU)

[A randomized clinical trial to compare the effectiveness of indinavir, ritonavir and saquinavir]. / Ensayo clínico comparativo, aleatorizado y abierto sobre la efectividad de indinavir, ritonavir y saquinavir.

BACKGROUND AND OBJECTIVE: HIV protease inhibitors (PI) were licensed without a direct evidence of their relative efficacy. PATIENTS AND METHOD: 137 patients attending our clinics between November 1997 and March 1998, to whom treatment with a PI was recommended, were randomized to receive indinavir (IDV), saquinavir (SQV) or ritonavir (RTV). Main outcome variables were one-year mean changes in HIV-RNA plasma concentrations and CD4 cells counts and proportion of patients with HIV viral load below level of detection. RESULTS: Mean HIV viral load reductions were 0.95 for SQV, 0.72 for IDV and 0.65 for RTV (p = 0.44), equaling losses and changes to failures. In a standard intent-to-treat analysis, mean changes in viral load were 1.16, 1.01 and 1.50 (p = 0.21), respectively. The proportion of patients with undetectable viral load was 50%, with no differences between treatment arms. CONCLUSIONS: No differences were observed in the effectiveness of SQV, IDV and RTV.

Ensayo clínico comparativo, aleatorizado y abierto sobre la efectividad de indinavir, ritonavir y saquinavir / A randomized clinical trial to compare the effectiveness of indinavir, ritonavir and saquinavir

FUNDAMENTO Y OBJETIVO: Los inhibidores de la proteinasa del virus de la inmunodeficiencia humana (VIH) fueron introducidos en la clínica sin datos directos de sus eficacias relativas. PACIENTES Y MÉTODO: Ciento treinta y siete pacientes atendidos entre noviembre de 1997 y marzo de 1998 en quienes se indicó tratamiento con un inhibidor de la proteinasa fueron asignados aleatoriamente a recibir indinavir, ritonavir o saquinavir. Las variables principales fueron los cambios medios respectivos en las concentraciones plasmáticas de VIH-ARN y en los recuentos de linfocitos CD4 y la proporción de pacientes con carga viral indetectable después de 12 meses. RESULTADOS: Los cambios respectivos del log10 de la carga viral fueron: saquinavir, 0,97; indinavir, 0,72 y ritonavir 0,65 (p = 0,44), equiparando pérdidas y cambios a fracaso. En un análisis estándar por intención de tratar, los cambios fueron 1,16, 1,01 y 1,50, respectivamente (p = 0,21). La proporción de pacientes con carga viral indetectable fue del 50 por ciento, sin diferencias entre los 3 grupos. CONCLUSIONES: No se observaron diferencias en la efectividad de saquinavir, indinavir y ritonavir para reducir la carga viral del VIH (AU)

[Incidence of bacteremia among histologic groups of hematologic malignancies]. / Incidencia de bacteriemia en grupos histológicos de neoplasias hematológicas.

INTRODUCTION: Subgroups having dissimilar prognoses are being identified among cancer patients with infection. Previous studies have suggested that these differences may be related to the histologic diagnosis, but this issue has not as yet been demonstrated. METHODS: We reviewed the medical records of all patients admitted with acute leukemia (AL) or lymphoma (ML) from 1988 to 1998. Incidence of bacteremia was calculated for the following subgroups: acute lymphocytic leukemia (ALL), acute myelocytic leukemia (AML), AML following refractory anaemia with excess blasts (AML-RAEB), high-grade ML (HGML), intermediate-grade ML (IGML), low-grade ML (LGML) and indeterminate ML (IML). Kaplan-Meier curves of time to the first positive blood culture were constructed and compared by means of log-rank test. RESULTS: In the period covered there were 244 new diagnoses of AL or ML: 62 AML, 32 ALL, 20 AML-RAEB, 78 HGML, 7 IGML, 37 LGML and 6 IML. At the end of the study period, 44 patients were alive, 147 were known to have died at a certain date and 53 had been formally lost to follow-up (most of them, transferred for hospice care). Among 684 blood cultures, there were 51 contaminations and 155 significant isolates. Among the latter, gram-positive bacteria were isolated in 74 and gram-negative bacteria in 47; in 27 cases more than 1 bacterial species were recovered. Fungi were isolated in 7 cases. The incidence of bacteremia expressed as cases per 1000 patient-days was 5.80 for AML, 5.03 for AML-RAEB, 1.56 for ALL, 0.21 for HGML and 0.40 for the remaining ML. Time to the first positive blood culture was significantly shorter for AML than for any other group, and was shorted for ALL and AML-RAEB than for ML. CONCLUSION: Differences in the incidence of bacteremia were observed among histologically-defined groups of unselected patients with hematologic malignancies.

