Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia

Study Overview
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Brief Summary
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For the majority of patients, management of HIV-1 infection involves effective and well tolerated antiretroviral therapy with simplified pill load and dosing, exemplified by the availability of single tablet regimens (STRs) with single tablet once daily dosing. STR therapy has been shown to improve adherence and reduce hospitalisations (Cohen et al., 2013; Sax et al., 2012). However, the aging of the HIV cohort in Australia and globally has raised issues of increasing co-morbidities and consequent polypharmacy to manage these (Jansson & Wilson, 2012; Edelman et al., 2013). Polypharmacy may not only impact on adherence, but also increases the potential for drug-drug interactions (Holtzman et al., 2013). Stribild, a highly effective STR, contains cobicistat to boost the levels of the component integrase inhibitor, elvitegravir. Cobicistat does not have antiretroviral activity, but acts by inhibiting Cyp3A4 of the cytochrome p450 metabolic pathway. Other drugs metabolized via this pathway may be affected by this drug-drug interaction (Rogatto et al., 2014). Additionally there is evidence of increased risk of nephrotoxicity with co-administration of tenofovir and non-steroidal anti-inflammatory medication (NSAIDS) (Marcotte et al., 2008). Data on use of concomitant medications in Australian patients with HIV is sparse. This study aims to determine, in a large caseload community HIV practice, the use of concomitant medications in HIV, patient pill load and dosing frequency, and potential drug-drug interactions with stribild.

Official Title
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Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia

Conditions
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HIV

Intervention / Treatment
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* Other: Retrospective Audit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented HIV-1 infection Attendance during the study period for at least 2 visits >3 months and <12 months apart with measured laboratory virological or immunological markers (either on-site or at a co-management site). Exclusion Criteria: Attendance by patient with HIV infection who does not have laboratory markers of HIV viral load or CD4 count Incomplete/inaccessible patient records

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Audit Group<br>Patients attending HHMP in Darlinghurst, Sydney, New South Wales with documented HIV-1 infection from 1st January 2005 to 31st July 2014, who were considered linked to care (Attendance during the study period for at least 2 visits >3 months and <12 months apart with measured laboratory virological or immunological markers (either on-site or at a co-management site)). | Other: Retrospective Audit<br>* Retrospective Audit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of concomitant medications used in patients with HIV-1 infection | The pill burden of concomitant medications for patients with HIV-1 infection | 9.5 years | 
| Types of concomitant medications used in patients with HIV-1 infection |  | 9.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total pill load in patients with HIV |  | 9.5 years | 
| Frequency of drug dosing |  | 9.5 years | 
| Use of concomitant medications that could have potential drug-drug interaction with stribild (co-formulated elvitegravir/cobicistat/tenofovir/emtricitabine) |  | 9.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polypharmacy, Medication Therapy Management