PMID- 28385065
OWN - NLM
STAT- MEDLINE
DCOM- 20171229
LR  - 20181113
IS  - 1758-1052 (Electronic)
IS  - 0956-4624 (Print)
IS  - 0956-4624 (Linking)
VI  - 28
IP  - 9
DP  - 2017 Aug
TI  - Similar efficacy and tolerability of raltegravir-based antiretroviral therapy in 
      HIV-infected patients, irrespective of age group, burden of comorbidities and 
      concomitant medication: Real-life analysis of the German 'WIP' cohort.
PG  - 893-901
LID - 10.1177/0956462416679550 [doi]
AB  - Only limited efficacy and tolerability data on raltegravir (RAL) use are 
      currently available. Study objectives were to describe the efficacy and 
      tolerability profile of RAL-based antiretroviral therapy (ART) in routine 
      clinical practice in Germany. The WIP study (WIP = "Wirksamkeit von Isentress 
      unter Praxisbedingungen", Efficacy of Isentress under routine clinical 
      conditions) was a prospective, multi-centre cohort study in Germany. Human 
      immunodeficiency virus (HIV)-infected patients aged >/= 18 years in whom 
      combinational ART with RAL 400 mg BID was indicated were enrolled. The primary 
      endpoint was virologic response (HIV-RNA <50 copies/mL; non-completion equals 
      failure) after 48 weeks. Of 451 patients, 85.1% (n = 384) were still receiving 
      RAL at week 48. At baseline (BL), the prevalence of concomitant diseases was 
      higher in patients of the age group >/=50 years (94.2% vs. 75.7%) as well as 
      concomitant medications (74.8 % vs. 55.4%). Virologic response at week 48 was 
      74.7% (overall), 75.0% (naive at BL), 81.5% (suppressed at BL), 47.1% 
      (interrupted previous treatment at BL) and 64.9% (failing at BL), without 
      significant differences by age group. A significant correlation of achievement of 
      HIV-RNA <50 copies/mL was seen with treatment status at BL (p = 0.004). In 
      addition, 77.3 % of the patients with a CD4 cell count >200 cells/microL at BL 
      achieved HIV-RNA <50 copies/mL (p = 0.029). RAL was well tolerated with 80 
      adverse events (AEs) in 49 patients (10.9%) and 8 serious AEs (SAEs) in 6 
      patients (1.3%) reported to be drug related. A total of 22 patients (4.9%) 
      discontinued treatment due to AEs. The WIP study shows that the previously 
      reported efficacy and safety profile of RAL can be achieved in a population with 
      multiple comorbidities and comedications, with no major difference observed in 
      ageing patients (>/=50 years) vs. younger patients. RAL is therefore an attractive 
      treatment option in routine medical care in Germany.
FAU - Naumann, U
AU  - Naumann U
AD  - 1 Praxiszentrum Kaiserdamm, Berlin, Germany.
FAU - Moll, A
AU  - Moll A
AD  - 1 Praxiszentrum Kaiserdamm, Berlin, Germany.
FAU - Schleehauf, D
AU  - Schleehauf D
AD  - 1 Praxiszentrum Kaiserdamm, Berlin, Germany.
FAU - Lutz, T
AU  - Lutz T
AD  - 2 Infektiologikum Frankfurt, Frankfurt, Germany.
FAU - Schmidt, W
AU  - Schmidt W
AD  - 3 MVZ Arzteforum Seestrasse, Berlin, Germany.
FAU - Jaeger, H
AU  - Jaeger H
AD  - 4 MVZ Karlsplatz, HIV Research and Clinical Care Centre, Munich, Germany.
FAU - Funke, B
AU  - Funke B
AD  - 5 MSD Sharp & Dohme GmbH, Haar, Germany.
FAU - Witte, V
AU  - Witte V
AD  - 5 MSD Sharp & Dohme GmbH, Haar, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01213316
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20161114
PL  - England
TA  - Int J STD AIDS
JT  - International journal of STD & AIDS
JID - 9007917
RN  - 0 (Anti-HIV Agents)
RN  - 0 (HIV Integrase Inhibitors)
RN  - 0 (Pyrrolidinones)
RN  - 0 (RNA, Viral)
RN  - 43Y000U234 (Raltegravir Potassium)
SB  - IM
EIN - Int J STD AIDS. 2017 Jun;28(7):738. PMID: 28361567
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-HIV Agents/adverse effects/*therapeutic use
MH  - *Antiretroviral Therapy, Highly Active
MH  - CD4 Lymphocyte Count
MH  - Female
MH  - Germany
MH  - HIV Infections/*drug therapy/virology
MH  - HIV Integrase Inhibitors/adverse effects/*therapeutic use
MH  - HIV-1/*drug effects/genetics
MH  - Humans
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pyrrolidinones/therapeutic use
MH  - RNA, Viral/blood/drug effects
MH  - Raltegravir Potassium/adverse effects/*therapeutic use
MH  - Treatment Outcome
PMC - PMC5513442
OTO - NOTNLM
OT  - ART
OT  - Antiviral
OT  - HIV
OT  - integrase
EDAT- 2016/01/01 00:00
MHDA- 2017/12/30 06:00
PMCR- 2017/07/17
CRDT- 2017/04/08 06:00
PHST- 2016/01/01 00:00 [pubmed]
PHST- 2017/12/30 06:00 [medline]
PHST- 2017/04/08 06:00 [entrez]
PHST- 2017/07/17 00:00 [pmc-release]
AID - 10.1177_0956462416679550 [pii]
AID - 10.1177/0956462416679550 [doi]
PST - ppublish
SO  - Int J STD AIDS. 2017 Aug;28(9):893-901. doi: 10.1177/0956462416679550. Epub 2016 
      Nov 14.