PMID- 31879782
OWN - NLM
STAT- MEDLINE
DCOM- 20210428
LR  - 20211204
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 71
IP  - 12
DP  - 2020 Dec 15
TI  - Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid-Initiation 
      Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis 
      of the DIAMOND Study.
PG  - 3110-3117
LID - 10.1093/cid/ciz1213 [doi]
AB  - BACKGROUND: Most guidelines recommend rapid treatment initiation for patients 
      with newly diagnosed human immunodeficiency virus type 1 (HIV-1) infection, but 
      prospective US data are limited. The DIAMOND (NCT03227861) study using 
      darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 
      800/150/200/10 mg is a phase 3 prospective study evaluating efficacy/safety of a 
      single-tablet regimen in a rapid-initiation model of care. METHODS: Adults aged 
      >/=18 years began D/C/F/TAF </=14 days from diagnosis without screening/baseline 
      results; as results became available, participants not meeting predefined 
      safety/resistance stopping rules continued. Primary endpoint was virologic 
      response (HIV-1 RNA <50 copies/mL; intent-to-treat; US Food and Drug 
      Administration [FDA] snapshot) at week 48; participant satisfaction was measured 
      via the HIV Treatment Satisfaction Questionnaire status version (HIVTSQs). 
      RESULTS: Of 109 participants, 87% were male, 32% black/African American, median 
      (range) age was 28 (range, 19-66) years, 25% of participants had HIV-1 RNA >/=100 
      000 copies/mL, 21% had CD4+ cell count <200 cells/microL, and 31% enrolled </=48 hours 
      from diagnosis. At week 48, 97 (89%) participants completed the study and 92 
      (84%) achieved HIV-1 RNA <50 copies/mL (FDA snapshot). There were no 
      protocol-defined virologic failures; incidences of adverse events (AEs) and 
      adverse drug reactions (33%) were low, no serious AEs were study drug related, 
      and 1 (<1%) participant discontinued due to study drug related AE(s). The overall 
      HIVTSQs score at week 48 was 58 (maximum: 60). CONCLUSIONS: At week 48, a high 
      proportion of participants starting D/C/F/TAF achieved HIV-1 RNA <50 copies/mL 
      and very few discontinued therapy. D/C/F/TAF was well tolerated, no participants 
      discontinued due to baseline resistance stopping criteria, and high treatment 
      satisfaction among participants was recorded. CLINICAL TRIALS REGISTRATION: 
      NCT03227861.
CI  - (c) The Author(s) 2019. Published by Oxford University Press for the Infectious 
      Diseases Society of America.
FAU - Huhn, Gregory D
AU  - Huhn GD
AD  - Ruth M. Rothstein CORE Center, Chicago, Illinois, USA.
FAU - Crofoot, Gordon
AU  - Crofoot G
AD  - Crofoot Research Center, Houston, Texas, USA.
FAU - Ramgopal, Moti
AU  - Ramgopal M
AD  - Midway Immunology and Research Center, Fort Pierce, Florida, USA.
FAU - Gathe, Joseph
AU  - Gathe J
AD  - Therapeutic Concepts, Houston, Texas, USA.
FAU - Bolan, Robert
AU  - Bolan R
AD  - Los Angeles LGBT Center, Los Angeles, California, USA.
FAU - Luo, Donghan
AU  - Luo D
AD  - Janssen Research & Development, LLC, Titusville, New Jersey, USA.
FAU - Simonson, Richard Bruce
AU  - Simonson RB
AD  - Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
FAU - Nettles, Richard E
AU  - Nettles RE
AD  - Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
FAU - Benson, Carmela
AU  - Benson C
AD  - Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
FAU - Dunn, Keith
AU  - Dunn K
AD  - Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03227861
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Drug Combinations)
RN  - 7782-40-3 (Diamond)
RN  - 99YXE507IL (Tenofovir)
RN  - EL9943AG5J (tenofovir alafenamide)
RN  - G70B4ETF4S (Emtricitabine)
RN  - JAC85A2161 (Adenine)
RN  - LW2E03M5PG (Cobicistat)
RN  - OF5P57N2ZX (Alanine)
RN  - YO603Y8113 (Darunavir)
SB  - IM
MH  - Adenine/analogs & derivatives
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Alanine
MH  - *Anti-HIV Agents/adverse effects
MH  - Cobicistat/therapeutic use
MH  - Darunavir/therapeutic use
MH  - Diamond/therapeutic use
MH  - Drug Combinations
MH  - Emtricitabine/therapeutic use
MH  - Female
MH  - *HIV Infections/drug therapy
MH  - *HIV-1
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Tenofovir/analogs & derivatives
MH  - Viral Load
MH  - Young Adult
PMC - PMC7819515
OTO - NOTNLM
OT  - D/C/F/TAF
OT  - HIV-1
OT  - darunavir
OT  - rapid initiation
OT  - single-tablet regimen
EDAT- 2019/12/28 06:00
MHDA- 2021/04/29 06:00
PMCR- 2019/12/27
CRDT- 2019/12/28 06:00
PHST- 2019/09/05 00:00 [received]
PHST- 2019/12/24 00:00 [accepted]
PHST- 2019/12/28 06:00 [pubmed]
PHST- 2021/04/29 06:00 [medline]
PHST- 2019/12/28 06:00 [entrez]
PHST- 2019/12/27 00:00 [pmc-release]
AID - 5687816 [pii]
AID - ciz1213 [pii]
AID - 10.1093/cid/ciz1213 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2020 Dec 15;71(12):3110-3117. doi: 10.1093/cid/ciz1213.