High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial.

TRIAL DESIGN: The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment with a boosted protease inhibitor (TT). METHODS: This was a 24-week, open-label, multicentre study in virologically-suppressed HIV-infected participants (N = 225) with a 2:1 randomization: 146 patients who switched to MT were compared with 79 patients who remained on a TT regimen. The primary endpoint was change in patient-reported outcomes in quality of life as measured by the MOS-HIV and EQ-5D questionnaires. Secondary endpoints included treatment adherence, patient satisfaction, incidence of adverse events and differences in plasma HIV-1 RNA viral load (VL) and CD4 cell counts. RESULTS: Baseline quality of life, measured with the MOS-HIV score, was very good (overall score of 83 ± 10.5 in the MT arm and 82.3 ± 11.3 in the TT arm) and suffered no change during the study in any of the arms (at week 24, 83.5 ± 12.2 in MT arm and 81.9 ± 12.7 in TT arm), without statistically significant differences when compared. In regards to adherence to therapy and patient satisfaction, some aspects (number of doses forgotten in the last week and satisfaction of treatment measured with the CESTA score, dimension 1) improved significantly with MT. There were also no differences in the incidence and severity of adverse events, even though 22.8% of those in the MT arm switched their treatment when they were included in the study. Moreover, there was also no significant difference between the immunological and virological evolution of MT and TT. In the MT arm, the VL was always undetectable in 83% of patients (vs 90.7% in the TT arm) and there were only 6.7% of virological failures with VL > 50 copies/mL (vs 2.3% in the TT arm), without resistance mutations and with resuppression of VL after switching back to TT. CONCLUSIONS: In a new clinical trial, monotherapy as a treatment simplification strategy in HIV-1 infected patients with sustained viral suppression has demonstrated quality of life, safety and efficacy profiles comparable to those of conventional triple therapy regimens.

Colesterol ligado a lipoproteínas de baja densidad en una serie de pacientes con infección por el virus de la inmunodeficiencia humana / LDL-cholesterol levels in a series of HIV-infected patients

Fundamento y objetivos:Conocer la prevalencia de pacientes con infección por el virus de la inmunodeficiencia humana que no cumplen los objetivos de colesterol ligado a lipoproteínas de baja densidad (cLDL).Pacientes y método: Estudio multicéntrico transversal de todos los pacientes con virus de la inmunodeficiencia humana que acudieron a revisión en 5 hospitales de la provincia de Málaga entre marzo y agosto de 2007. Se clasificaron en función de su cLDL deseable National Cholesterol Education Program (NCEP): grupo A inferior a 160mg/dl (pacientes sin factor de riesgo cardiovascular [FRCV] o solo un FRCV); grupo B inferior a 130mg/dl (pacientes con 2 o más FRCV), y grupo C inferior a 100mg/dl (pacientes con enfermedad cardiovascular o equivalentes o con un riesgo cardiovascular [RCV] a 10 años superior al 20%). Se contrastaron los pacientes con cLDL deseable con los que no lo alcanzaban. Programa estadístico: SPSS.Resultados: Se analizó a 1.019 pacientes, de los que 232 (22,8%) tenían un nivel de cLDL no deseable. En el grupo A había 693 pacientes, en el grupo B 163 pacientes y en el grupo C 153 pacientes; no alcanzaban el cLDL deseable el 6,6, el 53,3 y el 65,0%, respectivamente (p<0,05). Los únicos factores asociados a un cLDL no deseable fueron la obesidad (OR=1,98; IC 95%: 1,14–3,46; p=0,01), el tiempo de tratamiento antirretroviral (por cada 2 años, OR=1,92; IC 95%: 1,85–1,99; p=0,02) y estar incluido en los grupos B y C (OR=16,9; IC 95%: 10,8–26,6; p=0,00001) (AU)

