Estudio caso-control de tumores no definitorios de sida en una cohorte prospectiva de pacientes infectados por el VIH / A case-control study of non-AIDS-defining cancers in a prospective cohort of HIV-infected patients

Introducción: Presentamos un estudio caso-control de tumores no definitorios de sida (TNDS) en una cohorte de pacientes infectados por el VIH en la que valoramos las tasas de incidencia, supervivencia y factores pronósticos de mortalidad. Métodos: Se recogieron de forma prospectiva en 7 hospitales, los diagnósticos de TNDS realizados de 2007 a 2011, con seguimiento posterior hasta diciembre de 2013. Se seleccionaron de forma aleatoria un grupo control de 221 pacientes VIH sin diagnóstico de cáncer. Resultados: Se diagnosticaron 221 TNDS en una cohorte inicial de 7.067 pacientes VIH. Los más frecuentes: hepatocarcinoma 20,5%, pulmón 18,7%, cabeza y cuello 11,9% y anal 10,5%. La tasa de incidencia de desarrollo de TNDS fue de 7,84/1.000 pacientes-año. Además de la edad y el tabaco, el tiempo en TAR (OR 1,11; IC 95% 1,05-1,17) y el uso de IP (OR 1,72; IC 95% 1,0-2,96) aumentaron el riesgo de desarrollar un TNDS. Durante el seguimiento fallecieron el 53,42%, con una mediana de supervivencia de 199,5 días. En el análisis de los factores pronósticos de mortalidad, los valores bajos de CD4 en el momento del diagnóstico del tumor (OR 0,99; IC 95% 0,99-1,0; p=0,033) y el diagnóstico previo de sida (OR 2,06; IC 95% 1,08-3,92) se asociaron con una mayor mortalidad. Conclusiones: Los predictores de TNDS en nuestra cohorte fueron la edad, el consumo de tabaco, los linfocitos CD4 y el mayor tiempo en TAR. La mortalidad es alta, siendo factores de riesgo los CD4 bajos en el momento del diagnóstico del TNDS y el diagnóstico previo de sida

Introduction: We present a case-control study of non-AIDS-defining cancers (NADCs) in a cohort of HIV-infected patients where we value the incidence, survival and prognostic factors of mortality. Methods: All NADCs diagnosis conducted from 2007 to 2011 in 7 hospitals were collected prospectively, with a subsequent follow up until December 2013. A control group of 221 HIV patients without a diagnosis of cancer was randomly selected. Results: Two hundred and twenty-one NADCs were diagnosed in an initial cohort of 7,067 HIV-infected patients. The most common were: hepatocellular carcinoma 20.5%, lung 18.7%, head and neck 11.9% and anal 10.5%. The incidence rate of NADCs development was 7.84/1,000 people-year. In addition to aging and smoking, time on ART (OR 1.11; 95% CI 1.05-1.17) and PI use (OR 1.72; 95% CI 1.0-2.96) increased the risk of developing a NADC. During follow-up 53.42% died, with a median survival time of 199.5 days. In the analysis of the prognostic factors of mortality the low values of CD4 at tumour diagnosis (OR 0.99; 95% CI 0.99-1.0; P=.033), and the previous diagnosis of AIDS (OR 2.06; 95% CI 1.08-3.92) were associated with higher mortality. Conclusions: Predictors of NADCs in our cohort were age, smoking, CD4 lymphocytes and time on ART. Mortality is high, with NADC risk factors being low CD4 count and previous diagnosis of AIDS

A case-control study of non-AIDS-defining cancers in a prospective cohort of HIV-infected patients. / Estudio caso-control de tumores no definitorios de sida en una cohorte prospectiva de pacientes infectados por el VIH.

INTRODUCTION: We present a case-control study of non-AIDS-defining cancers (NADCs) in a cohort of HIV-infected patients where we value the incidence, survival and prognostic factors of mortality. METHODS: All NADCs diagnosis conducted from 2007 to 2011 in 7 hospitals were collected prospectively, with a subsequent follow up until December 2013. A control group of 221 HIV patients without a diagnosis of cancer was randomly selected. RESULTS: Two hundred and twenty-one NADCs were diagnosed in an initial cohort of 7,067 HIV-infected patients. The most common were: hepatocellular carcinoma 20.5%, lung 18.7%, head and neck 11.9% and anal 10.5%. The incidence rate of NADCs development was 7.84/1,000 people-year. In addition to aging and smoking, time on ART (OR 1.11; 95% CI 1.05-1.17) and PI use (OR 1.72; 95% CI 1.0-2.96) increased the risk of developing a NADC. During follow-up 53.42% died, with a median survival time of 199.5 days. In the analysis of the prognostic factors of mortality the low values of CD4 at tumour diagnosis (OR 0.99; 95% CI 0.99-1.0; P=.033), and the previous diagnosis of AIDS (OR 2.06; 95% CI 1.08-3.92) were associated with higher mortality. CONCLUSIONS: Predictors of NADCs in our cohort were age, smoking, CD4 lymphocytes and time on ART. Mortality is high, with NADC risk factors being low CD4 count and previous diagnosis of AIDS.

Long-term effectiveness and safety outcomes in HIV-1-infected patients after a median time of 6 years on nevirapine.

To report long-term data on safety and effectiveness of antiretroviral regimens, including nevirapine. HIV-1-infected patients who received nevirapine-based approaches for at least 4 years were identified in the databases of five centers and included in a retrospective cohort study. Data collected included plasma HIV-RNA (viral load) and CD4+ T-cell counts, lipid and liver function tests, at baseline, 2-year and > 4-year time points. Hepatitis C virus (HCV) coinfection, adverse events, and reasons for using nevirapine were also recorded. Two hundred and twenty-nine patients (139 males/90 females) were included. The mean age was 37 years (range 20-59). Most patients (n = 124; 54%) were former intravenous drug users. One hundred and thirty-five of the patients (59%) were coinfected with HCV. Median time on nevirapine was 72.6 months. The main reasons for nevirapine use included: second- or third-line therapy (39%), simplification of therapy (29%), first-line therapy (18%) and efavirenz intolerance (9%). LDL cholesterol and triglycerides decreased during the >4-year follow-up (135 mg/dl to 109 mg/dl, p = 0.04; and 216 mg/dl to 153 mg/dl, p<0.01, respectively), and HDL cholesterol increased from 48 mg/dl at baseline to 62 mg/dl (p<0.01). Liver enzymes remained without significant changes during follow-up. The reported follow-up pattern of laboratory tests was also found in the subset of HCV-coinfected patients, where men and women were compared and patients with a CD4+ cell count cut-off value of 250/mm(3) were stratified. Mean CD4+ T-cell counts increased from 439/mm(3) at baseline to 628/mm(3) at the last available visit (p<0.001). Ninety-four per cent (172 out of 184) of patients who remained on nevirapine-based therapy at last visit maintained viral load values below the limit of detection (<50 copies/ml). Throughout the follow-up nevirapine was stopped or withdrawn in 43 patients due to virological failure (n = 17), toxicity (n = 5), therapy interruption (n = 3), death (n = 2), dyslipidemia (n = 1), simplification (n = 1) or unknown reasons (n = 14). Adverse events were reported in 40 patients but none was directly attributed to nevirapine. Nevirapine-based antiretroviral therapy provides sustained immunological and virological effectiveness over a more than 4-year treatment period as well as a beneficial lipid metabolic profile and a favorable safety profile, even in HCV-coinfected patients and women with CD4+ cell counts above 250/mm(3). The study data support a nevirapine-based approach as a suitable long-term strategy in the HIV-1-infected population.