Spanish-language cognitive screening tests: a critical review.

INTRODUCTION: Dementia is a chronic, degenerative disease with a strong impact on families and health systems. The instruments currently in use for measuring cognitive impairment have different psychometric characteristics in terms of application time, cut-off point, reliability, and validity. The objective of this review is to describe the characteristics of the validated, Spanish-language versions of the Mini-Cog, Clock-Drawing Test, and Mini-Mental State Examination scales for cognitive impairment screening. DEVELOPMENT: We performed a three-stage literature search of articles published on Medline since 1953. We selected articles on validated, Spanish-language versions of the scales that included data on reliability, validity, sensitivity, and specificity. CONCLUSIONS: The 3 screening tools assessed in this article provide support for primary care professionals. Timely identification of mild cognitive impairment and dementia is crucial for the prognosis of these patients.

Escalas de tamizaje cognitivo en habla hispana: una revisión crítica / Spanish-language screening scales: A critical review

Introducción: La demencia es una enfermedad crónica degenerativa de alto impacto para las familias y los sistemas de salud. Los instrumentos de medición del deterioro cognitivo que se utilizan actualmente tienen características psicométricas diferentes en cuanto a tiempo de aplicación, punto de corte, confiabilidad y validez. El objetivo de la presente revisión fue describir las características de las escalas Mini Cog, Prueba del reloj y Mini- Mental para tamizaje de deterioro cognitivo validadas al idioma español. Desarrollo: La búsqueda bibliográfica se realizó en 3 etapas mediante la base de datos Medline a partir del año 1953. Se realizó una selección de publicaciones validadas al español que incluyeran la confiabilidad, validez, sensibilidad y especificidad de las escalas. Conclusiones: Las 3 herramientas de tamizaje descritas en este artículo proporcionan un apoyo para el personal de salud. La detección oportuna es crucial para el pronóstico de las personas que viven con deterioro cognitivo leve o demencia. (AU)

Introduction: Dementia is a chronic, degenerative disease with a strong impact on families and health systems. The instruments currently in use for measuring cognitive impairment have different psychometric characteristics in terms of application time, cut-off point, reliability, and validity. The objective of this review is to describe the characteristics of the validated, Spanish-language versions of the Mini-Cog, Clock-Drawing Test, and Mini–Mental State Examination scales for cognitive impairment screening. Development: We performed a three-stage literature search of articles published on Medline since 1953. We selected articles on validated, Spanish-language versions of the scales that included data on reliability, validity, sensitivity, and specificity. Conclusions: The 3 screening tools assessed in this article provide support for primary care professionals. Timely identification of mild cognitive impairment and dementia is crucial for the prognosis of these patients. (AU)

Impact of specific modes of circumferential resection margin involvement in rectal cancer local recurrence: A retrospective study.

PURPOSE: To compare the local recurrence rate and overall survival between patients with circumferential resection margin (CRM) involvement by direct tumor spread and by a tumor within a lymph node. METHODS: A total of 776 patients diagnosed with rectal cancer underwent rectal resection. Patients with CRM involvement by direct tumor spread were named group A. CRM involvement by tumor within a lymph node formed group B. Patient data, including sex, age, pT, pN, stage I-III versus IV, neoadjuvant radiotherapy, adjuvant chemotherapy, carcinoembryonic antigen, primary tumor location, lymph node retrieval, and need for abdominoperineal resection, were compared between both groups. RESULTS: In total, 10.5% of the patients had CRM involvement. Of these, in 57 cases (7.3%), it was by direct tumor spread and in 19 cases (2.4%) by tumor within a lymph node. Other types of CRM involvement were found in six patients. With a mean follow-up of 32.9 months, 18 patients from group A (31.5%) and one patient from group B (5.2%) suffered a local recurrence. Local recurrence-free survival was significantly higher in patients from group B (P = 0.049). Patients in stage I-III (P = 0.037) and from group B ( P = 0.049) had better overall survival. CONCLUSION: Patients with CRM involvement by tumor within a lymph node have a low risk of local recurrence and better overall survival than patients with CRM involvement by direct tumor spread.

