Long-Term Efficacy and Safety of Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced Patients with HIV Type 1 Infection

Abstract

Atazanavir-based regimens have established efficacy and safety in both antiretroviral (ARV)-naive and -experienced patients. However, data evaluating effectiveness beyond 2 years is sparse. Therefore, we assessed the long-term outcomes of ritonavir-boosted atazanavir (ATV/r)-containing regimens in ARV-experienced patients in a clinical setting in a noncomparative, retrospective, observational study collecting data from three European HIV databases on ARV-experienced adults with HIV-1 infection starting an ATV/r-based regimen. Data were extracted every 6 months (maximum follow-up 5 years). Primary outcome was the proportion of patients remaining on ATV/r by baseline HIV-1 RNA ( < 500 or ‡ 500 copies/ml). Secondary outcomes included time to virologic failure, reasons for discontinuation, and long-term safety profile. The duration of treatment and time to virologic failure were analyzed using the Kaplan-Meier method. Data were analyzed for 1,294 ARV-experienced patients (male 74%; mean ART exposure 5.7 years). After 3 years, 56% (95% CI: 52%, 60%) of patients with baseline HIV-1 RNA < 500 copies/ml and 53% (95% CI: 49%, 58%) of those with HIV-1 RNA ‡ 500 copies/ml remained on ATV/r. After 3 years, 75% (95% CI: 69%, 80%) of patients with baseline HIV-1 RNA < 50 copies/ml remained suppressed and 51% (95% CI: 47%, 55%) of those with baseline HIV-1 RNA ‡ 50 copies/ml achieved and maintained virologic suppression. Although adverse events (AEs) were the main known reason for discontinuation, no unexpected AEs were observed. In a real-life setting ATV/r-based regimens demonstrated sustained virologic suppression in ARV-experienced patients. After long-term therapy the majority of patients remained on treatment and no unexpected AEs were observed.

Long-Term Gender-Based Outcomes for Atazanavir/Ritonavir (ATV/r)- Containing Regimens in Treatment-Experienced Patients with HIV

“…Treatment discontinuation was greater for women, as noted in the previous analysis of the current cohort [31]; however, overall rates of discontinuation up to 5 years were favorable when compared with other cohort studies examining discontinuation rates with several different ARV regimens [21, 42]. The convenience of once-daily administration with ATV/r consequently reducing pill burden and the overall good safety and tolerability profile of ATV/r may have contributed to these favorable rates of discontinuation in both women and men.…”

“…HIV-1 RNA < 500 copies/mL or ≥ 500 copies/mL at study entry), and secondary endpoints have been previously reported [31]. Here we report results of a pre-planned sub-analysis by patient gender.…”

“…In the overall cohort population, durable virological suppression with a good safety and tolerability profile has been demonstrated [31]. The aim of the present sub-analysis of this cohort was to specifically evaluate the effect of gender on the long-term outcomes of ATV/r-containing regimens in a clinical setting.…”

Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naïve Patients with HIV-1 Infection: the REMAIN Study

“…Persistence with ATV/r-based regimens over time was good, with 51.5% of patients remaining on treatment up to five years in the current study; this compares favorably with the results of other cohort studies examining discontinuation rates with several different first-line ARV-regimens 10−12 and in other cohort studies in treatment-experienced patients. 18,19 In the Swiss HIV Cohort Study, comparing seven initial ARV treatment regimens, rates of treatment modification one year after the start of treatment were lowest for ATV/r plus TDF/FTC (24.1%) and highest for ritonavir-boosted lopinavir plus zidovudine/lamivudine (70.7%). 10 Similarly, in a comparative five-year cohort study of first-line combination ARV therapy, ATV/r showed greater persistence (1016 days) than efavirenz (974 days) or ritonavir-boosted lopinavir (382 days).…”

AIDS: The Final Chapter?

“…The journal continues to serve the AIDS research community by publishing articles describing those challenges-such as toxicities, comorbidities, and resistance mutations. [4][5][6][7][8] Today, we find ourselves at a critical juncture. Before us stands the opportunity to end an epidemic that has taken the lives of 36 million people around the world, and continues to affect the lives of tens of millions more.…”