Lopinavir-Ritonavir Monotherapy Versus Lopinavir-Ritonavir and 2 Nucleosides for Maintenance Therapy of HIV: 96-Week Analysis

Abstract

At 96-week lopinavir/ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy. Incidence of adverse events leading to treatment discontinuation was significantly lower with monotherapy. (ClinicalTrials.gov number, NCT00114933).

Viral response in stable patients switching to fosamprenavir/ritonavir monotherapy (the FONT Study)

“…Nevertheless, some patients under PI monotherapy have shown viral replication in CSF despite viral control in blood [2,5,12]. Consistent with these findings, neurological symptoms have been reported in patients on monotherapy with LPV and DRV [2,5]; however, no neurological manifestations have been reported in other monotherapy trials [1,3,6,7]. Data regarding PI monotherapy in the genital tract compartment are scarce and controversial [12][13][14][15].…”

“…However, the noninferiority of PI/r monotherapy compared with standard triple therapy has not been consistently demonstrated. For example, noninferiority relative to lopinavir/ritonavir (LPV/r) was achieved only if reintroduction of nucleoside reverse transcriptase inhibitors (NRTIs) was not considered a failure [1], and noninferiority relative to darunavir (DRV)/r was observed in the MONOI study only in the per protocol analysis [2], and in the MONET study at 48 weeks [3] but not at 96 weeks [4]. Discordant results have been found for atazanavir/ritonavir Correspondence: Daniel Podzamczer, HIV Unit, Infectious Disease Service, Bellvitge University Hospital, C/Feixa Llarga s/n, 08907 Hospitalet de Llobregat, Barcelona, Spain.…”

“…Several studies have recently explored the benefits of a ritonavir-boosted protease inhibitor (PI/r) given as a single agent in virologically suppressed patients [1][2][3][4][5][6][7] in preventing long-term side effects, facilitating compliance and reducing costs. However, the noninferiority of PI/r monotherapy compared with standard triple therapy has not been consistently demonstrated.…”

Assessment of Second-Line Antiretroviral Regimens for HIV Therapy in Africa

“…Furthermore, we hypothesized that removing NRTIs entirely (using a protease inhibitor alone) would be noninferior to the standard regimen (as has been shown in some first-line studies), [6][7][8] with the advantage of reduced toxicity, regimen complexity, and cost.…”

Detection of HIV-1 at between 20 and 49 Copies per Milliliter by the Cobas TaqMan HIV-1 v2.0 Assay Is Associated with Higher Pretherapy Viral Load and Less Time on Antiretroviral Therapy

“…Our findings suggest potential value in quantifying HIV-1 loads below 50 cp/ml. In this regard, the detection of an increase in residual viremia in some patients undergoing simplification regimens by SCA before virologic failure has been reported recently (1,9). The clinical relevance of the presence of HIV-1 viremia at levels between 20 and 49 RNA cp/ml deserves further investigation, and outcome studies should be performed.…”