Epidemiological trends of HIV/HCV coinfection in Spain, 2015-2019.

OBJECTIVES: We assessed the prevalence of anti-hepatitis C virus (HCV) antibodies and active HCV infection (HCV-RNA-positive) in people living with HIV (PLWH) in Spain in 2019 and compared the results with those of four similar studies performed during 2015-2018. METHODS: The study was performed in 41 centres. Sample size was estimated for an accuracy of 1%. Patients were selected by random sampling with proportional allocation. RESULTS: The reference population comprised 41 973 PLWH, and the sample size was 1325. HCV serostatus was known in 1316 PLWH (99.3%), of whom 376 (28.6%) were HCV antibody (Ab)-positive (78.7% were prior injection drug users); 29 were HCV-RNA-positive (2.2%). Of the 29 HCV-RNA-positive PLWH, infection was chronic in 24, it was acute/recent in one, and it was of unknown duration in four. Cirrhosis was present in 71 (5.4%) PLWH overall, three (10.3%) HCV-RNA-positive patients and 68 (23.4%) of those who cleared HCV after anti-HCV therapy (p = 0.04). The prevalence of anti-HCV antibodies decreased steadily from 37.7% in 2015 to 28.6% in 2019 (p < 0.001); the prevalence of active HCV infection decreased from 22.1% in 2015 to 2.2% in 2019 (p < 0.001). Uptake of anti-HCV treatment increased from 53.9% in 2015 to 95.0% in 2019 (p < 0.001). CONCLUSIONS: In Spain, the prevalence of active HCV infection among PLWH at the end of 2019 was 2.2%, i.e. 90.0% lower than in 2015. Increased exposure to DAAs was probably the main reason for this sharp reduction. Despite the high coverage of treatment with direct-acting antiviral agents, HCV-related cirrhosis remains significant in this population.

Strategies to reengage patients lost to follow up in HIV care in high income countries, a scoping review.

BACKGROUND: Despite remarkable achievements in antiretroviral therapy (ART), losses to follow-up (LTFU) might prevent the long-term success of HIV treatment and might delay the achievement of the 90-90-90 objectives. This scoping review is aimed at the description and analysis of the strategies used in high-income countries to reengage LTFU in HIV care, their implementation and impact. METHODS: A scoping review was done following Arksey & O'Malley's methodological framework and recommendations from Joanna Briggs Institute. Peer reviewed articles were searched for in Pubmed, Scopus and Web of Science; and grey literature was searched for in Google and other sources of information. Documents were charted according to the information presented on LTFU, the reengagement procedures used in HIV units in high-income countries, published during the last 15 years. In addition, bibliographies of chosen articles were reviewed for additional articles. RESULTS: Twenty-eight documents were finally included, over 80% of them published in the United States later than 2015. Database searches, phone calls and/or mail contacts were the most common strategies used to locate and track LTFU, while motivational interviews and strengths-based techniques were used most often during reengagement visits. Outcomes like tracing activities efficacy, rates of reengagement and viral load reduction were reported as outcome measures. CONCLUSIONS: This review shows a recent and growing trend in developing and implementing patient reengagement strategies in HIV care. However, most of these strategies have been implemented in the United States and little information is available for other high-income countries. The procedures used to trace and contact LTFU are similar across reviewed studies, but their impact and sustainability are widely different depending on the country studied.

HIV/HBV coinfection: temporal trends and patient characteristics, Spain, 2002 to 2018.