Spanish-language screening scales: A critical review. / Escalas de tamizaje cognitivo en habla hispana: una revisión crítica.

INTRODUCTION: Dementia is a chronic, degenerative disease with a strong impact on families and health systems. The instruments currently in use for measuring cognitive impairment have different psychometric characteristics in terms of application time, cut-off point, reliability, and validity. The objective of this review is to describe the characteristics of the validated, Spanish-language versions of the Mini-Cog, Clock-Drawing Test, and Mini-Mental State Examination scales for cognitive impairment screening. DEVELOPMENT: We performed a three-stage literature search of articles published on Medline since 1953. We selected articles on validated, Spanish-language versions of the scales that included data on reliability, validity, sensitivity, and specificity. CONCLUSIONS: The 3 screening tools assessed in this article provide support for primary care professionals. Timely identification of mild cognitive impairment and dementia is crucial for the prognosis of these patients.

Emerging resistance mutations in PI-naive patients failing an atazanavir-based regimen (ANRS multicentre observational study).

Background: Atazanavir is a PI widely used as a third agent in combination ART. We aimed to determine the prevalence and the patterns of resistance in PI-naive patients failing on an atazanavir-based regimen. Methods: We analysed patients failing on an atazanavir-containing regimen used as a first line of PI therapy. We compared the sequences of reverse transcriptase and protease before the introduction of atazanavir and at failure [two consecutive viral loads (VLs) >50 copies/mL]. Resistance was defined according to the 2014 Agence Nationale de Recherche sur le SIDA et les Hépatites Virales (ANRS) algorithm. Results: Among the 113 patients, atazanavir was used in the first regimen in 71 (62.8%) patients and in the first line of a PI-based regimen in 42 (37.2%). Atazanavir was boosted with ritonavir in 95 (84.1%) patients and combined with tenofovir/emtricitabine or lamivudine (n = 81) and abacavir/lamivudine or emtricitabine (n = 22). At failure, median VL was 3.05 log10 copies/mL and the median CD4+ T cell count was 436 cells/mm3. The median time on atazanavir was 21.2 months. At failure, viruses were considered resistant to atazanavir in four patients (3.5%) with the selection of the following major atazanavir-associated mutations: I50L (n = 1), I84V (n = 2) and N88S (n = 1). Other emergent PI mutations were L10V, G16E, K20I/R, L33F, M36I/L, M46I/L, G48V, F53L, I54L, D60E, I62V, A71T/V, V82I/T, L90M and I93L/M. Emergent NRTI substitutions were detected in 21 patients: M41L (n = 2), D67N (n = 3), K70R (n = 1), L74I/V (n = 3), M184V/I (n = 16), L210W (n = 1), T215Y/F (n = 3) and K219Q/E (n = 2). Conclusions: Resistance to atazanavir is rare in patients failing the first line of an atazanavir-based regimen according to the ANRS. Emergent NRTI resistance-associated mutations were reported in 18% of patients.

Performance of genotypic algorithms for predicting tropism for HIV-1 CRF01_AE recombinant.

OBJECTIVES: There is no consensus about the performances of genotypic rules for predicting HIV-1 non-B subtype tropism. Three genotypic methods were compared for CRF01_AE HIV-1 tropism determination. METHODS: The V3 env region of 207 HIV-1 CRF01_AE and 178 B subtypes from 17 centers in France and 1 center in Switzerland was sequenced. Tropism was determined by Geno2Pheno algorithm with false positive rate (FPR) 5% or 10%, the 11/25 rule or the combined criteria of the 11/25, net charge rule and NXT/S mutations. RESULTS: Overall, 72.5%, 59.4%, 86.0%, 90.8% of the 207 HIV-1 CRF01_AE were R5-tropic viruses determined by Geno2pheno FPR5%, Geno2pheno FPR10%, the combined criteria and the 11/25 rule, respectively. A concordance of 82.6% was observed between Geno2pheno FPR5% and the combined criteria for CRF01_AE. The results were nearly similar for the comparison between Geno2pheno FPR5% and the 11/25 rule. More mismatches were observed when Geno2pheno was used with the FPR10%. Neither HIV viral load, nor current or nadir CD4 was associated with the discordance rate between the different algorithms. CONCLUSION: Geno2pheno predicted more X4-tropic viruses for this set of CRF01_AE sequences than the combined criteria or the 11/25 rule alone. For a conservative approach, Geno2pheno FPR5% seems to be a good compromise to predict CRF01_AE tropism.

