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Improving Adherence With Simplified HAART Regimens Improving Clinical Outcomes in HIV Patients

Improving Adherence With Simplified HAART Regimens Improving Clinical Outcomes in HIV Patients

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Improving Adherence With Simplified HAART Regimens Improving Clinical Outcomes in HIV Patients

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  1. Improving Adherence With Simplified HAART Regimens Improving Clinical Outcomes in HIV Patients

  2. Adherence to HAART Is Essential • “Adherence to the [HAART] regimen is essential for successful treatment and has been reported to increase sustained virologic control, which is critical in reducing HIV-related morbidity and mortality.”1 • “Conversely, suboptimal adherence has been reported to decrease virologic control and has been associated with increased morbidity and mortality. Suboptimal adherence also leads to drug resistance, limiting effectiveness of therapy.”1 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:9. 1

  3. Relationship Between Adherence and HIV Suppression †Prospective, observational study of 81 HIV patients. ‡MEMS, Medication Events Monitoring System. *Series of 886 treatment-naive HIV patients; CD4 cell count <500 x 106 cells/L or plasma viral load >5000 copies/mL. 1. Low-Beer S et al. JAIDS. 2000;23:360-361. Letter. 2. Paterson DL et al. Ann Intern Med. 2000;133:21-30. 2

  4. Relationship Between Adherence and CD4 Cell Count Homer Study*1 *Observational and research study of 1522 ART-naive patients initiated on HAART; adherence was measured as prescriptions refilled. 1. Wood et al. JAIDS. 2004;35:261-268. 3

  5. Virological Response by Daily Pill Burden*1 * Symbol size is directly proportional to weight of the data point in analysis. 1. Bartlett JA et al. AIDS. 2001;15:1369-1377. 4

  6. For every 10% decrease in adherence Adherence Impacts HIV-Related Mortality and AIDS Progression*1 *Prospective, observational study of 950 ART-naive patients treated with triple- combination therapy; adherence was estimated by prescriptions dispensed. 1. Hogg et al. 7th CROI 2000. Abstract 73. 16% increase in HIV-related mortality 1.17 times higher likelihood of progression to AIDS and/or death 5

  7. Regimen-Related Drivers of Adherence1 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:12. 6

  8. HAART Patients Commonly Miss Doses Due to Side Effects*1 *Community Prescription Service (CPS) phone survey of 400 people with HIV, most of whom were on triple combination therapy. 1. Munk. CPS Info Pack (suppl). POZ. 1998. 7

  9. ART-Related Toxicities Are the Largest Cause of Discontinuation Major Reasons for HAART Discontinuation *Retrospective study of 345 ART-naive patients initiated on HAART and followed for a median of 8.1 months; 211 patients (61%) discontinued therapy. †Population-based cohort of 862 ART-naive patients initiated on HAART and followed for a median of 45 weeks; 312 patients (36%) discontinued therapy. 1. O’Brien et al. JAIDS. 2003;34:407-414. 2. Monforte et al. AIDS. 2000;14:499-507. 8

  10. Nausea Often Results in HAART Discontinuation*1 *Retrospective study of 345 ART-naive patients initiated on HAART and followed for a median of 8.1 months. Of 211 patients who discontinued therapy, 40% did so due to AEs. 1. O’Brien et al. JAIDS. 2003;34:407-414. 9

  11. Patients Prefer QD HAART Regimens*1 *Survey of 536 HIV+ patients conducted via telephone, Internet, and mail during 2001 to 2002. 1. Bass, Smith. XIV Intl AIDS Conf (IAC) 2002. Abstract MoPeB3290. 10

  12. Once-Daily Regimens May Improve Adherence*1 *Percentage of patients reporting they have forgotten doses among 504 patients who underwent standardized interviews; APPT-1 pan-European survey. 1. Moyle et al. 6th Intl Congress on Drug Ther in HIV Inf 2002. Poster 99. 11

  13. ART Agents FDA-Approved for QD Dosing1 1. Adapted from: DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:21. 12

  14. NRTIs and Food Restrictions1 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:59. 13

  15. NNRTIs and Food Restrictions1 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:59.

  16. PIs and Food Restrictions1 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:59.

  17. PIs and Food Restrictions1 (continued) 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:59.

  18. Recommendations for Once-Daily Therapy • “The Panel recommends once-daily dosing with antiretroviral agents that have pharmacokinetic profiles that justify once-daily use (didanosine, lamivudine, tenofovir, efavirenz and atazanavir)....Once-daily therapy is desired for patient convenience and adherence.”*1 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:20. 15

  19. Half-lives of NRTIs1 * XR, extended release. 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:59-60, Table 15. 14

  20. Half-lives of Once-Daily NRTIs1 * XR, extended release. 1. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:59-60, Table 15. 14

  21. Patient Persistency in December 2003January 2003 New to Product Patients1 NRTI Product Loyalty in 2003 1. NDC Retail Pharmacy Patient Database, Update Feb. 2004.

  22. Conclusions • HAART adherence in HIV+ patients may improve with simplified regimens1 • Once-daily regimens may improve patient adherence1 and virologic suppression2-4 • ART agents with pharmacokinetic profiles that support once-daily use are recommended5 • ART-related toxicities are the leading cause of compromised adherence/discontinuation6-7 and should be considered in the selection of HIV treatment 1. Moyle G et al.6th Intl Congress on Drug Ther in HIV Inf 2002. Poster 99. 2. Low-Beer S et al. JAIDS. 2000; 23:360-361. Letter. 3. Paterson DL et al. Ann Intern Med. 2000;133:21-30. 4. Bartlett J et al. 7th CROI 2000. Abstract 519. 5. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. Mar 23, 2004:20. 6. O’Brien ME et al. JAIDS. 2003;34:407-414. 7. Monforte A et al. AIDS. 2000;14:499-507. 24

  23. © 2004 Gilead Sciences, Inc. All rights reserved. 04/04