BackgroundRecent and reliable estimates on the prevalence of coinfection with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) in Europe are lacking.AimLeveraged on a study designed to assess HIV/HCV coinfection prevalence, we assessed the prevalence of HIV/HBV coinfection in Spain in 2018 and compared the results with five similar studies performed since 2002.MethodsThis cross-sectional prevalence study was carried out in 43 centres, and patients were selected using simple random sampling. The reference population comprised 40,322 patients and the sample size were 1,690 patients.ResultsThe prevalence of HIV/HBV coinfection in Spain at the end of 2018 was 3.2%. The prevalence in 2002, 2009, 2015, 2016 and 2017 was 4.9%, 3.4%, 3%, 3.9% and 3%, respectively. Among the HIV/HBV-coinfected patients identified in 2018, 16.7% had cirrhosis according to transient elastography and 26.3% tested positive for antibodies against hepatitis D virus. All HIV/HBV-coinfected patients were receiving drugs with activity against HBV, and 97% of those tested for HBV DNA had an HBV DNA load < 80 IU/mL.ConclusionsThe prevalence of HIV/HBV coinfection in Spain remained stable at around 3% for a decade. Our data could facilitate the design of national programmes to control HBV infection and help identify areas of patient management that need improvement.

A Composite of Functional Status and Pneumonia Severity Index Improves the Prediction of Pneumonia Mortality in Older Patients.

BACKGROUND: The baseline health status may be a determinant of interest in the evolution of pneumonia. OBJECTIVE: Our objective was to assess the predictive ability of community-acquired pneumonia (CAP) mortality by combining the Barthel Index (BI) and Pneumonia Severity Index (PSI) in patients aged ≥ 65 years. DESIGN, PATIENTS AND MAIN MEASURES: In this prospective, observational, multicenter analysis of comorbidities, the clinical data, additional examinations and severity of CAP were measured by the PSI and functional status by the BI. Two multivariable models were generated: Model 1 including the PSI and BI and model 2 with PSI plus BI stratified categorically. KEY RESULTS: The total population was 1919 patients, of whom 61% had severe pneumonia (PSI IV-V) and 40.4% had some degree of dependence (BI ≤ 90 points). Mortality in the PSI V-IV group was 12.5%. Some degree of dependence was associated with increased mortality in both the mild (7.2% vs. 3.2%; p = 0.016) and severe (14% vs. 3.3%; p < 0.001) pneumonia groups. The combination of PSI IV-V and BI ≤ 90 was the greatest risk factor for mortality (aOR 4.17; 95% CI 2.48 to 7.02) in our series. CONCLUSIONS: The use of a bimodal model to assess CAP mortality (PSI + BI) provides more accurate prognostic information than the use of each index separately.

Asthma and influenza vaccination in elderly hospitalized patients: Matched case-control study in Spain.

OBJECTIVES: Influenza infection is an exacerbating factor for asthma, and its prevention is critical in managing asthmatic patients. We investigated the effect of influenza vaccination on asthmatic and non-asthmatic patients hospitalized with laboratory-confirmed influenza in Spain. METHODS: We made a matched case-control study to assess the frequency of hospitalization for influenza in people aged ≥65 years. Hospitalized patients with unplanned hospital admissions were recruited from 20 hospitals representing seven Spanish regions. Cases were defined as those hospitalized due to a laboratory-confirmed influenza infection and controls were matched by age, sex, and hospital. Data were obtained from clinical records, and patients stratified by clinical asthma history. Vaccination status and asthma due to influenza infection were analyzed according to sociodemographic variables and medical risk conditions. Multivariable analysis was made using conditional logistic regression models. RESULTS: 582 hospitalized patients with influenza (15.8% asthmatic) and 1,570 hospitalized patients without influenza (7.9% asthmatic) were included. In the multivariable conditional logistic regression using unvaccinated and non-asthmatic patients as the reference group, vaccination significantly prevented influenza in non-asthmatic patients (aOR = 0.63; 95% CI: 0.45, 0.88) and also showed a trend for a possibly protective effect in asthmatic patients (aOR = 0.79; 95% CI: 0.34, 1.81). CONCLUSION: Our results suggest that influenza vaccination could be a protective factor for asthmatic patients, although the results are inconclusive and further research is required. Practically, given the better clinical evolution of vaccinated asthma cases, and the lack of better evidence, the emphasis on vaccination of this group should continue.

Efficacy and safety of direct antiviral agents in a cohort of cirrhotic HCV/HIV-coinfected patients.

