PMID- 23328090
OWN - NLM
STAT- MEDLINE
DCOM- 20130308
LR  - 20201209
IS  - 1944-7884 (Electronic)
IS  - 1525-4135 (Linking)
VI  - 62
IP  - 2
DP  - 2013 Feb 1
TI  - Efficacy and safety of lersivirine (UK-453,061) versus efavirenz in 
      antiretroviral treatment-naive HIV-1-infected patients: week 48 primary analysis 
      results from an ongoing, multicenter, randomized, double-blind, phase IIb trial.
PG  - 171-9
LID - 10.1097/QAI.0b013e31827a2ba2. [doi]
AB  - OBJECTIVE: A 96-week clinical study was planned to estimate the antiviral 
      activity and safety of lersivirine in treatment-naive HIV-1-infected patients. 
      METHODS: This ongoing international, multicenter, double-blind, randomized, Phase 
      IIb exploratory study evaluates the efficacy and safety of 2 doses of lersivirine 
      or 1 of efavirenz, each combined with tenofovir disoproxil 
      fumarate/emtricitabine. Patients were randomized 1:1:1 to receive lersivirine 
      (500 or 750 mg once daily) or efavirenz (600 mg once daily), each administered 
      with tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg, once daily). The 
      primary endpoint is the proportion of patients with HIV-1 RNA <50 copies per 
      milliliter (missing/discontinuation = failure) at week 48. RESULTS: For the 193 
      patients in the study, baseline mean plasma HIV-1 RNA was 4.7 log10 copies per 
      milliliter, and median CD4 cell count was 312 cells per cubic millimeter. At week 
      48, the percentage of patients with HIV-1 RNA <50 copies per milliliter was 78.5% 
      (51/65), 78.5% (51/65), and 85.7% (54/63) in the lersivirine 500 mg, 750 mg, and 
      efavirenz groups, respectively. CD4 cell count changes from baseline were similar 
      across groups. Virologic failure occurred in 7 patients (11%) in each of the 
      lersivirine groups and 3 patients (5%) in the efavirenz group. The pattern of 
      lersivirine resistance was distinct from other nonnucleoside reverse 
      transcriptase inhibitors. Overall incidences of all-causality treatment-related 
      or grade 3/4 adverse events (AEs) or AE-related discontinuations were lower with 
      lersivirine than with efavirenz, and serious AEs occurred at similar rates across 
      treatment groups. CONCLUSIONS: Both lersivirine doses showed broadly comparable 
      efficacy to efavirenz over 48 weeks in treatment-naive patients, with different 
      AE profiles from efavirenz.
FAU - Vernazza, Pietro
AU  - Vernazza P
AD  - Cantonal Hospital, St. Gallen, Switzerland. pietro.vernazza@kssg.ch
FAU - Wang, Cunshan
AU  - Wang C
FAU - Pozniak, Anton
AU  - Pozniak A
FAU - Weil, Elizabeth
AU  - Weil E
FAU - Pulik, Piotr
AU  - Pulik P
FAU - Cooper, David A
AU  - Cooper DA
FAU - Kaplan, Richard
AU  - Kaplan R
FAU - Lazzarin, Adriano
AU  - Lazzarin A
FAU - Valdez, Hernan
AU  - Valdez H
FAU - Goodrich, James
AU  - Goodrich J
FAU - Mori, Julie
AU  - Mori J
FAU - Craig, Charles
AU  - Craig C
FAU - Tawadrous, Margaret
AU  - Tawadrous M
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Alkynes)
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Benzoxazines)
RN  - 0 (Cyclopropanes)
RN  - 0 (Nitriles)
RN  - 0 (Organophosphonates)
RN  - 0 (Pyrazoles)
RN  - 0 (RNA, Viral)
RN  - 0 (Reverse Transcriptase Inhibitors)
RN  - 0 (UK 453,061)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 99YXE507IL (Tenofovir)
RN  - G70B4ETF4S (Emtricitabine)
RN  - JAC85A2161 (Adenine)
RN  - JE6H2O27P8 (efavirenz)
SB  - IM
MH  - Adenine/analogs & derivatives/therapeutic use
MH  - Adult
MH  - Alkynes
MH  - Anti-HIV Agents/adverse effects/*therapeutic use
MH  - Benzoxazines/adverse effects/*therapeutic use
MH  - CD4 Lymphocyte Count
MH  - Cyclopropanes
MH  - Deoxycytidine/analogs & derivatives/therapeutic use
MH  - Double-Blind Method
MH  - Drug Resistance, Viral/genetics
MH  - Drug Therapy, Combination/adverse effects
MH  - Emtricitabine
MH  - Female
MH  - HIV Infections/*drug therapy/immunology
MH  - HIV-1/*genetics
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Mutation
MH  - Nitriles/adverse effects/*therapeutic use
MH  - Organophosphonates/therapeutic use
MH  - Pyrazoles/adverse effects/*therapeutic use
MH  - RNA, Viral/blood
MH  - Reverse Transcriptase Inhibitors/therapeutic use
MH  - Tenofovir
MH  - Young Adult
EDAT- 2013/01/19 06:00
MHDA- 2013/03/09 06:00
CRDT- 2013/01/19 06:00
PHST- 2013/01/19 06:00 [entrez]
PHST- 2013/01/19 06:00 [pubmed]
PHST- 2013/03/09 06:00 [medline]
AID - 00126334-201302010-00007 [pii]
AID - 10.1097/QAI.0b013e31827a2ba2. [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2013 Feb 1;62(2):171-9. doi: 
      10.1097/QAI.0b013e31827a2ba2..