Efficacy of Rilpivirine-based Regimens as Switch Therapy Clinical Trial
Official title:
Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients With Complete Virological Suppression: A Randomized Controlled Trial
Background: Nevirapine (NVP)-based antiretroviral therapy (ART) remains to be used in
HIV-infected patients in resource limited countries despite its compliance and adverse effect
concerns. Rilpivirine (RPV), a newer non-nucleoside reverse transcriptase inhibitor, could be
used as an alternative to NVP in virologically suppressed patients. However, there has been
limited experience with switching from NVP-based to RPV-based regimens. The investigators
aimed to study efficacy and adverse events after ART switching from NVP-based to RPV-based
regimens.
Methods: A randomized controlled non-inferiority trial was conducted in HIV-infected patients
who received NVP-based regimens and had undetectable plasma HIV RNA for more than 6 months.
Patients were randomized 1:1 to continuation arm (NVP-based regimens were continued) or
switch arm (NVP-based regimens were switched to RPV-based regimens). Tenofovir disoproxil
fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the
regimens. Primary endpoint was HIV RNA <40 copies/mL at 48 weeks, with a non-inferiority
margin of 12%. Changes of CD4 cell counts and lipid profiles from baseline were analyzed.
A single-center randomized controlled, non-inferiority trial to study 48-week treatment outcomes of RPV as a switch therapy was conducted at Ramathibodi Hospital, a tertiary care health center in Thailand from December 2016 to October 2017 Eligible patients who currently received TDF/3TC/NVP (group A) or TDF/FTC/NVP (group B) were block 4 randomly assigned (1:1) by computer-generated random numbers, to continue their current regimen of NVP 200 mg twice daily plus TDF/3TC (group A1) and plus TDF/FTC (groupB1), or to switch from NVP to RPV 25 mg once-daily plus TDF/3TC (group A2) and plus TDF/FTC (groupB2). Patients were advised to take RPV with a meal. Patients were scheduled trial visits at baseline, week 12, 24, 36 and week 48. The laboratory assessment was performed at baseline week 24 and week 48. ;