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

NCT02295384 | Completed

• 1 other identifier: Polypharmacy Audit
• Study Type: observational
• Target: 1,104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

Polypharmacy; Medication Therapy Management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Audit Group

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

Interventions

Retrospective Audit OTHER

Retrospective Audit

Audit Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients attending HHMP from 1st January 2005 to 31st July 2014 inclusive, who had at least 2 practice visits separated by ≥90 days in a year involving HIV laboratory monitoring whilst attending HHMP (either on-site or at a co-management site).

You may qualify if:

• 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).

You may not qualify if:

• Attendance by patient with HIV infection who does not have laboratory markers of HIV viral load or CD4 count
• Incomplete/inaccessible patient records

Sponsors & Collaborators

• Holdsworth House Medical Practice: lead
• Gilead Sciences: collaborator

Study Sites (1)

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Location

Related Publications (6)

• Jansson J, Wilson DP. Projected demographic profile of people living with HIV in Australia: planning for an older generation. PLoS One. 2012;7(8):e38334. doi: 10.1371/journal.pone.0038334. Epub 2012 Aug 9.

  PMID: 22912660 BACKGROUND

• Edelman EJ, Gordon KS, Glover J, McNicholl IR, Fiellin DA, Justice AC. The next therapeutic challenge in HIV: polypharmacy. Drugs Aging. 2013 Aug;30(8):613-28. doi: 10.1007/s40266-013-0093-9.

  PMID: 23740523 BACKGROUND

• Holtzman C, Armon C, Tedaldi E, Chmiel JS, Buchacz K, Wood K, Brooks JT; , and the HOPS Investigators. Polypharmacy and risk of antiretroviral drug interactions among the aging HIV-infected population. J Gen Intern Med. 2013 Oct;28(10):1302-10. doi: 10.1007/s11606-013-2449-6. Epub 2013 Apr 20.

  PMID: 23605401 BACKGROUND

• Cohen CJ, Meyers JL, Davis KL. Association between daily antiretroviral pill burden and treatment adherence, hospitalisation risk, and other healthcare utilisation and costs in a US medicaid population with HIV. BMJ Open. 2013 Aug 1;3(8):e003028. doi: 10.1136/bmjopen-2013-003028.

  PMID: 23906955 RESULT

• Sax PE, Meyers JL, Mugavero M, Davis KL. Adherence to antiretroviral treatment and correlation with risk of hospitalization among commercially insured HIV patients in the United States. PLoS One. 2012;7(2):e31591. doi: 10.1371/journal.pone.0031591. Epub 2012 Feb 24.

  PMID: 22384040 RESULT

• Bpharm SM, Talbot A, Trottier B. Acute renal failure in four HIV-infected patients: Potential association with tenofovir and nonsteroidal anti-inflammatory drugs. Can J Infect Dis Med Microbiol. 2008 Jan;19(1):75-6. doi: 10.1155/2008/370535. No abstract available.

  PMID: 19145267 RESULT

Related Links

• Co-prescription of Non-HIV Medications in HIV-Infected Individuals in 5 European Countries and the Possible Impact of Interactions With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir (E/C/F/TDF)

Study Officials

• Mark Bloch, MBBS, M Med

  Holdsworth House Medical Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Locations

AU (1)