Background: New direct-acting antiviral agents (DAAs) have shown great efficacy and tolerability in clinical trials and real-life cohorts. However, data are scarce regarding efficacy and safety in cirrhotic HCV/HIV-coinfected patients. Methods: A multicentre prospective analysis was performed in 13 Spanish hospitals, including all cirrhotic HCV/HIV-coinfected patients starting DAA combinations from January to December 2015. Sustained virological response 12 weeks after treatment (SVR12) was analysed. Withdrawal due to toxicity and/or hepatic decompensation and change in liver stiffness measurement (LSM) after HCV treatment were evaluated. Results: Patients (n = 170) were mostly male (n = 125; 74.3%) with the following HCV genotype (Gt) distribution: Gt-1a, 68 (40%); Gt-1b, 21 (12.4%); Gt-4, 47 (27.6%); and Gt-3, 26 (15.3%). Baseline median LSM was 20.6 kPa (IQR 16.1-33.7) and log10 HCV-RNA 6.1 IU/mL (IQR 5.7-6.5). Most patients had a Child-Pugh class A score (n = 127; 74.7%) and 28 (16.5%) had prior hepatic decompensation. There were 89 (52.4%) pretreated patients with 40.4% (n = 36) of null responders. Preferred regimens were as follows: sofosbuvir/ledipasvir + ribavirin, 43 (25.3%) patients; sofosbuvir + simeprevir + ribavirin, 34 (20%); sofosbuvir/ledipasvir, 26 (15.3%) and sofosbuvir + daclatasvir + ribavirin, 25 (14.7%). Overall SVR12 was 92.9% (158/170), without differences between genotypes. Pretreated patients had lower SVR12 rates compared with naive (88.8% versus 97.5%; P = 0.026). Treatment failures were as follows: 7 (4.1%) relapses; 2 (1.2%) lost to follow-up; 1 (0.6%) toxicity-related discontinuation; 1 (0.6%) hepatic decompensation; and 1 (0.6%) viral breakthrough. On-treatment hepatic decompensation was recorded in four (2.4%) patients (encephalopathy and ascites, two each). Paired LSM in 33 patients showed a decrease of 5.6 kPa (95% CI 1.8-9.2; P = 0.004). Conclusions: In our cohort of cirrhotic HCV/HIV-coinfected patients, DAAs were highly safe and efficacious. Viral eradication was associated with a significant decrease in liver stiffness.

Estudio del impacto a nivel de salud pública del cribado universal del virus de la inmunodeficiencia humana en un servicio de Urgencias / Level of impact on the public health of universal human immunodeficiency virus screening in an Emergency Department

Introducción: El objetivo fue determinar la prevalencia de VIH y la aceptabilidad del uso de la prueba rápida en un servicio de Urgencias (SU) en Barcelona (6/07/2011-8/03/2013). Método: Estudio descriptivo que analizó la realización de la prueba rápida del VIH en fluido oral en un SU. La muestra se conformó por conveniencia y los participantes firmaron el consentimiento informado. Resultados reactivos confirmados por métodos convencionales. Resultado: A 2.140 se les ofreció realizar la prueba. La tasa de rechazo fue de un 5% (107/2.140). Tres sujetos (3/2.033 [0,15%]) tuvieron la prueba reactiva con confirmación del diagnóstico. Sujetos con mayor nivel educativo tenían una mayor probabilidad de aceptar realizar la prueba rápida de VIH en el SU (p<0,005). Conclusión: Se encontró una baja prevalencia de nuevos diagnósticos de VIH entre los participantes y una alta aceptabilidad a realizar la prueba rápida en el SU (AU)

Introduction: The aim of this study was to determine the prevalence of HIV and the acceptability of rapid testing in an emergency department (ED), Barcelona (6/07/2011 to 8/03/2013). Method: A convenience sample was used, depending on nurse availability in the ED. Participants signed an informed consent. Results were confirmed by conventional methods. Result: A total of 2,140 individuals were offered testing, and 5% rejected taking part (107/2,140). Three subjects (3/2,033 [0.15%]) had confirmed reactive test. Individuals with a higher education were more likely to perform a rapid HIV test in ED (P<.005). Conclusion: A low prevalence of new HIV diagnoses was found among participants, although there was a high acceptability rate to perform rapid testing in the ED (AU)

Asthma in older people hospitalized with influenza in Spain: A case-control study.

