Effectiveness of an HIV care model integrated into addiction care based on medication-assisted treatment for HIV-positive people who use drugs.

Our objective was to evaluate the effectiveness of initiated or reinitiated antiretroviral therapy (ART) in HIV-positive active drug users receiving integrated HIV and addiction care in a harm reduction setting. We performed a study of HIV-positive persons who use drugs (PWUD) in a harm reduction unit in Madrid, Spain. Participants received HIV care integrated into addiction care and received at least one dose of observed ART based on medication-assisted treatment between January 2013 and December 2019. Individuals newly diagnosed with HIV (n = 13) had a greater median CD4 cell count at baseline were less likely to be late presenters, had a greater CD4 cell count increase, and were less likely to have AIDS in comparison to those who were aware of their HIV status (n = 87) at initiation or reinitiation of ART. The overall VS was 73% in the intention-to-treat (ITT) analysis and 92.4% in the modified intention-to-treat (mITT) analysis. People who were engaged in OST, people with >90% adherence to ART, and older people were positively associated with VS in the multivariate analysis. An HIV care model integrated into a harm reduction facility demonstrated a high uptake of HIV treatment, retention in care, improvement in adherence, and achievement of VS.

Deprescribing of non-antiretroviral therapy in HIV-infected patients.

PURPOSE: In recent decades, the life expectancy of HIV-infected patients has increased considerably, to the extent that the disease can now be considered chronic. In this context of progressive aging, HIV-infected persons have a greater prevalence of comorbid conditions. Consequently, they usually take more non-antiretroviral drugs, and their drug therapy are more complex. This supposes a greater risk of drug interactions, of hospitalization, falls, and death. In the last years, deprescribing has gained attention as a means to rationalize medication use. METHODS: Review of the different therapeutic approach that includes optimization of polypharmacy and control and reduction of potentially inappropriate prescription. RESULTS: There are several protocols for systematizing the deprescribing process. The most widely used tool is the Medication Regimen Complexity Index, an index validated in HIV-infected persons. Anticholinergic medications are the agents that have been most associated with major adverse effects so, various scales have been employed to measure it. Other tools should be employed to detect and prevent the use of potentially inappropriate drugs. Prioritization of candidates should be based, among others, on drugs that should always be avoided and drugs with no justified indication. CONCLUSIONS: The deprescribing process shared by professionals and patients definitively would improve management of treatment in this population. Because polypharmacy in HIV-infected patients show that a considerable percentage of patients could be candidates for deprescribing, we must understand the importance of deprescribing and that HIV-infected persons should be a priority group. This process would be highly feasible and effective in HIV-infected persons.

High rates of early HCV reinfection after DAA treatment in people with recent drug use attended at mobile harm reduction units.

BACKGROUND AND AIMS: The World Health Organization recently called for the elimination of hepatitis C virus (HCV) and has identified people who inject drugs (PWID) as a key target population. Clinical trials analyzing currently available all-oral regimens have demonstrated a high degree of efficacy in this population, with a relatively low reinfection rate. There is an urgent need to confirm these data in a harm reduction and active consumption setting. The primary aim of this study was to evaluate the HCV reinfection rate in people with recent drug use followed at low-threshold mobile harm reduction units. METHOD: We included people with recent drug use (smoked or injected heroin/cocaine in the previous 6 months) who received HCV treatment and were attended at two low-threshold mobile harm reduction units over 19 months. Sustained virologic response was assessed 12 weeks after therapy (SVR12). The incidence density of HCV reinfection was defined as the number of reinfections per 100-person years (PY) using person-time of observation and was stratified by drug consumption at initiation of HCV treatment. Cox proportional hazard regression analysis was used to assess factors associated with reinfection. RESULTS: During the study period, 160 people who used drugs in the past 6 months completed HCV therapy. 122 (73.9%) and 88 (53.3%) reported injecting drug use in the 6 months and 30 days prior to HCV treatment, respectively. The overall SVR12 was 68% in the ITT analysis (reinfection = failure) and 90.7% in the modified intent-to-treat analysis (considering reinfections as response and removing people who were missing SVR data). The cohort at-risk for reinfection (n = 121) included 47 (39.2%) people who initiated HCV treatment with recently reported abstinence. Reinfection was identified in 10 persons (8.3%), and the median time to reinfection was 7.2 (IQR 4.2-18) months. Total follow-up time at-risk was 101.1-PY (median 0.6 years, IQR 0.3-1.3). The overall incidence of reinfection was 9.8 per 100-PY (95% CI 4.7,18.2). The incidence of reinfection was higher amongst those who had injected drugs in the previous 6 months (16.7 [95%CI 8.0; 30.7] per 100-PY) and in the previous 30 days (18.9 [95% CI 8.1; 37.2] per 100-PY). In the adjusted analysis, only injecting drugs use in the month prior to initiation of HCV therapy was associated with reinfection (aHR 8.7, 95%CI 1.0; 73.6; p 0.04). CONCLUSION: High efficacy of HCV treatment, was found in people with recent drug use attended and followed at low-threshold mobile harm reduction units. The high rate of early HCV reinfections in this setting should promote surveillance for reinfection at 7-month intervals after ending the treatment or earlier.

