Determinants of access to experimental antiretroviral drugs in an Italian cohort of patients with HIV: A multilevel analysis

Enrico Girardi, Paola Scognamiglio, Claudio Angeletti, Andrea Gori, Dora Buonfrate, Massimo Arlotti, Giovanni Mazzarello, Antonella Castagna, Massimo Andreoni, Antonella D'Arminio Monforte, Andrea Antinori, Giuseppe Ippolito

Research output: Contribution to journalArticle

Abstract

Background. Identification of the determinants of access to investigational drugs is important to promote equity and scientific validity in clinical research. We aimed to analyze factors associated with the use of experimental antiretrovirals in Italy. Methods. We studied participants in the Italian Cohort of Antiretroviral-Naive Patients (ICoNA). All patients 18 years or older who had started cART ( 3 drugs including at least two NRTI) after their enrolment and during 1997-2007 were included in this analysis. We performed a random effect logistic regression analysis to take into account clustering observations within clinical units. The outcome variable was the use of an experimental antiretroviral, defined as an antiretroviral started before commercial availability, in any episode of therapy initiation/change. Use of an experimental antiretroviral obtained through a clinical trial or an expanded access program (EAP) was also analyzed separately. Results. A total of 9,441 episodes of therapy initiation/change were analyzed in 3,752 patients. 392 episodes (360 patients) involved an experimental antiretroviral. In multivariable analysis, factors associated with the overall use of experimental antiretrovirals were: number of experienced drugs ( 8 drugs versus "naive": adjusted odds ratio [AOR] = 3.71) or failed antiretrovirals(3-4 drugs and 5 drugs versus 0-2 drugs: AOR = 1.42 and 2.38 respectively); calendar year (AOR = 0.80 per year) and plasma HIV-RNA copies/ml at therapy change ( 4 log versus <2 log: AOR = 1.55). The probability of taking an experimental antiretroviral through a trial was significantly lower for patients suffering from liver co-morbidity(AOR = 0.65) and for those who experienced 3-4 drugs (vs naive) (AOR = 0.55), while it increased for multi-treated patients(AOR = 2.60). The probability to start an experimental antiretroviral trough an EAP progressively increased with the increasing number of experienced and of failed drugs and also increased for patients with liver co-morbidity (AOR = 1.44; p = 0.053). and for male homosexuals (vs heterosexuals: AOR = 1.67). Variability of the random effect associated to clinical units was statistically significant (p <0.001) although no association was found with specific characteristics of clinical unit examined. Conclusions. Among patients with HIV infection in Italy, access to experimental antiretrovirals seems to be influenced mainly by exhaustion of treatment options and not by socio-demographic factors.

Original languageEnglish
Article number38
JournalBMC Health Services Research
Volume12
Issue number1
DOIs
Publication statusPublished - 2012

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Multilevel Analysis
Odds Ratio
HIV
Pharmaceutical Preparations
Italy
Investigational Drugs
Morbidity
Liver
Heterosexuality
Therapeutics
Statistical Factor Analysis
HIV Infections
Cluster Analysis
Logistic Models
Regression Analysis
Demography
Clinical Trials
RNA

Keywords

  • antiretroviral therapy
  • clinical trial
  • cohort study
  • expanded access program
  • experimental drug
  • HIV
  • multilevel analysis

ASJC Scopus subject areas

  • Health Policy

Cite this

Determinants of access to experimental antiretroviral drugs in an Italian cohort of patients with HIV : A multilevel analysis. / Girardi, Enrico; Scognamiglio, Paola; Angeletti, Claudio; Gori, Andrea; Buonfrate, Dora; Arlotti, Massimo; Mazzarello, Giovanni; Castagna, Antonella; Andreoni, Massimo; D'Arminio Monforte, Antonella; Antinori, Andrea; Ippolito, Giuseppe.

In: BMC Health Services Research, Vol. 12, No. 1, 38, 2012.