BACKGROUND: Influenza infection is an exacerbating factor for asthma, and its prevention is critical in older patients with asthma. OBJECTIVE: This study investigated the association between asthma and influenza-related hospitalization, in Spain, of patients ages ≥ 65 years and their clinical evolution. METHODS: A multicenter case-control study was carried out in 20 Spanish hospitals during the 2013-2014 and 2014-2015 influenza seasons. Patients ages ≥ 65 years hospitalized with laboratory-confirmed influenza with and without asthma were matched with controls according to the presence of asthma, sex, age, hospital, and date of hospitalization. RESULTS: A total of 561 patients with influenza (15.9% with asthma) and 1258 patients without influenza (8.0% with asthma) were included as cases and controls, respectively. The adjusted risk of influenza for patients with asthma was calculated by multivariate conditional logistic regression. The adjustment variables were the following: smoker/nonsmoker, pneumonia in the 2 years before hospital admission, previous oral treatment with corticosteroids, influenza vaccination during the seasonal campaign, Barthel index (ordinal scale used to measure performance in activities of daily living), level of education, obesity, and the presence of other comorbidities. Patients with asthma presented a great risk of influenza (adjusted odds ratio 2.64 [95% confidence interval, 1.77-3.94]). Compared with patients without asthma, patients with asthma had more symptoms, and these had been present for longer before admission but presented a lower hospital or postdischarge mortality. CONCLUSION: This study indicated that asthma was associated with hospitalization from influenza A infection. Although patients with asthma and with influenza had more symptoms, hospital or postdischarge mortality was lower, probably due to a better response to medical treatment.

Effectiveness of 23-valent pneumococcal polysaccharide vaccination in preventing community-acquired pneumonia hospitalization and severe outcomes in the elderly in Spain.

Pneumococcal pneumonia is a serious cause of morbidity and mortality in the elderly, but investigation of the etiological agent of community-acquired pneumonia (CAP) is not possible in most hospitalized patients. The aim of this study was to estimate the effect of pneumococcal polysaccharide vaccination (PPSV23) in preventing CAP hospitalization and reducing the risk of intensive care unit admission (ICU) and fatal outcomes in hospitalized people aged ≥65 years. We made a multicenter case-control study in 20 Spanish hospitals during 2013-2014 and 2014-2015. We selected patients aged ≥65 years hospitalized with a diagnosis of pneumonia and controls matched by sex, age and date of hospitalization. Multivariate analysis was performed using conditional logistic regression to estimate vaccine effectiveness and unconditional logistic regression to evaluate the reduction in the risk of severe and fatal outcomes. 1895 cases and 1895 controls were included; 13.7% of cases and 14.4% of controls had received PPSV23 in the last five years. The effectiveness of PPSV23 in preventing CAP hospitalization was 15.2% (95% CI -3.1-30.3). The benefit of PPSV23 in avoiding ICU admission or death was 28.1% (95% CI -14.3-56.9) in all patients, 30.9% (95% CI -32.2-67.4) in immunocompetent patients and 26.9% (95% CI -38.6-64.8) in immunocompromised patients. In conclusion, PPSV23 showed a modest trend to avoidance of hospitalizations due to CAP and to the prevention of death or ICU admission in elderly patients hospitalized with a diagnosis of CAP.

Level of impact on the public health of universal human immunodeficiency virus screening in an Emergency Department. / Estudio del impacto a nivel de salud pública del cribado universal del virus de la inmunodeficiencia humana en un servicio de Urgencias.

