PMID- 25394009
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160121
LR  - 20181023
IS  - 1758-2652 (Electronic)
IS  - 1758-2652 (Linking)
VI  - 17
IP  - 4 Suppl 3
DP  - 2014
TI  - Safety and efficacy of ombitasvir - 450/r and dasabuvir and ribavirin in 
      HCV/HIV-1 co-infected patients receiving atazanavir or raltegravir ART regimens.
PG  - 19500
LID - 10.7448/IAS.17.4.19500 [doi]
LID - 19500 [doi]
AB  - OBJECTIVE: Whether concomitant HIV antiretroviral therapy (ART) affects the 
      safety and efficacy of interferon-free HCV therapies or whether HCV treatment may 
      negatively affect HIV control is unclear. We assessed the 3 direct-acting 
      antiviral (3D) regimen of ombitasvir, ABT-450 (identified by AbbVie and Enanta; 
      co-dosed with ritonavir) and dasabuvir with ribavirin (RBV) in HCV/HIV-1 
      co-infected patients with and without cirrhosis, including HCV 
      treatment-experienced, receiving atazanavir (ATV)- or raltegravir (RAL)-based ART 
      therapy. METHODS: HCV genotype 1-positive treatment-naive or 
      pegIFN/RBV-experienced patients, with or without Child-Pugh A cirrhosis, CD4+ 
      count >/=200 cells/mm(3) or CD4 + % >/=14%, and plasma HIV-1 RNA suppressed on stable 
      ART received open-label 3D + RBV for 12 or 24 weeks. Rates of HCV-sustained 
      virologic response at post-treatment weeks 4 and 12 (SVR4 and SVR12, 
      respectively) and bilirubin-related adverse events (AEs) are reported from 
      post-hoc analyses for subgroups defined by treatment duration and ART regimen. 
      RESULTS: The SVR12 rate for patients receiving 12 weeks of 3D + RBV was 93.5% 
      with comparable rates in patients receiving either ATV (93.8%) or RAL therapy 
      (93.3%) (Table 1). The SVR4 rate for the 24-week arm was 96.9% with a single 
      virologic breakthrough at treatment week 16 in a patient receiving RAL therapy. 
      Patients receiving concomitant ATV had more AEs related to indirect 
      hyperbilirubinemia including ocular icterus, jaundice and grade 3 or 4 elevations 
      in total bilirubin (predominantly indirect). No patient discontinued the study 
      due to AEs, and no serious AEs were reported during or after treatment. No 
      patient had a confirmed plasma HIV-1 RNA value >/=200 copies/mL during the 
      treatment period. CONCLUSIONS: In this first study to evaluate an IFN-free 
      regimen in HCV genotype 1-positive treatment-naive and experienced patients with 
      HIV-1 co-infection, including those with cirrhosis, high rates of SVR were 
      comparable to those with HCV monoinfection. Indirect hyperbilirubinemia was 
      consistent with the known ABT-450 inhibition of the OATP1B1 bilirubin 
      transporter, RBV-related haemolytic anaemia and inhibitory effect of ATV on 
      bilirubin conjugation. The laboratory abnormalities and AEs observed did not 
      negatively affect treatment response or lead to treatment discontinuation.
FAU - Eron, Joseph J
AU  - Eron JJ
AD  - Division of Infectious Diseases, University of North Carolina, Chapel Hill, NC, 
      USA.
FAU - Lalezari, Jay
AU  - Lalezari J
AD  - Quest Clinical Research, San Francisco, CA, USA.
FAU - Slim, Jihad
AU  - Slim J
AD  - Infectious Disease Medicine, St. Michael's Medical Center, Newark, NJ, USA.
FAU - Gathe, Joseph
AU  - Gathe J
AD  - Infectious Disease, Cure C. Consortium, Houston, TX, USA.
FAU - Ruane, Peter J
AU  - Ruane PJ
AD  - Peter J. Ruane, MD, Inc., Infectious Disease, Los Angeles, CA, USA.
FAU - Wang, Chia
AU  - Wang C
AD  - Infectious Diseases, Virginia Mason Medical Center, Seattle, WA, USA.
FAU - Elion, Richard
AU  - Elion R
AD  - Clinical Medicine, Whitman-Walker Health, Washington, DC, USA.
FAU - Blick, Gary
AU  - Blick G
AD  - Infectious Diseases, CIRCLE CARE Center, Norwalk, CT, USA.
FAU - Khatri, Amit
AU  - Khatri A
AD  - Clinical Pharmacokinetics, AbbVie Inc., North Chicago, IL, USA.
FAU - Hu, Yiran B
AU  - Hu YB
AD  - Statistics, AbbVie Inc., North Chicago, IL, USA.
FAU - Gibbons, Krystal
AU  - Gibbons K
AD  - Clinical Research Management, AbbVie Inc., North Chicago, IL, USA.
FAU - Fredrick, Linda
AU  - Fredrick L
AD  - Statistics, AbbVie Inc., North Chicago, IL, USA.
FAU - Co, Melannie
AU  - Co M
AD  - Medical Review, AbbVie Inc., North Chicago, IL, USA.
FAU - D'Amico, Ronald
AU  - D'Amico R
AD  - Medical Affairs, AbbVie Inc., North Chicago, IL, USA.
FAU - Da Silva-Tillmann, Barbara
AU  - Da Silva-Tillmann B
AD  - Medical Safety Evaluation, AbbVie Inc., North Chicago, IL, USA.
FAU - Trinh, Roger
AU  - Trinh R
AD  - Antiviral Global Project Team, AbbVie Inc., North Chicago, USA.
FAU - Sulkowski, Mark S
AU  - Sulkowski MS
AD  - Viral Hepatitis Center, Johns Hopkins University, Baltimore, MD, USA.
LA  - eng
GR  - P30 AI050410/AI/NIAID NIH HHS/United States
PT  - Journal Article
DEP - 20141102
PL  - Switzerland
TA  - J Int AIDS Soc
JT  - Journal of the International AIDS Society
JID - 101478566
PMC - PMC4224905
EDAT- 2014/11/14 06:00
MHDA- 2014/11/14 06:01
PMCR- 2014/11/02
CRDT- 2014/11/14 06:00
PHST- 2014/11/14 06:00 [entrez]
PHST- 2014/11/14 06:00 [pubmed]
PHST- 2014/11/14 06:01 [medline]
PHST- 2014/11/02 00:00 [pmc-release]
AID - 19500 [pii]
AID - 10.7448/IAS.17.4.19500 [doi]
PST - epublish
SO  - J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19500. doi: 10.7448/IAS.17.4.19500. 
      eCollection 2014.