Introduction. The human retrovirus that has had the greatest impact on society and medicine is the HIV-1. The traditional treatment, according to national and international guidelines, involves a combination of three or four drugs that can quickly stop the viral replication, preserve immune function and decrease the emergence of drug-resistant viral mutants. Several new therapies for HIV infection have changed the approach to antiretroviral therapy, such as the semplification with a lower number of drugs (dual therapy) in virological stable patients, in order to reduce the systemic toxicity and improve compliance at equal clinical efficacy. The aim of the study was to evaluate the pharmacoeconomic aspect of antiretroviral therapies and, for patients that have simplified therapy, analyze dual - therapy prescriptive trend, the reasons for the shift and tolerability to treatment. Materials and methods. Pharmacoepidemiological and pharmacoeconomic analysis was conducted for the treatments of HIV patients followed at U.O of Infectious Diseases in the years 2012 - 2014 using the spending flows F of the New Health Information System (NSIS). The consultation of medical records of patients who have been simplified therapy in the period October 2012 - October 2014, the laboratory data and any adverse reactions to drug treatment were evaluated. Results. Patients being treated with antiretroviral drugs during the years 2012 - 2014 are in total 681, for a total cost of€10.584.444; 31% of these, were modified therapy. In both years, 54 patients have been simplified treatment to a dual therapy; only the 7.6% are being treated from October 2012. Most of whom are being treated with the combination raltegravir + darunavir + ritonavir. The shift was necessary both for the appearance of side effects that for virological failure. In patients treated with dual therapy it was observed an improvement in the tolerability profile and greater adherence to treatment. Discussion. In both years, there was an increase in the number of patients treated with dual therapy during the period October 2013 - October 2014; our group seen that the the association raltegravir + darunavir + ritonavir is the most practiced dual therapy and only in the switch from three traditional regimens resulted in a saving. However, the extensive use of this regimen is justified by a favorable safety profile and reduced incidence of drug interactions. The analysis of the clinical data showed the absence of severe adverse reactions, mainly involving renal and hepatic systems, more concerned with traditional regimens. Conclusion. In con- clusion the data collected in the period between October 2012 and October 2014 show an increase of about 4 times of the patients treated with dual therapy. Moreover, it is observed the best safety profile of dual therapy and reduced costs for some regimens.
Analisi delle Dual Therapy nei pazienti con HIV: Aspetti farmacoeconomici-epidemiologici e clinici / Serra, Eleonora; Azara, Luana; Madeddu, Giordano; Calia, Giovanna M.; Mura, Maria Stella Anna; Bagella, Paola; Sulas, Liliana. - In: GIORNALE ITALIANO DI FARMACIA CLINICA. - ISSN 1120-3749. - 30:3(2016), pp. 142-151.
Analisi delle Dual Therapy nei pazienti con HIV: Aspetti farmacoeconomici-epidemiologici e clinici
SERRA, Eleonora;AZARA, Luana;MADEDDU, Giordano;MURA, Maria Stella Anna;BAGELLA, Paola;
2016-01-01
Abstract
Introduction. The human retrovirus that has had the greatest impact on society and medicine is the HIV-1. The traditional treatment, according to national and international guidelines, involves a combination of three or four drugs that can quickly stop the viral replication, preserve immune function and decrease the emergence of drug-resistant viral mutants. Several new therapies for HIV infection have changed the approach to antiretroviral therapy, such as the semplification with a lower number of drugs (dual therapy) in virological stable patients, in order to reduce the systemic toxicity and improve compliance at equal clinical efficacy. The aim of the study was to evaluate the pharmacoeconomic aspect of antiretroviral therapies and, for patients that have simplified therapy, analyze dual - therapy prescriptive trend, the reasons for the shift and tolerability to treatment. Materials and methods. Pharmacoepidemiological and pharmacoeconomic analysis was conducted for the treatments of HIV patients followed at U.O of Infectious Diseases in the years 2012 - 2014 using the spending flows F of the New Health Information System (NSIS). The consultation of medical records of patients who have been simplified therapy in the period October 2012 - October 2014, the laboratory data and any adverse reactions to drug treatment were evaluated. Results. Patients being treated with antiretroviral drugs during the years 2012 - 2014 are in total 681, for a total cost of€10.584.444; 31% of these, were modified therapy. In both years, 54 patients have been simplified treatment to a dual therapy; only the 7.6% are being treated from October 2012. Most of whom are being treated with the combination raltegravir + darunavir + ritonavir. The shift was necessary both for the appearance of side effects that for virological failure. In patients treated with dual therapy it was observed an improvement in the tolerability profile and greater adherence to treatment. Discussion. In both years, there was an increase in the number of patients treated with dual therapy during the period October 2013 - October 2014; our group seen that the the association raltegravir + darunavir + ritonavir is the most practiced dual therapy and only in the switch from three traditional regimens resulted in a saving. However, the extensive use of this regimen is justified by a favorable safety profile and reduced incidence of drug interactions. The analysis of the clinical data showed the absence of severe adverse reactions, mainly involving renal and hepatic systems, more concerned with traditional regimens. Conclusion. In con- clusion the data collected in the period between October 2012 and October 2014 show an increase of about 4 times of the patients treated with dual therapy. Moreover, it is observed the best safety profile of dual therapy and reduced costs for some regimens.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.