INTRODUCTION: The aim of this study was to determine the prevalence of HIV and the acceptability of rapid testing in an emergency department (ED), Barcelona (6/07/2011 to 8/03/2013). METHOD: A convenience sample was used, depending on nurse availability in the ED. Participants signed an informed consent. Results were confirmed by conventional methods. RESULT: A total of 2,140 individuals were offered testing, and 5% rejected taking part (107/2,140). Three subjects (3/2,033 [0.15%]) had confirmed reactive test. Individuals with a higher education were more likely to perform a rapid HIV test in ED (P<.005). CONCLUSION: A low prevalence of new HIV diagnoses was found among participants, although there was a high acceptability rate to perform rapid testing in the ED.

Factors associated with pneumococcal polysaccharide vaccination of the elderly in Spain: A cross-sectional study.

Vaccination of the elderly is an important factor in limiting the impact of pneumonia in the community. The aim of this study was to investigate the factors associated with pneumococcal polysaccharide vaccination in patients aged ≥ 65 years hospitalized for causes unrelated to pneumonia, acute respiratory disease, or influenza-like illness in Spain. We made a cross-sectional study during 2013-2014. A bivariate analysis was performed comparing vaccinated and unvaccinated patients, taking into account sociodemographic variables and risk medical conditions. A multivariate analysis was performed using multilevel regression models. 921 patients were included; 403 (43.8%) had received the pneumococcal vaccine (394 received the polysaccharide vaccine). Visiting the general practitioner ≥ 3 times during the last year (OR = 1.79; 95% CI 1.25-2.57); having received the influenza vaccination in the 2013-14 season (OR = 2.57; 95% CI 1.72-3.84) or in any of the 3 previous seasons (OR = 11.70; 95% CI 7.42-18.45) were associated with receiving the pneumococcal polysaccharide vaccine. Pneumococcal vaccination coverage of hospitalized elderly people is low. The elderly need to be targeted about pneumococcal vaccination and activities that encourage healthcare workers to proactively propose vaccination might be useful. Educational campaigns aimed at the elderly could also help to increase vaccination coverages and reduce the burden of pneumococcal disease in the community.

Dolutegravir for the treatment of HIV-2 infection.

BACKGROUND: Therapeutic options are limited for HIV-2 infected persons, largely in part due to the lack of susceptibility to HIV-1 non-nucleoside reverse transcriptase inhibitors and poor susceptibility to some HIV-1 protease inhibitors. This is particularly worrisome for HIV-2 patients with prior antiretroviral failure. OBJECTIVES: Report the virological response to dolutegravir in HIV-2-infected individuals. STUDY DESIGN: Retrospective observational assessment of all HIV-2 individuals treated with dolutegravir in Spain. RESULTS: From 297 HIV-2-infected individuals recorded at the Spanish national registry, 26% received antiretroviral therapy. Six out of 8 failing on raltegravir selected for integrase resistance mutations N155H (4), Y143G (1) and Q148R (1). Two patients bearing N155H subsequently received dolutegravir. Both experienced initially more than 1.5 log drop in plasma HIV-2 RNA and significant CD4 gains. Whereas one kept on undetectable viremia 6 months later, the other experienced viral rebound. CONCLUSION: Dolutegravir may be a good therapeutic option for patients with HIV-2 infection, including those that previously failed other integrase inhibitors.

Three-year follow-up of protease inhibitor-based regimen simplification in HIV-infected patients.

Patients with sustained virological suppression on protease inhibitor (PI)-based therapy were randomly assigned to switch the PI to nevirapine (n = 155), efavirenz (n = 156), or abacavir (n = 149) and were followed for at least 3 years regardless of the discontinuation of assigned therapy. There was a higher probability of maintaining virological suppression after 3 years of follow-up with nevirapine or efavirenz than with abacavir. In contrast, abacavir showed a lower incidence of adverse effects leading to drug discontinuation.

