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Background: Antiretroviral therapy (ART), which is increasingly used by people with HIV, accounts for significant care costs, particularly because of single‐tablet regimens (STRs). This study explored de‐simplification to a two‐tablet regimen (TTR) for cost reduction. The objectives of this study were: (1) acceptance of de‐simplification, (2) patient‐reported outcomes, and (3) cost savings. Methods: All individuals on Triumeq®, Atripla® or Eviplera® in five HIV clinics in the Netherlands were eligible. Healthcare providers informed individuals of this study. After inclusion, individuals were free to de‐simplify. An electronic questionnaire was sent to assess study acceptance, adherence, quality of life (SF12) and treatment satisfaction (HIVTSQ). After 3 and 12 months, questionnaires were repeated. Cost savings were calculated using Dutch drug prices. Results: In total, 283 individuals were included, of whom 55.5% agreed to de‐simplify their ART, with a large variability between treatment centres: 41.1–74.2%. Individuals who were willing to de‐simplify tended to be older, had a longer history of HIV diagnosis, and used more co‐medication than those who preferred to remain on an STR regimen. Patient‐reported outcomes, including quality of life and treatment satisfaction, showed no significant difference between people with HIV who switched to a TTR and those who remained on an STR regimen. Furthermore, we observed a 17.8% reduction in drug costs in our cohort of people with HIV who were initially on an STR. Conclusions: De‐simplification from an STR to a TTR within the Dutch healthcare setting has been demonstrated as feasible, leads to significant cost reductions and should be discussed with every eligible person with HIV in the Netherlands. [ABSTRACT FROM AUTHOR]

Objectives The aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor ( NRTI) regimen, with potential beneficial metabolic effects, as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor ( PI). Methods An open-label, noninferiority study was carried out. Antiretroviral therapy ( ART)-naïve patients with CD4 count ≤ 350 cells/μL and HIV-1 RNA > 30 000 copies/mL ( n = 207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV-1 RNA < 50 copies/mL on two consecutive occasions between weeks 12 and 24 after baseline, 120 patients (baseline: median HIV-1 RNA 5.19 log10 copies/mL; median CD4 count 180 cells/μL) were randomized to receive abacavir/lamivudine/zidovudine ( ABC/3 TC/ ZDV) ( n = 61) or to continue the PI-based ART ( n = 59). Results For the proportions of patients (intention-to-treat; missing = failure) with HIV-1 RNA < 400 copies/mL ( PI group, 66%; ABC/3 TC/ ZDV group, 71%) and < 50 copies/mL ( PI group, 63%; ABC/3 TC/ ZDV group, 62%) at 96 weeks, switching to ABC/3 TC/ ZDV was noninferior compared with continuing the PI regimen; the difference in failure rate ( ABC/3 TC/ ZDV minus PI) was −4.4 percentage points [95% confidence interval ( CI) −21.0 to +12.3 percentage points] and +0.4 percentage points (95% CI −16.9 to +17.7 percentage points), respectively. In the per protocol analysis, the difference in virological failure for HIV-1 RNA > 400 copies/mL (0 of 39 patients in the PI group and two of 45 patients in the NRTI group) and for HIV-1 RNA > 50 copies/mL (two of 39 and three of 45 patients, respectively) was +4.4 percentage points (95% CI −2.1 to +11.0 percentage points) and +1.5 percentage points (95% CI −8.6 to +11.7 percentage points), respectively, also showing noninferiority. Serum lipids significantly improved in the NRTI group, but not in the PI arm. Conclusions A single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline, with improved serum lipids. [ABSTRACT FROM AUTHOR]

Objectives The aim of the study was to investigate the effect of a simplified regimen, in terms of reducing pill burden, dietary requirements and possible adverse effects, on patients' adherence, treatment satisfaction and quality of life ( QoL). Methods Antiretroviral-naïve patients who achieved a viral load < 50 HIV-1 RNA copies/ml after induction therapy with twice-daily (bid) lopinavir/ritonavir ( LPV/r) and fixed-dose zidovudine ( ZDV)/lamivudine ( 3TC) ( CBV) were randomly assigned to continue CBV/ LPV/r or switch to fixed-dose ZDV/ 3TC/abacavir ( TZV). Patients completed standardized questionnaires on adherence, treatment satisfaction and QoL at randomization (between weeks 12 and 24) and at weeks 48, 72 and 96. Results Patients on CBV/ LPV/r were more likely to have skipped medicines in the last week ( P = 0.035) and during the preceding weekend ( P = 0.027) than patients on TZV. Patients on CBV/ LPV/r were significantly less satisfied with the convenience of their treatment ( P = 0.004) and tended to be less satisfied with the side effects of their treatment ( P = 0.091) and continuation of their present treatment ( P = 0.056) than patients on TZV. Patients on CBV/ LPV/r reported significantly lower levels of role functioning ( P = 0.013) than patients on TZV. Conclusions In this randomized controlled trial, simplification of therapy to fixed-dose TZV among patients with suppressed HIV RNA was perceived to be more convenient, and resulted in improved adherence and better role functioning, than continuing treatment with CBV/ LPV/r. [ABSTRACT FROM AUTHOR]

Background Adherence to treatment is the key to the success of combination antiretroviral therapy (cART) for HIV infection. It is generally assumed that simplification of cART will lead to better adherence, higher treatment satisfaction, and quality of life (QoL), but randomized studies demonstrating such advantages of simplified regimens are scarce. Methods Antiretroviral-naïve patients who achieved viral load <50 c/ml in two consecutive samples between 12-24 weeks after commencing induction therapy with bid lopinavir/ritonavir (LPV/r) and fixed-dose combination AZT/3TC (Combivir®) were randomly assigned to either continue LPV/r/Combivir® or switch to simplified therapy with bid fixed-dose AZT/3TC/abacavir (Trizivir®). Both arms yielded similar antiviral efficacy after 48 weeks as reported previously [1]. Patients completed standardized questionnaires on adherence (Simplified Medication Adherence Questionnaire (SMAQ)), treatment satisfaction (HIVTSQ) and QoL (MOS-HIV) at randomization and at weeks 48, 72 and 96. Adherence data were analyzed using generalized estimating equations, and satisfaction and QoL using mixed linear models. Results Patients in the Trizivir®-group (n=30) tended to skip fewer doses both during the preceding 7 days (p=0.055) and during the preceding weekend (p=0.09) than patients in the LPV/r-group (n=20). Moreover, patients in the Trizivir®-group found their regimen significantly more convenient (p=0.022) than patients in the LPV/r-group. However, patients in the LPV/r-group reported a better QoL than patients in the Trizivir®-group in the domains measuring cognitive functioning (p=0.003), energy/fatigue (p=0.046) and social functioning (p=0.074). Conclusions In this randomized trial simplification of therapy to fixed-dose Trizivir® was perceived to be more convenient, and tended to result in improved adherence, but at the expense of a lower level of QoL. Our findings suggest that the choice for simplified regimens should be individualized and may involve a trade-off between convenience and QoL. [ABSTRACT FROM AUTHOR]