Infliximab Biosimilars: A Promising but Unusual Treatment for Mycobacterial Immune Reconstitution Inflammatory Syndrome in Human Immunodeficiency Virus-Infected Patients.

Immune reconstitution inflammatory syndrome can present as a paradoxical reaction after initiation of antiretroviral treatment in patients with severe immunosuppression and underlying infections. Immune reconstitution inflammatory syndrome has often been associated with mycobacteria, and the clinical response to traditional treatment with corticosteroids is not always satisfactory. Consequently, administration of an infliximab biosimilar could lead to an improvement in the clinical status of these patients.

Study of the gastrointestinal tolerance of a new tablet formulation of the lopinavir/ritonavir antiretroviral in HIV-infected patients.

BACKGROUND: Preliminary studies suggest that the new film-coated tablet formulation of lopinavir/ritonavir (LPV/r-fct) could cut down the rate of adverse gastrointestinal symptoms of the conventional lopinavir/ritonavir soft gelatine capsules (LPV/r-sgc). OBJECTIVE: To ascertain the difference in the rate of adverse gastrointestinal symptoms in patients who switch from LPV/r-sgc to LPV/r-fct. METHODS: An uncontrolled, open, prospective study including a pre/post comparison using the Gastrointestinal Symptom Rating Scale (GSRS) modified to the characteristics of the protease inhibitors. RESULTS: Seventy patients were included, with a mean time of treatment, with the new formulation of 77 days [confidence interval (CI) 95%: 70 to 84]. The total GSRS score was 26.96 (CI 95%: 25.02 to 28.89) in the prechange survey and 26.27 (CI 95%: 24.08 to 28.47) in the postchange survey, with a mean difference of 0.69 points (CI 95%: -1.18 to 2.55, P = 0.47). None of the questions obtained the objective of a difference of at least 2 points, previously set as a clinically significant difference. Only 1 patient dropped the study due to gastrointestinal toxicity. CONCLUSIONS: Our study has unearthed no clinically significant differences in the gastrointestinal tolerance profile of (LPV/r-sgc) and (LPV/r-fct), measuring this tolerance level by application of the GSRS scale.

Análisis farmacoeconómico de una estrategia de mantenimiento con lopinavir/ritonavir como monoterapia en pacientes con infección por el VIH / Pharmacoeconomic analysis of a maintenance strategy with lopinavir/ritonavir monotherapy in HIV-infected patients