Prevalence of HIV-1 drug resistance in treated patients with viral load >50 copies/mL: a 2014 French nationwide study.

Background: Surveillance of HIV-1 resistance in treated patients with a detectable viral load (VL) is important to monitor, in order to assess the risk of spread of resistant viruses and to determine the proportion of patients who need new antiretroviral drugs with minimal cross-resistance. Methods: The HIV-1 protease and reverse transcriptase (RT) and integrase genes were sequenced in plasma samples from 782 consecutive patients on failing antiretroviral regimens, seen in 37 specialized centres in 2014. The genotyping results were interpreted using the ANRS v24 algorithm. Prevalence rates were compared with those obtained during a similar survey conducted in 2009. Results: The protease and RT sequences were obtained in 566 patients, and the integrase sequence in 382 patients. Sequencing was successful in 60%, 78%, 78% and 87% of patients with VLs of 51-200, 201-500, 501-1000 and >1000 copies/mL, respectively. Resistance to at least one antiretroviral drug was detected in 56.3% of samples. Respectively, 3.9%, 8.7%, 1.5% and 3.4% of patients harboured viruses that were resistant to any NRTI, NNRTI, PI and integrase inhibitor (INI). Resistance rates were lower in 2014 than in 2009. Resistance was detected in 48.5% of samples from patients with a VL between 51 and 200 copies/mL. Conclusion: In France in 2014, 90.0% of patients in AIDS care centres were receiving antiretroviral drugs and 12.0% of them had VLs >50 copies/mL. Therefore, this study suggests that 6.7% of treated patients in France might transmit resistant strains. Resistance testing may be warranted in all treated patients with VL > 50 copies/mL.

Características clínicas y demográficas de pacientes oncológicos del Hospital Base Valdivia con complicaciones infecciosas. Enero-Julio 2013 / Clinical and demographic description of Oncological Patients with ongoing infectious complications in Hospital Base Valdivia. January - July 2013

El cáncer constituye la segunda causa de muerte en Chile y las infecciones constituyen uno de los principales gatillantes del deceso. El objetivo principal de esta investigación es describir las características clínicas y demográficas de los pacientes oncológicos del Hospital Base Valdivia (HBV) que presentaron complicaciones infecciosas entre el periodo enero-julio de 2013. Materiales y métodos: Se realizó un estudio de serie de casos que incluyó a todos los pacientes oncológicos hospitalizados que presentaron complicaciones infecciosas entre enero-julio de 2013, excluyendo a quienes rechazaran el consentimiento informado o tuvieran fichas clínicas incompletas. Se aplicaron instrumentos para determinar estado nutricional y nivel socioeconómico. Análisis computacional con estadística descriptiva. Resultados: Se pesquisaron 38 pacientes con un total de 52 infecciones. Dieciséis eran hombres y 22 mujeres, edad promedio 59 años. La mayoría pertenecía a estratos socioeconómicos bajos y poseía estudios básicos. Las neoplasias subyacentes más frecuentes fueron el cáncer de mama y cervicouterino. Dieciséis pacientes se encontraban en etapa IV y cerca de 2/3 estaban desnutridos. De las 52 infecciones 31 fueron localizadas, mientras 21 tuvieron respuesta sistémica, 2 pacientes fallecieron debido a la infección. Los sitios más frecuentes de afección fueron: árbol bronquial, tracto genitourinario y cavidad oral. Clínicamente se determinó que 44 de los cuadros fueron bacterianos, 3 fúngicos, 3 virales y 2 combinados. Discusión: Llama la atención el predominio de pacientes provenientes de niveles socioeconómicos y educacionales bajos. Si bien las infecciones pueden corresponder a cuadros potencialmente fatales en pacientes oncológicos, la mayoría de nuestros casos correspondieron a cuadros leves.