Background and objective: To analyse the prevalence of HIV-infected patients who do not reach their target LDL-cholesterol (LDL-C) levels. Patients and methods:Multicenter, cross-sectional study of all HIV-infected patients on regular follow-up in 5 hospitals in the province of Malaga (March-August/07). They were classified depending on their target LDL-C levels (NCEP): group A:<160mg/dl, if ≤1 cardiovascular risk factor (CVRF); group B: <130mg/dl, if ≥2 CVRF; group C: <100mg/dl, if cardiovascular disease or equivalents or CVR at 10 years >20%). A comparison between patients reaching their target LDL-C levels and those not reaching them was done. Statistic program: SPSS.Results: Of 1019 included patients, 232 (22.8%) did not reach their target LDL-C levels. There were 693 patients in Group A, 163 in Group B, and 153 in Group C (6.6%, 53.3 % and 65.0% respectively (p<0.05)) who did not reach their target LDL-C. Factors associated with LDL-C levels higher than target were: obesity (OR=1.98; 95%CI: 1.14–3.46; p=0.01), time on antiretroviral therapy (for each 2 years OR=1.92; 95%CI: 1.85–1.99; p=0.02), and being included in Groups B and C (OR=16.9; 95%CI: 10.8–26.6; p=0.00001). Conclusions: More than 20% of the patients in this cohort did not reach their target LDL-C levels. Factors associated with high LDL-C levels were central obesity, time on antiretroviral therapy and being included in Groups B and C (AU)

[LDL-cholesterol levels in a series of HIV-infected patients]. / Colesterol ligado a lipoproteínas de baja densidad en una serie de pacientes con infección por el virus de la inmunodeficiencia humana.

BACKGROUND AND OBJECTIVE: To analyse the prevalence of HIV-infected patients who do not reach their target LDL-cholesterol (LDL-C) levels. PATIENTS AND METHODS: Multicenter, cross-sectional study of all HIV-infected patients on regular follow-up in 5 hospitals in the province of Malaga (March-August/07). They were classified depending on their target LDL-C levels (NCEP): group A:<160mg/dl, if /=2 CVRF; group C: <100mg/dl, if cardiovascular disease or equivalents or CVR at 10 years >20%). A comparison between patients reaching their target LDL-C levels and those not reaching them was done. Statistic program: SPSS. RESULTS: Of 1019 included patients, 232 (22.8%) did not reach their target LDL-C levels. There were 693 patients in Group A, 163 in Group B, and 153 in Group C (6.6%, 53.3 % and 65.0% respectively (p<0.05)) who did not reach their target LDL-C. Factors associated with LDL-C levels higher than target were: obesity (OR=1.98; 95%CI: 1.14-3.46; p=0.01), time on antiretroviral therapy (for each 2 years OR=1.92; 95%CI: 1.85-1.99; p=0.02), and being included in Groups B and C (OR=16.9; 95%CI: 10.8-26.6; p=0.00001). CONCLUSIONS: More than 20% of the patients in this cohort did not reach their target LDL-C levels. Factors associated with high LDL-C levels were central obesity, time on antiretroviral therapy and being included in Groups B and C.

Prevalencia de factores de riesgo cardiovascular y de síndrome metabólico en una cohorte de pacientes con infección por el virus de la inmunodeficiencia humana del sur de España. Estudio PREGO / Prevalence of cardiovascular risk factors and metabolic syndrome in a cohort of HIV-infected patients in Southern Spain. PREGO Study

Objetivo. Conocer la prevalencia de factores de riesgo cardiovascular (FRCV) y síndrome metabólico (SM) en pacientes con infección por el virus de la inmunodeficiencia humana (VIH). Métodos. Estudio observacional, multicéntrico y transversal de todos los pacientes con infección por el VIH atendidos de forma ambulatoria en 5 hospitales de la provincia de Málaga entre marzo y agosto de 2007. A todos los pacientes se realizó un cuestionario sobre FRCV, examen físico y analítica en ayunas. El riesgo cardiovascular (RCV) a 10 años se realizó mediante la ecuación de Framingham y el diagnóstico de SM se hizo en función de los criterios del National Cholesterol Education Program. Resultados. Se incluyó a 1.155 pacientes. El 76,9% eran varones y la edad media fue de 44,3 años. El 86,1% de los pacientes estaba en tratamiento antirretroviral. La prevalencia de FRCV fue la siguiente: tabaco 59%, hipertrigliceridemia 38,2%, cHDL bajo 40,6%, hipertensión arterial 10,6% y diabetes mellitus 9,4%. El 14,3% de los pacientes cumplía criterios de SM y los componentes más frecuentes fueron hipertrigliceridemia (88,3%) y colesterol unido a lipoproteínas de alta densidad bajo (78,7%). Los pacientes con SM tenían mayor RCV a 10 años (el 10,9 frente al 5,6%; p < 0,0001). El único factor asociado al SM fue la edad (odds ratio = 4,7; intervalo de confianza del 95%, 4,6-4,8). Conclusiones. Los FRCV en pacientes con infección por el VIH de nuestro medio son muy frecuentes, entre los cuales destaca el consumo de tabaco. La prevalencia de SM es similar a la de la población general española y se asocia a un mayor RCV. El único factor asociado al desarrollo de SM fue la edad (AU)