Los resultados del presente estudio se han comunicado como Abstract en el 10th European AIDS Conference (EACS). Dublín, 2005 (Abstract PE 19.5/2). Objetivo. Análisis farmacoeconómico del coste y la eficacia del tratamiento con lopinavir/ritonavir (LPV/r) en monoterapia tras inducir respuesta virológica con triple terapia que incluye LPV/r. El análisis farmacoeconómico se realiza desde la perspectiva del Sistema Público de Salud. Métodos. Se realizó un análisis del coste y la eficacia del ensayo clínico piloto en fase IV-II, comparativo, aleatorizado y multicéntrico abierto en el que se evaluó la eficacia y la seguridad de la terapia de mantenimiento con LPV/r en monoterapia frente a la continuación de la terapia triple en pacientes infectados por el VIH que han mantenido la carga viral indetectable durante 6 meses. Para el análisis farmacoeconómico se definió eficacia como la proporción de pacientes con concentraciones de ARN del VIH en plasma < 50 copias/ml a las 48 semanas de iniciado el estudio. El análisis se realizó por intención de tratamiento. Los costes considerados son todos costes directos. Se calcularon los costes, la eficacia y la razón para cada alternativa de tratamiento. Resultados. La relación del coste y la eficacia del tratamiento con LPV/r es de 5.186 euros por cada unidad de efecto alcanzado (paciente con concentraciones de ARN del VIH en plasma < 50 copias/ml a las 48 semanas), mientras que el mantenimiento con triple terapia tiene una relación entre el coste y la eficacia de 8.688 euros por unidad de efecto alcanzado. Conclusión. Utilizar LPV/r como único tratamiento antirretroviral en el paciente con infección por el VIH tras inducir respuesta virológica con triple terapia que incluye lopinavir/ritonavir podría ser una alternativa más eficiente que mantener la triple terapia, al presentar una mejor relación entre el coste y la eficacia (AU)

Aims. To conduct a cost-efficacy analysis of lopinavir/ritonavir (LPV/r) monotherapy as a maintenance regimen following induction of virological response with triple therapy including LPV/r. The pharmacoeconomic analysis was performed from the perspective of the Spanish public health system. Methods. A cost-efficacy analysis was performed in a phase IV-II, comparative, randomized, multicenter, open-label clinical trial evaluating the efficacy and safety of maintenance therapy with LPV/r monotherapy versus continuation of triple therapy in HIV-infected patients with a persistently undetectable viral load for 6 months. For the pharmacoeconomic analysis, efficacy was defined as the proportion of patients with plasma HIV RNA concentrations < 50 copies/mL at 48 weeks from the start of the study. An intent-to-treat analysis was performed. Only direct costs were considered. Cost, efficacy and the cost-efficacy ratio were calculated for each treatment option. Results. The cost-efficacy ratio of LPV/r maintenance monotherapy was 5186 euros per unit of achieved effect (patient with plasma HIV RNA concentrations < 50 copies/mL at 48 weeks), whereas maintenance with triple therapy had a cost-efficacy ratio of 8688 euros per unit of achieved effect. Conclusion. The option of LPV/r monotherapy as maintenance therapy in HIV-infected patients following induction of virological response with triple therapy including LPV/r might be a more efficient alternative than maintaining triple therapy, as evidenced by a more favorable cost-efficacy ratio (AU)

[Pharmacoeconomic analysis of a maintenance strategy with lopinavir/ritonavir monotherapy in HIV-infected patients]. / Análisis farmacoeconómico de una estrategia de mantenimiento con lopinavir/ritonavir como monoterapia en pacientes con infección por el VIH.

AIMS: To conduct a cost-efficacy analysis of lopinavir/ritonavir (LPV/r) monotherapy as a maintenance regimen following induction of virological response with triple therapy including LPV/r. The pharmacoeconomic analysis was performed from the perspective of the Spanish public health system. METHODS: A cost-efficacy analysis was performed in a phase IV-II, comparative, randomized, multicenter, open-label clinical trial evaluating the efficacy and safety of maintenance therapy with LPV/r monotherapy versus continuation of triple therapy in HIV-infected patients with a persistently undetectable viral load for 6 months. For the pharmacoeconomic analysis, efficacy was defined as the proportion of patients with plasma HIV RNA concentrations < 50 copies/mL at 48 weeks from the start of the study. An intent-to-treat analysis was performed. Only direct costs were considered. Cost, efficacy and the cost-efficacy ratio were calculated for each treatment option. RESULTS: The cost-efficacy ratio of LPV/r maintenance monotherapy was 5186 euros per unit of achieved effect (patient with plasma HIV RNA concentrations < 50 copies/mL at 48 weeks), whereas maintenance with triple therapy had a cost-efficacy ratio of 8688 euros per unit of achieved effect. CONCLUSION: The option of LPV/r monotherapy as maintenance therapy in HIV-infected patients following induction of virological response with triple therapy including LPV/r might be a more efficient alternative than maintaining triple therapy, as evidenced by a more favorable cost-efficacy ratio.