Cancer is the second leading cause of death in Chile and infections are one of the main-triggering of death. The main objective of this research is to describe clinical and demographic characteristics of oncological patients of Hospital Base Valdivia with ongoing infectious complications between January-July 2013. Material and methods: series of cases, we reviewed the medical records of all oncological patients who had infectious complications between January-July 2013, excluding those who rejected the invitation or had incomplete medical records. Also, tools for determining nutritional status and socioeconomic status were applied. Data went through computational analysis with determination of descriptive statistics. Result: 38 patients were included with total of 52 infections. Sixteen were men and 22 women, average age was 59 years. Most belonged to lower socioeconomic strata and only had basic education. The most common underlying neoplasms were breast and cervical cancer. Sixteen patients were in stage IV and about two-thirds were malnourished. 31 of the 52 infections were localized, while in 21 there was systemic response, 5 progressed to sepsis and 2 to septic shock, 2 patients died because of their infections. The most common sites of infection were: bronchia, genitourinary tract and oral cavity. Clinically it was determined that 44 were bacterial infections, 3 fungal, 2 viral and 2 combined. Discussion: it draws our attention the predominance of patients from low socioeconomic and educational levels. While infections may correspond to potentially fatal complications in cancer patients, the majority of our cases were mild.

Eficacia del protocolo de fisioterapia del Hospital Universitario de Getafe, establecido para la mejoría de la incontinencia urinaria femenina / Protocol for female urinary incontinence improvement in the Getafe's University Hospital's pelvic floor physiotherapy unit: evidence if its efficacy

Objetivo Comprobar la eficacia de un tratamiento de fisioterapia perineal en mujeres con incontinencia urinaria (IU). Se buscó determinar la mejoría objetiva y la percepción de la calidad de vida, así como la relación entre dicha mejoría y el cumplimiento posterior del tratamiento en domicilio. Pacientes y métodos Estudio observacional prospectivo: 46 mujeres con IU que reciben tratamiento de fisioterapia perineal durante el año 2010. Las pacientes fueron evaluadas antes del tratamiento y a los 3 meses. Se analizaron tanto variables objetivas (analizadas con el test de la t de Student) como subjetivas. Resultados Se observó que la realización de los ejercicios abdominoperineales en el domicilio disminuyó significativamente (p<0,001) las variables objetivas (frecuencias miccionales total, diurna y nocturna, y frecuencia de pérdidas de orina), especialmente el número de pérdidas de orina (reducción del 52%). Por el contrario, las pacientes que no realizaron los ejercicios mejoraron (p<0,001) solo en las variables relacionadas con la reeducación de hábitos miccionales (frecuencias miccionales total y diurna). Se demostró que dos tercios de las mujeres tenían percepción de mejoría tras la realización de los ejercicios abdominoperineales. Conclusiones Las pacientes con IU que recibieron el tratamiento de fisioterapia perineal presentaron una mejoría objetiva y subjetiva. Su eficacia está relacionada con la continuidad en el tiempo en la realización de los ejercicios abdominoperineales (AU)

Objective This study aimed to verify the efficacy of perineal physiotherapy in women suffering from urinary incontinence (UI). It was aimed to determine objective improvement, perception of improvement in the quality of the patient's life, and the relation between said improvements and subsequent treatment compliance in the home. Patients and methods A prospective observational study was performed in a sample of 46 female patients suffering from UI who received perineal physiotherapy during 2010. Patients were assessed before receiving treatment and again three months after initiation of treatment. Objective (analyzed with the Student's T test) and subjective variables were analyzed. Results Our study has shown that implementation of the abdominoperineal physical exercises in the home significantly decreased (P<.001) objective indicators of UI (total voiding frequency, daytime voiding frequency, nighttime voiding frequency, urine leakage frequency), especially the number of urine leakage which showed a 52% reduction. On the contrary, patients unwilling to implement the prescribed physical exercises at home only experienced improvement (P<.001) in the indicators related to the reeducation of their voiding habits (total voiding frequency, day-time voiding frequency). The study also showed that 2/3 of the sampled patients perceived some improvement after having completed their abdominoperineal physical exercises. Conclusions UI patients receiving perineal physiotherapy experienced both objective and subjective improvement in their condition. The efficacy of the treatment is apparently a function of the patients’ perseverance to carry out the prescribed abdominoperineal physical exercises over time (AU)

Multicenter evaluation of the NucliSens EasyQ HIV-1 v1.1 assay for the quantitative detection of HIV-1 RNA in plasma.

