Abstract
In low- and middle-income countries (LMICs), a substantial unmet need for affordable single-tablet regimen (STR) options remains. Rilpivirine (RPV, TMC278) is formulated in a low-cost STR with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Switching at Low HIV-1 RNA into Fixed Dose Combinations (SALIF) compared RPV with efavirenz (EFV), both as STRs with TDF and FTC, in maintaining virologic suppression. SALIF was a phase 3b, randomised, open-label, non-inferiority study in virologically suppressed adults (HIV-1 RNA < 50 copies/mL) on non-nucleoside reverse transcriptase inhibitor (NNRTI)-based first-line antiretroviral therapy (ART) in Cameroon, Kenya, Senegal, South Africa, Uganda and Thailand. Patients (N = 426), stratified by NNRTI use, were randomised 1:1 to receive TDF/FTC/RPV (300/200/25 mg qd) or TDF/FTC/EFV (300/200/600 mg qd). Primary endpoint was proportion of patients with virologic suppression (HIV-1 RNA < 400 copies/mL) at week 48 (intent-to-treat, modified Food and Drug Administration Snapshot, 10% non-inferiority margin). Patients received TDF/FTC/RPV (n = 213) or TDF/FTC/EFV (n = 211). At week 48, virologic suppression was maintained in 200/213 (93.9%) patients in the RPV arm and 203/211 (96.2%) i...Continue Reading
References
Jan 5, 2010·Current Opinion in HIV and AIDS·Nathan Ford, Alexandra Calmy
Jul 19, 2011·Lancet·Calvin J CohenUNKNOWN THRIVE study group
Jul 19, 2011·Lancet·Jean-Michel MolinaUNKNOWN ECHO study group
Feb 22, 2012·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Calvin J CohenUNKNOWN THRIVE Study Group
Dec 6, 2012·AIDS·Calvin J CohenUNKNOWN ECHO, THRIVE study groups
May 17, 2013·Bulletin of the World Health Organization·James H McMahonMichael R Jordan
Nov 21, 2013·Enfermedades infecciosas y microbiología clínica·Pere Domingo, Esteban Ribera
Mar 29, 2014·AIDS·Frank J PalellaTodd Fralich
Oct 14, 2014·Antiviral Therapy·Marco VitoriaCharles Flexner
Jan 28, 2015·AIDS Research and Human Retroviruses·Casper RokxBart J A Rijnders
Apr 9, 2015·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Nathan FordAlexandra Calmy
Apr 25, 2015·AIDS Research and Therapy·Weerawat ManosuthiUNKNOWN Adults and Adolescents Committee of the Thai National HIV Guidelines Working Group
Jun 20, 2015·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Carmela PinnettiMauro Zaccarelli
Aug 2, 2015·Journal of the International AIDS Society·Nicola GianottiAntonella Castagna
Nov 1, 2015·The Journal of Antimicrobial Chemotherapy·Ujjwal NeogiAnders Sönnerborg
Dec 15, 2015·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Rochelle P WalenskyA David Paltiel
Dec 20, 2015·AIDS·Jan van LunzenShampa De-Oertel
Feb 27, 2016·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Anna H TranUNKNOWN IMPAACT P1026s Protocol Team
Jul 13, 2016·JAMA : the Journal of the American Medical Association·Huldrych F GünthardPaul A Volberding
Oct 6, 2016·Open Forum Infectious Diseases·Sean E CollinsSabin Nsanzimana
Feb 2, 2017·The Journal of Infection·Joseph M LewisMark Nelson
Feb 17, 2017·PloS One·Amanda HäggblomVeronica Svedhem
Mar 9, 2017·Journal of Acquired Immune Deficiency Syndromes : JAIDS·François RaffiMartin S Rhee
Jul 8, 2017·BMC Infectious Diseases·Delphine SculierUNKNOWN Swiss HIV Cohort Study
Mar 24, 2018·Southern African Journal of HIV Medicine·Graeme MeintjesFrancois Venter