[Recommendations from GESIDA/SEFH/PNS to improve adherence to antiviral treatment (2004)]. / Recomendaciones GESIDA/SEFH/PNS para mejorar la adherencia al tratamiento antirretroviral en el año 2004.

Since the early days of antiretroviral therapy, adherence has emerged as the milestone of success; in fact, it is the most potent predictor of effectiveness. The main factors related to adherence include the complexity of the therapeutic regimen, adverse effects, psychological problems, alcoholism and active addiction to drugs, lack of social and family support and the patient's beliefs and attitudes about the treatment. Adherence monitoring should be part of the HIV patient's regular care, and should be done with feasible, easily applied methods adapted to the different clinical settings. The minimally acceptable measures should include use of a validated questionnaire, together with data from the Pharmacy Department's drug dispensation registry. All patients that begin HAART or undergo a change of treatment should participate in a treatment education program imparted by health professionals with knowledge and experience in the management of patients with HIV infection. The health team (doctors, pharmacists and nursing professionals) should offer maximum availability to solve the doubts and problems that may occur during treatment. When sub-optimal adherence is detected, intervention strategies based on psychological therapy, educational efforts and personal advice should be attempted, in order to adapt the treatment scheme to the patient's habits and provide solutions to the problem of non-compliance. In certain situations, co-morbid conditions will also require attention. Treatment adherence, being a multidimensional problem, needs a multidisciplinary team approach. The choice of therapy, only one aspect of the multidimensional problem of adherence, must be a careful and individualized decision; however, simpler regimens with regard to the number of pills and daily dose are desirable.

Recomendaciones GESIDA/SEFH/PNS para mejorar la adherencia al tratamiento antirretroviral en el año 2004 / Recommendations from GESIDA/SEFH/PNS to improve adherence to antiviral treatment (2004)

El cumplimiento incorrecto del tratamiento antirretroviral(TAR) constituye el factor principal de fracaso terapéutico. Los factores que han demostrado estar relacionados con la adherencia de forma más relevante incluyen la complejidad del tratamiento, los efectos secundarios, los problemas psicológicos, la adicción activa a drogas y/o alcohol, la falta de soporte socio familiar y las actitudes y creencias del paciente acerca del tratamiento. La monitorización del cumplimiento debe formar parte de la atención habitual del paciente con infección por el virus de la inmunodeficiencia humana (VIH), deben utilizarse métodos factibles, adaptados a la realidad del hospital y lo más universalmente aplicables. Puede considerarse un mínimo aceptable la asociación de un cuestionario validado y el registro de dispensación del servicio de farmacia. Todo paciente que inicie o cambie el tipo de TAR debe realizar un programa de educación sanitaria sobre el tratamiento, a cargo de profesionales sanitarios con experiencia y conocimiento del manejo de pacientes con infección por VIH. Debe procurarse la máxima disponibilidad del equipo asistencial (médicos, farmacéuticos y profesionales de enfermería) para resolverlas dudas y problemas que se presenten a lo largo del tratamiento. En los pacientes en los que no se alcancen niveles de cumplimiento adecuados, se deben intentar estrategias de intervención, basadas en aspectos psico-educativos y de asesoramiento personal, con capacidad para adaptar el esquema del TAR a los hábitos de vida del paciente y proporcionando estrategias de resolución de problemas. En determinadas situaciones será necesario resolverla comorbilidad, por lo tanto el enfoque debe ser pluridisciplinar. Son aconsejables pautas más sencillas en cuanto a número de comprimidos y a dosis diarias (AU)