Research output: Contribution to journalArticle

Girardi, Enrico ; Scognamiglio, Paola ; Angeletti, Claudio ; Gori, Andrea ; Buonfrate, Dora ; Arlotti, Massimo ; Mazzarello, Giovanni ; Castagna, Antonella ; Andreoni, Massimo ; D'Arminio Monforte, Antonella ; Antinori, Andrea ; Ippolito, Giuseppe. / Determinants of access to experimental antiretroviral drugs in an Italian cohort of patients with HIV : A multilevel analysis. In: BMC Health Services Research. 2012 ; Vol. 12, No. 1.
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abstract = "Background. Identification of the determinants of access to investigational drugs is important to promote equity and scientific validity in clinical research. We aimed to analyze factors associated with the use of experimental antiretrovirals in Italy. Methods. We studied participants in the Italian Cohort of Antiretroviral-Naive Patients (ICoNA). All patients 18 years or older who had started cART ( 3 drugs including at least two NRTI) after their enrolment and during 1997-2007 were included in this analysis. We performed a random effect logistic regression analysis to take into account clustering observations within clinical units. The outcome variable was the use of an experimental antiretroviral, defined as an antiretroviral started before commercial availability, in any episode of therapy initiation/change. Use of an experimental antiretroviral obtained through a clinical trial or an expanded access program (EAP) was also analyzed separately. Results. A total of 9,441 episodes of therapy initiation/change were analyzed in 3,752 patients. 392 episodes (360 patients) involved an experimental antiretroviral. In multivariable analysis, factors associated with the overall use of experimental antiretrovirals were: number of experienced drugs ( 8 drugs versus {"}naive{"}: adjusted odds ratio [AOR] = 3.71) or failed antiretrovirals(3-4 drugs and 5 drugs versus 0-2 drugs: AOR = 1.42 and 2.38 respectively); calendar year (AOR = 0.80 per year) and plasma HIV-RNA copies/ml at therapy change ( 4 log versus <2 log: AOR = 1.55). The probability of taking an experimental antiretroviral through a trial was significantly lower for patients suffering from liver co-morbidity(AOR = 0.65) and for those who experienced 3-4 drugs (vs naive) (AOR = 0.55), while it increased for multi-treated patients(AOR = 2.60). The probability to start an experimental antiretroviral trough an EAP progressively increased with the increasing number of experienced and of failed drugs and also increased for patients with liver co-morbidity (AOR = 1.44; p = 0.053). and for male homosexuals (vs heterosexuals: AOR = 1.67). Variability of the random effect associated to clinical units was statistically significant (p <0.001) although no association was found with specific characteristics of clinical unit examined. Conclusions. Among patients with HIV infection in Italy, access to experimental antiretrovirals seems to be influenced mainly by exhaustion of treatment options and not by socio-demographic factors.",
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author = "Enrico Girardi and Paola Scognamiglio and Claudio Angeletti and Andrea Gori and Dora Buonfrate and Massimo Arlotti and Giovanni Mazzarello and Antonella Castagna and Massimo Andreoni and {D'Arminio Monforte}, Antonella and Andrea Antinori and Giuseppe Ippolito",
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T1 - Determinants of access to experimental antiretroviral drugs in an Italian cohort of patients with HIV