Results of a study of prolonging treatment with pegylated interferon-alpha2a plus ribavirin in HIV/HCV-coinfected patients with no early virological response.

OBJECTIVE: To assess the efficacy and safety of an extended treatment period in HIV/hepatitis C virus (HCV)-coinfected patients without early virological response (EVR). METHODS: Patients received pegylated interferon (peg-INF)-alpha2a 180 microg/week plus ribavirin 800 mg/d for 12 weeks. Patients achieving EVR at week 12 continued under therapy for an additional 12 or 36 weeks depending on genotype. Patients without EVR were randomized to complete the standard treatment or treatment lasting 72 weeks (extension arm). RESULTS: One hundred and ten patients were included (mean age 38.7 years, mean weight 68 kg, 74% males, 74% on highly active antiretroviral therapy, mean CD4+ T-cell count 564 cells/mm3). Fifty-one patients harboured genotype 1, 44 genotype 2/3, and 15 genotype 4. Fifty-three had an HCV load >800,000 IU/ml. Premature interruptions occurred in 32.7%. EVR was achieved in 63.6% (51% in genotype 1, 88.6% in genotype 2/3, 33.3% in genotype 4). End-of-treatment response was 52.7% (47.2% in genotype 1, 68.2% in genotype 2/3, 26.7% in genotype 4). Sustained virological response (SVR) was achieved in 41.8% (37.3% in genotype 1, 54.6% in genotype 2/3, 20% in genotype 4). Only one patient allocated to the extended arm achieved SVR. The rate of drop-outs in the extension arm was 68%. The negative predictive value of EVR was 97.5%. CONCLUSIONS: This study shows no benefit of extending therapy in patients without EVR at week 12. Measures to improve adherence to HCV antiviral therapy should be considered when new approaches based on extended periods of treatment are investigated.

[Validation of a questionnaire to estimate satisfaction with antiretroviral treatment: CESTA questionnaire]. / Validación del cuestionario de satisfacción con el tratamiento antirretroviral: cuestionario CESTA.

BACKGROUND: Assessment of patient satisfaction with antiretroviral therapy is generating increasing interest in clinical practice, since the outcome is directly related with compliance with therapy and its effectiveness. Currently, there is no validated patient satisfaction questionnaire to evaluate this factor as related to control of the disease. PATIENTS AND METHODS: An "ad hoc" questionnaire--Cuestionario Español de Satisfacción con el Tratamiento Antiretroviral (CESTA), Spanish Antiretroviral Treatment Satisfaction Questionnaire--was developed to evaluate satisfaction in patients switching to a simplified regimen. In a second phase, the questionnaire was validated in an observational study including 321 patients divided into two cohorts (patients switching to a simplified regimen and patients maintaining the same regimen). RESULTS: A total of 99% and 93% patients, respectively, completed the questionnaire at baseline and at the end-of-study visit. Cronbach's alpha coefficient for internal consistency and test-retest reliability were 0.82 and 0.69, respectively. Patients switching to a simplified regimen showed a statistically significant higher overall satisfaction score at the third-month visit than at baseline. CONCLUSIONS: The CESTA questionnaire is a valid instrument for use in clinical practice and provides valuable information on patient satisfaction with antiretroviral therapy.

Validación del cuestionario de satisfacción con el tratamiento antirretroviral: cuestionario CESTA / Validation of a questionnaire to estimate satisfaction with antiretroviral treatment: CESTA questionnaire