Since the early days of antiretroviral therapy, adherence has emerged as the milestone of success; in fact, it is the most potent predictor of effectiveness. The main factors related to adherence include the complexity of the therapeutic regimen, adverse effects, psychological problems, alcoholism and active addiction to drugs, lack of social and family support and the patient’s beliefs and attitudes about the treatment. Adherence monitoring should be part of the HIV patient’s regular care, and should be done with feasible, easily applied methods adapted to the different clinical settings. The minimally acceptable measures should include use of a validated questionnaire, together with data from the Pharmacy Department’s drug dispensation registry. All patients that begin HAART or under go a change of treatment should participate in a treatment education program imparted by health professionals with knowledge and experience in the management of patients with HIV infection. The health team (doctors, pharmacists and nursing professionals) should offer maximum availability to solve the doubts and problems that may occur during treatment. When sub-optimal adherence is detected, intervention strategies based on psychological therapy, educational efforts and personal advice should be attempted, in order to adapt the treatment scheme to the patient’s habits and provide solutions to the problem of non-compliance. In certain situations, co-morbid conditions will also require attention. Treatment adherence, being a multidimensional problem, needs a multidisciplinary team approach. The choice of therapy, only one aspect of the multidimensional problem of adherence, must be a careful and individualized decision; however, simpler regimens with regard to the number of pills and daily dose are desirable (AU)

Evaluation of an antibiotic intravenous to oral sequential therapy program.

AIM: This study was designed to analyse the drug consumption difference and economic impact of an antibiotic sequential therapy focused on quinolones. METHOD: We studied the consumption of quinolones (ofloxacin/levofloxacin and ciprofloxacin) 6 months before and after the implementation of a sequential therapy program in hospitalised patients. It was calculated for each antibiotic, in its oral and intravenous forms, in defined daily dose (DDD/100 stays per day) and economical terms (drug acquisition cost). At the beginning of the program ofloxacin was replaced by levofloxacin and, since their clinical uses are similar, the consumption of both drugs was compared during the period. RESULTS: In economic terms, the consumption of intravenous quinolones decreased 60% whereas the consumption of oral quinolones increased 66%. In DDD/100 stays per day, intravenous forms consumption decreased 53% and oral forms consumption increased 36%. CONCLUSIONS: Focusing on quinolones, the implementation of a sequential therapy program based on promoting an early switch from intravenous to oral regimen has proved its capacity to alter the utilisation profile of these antibiotics. The program has permitted the hospital a global saving of 41420 dollars for these drugs during the period of time considered.

Factors affecting patient adherence to highly active antiretroviral therapy.

OBJECTIVE: To determine the clinical and demographic variables related to adherence to highly active antiretroviral therapy (HAART) in patients treated in our hospital and identify the characteristics of nonadherent patients. METHODS: Outpatients receiving treatment with HAART (n = 283) were asked about variables related to adherence and to complete the APGAR (family support), State-Trait Anxiety questionnaire (STAI) (emotional situation), and IAS (social support) questionnaires. Patients were classified in 2 groups depending on whether adherence was > or =95% or <95%. Adherence was defined as the percentage of dosage forms prescribed that were obtained by the patient at the hospital pharmacy. A multivariate analysis was created to analyze how each significant variable affected adherence. RESULTS: Our data showed significant nonadherence for patients with the following factors: low level of education, unemployed, emotional situation, and abuse of substances including intravenous drugs. All significant variables were included in a logistic regression model to optimize the results. This model considered 4 variables: age (95% CI 0.89 to 0.99), number of antiretroviral drugs (95% CI 1.05 to 2.11), STAI Anxiety/Trait test (95% CI 2.02 to 6.02), and abuse of drugs (95% CI 1.20 to 3.95). CONCLUSIONS: We recommended special intervention to reinforce adherence for younger patients, patients taking a high number of antiretroviral drugs, those who have a history of intravenous drug use, and those with high anxiety status.