The Nuclisens EasyQ HIV-1 v1.1 assay (Biomerieux) is a real-time detection method combined with NASBA technology designed to measure plasma HIV-RNA. Its performance was assessed in 1008 clinical specimens collected from individuals infected with clade B (774) and non-B (234) HIV-1 variants at four European laboratories. The results were compared with those obtained using three other commercial viral load assays: Cobas Amplicor Monitor HIV-1 v1.5 (Roche), Versant HIV-1 RNA assay (Bayer) and Nuclisens HIV-1 QT (Biomerieux). Overall, the linearity, specificity and reproducibility of the EasyQ assay was comparable with that from the other tests. The correlation coefficient (R) between methodologies was 0.85 for Amplicor; 0.87 for Versant; and 0.91 for Nuclisens. The specificity of the assay was 99.4%. Of note, Versant missed 17% of specimens with non-B subtypes which could be detected by EasyQ, while Amplicor provided similar results than EasyQ. HIV-1 group O specimens were only detected by the EasyQ assay. In conclusion, the performance of the EasyQ assay seems to be similar to that of other HIV-1 viral load tests currently on the market, but it is more sensitive than Versant for HIV-1 non-B subtypes and shows a wider dynamic range than Amplicor. Moreover, as it incorporates the advantage of real-time detection procedures, it facilitates high throughput and short turnaround time.

Patterns of resistance mutations to antiretroviral drugs in extensively treated HIV-1-infected patients with failure of highly active antiretroviral therapy.

Resistance-mutation patterns in the reverse transcriptase (RT) and protease genes of HIV-1 were analyzed in 22 patients who had been extensively pretreated and who failed to respond to highly active antiretroviral therapy (HAART). The number of mutations ranged from 8 to 19 (median, 13): 4 to 12 (median, 6) mutations in the RT gene, and 4 to 8 (median, 7) mutations in the protease gene. In the RT gene, the most frequent resistance mutations were found at codons 215 (100%), 41 (95%), 67 (91%), and 210 (77%). Multidrug-resistant mutation patterns including Q151M and insertion mutations at codon 69, which confer cross-resistance to the different nucleoside analogue RT inhibitors were detected in 1 and 3 patients, respectively; 1 patient with insertion mutation displayed a NGQGV [corrected] sequence at codons 67 to 70. In the protease gene, the most frequent mutations were found at codons 63 (95%), 10 (86%), 90(86%), 71(77%), 46 (50%), 36 (45%), and 84 (45%). Genotypic resistance to zidovudine, saquinavir, and indinavir was found in 100% of the patients. All patients showed also resistance or possible resistance to stavudine, abacavir, ritonavir, and nelfinavir. Mutations conferring genotypic resistance to nonnucleoside analogue RT inhibitors (NNRTIs) were found in 12 (80%) of the NNRTI-experienced patients and 1 of 7 NNRTI-naive patients. Our results indicate that failure of HAART in the patients extensively pretreated results from the multiplicity of RT and protease mutations that confer genotypic resistance to almost all available antiretroviral drugs. In these patients, genotypic resistance tests confirm the lack of alternative salvage therapy strategies based on the currently available antiretroviral drugs.

[Distribution, abundance and population parameters of Diapterus rhombeus (Pisces: Gerreidae) in Laguna de Términos, Campeche, Mexico]. / Distribución, abundancia y parámetros poblacionales de la mojarra Diapterus rhombeus (Pisces: Gerreidae) en la Laguna de Términos, Campeche, México.

