Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96

Abstract

Treatment with DRV/r 600/100 mg twice daily was well tolerated and led to sustained virological and immunological responses in treatment-experienced HIV-1-infected patients over 96 weeks.

Darunavir Outcomes Study: Comparative Effectiveness of Virologic Suppression, Regimen Durability, and Discontinuation Reasons for Three-Class Experienced Patients at 48 Weeks

“…The observation of lower rates of adverse events in the DRV/r and PI-Sparing treatment strategies echo the favorable safety profiles for post-2006 treatment options reported in recent clinical trials. [2][3][4][6][7][8][9][10][11][12] The results of this study should be interpreted within the context of its limitations. As a single academic HIV clinic in the Southeastern USA, results may not be generalizable to other locations.…”

“…With various clinical trials highlighting the safety and superior efficacy of these newer agents, complete virologic suppression has become the therapeutic goal for all HIV-infected patients, including those who are treatment-experienced. [1][2][3][4][5][6][7][8][9][10][11][12] Despite the accumulating body of evidence from clinical trials, a paucity of published data addressing the effectiveness of these newer agents in routine clinical care settings exists. Evaluating both the efficacy and effectiveness of newer agents is important to ensure that the results obtained from clinical trials are generalizable to populations treated through routine care.…”

Non-AIDS Morbidity among HIV Patients

“…In a trial among ART-naive individuals, ATV/r showed a better virological response and better retention in care when compared with LPV/r (224). In two studies, people receiving DRV/rcontaining regimens also showed better virological response and retention in care than people receiving LPV/r, both in treatment-naive and experienced people (222,226). DRV/r has been used for second-line therapy in high-income settings.…”

“…Taken together, these data support the efficacy of these agents in highly ART-experienced patients. In a published pooled subgroup analysis, DRV/r plus an optimized background regimen (OBR) chosen by genotyping and phenotyping was shown to be superior to the control group (boosted PI + OBR where the investigator selected the boosted PI) among highly treatment-experienced individuals (222). DRV/r was also shown to be non-inferior to LPV/r among treatment-experienced people after 96 weeks (223).…”

“…A systematic review (Web Annex www.who.int/hiv/pub/guidelines/arv2013/annexes) of data from six clinical trials comparing drugs used for second-line ART (ATV/r, LPV/r and DRV/r) concluded that there was no evidence to support changing the recommendation in the 2010 neW guidelines (221)(222)(223)(224)(225)(226). These studies showed low-to very-low-quality evidence (downgraded in the GRADE evaluation primarily for indirectness and imprecision) for using ATV/r or DRV/r (once-daily) over LPV/r (twice-daily) or vice versa as preferred boosted PI options.…”