T2 - A multilevel analysis

AU - Girardi, Enrico

AU - Scognamiglio, Paola

AU - Angeletti, Claudio

AU - Gori, Andrea

AU - Buonfrate, Dora

AU - Arlotti, Massimo

AU - Mazzarello, Giovanni

AU - Castagna, Antonella

AU - Andreoni, Massimo

AU - D'Arminio Monforte, Antonella

AU - Antinori, Andrea

AU - Ippolito, Giuseppe

PY - 2012

Y1 - 2012

N2 - Background. Identification of the determinants of access to investigational drugs is important to promote equity and scientific validity in clinical research. We aimed to analyze factors associated with the use of experimental antiretrovirals in Italy. Methods. We studied participants in the Italian Cohort of Antiretroviral-Naive Patients (ICoNA). All patients 18 years or older who had started cART ( 3 drugs including at least two NRTI) after their enrolment and during 1997-2007 were included in this analysis. We performed a random effect logistic regression analysis to take into account clustering observations within clinical units. The outcome variable was the use of an experimental antiretroviral, defined as an antiretroviral started before commercial availability, in any episode of therapy initiation/change. Use of an experimental antiretroviral obtained through a clinical trial or an expanded access program (EAP) was also analyzed separately. Results. A total of 9,441 episodes of therapy initiation/change were analyzed in 3,752 patients. 392 episodes (360 patients) involved an experimental antiretroviral. In multivariable analysis, factors associated with the overall use of experimental antiretrovirals were: number of experienced drugs ( 8 drugs versus "naive": adjusted odds ratio [AOR] = 3.71) or failed antiretrovirals(3-4 drugs and 5 drugs versus 0-2 drugs: AOR = 1.42 and 2.38 respectively); calendar year (AOR = 0.80 per year) and plasma HIV-RNA copies/ml at therapy change ( 4 log versus <2 log: AOR = 1.55). The probability of taking an experimental antiretroviral through a trial was significantly lower for patients suffering from liver co-morbidity(AOR = 0.65) and for those who experienced 3-4 drugs (vs naive) (AOR = 0.55), while it increased for multi-treated patients(AOR = 2.60). The probability to start an experimental antiretroviral trough an EAP progressively increased with the increasing number of experienced and of failed drugs and also increased for patients with liver co-morbidity (AOR = 1.44; p = 0.053). and for male homosexuals (vs heterosexuals: AOR = 1.67). Variability of the random effect associated to clinical units was statistically significant (p <0.001) although no association was found with specific characteristics of clinical unit examined. Conclusions. Among patients with HIV infection in Italy, access to experimental antiretrovirals seems to be influenced mainly by exhaustion of treatment options and not by socio-demographic factors.

AB - Background. Identification of the determinants of access to investigational drugs is important to promote equity and scientific validity in clinical research. We aimed to analyze factors associated with the use of experimental antiretrovirals in Italy. Methods. We studied participants in the Italian Cohort of Antiretroviral-Naive Patients (ICoNA). All patients 18 years or older who had started cART ( 3 drugs including at least two NRTI) after their enrolment and during 1997-2007 were included in this analysis. We performed a random effect logistic regression analysis to take into account clustering observations within clinical units. The outcome variable was the use of an experimental antiretroviral, defined as an antiretroviral started before commercial availability, in any episode of therapy initiation/change. Use of an experimental antiretroviral obtained through a clinical trial or an expanded access program (EAP) was also analyzed separately. Results. A total of 9,441 episodes of therapy initiation/change were analyzed in 3,752 patients. 392 episodes (360 patients) involved an experimental antiretroviral. In multivariable analysis, factors associated with the overall use of experimental antiretrovirals were: number of experienced drugs ( 8 drugs versus "naive": adjusted odds ratio [AOR] = 3.71) or failed antiretrovirals(3-4 drugs and 5 drugs versus 0-2 drugs: AOR = 1.42 and 2.38 respectively); calendar year (AOR = 0.80 per year) and plasma HIV-RNA copies/ml at therapy change ( 4 log versus <2 log: AOR = 1.55). The probability of taking an experimental antiretroviral through a trial was significantly lower for patients suffering from liver co-morbidity(AOR = 0.65) and for those who experienced 3-4 drugs (vs naive) (AOR = 0.55), while it increased for multi-treated patients(AOR = 2.60). The probability to start an experimental antiretroviral trough an EAP progressively increased with the increasing number of experienced and of failed drugs and also increased for patients with liver co-morbidity (AOR = 1.44; p = 0.053). and for male homosexuals (vs heterosexuals: AOR = 1.67). Variability of the random effect associated to clinical units was statistically significant (p <0.001) although no association was found with specific characteristics of clinical unit examined. Conclusions. Among patients with HIV infection in Italy, access to experimental antiretrovirals seems to be influenced mainly by exhaustion of treatment options and not by socio-demographic factors.

KW - antiretroviral therapy

KW - clinical trial

KW - cohort study

KW - expanded access program

KW - experimental drug

KW - HIV

KW - multilevel analysis

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