Incidencia de bacteriemia en grupos histológicos de neoplasias hematológicas / Incidence of bacteremia among histologic groups of hematologic malignancies

INTRODUCCIÓN. Se están identificando subgrupos con pronóstico diferente entre los pacientes con cáncer e infecciones. Estudios previos han sugerido diferencias relacionadas con el diagnóstico histológico que no han sido demostradas definitivamente. MÉTODOS. Se revisaron las historias clínicas de los pacientes ingresados con diagnóstico de leucemia aguda o linfoma maligno entre 1988 y 1998. Se calculó la incidencia de bacteriemia para los siguientes subgrupos; leucemia linfoblástica aguda (LLA); leucemia mieloblástica aguda (LMA); LMA con antecedente de anemia refractaria con exceso de blastos (AREB); linfoma maligno de alto grado (LMAG); linfoma maligno de grado intermedio (LMGI); linfoma maligno de bajo grado (LMBG); y linfoma maligno indeterminado (LMI). Se construyeron las curvas de Kaplan-Meier de tiempo hasta el primer hemocultivo positivo y se compararon por el test del rango logarítmico. RESULTADOS. Se diagnosticaron 244 nuevas leucemias agudas o linfomas en el período estudiado: 62 LMA, 34 LLA, 20 LMA-AREB, 78 LMAG, 7 LMGI, 37 LMBG y 6 LMI.En el momento del cierre del estudio, 44 pacientes estaban vivos, 147 tenían una fecha de fallecimiento conocida y 53 habían sido formalmente perdidos del seguimiento (la mayoría, trasladados para tratamiento paliativo). En 684 hemocultivos se detectaron 51 contaminaciones y 155 aislamientos significativos. De ellos, 74 fueron bacterias grampositivas; 47, gramnegativas; 27, polimicrobianas, y 7, hongos. La incidencia de bacteriemia en casos por 1.000 paciente-días fue 5,80 para la LMA, 5,03 para la LMA-AREB, 1,56 para la LLA, 0,21 para los LMAG y 0,40 para los restantes linfomas. El tiempo hasta el primer hemocultivo positivo fue significativamente menor para la LMA que para cualquier otro grupo; y para la LLA y LMA-AREB que para los linfomas. CONCLUSIÓN. Se observó una diferencia en la incidencia de bacteriemia entre grupos definidos histológicamente de pacientes no seleccionados con neoplasias hematológicas (AU)

[A cross-sectional study on the epidemiological and clinical characteristics of HIV-1 infection in gypsies and in other minorities in Bilbao, Northern Spain]. / Estudio transversal sobre las características clínicas y epidemiológicas de la infección por el virus de la inmunodeficiencia humana en gitanos y otras minorías en Bilbao.

BACKGROUND: The health status and needs of gypsies have been insufficiently studied. PATIENTS AND METHOD: We studied the clinicoepidemiological characteristics of all HIV-1 infected patients attending in our outpatients clinic and hospitalized who were classified according to their ethnic origin as <>, <> (Caucasian non-gypsy Spanish natives) or <>. RESULTS: Overall, there were 563 patients out of 674 previously appointed (83%). Intravenous drug use (IVDU) was the HIV acquisition mechanism in 70%, 95% and 25% (p < 0.000) and attendance was considered regular in 89%, 48% and 89% payos, gypsies and immigrants (p < 0.01), respectively. CONCLUSIONS: IVDU as the HIV transmission mechanism and lower clinic attendance rates were the most relevant differences observed between gypsy and payo subjects.