Antecedentes. La evaluación de la satisfacción con el tratamiento es una medida que centrada en el paciente está adquiriendo mayor importancia en la práctica clínica ya que podría incidir en el cumplimiento de los regímenes terapéuticos y por tanto en la efectividad del mismo. En la actualidad no existe ningún cuestionario validado de satisfacción con el tratamiento antirretroviral que permita valorar la importancia del control de la enfermedad. Pacientes y métodos. Se elaboró un cuestionario ad hoc (Cuestionario Español de Satisfacción con el Tratamiento Antirretroviral; CESTA) para evaluar la satisfacción de los pacientes que cambiaban a un régimen terapéutico de simplificación. Posteriormente se ha validado el cuestionario mediante un estudio observacional con 312 pacientes divididos en dos cohortes: pacientes que simplificaban su régimen terapéutico y pacientes estables que no variaban su pauta de tratamiento. Resultados. El cuestionario fue completado por más del 99% de los pacientes en la visita basal y por el 93% en la final. En los parámetros de consistencia interna se obtuvo un coeficiente a de Cronbach de 0,82 y una fiabilidad test-retest de 0,69. Los pacientes del grupo de simplificación obtuvieron puntuaciones significativamente más altas a los 3 meses de seguimiento respecto a los valores basales. Conclusiones. El cuestionario CESTA es un instrumento válido para su aplicación en el contexto de la práctica clínica proporcionando información sobre la importancia que cada paciente asigna a cada uno de los aspectos o cuestiones relacionadas con la satisfacción del tratamiento antirretroviral (AU)

Background. Assessment of patient satisfaction with antiretroviral therapy is generating increasing interest in clinical practice, since the outcome is directly related with compliance with therapy and its effectiveness. Currently, there is no validated patient satisfaction questionnaire to evaluate this factor as related to control of the disease Patients and methods. An "ad hoc" questionnaire --Cuestionario Español de Satisfacción con el Tratamiento Antiretroviral (CESTA), Spanish Antiretroviral Treatment Satisfaction Questionnaire-- was developed to evaluate satisfaction in patients switching to a simplified regimen. In a second phase, the questionnaire was validated in an observational study including 321 patients divided into two cohorts (patients switching to a simplified regimen and patients maintaining the same regimen). Results. A total of 99% and 93% patients, respectively, completed the questionnaire at baseline and at the end-of-study visit. Cronbach's alpha coefficient for internal consistency and test-retest reliability were 0.82 and 0.69, respectively. Patients switching to a simplified regimen showed a statistically significant higher overall satisfaction score at the third-month visit than at baseline. Conclusions. The CESTA questionnaire is a valid instrument for use in clinical practice and provides valuable information on patient satisfaction with antiretroviral therapy (AU)

Failure of cetirizine to prevent nevirapine-associated rash: a double-blind placebo-controlled trial for the GESIDA 26/01 Study.

OBJECTIVES: Rash is the most frequent adverse event associated with nevirapine. The use of antihistamines remains unclear in this setting. A double-blind placebo-controlled study was performed to evaluate the efficacy of cetirizine in the prevention of nevirapine rash. METHODS: A multicenter, randomized, double-blind, placebo-controlled clinical trial with cetirizine (10 mg/d x 30 days) was conducted. Inclusion criteria were HIV-1 infection and nevirapine therapy started with any CD4 cell count or plasma viral load and without simultaneous use of abacavir, cotrimoxazole, or rifampin. Clinical follow-up was performed at 15, 30, and 90 days. RESULTS: Two hundred seventeen evaluable patients were enrolled (107 patients receiving cetirizine and 110 patients receiving placebo), 32.3% of whom were women. The median baseline CD4 cell count and plasma viral load were 341 cells/mm and 11,000 copies/mL, respectively. Overall, 29 rashes (13.4%) were detected: 16 (15.0%) in the cetirizine group and 13 (11.8%) in the placebo group (odds ratio [OR] = 1.31, 95% confidence interval [CI]: 0.60-2.88; P = 0.50). The incidence of moderate to severe rashes leading to nevirapine withdrawal was 10.3% (11 of 107 patients) in the cetirizine group and 7.3% (8 of 110 patients) in the placebo group (OR = 1.46, 95% CI: 0.52-4.18; P = 0.43). Adverse events leading to withdrawal of therapy appeared in 14 patients (13.1%) from the cetirizine group and 10 (9.1%) from the placebo group (P = 0.34). CONCLUSION: Cetirizine does not prevent the incidence or affect the severity of nevirapine-associated rash.