Diapterus rhombeus dominates the nektonic community of Terminos Lagoon and is associated to zones with submerged vegetation, temperatures between 27 and 33 degrees C and salinity between 25 and 36.5 UPS. A total of 3,024 individuals were collected with a trawl net in 23 sites between September 1997 and September 1998. The length-weight model parameters are a = 0.0098; b = 3.155 with a 96% correlation. The growth parameters are L infinity = 20.4 cm, k = 0.74 and t(o) = -4.207 and the total mortality coefficient is 3.526. Fish length is 2.5-18.0 cm with a mode of 7.5 cm. Recruitment is continuous with a peak from May to August. The species uses several habitats of the lagoon mainly for feeding and growth, reproduction probably occurs in the adjacent continental shelf. Movements between continental shelf and the estuarine system represent a continuous energy flow.

Emergence of zidovudine and multidrug-resistance mutations in the HIV-1 reverse transcriptase gene in therapy-naive patients receiving stavudine plus didanosine combination therapy. STADI Group.

OBJECTIVE: Assessment of genotypic changes in the reverse transcriptase gene of HIV-1 occurring in antiretroviral naive patients treated by stavudine plus didanosine combination therapy. METHODS: Sequence analysis (codons 1-230) was performed after amplification of the reverse transcriptase gene from plasma samples collected at baseline and at the end of treatment from 39 previously treatment-naive patients treated for 24-48 weeks. RESULTS: At baseline, mutations associated with zidovudine resistance were detected in plasma from two patients: Asp67Asn/Lys219Gln and Leu210Trp. Among the 39 subjects, 18 (46%) developed mutations: one developed the Val75Thr/Ala mutation, four (10%) developed a Gln151Met multidrug-resistance mutation (MDR), associated in one of them with the Phe77Leu and the Phe116Tyr MDR mutations and 14 (36%) developed one or more zidovudine-specific mutations (Met41Leu, Asp67Asn, Lys70Arg, Leu210Trp, Thr215Tyr/Phe). The development of a Met41Leu zidovudine-specific mutation was associated with the development of a Gln151Met mutation in one patient. Other reverse transcriptase mutations known to confer resistance to nucleoside analogues were not detected. At inclusion, there was no statistical difference in HIV-1 load between patients who developed resistance mutations and those who did not. RNA HIV-1 load decrease was higher (P = 0.05) in patients who maintained a wild-type reverse transcriptase genotype (-2.22 log10 copies/ml) than in patients who developed resistance mutations (-1.14 log10 copies/ml). CONCLUSION: Stavudine/didanosine combination therapy is associated with emergence of zidovudine-related resistance or MDR mutations in naive patients. These findings should be considered when optimizing salvage therapy for patients who have received a treatment including stavudine/didanosine combination.

Evaluation of the Nuclisens HIV-1 QT assay for quantitation of human immunodeficiency virus type 1 RNA levels in plasma.

Nuclisens HIV-1 QT is a new version of the NASBA HIV-1 QT assay for quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma. The specificity of this assay was 100% in one laboratory and 99%-with nonrepeatability of the initial false positive-in another. The test was linear between 2.0 and 6.0 log RNA copies per ml. According to the input HIV-1 RNA concentration, accuracy varied from -0.11 to +0.10 log RNA copy per ml and precision varied from 0.66 to 0.14 log RNA copy per ml. Reproducibility decreased when the HIV-1 RNA level was near the lower limit of quantitation of the test. HIV-1 RNA could be quantitated by Nuclisens HIV-1 QT in 36% (laboratory 1) and 24% (laboratory 2) of clinical samples with HIV-1 RNA levels lower than the lower limit of quantitation by NASBA HIV-1 QT. Nuclisens HIV-1 QT was not suitable for measurement of RNA from clade G and group O HIV-1 strains.

Comparison of the QUANTIPLEX HIV-1 RNA 2.0 assay with the AMPLICOR HIV-1 MONITOR 1.0 assay for quantitation of levels of human immunodeficiency virus type 1 RNA in plasma of patients receiving stavudine-didanosine combination therapy.