Objective. To analyse the prevalence of cardiovascular risk factors (CVRF) and metabolic syndrome (MS) in a cohort of HIV-infected patients. Methods. Observational, multicenter, and cross-sectional study of all HIV-infected outpatients from five hospitals in Málaga (Southern Spain). A questionnaire about CVRF, a physical exploration, and 12 hours fasting blood tests were performed in all cases. Cardiovascular risk at 10 years was assessed by Framingham equation, and MS diagnosis was based on the NCEP criteria. Results. 1155 patients were included. 76.9% were men, and the mean age was 44.3 years. 86.1% of the patients were on antiretroviral therapy. The prevalence of CVRF was the following: tobacco 59%, hypertriglicerydemia 38.2%, low cHDL 40.6%, hypertension 10.6%, diabetes 9.4%. 14.3% patients had MS, being hypertriglycerydemia (88.3%) and low cHDL (78.7%) the most frequent criteria. Patients with MS had a higher CVR at 10 years (10.9 vs 5.6%, p < 0.0001). Age was the only factor associated with MS (odds ratio = 4.7; 95% confidence interval 4.6-4.8). Conclusions. CVRF, mainly tobacco use, are very frequent among HIV-patients in our area. The prevalence of MS is similar as that of the Spanish general population and it is associated with a higher CVR. Age was the only factor associated with the development of MS (AU)

Hepatic safety of tipranavir plus ritonavir (TPV/r)-based antiretroviral combinations: effect of hepatitis virus co-infection and pre-existing fibrosis.

OBJECTIVES: The aim of this study was to evaluate the incidence and risk factors of severe liver events among HIV-infected patients treated with drug combinations including tipranavir boosted with ritonavir (TPV/r). METHODS: One hundred and fifty patients were selected because they started a regimen that included TPV/r (500/200 mg twice a day) and had clinical visits at least every 3 months. Patients who discontinued TPV/r before their first visit were included. RESULTS: Twelve (8%) individuals developed grade>or=3 transaminase elevation (G>or=3TE). Nine (6%) patients discontinued TPV/r due to liver events. Six (8.6%) of 70 hepatitis C virus (HCV) co-infected patients and 6 (7.5%) of 80 subjects without HCV co-infection developed G>or=3TE (P=1). Liver fibrosis was evaluable in 48 (63%) of 76 individuals with hepatitis B virus and/or HCV infection. Four (13%) of 30 subjects with moderate-to-severe fibrosis and none of 18 with mild fibrosis showed G>or=3TE (P=0.3). None of nine patients with cirrhosis showed G>or=3TE. CONCLUSIONS: Liver tolerability of TPV/r was generally good in a cohort of patients with a high proportion of HCV co-infection, including subjects with advanced fibrosis. The presence of HCV co-infection was not associated with an increased risk of severe transaminase elevations.

High prevalence of hepatitis C virus subtypes 4c and 4d in Malaga (Spain): phylogenetic and epidemiological analyses.

Hepatitis C virus (HCV) is a major aetiological agent of chronic hepatitis and it may lead to the development of liver cirrhosis and hepatocellular carcinoma. HCV has been classified into six clades as a result of high genetic variability. A commercial procedure to genotype HCV in 678 patients from Carlos Haya Regional University Hospital, Malaga was used to study the distribution of HCV genotypes in Malaga, southern Spain. A high prevalence of HCV-4 (10.2%) was found. This genotype is found more commonly in Egypt, Central Africa and the Middle East. The distribution of the different subtypes in the 69 patients with HCV-4 was as follows: 4.3% subtype 4e, 7.2% subtype 4a, 11.5% not subtypable, and 76.8% subtype 4c/4d. Of the 53 4c/4d patients, 69% were intravenous drug users and 31% non-intravenous drug users. In order to characterise further the HCV-4c/4d patients, sequences of the non-structural 5B gene (393 bp) were obtained from 36 HCV-4c/4d-infected untreated patients. Phylogenetic tree topologies distinguished clearly the two subtypes: 11 patients were infected by subtype 4c and 25 by 4d. This phylogenetic analysis, reinforced by the epidemiological characteristics, suggests the extension of the HCV-4c and -4d subtypes in the area of Malaga among both intravenous drug users and non-intravenous drug users.