Guideline-Preferred ART Regimens for Patients with HIV

San Diego—In March 2012, the U.S. Department of Health & Human Services (HHS) issued guidelines for the use of antiretroviral therapy (ART) in patients with HIV that recommend 4 specific preferred ART regimens for ART-naïve patients. In spite of trials of the guideline-preferred regimens showing “optimal and durable virologic efficacy, favorable tolerability and toxicity profiles, and ease of use,” there is real-world evidence suggesting that some healthcare providers prescribe non-preferred ART.

Researchers recently conducted a retrospective study to assess the extent to which the benefits of preferred ART regimens translate into improved ART persistence and adherence or lower healthcare costs. They reported results of the study during a poster session at the AMCP meeting. The poster was titled Antiretroviral Persistence and Adherence and Total Healthcare Expenditures in Medicaid-Insured HIV Patients Initiating Current Guideline-Preferred Compared with Non-Preferred First-Line Antiretroviral Therapy.

The researchers analyzed data from the 2004-2011 Truven Health Analytics MarketScan^® Multi-State Medicaid Database. This database was selected because Medicaid is the largest source of health insurance for patients with HIV in the United States.

Inclusion criteria were patients with HIV who initiated HIV-related ART between January 1, 2007, and September 30, 2011. The date of ART initiation was designated as the index date. Patients had to be 18 to 64 years of age on the index date, have had continuous enrollment with pharmacy benefits for 6 months prior to and at least 3 months after the index date, have no Medicare eligibility, and no evidence of pregnancy, hepatitis B infection, or HIV-related ART prescriptions any time prior to the index date.

The follow-up period was the number of days from the index date until the earliest of the following events: (1) first occurrence of a prescription claim for an ART that was not part of the initiated ART regimen; (2) ≥30 day continuous gap in any agent from the ART regimen; (3) disenrollment from Medicaid benefits; or (4) study end date of December 31, 2011.

Primary study outcomes were ART persistence, ART adherence, and healthcare expenditures in 2011 US dollars. Patients were considered nonpersistant if their follow-up period terminated with a filled prescription for an ART that was not part of the initiated first-line ART or a ≥30 day gap in therapy for any agent within the initiated first-line ART regimen.

ART adherence was measured as the proportion of days covered (proportion of days that patients had all components of their ART regimen “on hand” during the follow-up period). Adherence was dichotomized at ≥80% and ≥95% according to guideline recommendations and clinical evidence.

Healthcare expenditures were measured for all causes throughout the follow-up period and summarized as per-patient-per-month (PPPM) units.

There were 3593 patients included in the study; 55.1% (n=1979) initiated a guideline-preferred ART regimen and 44.9% (n=1614) initiated a non-preferred ART. Overall mean age was 41 years and 48% were female.

In the preferred group, the unadjusted incidence rate of non-persistence per 10 years was 9 compared with 20 in the non-preferred group. Unadjusted proportions of patients achieving ≥80% and ≥95% adherence rates were 87.2% in the preferred group and 81.9% and 43.1% in the non-preferred group. Unadjusted PPPM total healthcare expenditures were $341 lower in the preferred group than in the non-preferred group, a difference that was not statistically significant.

In conclusion, the researchers said, “Compared with patients initiating non-preferred ART, those initiating guideline-preferred ART regimens had significantly longer durations of time to ART non-persistence, were significantly more likely to adhere to their ART, and had similar PPPM total healthcare expenditures.”

“This study reinforces the value of HHS recommendations for first-line ART,” they added.

This analysis was funded by Bristol-Myers Squibb.