We compared the QUANTIPLEX HIV-1 RNA 2.0 assay with the AMPLICOR HIV-1 MONITOR 1.0 assay for quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma in the Stadi trail, which evaluated a stavudine plus didanosine combination therapy in 52 patients. HIV-1 RNA baseline values measured with AMPLICOR HIV-1 MONITOR 1.0 were significantly higher than those measured with QUANTIPLEX HIV-1 RNA 2.0, and decreases in HIV-1 RNA levels from baseline were also found to be significantly higher when measured with the AMPLICOR HIV-1 MONITOR 1.0 assay. The frequency of HIV-1 RNA levels below the lower limit of quantitation was significantly higher with QUANTIPLEX HIV-1 RNA 2.0 than with AMPLICOR HIV-1 MONITOR 1.0. Reanalysis of these results by an ultrasensitive procedure of AMPLICOR HIV-1 MONITOR 1.0 or by a modified version of the test that included additional primers adapted for non-B HIV-1 clades yielded greater differences between the QUANTIPLEX HIV-1 RNA 2.0 assay and the AMPLICOR HIV-1 MONITOR 1.0 assay. Our results indicate that a valid comparison of the virological efficacies obtained with different antiretroviral drug regimens requires the use of the same viral load quantitation procedure; further standardization between the different HIV-1 RNA quantitation kits is therefore needed.

[Once-daily administration of didanosine in combination with anti-retroviral zidovudine in previously untreated patients]. / Administration en prise unique quotidienne de la didanosine dans une association anti-rétrovirale avec la zidovudine chez des patients non préalablement traités.

25 HIV-infected antiretroviral-naive adults were included in a 24-week study to evaluate the efficacy and the tolerability of a zidovudine/didanosine combination therapy in which didanosine was administered once daily (200 mg if weight < 60 kg, 300 mg if weight > 60 kg) and zidovudine twice daily (500 mg/day if weight < 90 kg, 600 mg/day if weight > 90 kg). 5 patients discontinued their treatment early: 3 had poor compliance and 2 presented adverse events. Evaluation of treatment efficacy was based on CD4+ T cell enumeration and HIV RNA level quantitation in plasma (NASBA). Baseline values were 278 CD4+/mm3 and 5.42 log RNA copies/ml. Mean changes from baseline were +102 CD4+/mm3 and -2.14 log RNA copies/ml at week 8 and +156 CD4+/mm3 and -2.07 log RNA copies/ml at week 24. HIV RNA in plasma was lower than the detection limit (2.60 log RNA copies/ml) in 55% of patients at week 8 and in 30% at week 24. No major adverse events such as neuropathy or pancreatitis were observed. Once-daily administration of didanosine in combination with twice-daily administration of zidovudine is a well tolerated regimen that appears to be as effective ad the conventional zidovudine/didanosine combination regimen.

Comparative evaluation of three assays for the quantitation of human immunodeficiency virus type 1 RNA in plasma.

Reverse transcriptase-coupled polymerase chain reaction (Amplicor HIV-1 Monitor), the branched DNA (bDNA) method (Quantiplex HIV-1 RNA) and the nucleic acid sequence-based assay (NASBA HIV-1 RNA QT) were comparatively evaluated for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma. Among 60 plasma specimens from HIV-1 infected patients, HIV-1 RNA was detected in 56 by Amplicor (sensitivity, 93.3%), in 41 by bDNA (sensitivity, 68.3%), and in 60 by NASBA (sensitivity, 100%). HIV-1 RNA was not detected by any of these methods in 34/34 plasma specimens from HIV-1-seronegative blood donors (specificity, 100%). The HIV-1 RNA levels as determined by the different methods were correlated significantly. The frequency of concordant results (log difference < 0.50) was 80.4% between Amplicor and NASBA, 77.5% between Amplicor and bDNA, and 58.6% between bDNA and NASBA. After initiation of antiviral therapy, HIV-1 RNA level variations observed with the three methods were similar. HIV-1 RNA levels were inversely correlated with the CD4+ T cell counts, whereas no correlation was found with HIV-1 p24-antigen levels. When the methods were evaluated for reproducibility, coefficients of variation ranged from 11% to 40% for Amplicor, from 6% to 35% for bDNA, and from 13% to 62% for NASBA. Quantitation of HIV-1 RNA in culture supernatants from HIV-1 subtype A to H strains showed that bDNA can be used to quantitate RNA from all HIV-1 subtypes, whereas Amplicor failed to detect RNA from subtype A strains and NASBA subtype G strains.