- 1.
CDR submission: Tivicay™ (dolutegravir) 50mg tablets; Company: ViiV Healthcare ULC [CONFIDENTIAL manufacturer’s submission]. Laval (QC): ViiV Healthcare ULC; 2013
Dec.
- 2.
Pharmacoeconomic evaluation. In: CDR submission: Tivicay™ (dolutegravir) 50mg tablets; Company: ViiV Healthcare ULC [CONFIDENTIAL manufacturer’s submission]. Laval (QC): ViiV Healthcare ULC; 2013
Dec.
- 3.
Clinical study report: ING114467 (SINGLE). A phase III, randomized, double-blind study of the safety and efficacy of dolutegravir plus abacavir-lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects [CONFIDENTIAL internal manufacturer’s report]. Brentford, UK: ViiV Healthcare and the GlaxoSmithKline Group; 2013
Aug.
- 4.
Clinical study report: ING113086 (SPRING-2). A phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50mg once daily compared to raltegravir 400mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naive adult subjects. 48 week results [CONFIDENTIAL internal manufacturer’s report]. Brentford, UK: ViiV Healthcare and the GlaxoSmithKline Group; 2012
Jul.
- 5.
Clinical study report: ING114915 (FLAMINGO). A phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects. [CONFIDENTIAL internal manufacturer’s report]. Brentford, UK: ViiV Healthcare and the GlaxoSmithKline Group; 2013
Jul
24.
- 6.
Isogai
PK, Rueda
S, Rachlis
AR, Rourke
SB, Mittmann
N, OHTN Cohort Study Team. Prediction of health preference values from CD4 counts in individuals with HIV. Med Decis Making. 2013
May;33(4):558–66. [
PubMed: 22875722]
- 7.
Franks
P, Hanmer
J, Fryback
DG. Relative disutilities of 47 risk factors and conditions assessed with seven preference-based health status measures in a national U.S. sample: toward consistency in cost-effectiveness analyses. Med Care. 2006
May;44(5):478–85. [
PubMed: 16641667]
- 8.
Krentz
HB, Gill
MJ. Cost of medical care for HIV-infected patients within a regional population from 1997 to 2006. HIV Med. 2008
Oct;9(9):721–30. [
PubMed: 18643856]
- 9.
Anis
AH, Guh
D, Hogg
RS, Wang
X-H, Yip
B, Craib
KJ, et al. The cost effectiveness of antiretroviral regimens for the treatment of HIV/AIDS. PharmacoEconomics. 2000
Oct;18(4):393–404. [
PubMed: 15344307]
- 10.
Fassbender
K, Fainsinger
RL, Carson
M, Finegan
BA. Cost trajectories at the end of life: the Canadian experience. J Pain Symptom Manage. 2009;38(1):75–80. [
PubMed: 19615630]
- 11.
Smolderen
KG, Bell
A, Lei
Y, Cohen
EA, Steg
PG, Bhatt
DL, et al. One-year costs associated with cardiovascular disease in Canada: Insights from the REduction of Atherothrombosis for Continued Health (REACH) registry. Can J Cardiol. 2010
Oct;26(8):297–305. [
PMC free article: PMC2954538] [
PubMed: 20931098]
- 12.
Clinical study report: ING111762 (SAILING). A phase III randomized, double-blind study of the safety and efficacy of GSK1349572 50 mg once daily versus raltegravir 400 mg twice daily, both administered with an investigator selected background regimen over 48 weeks in HIV-1 infected, integrase inhibitor-naïve, antiretroviral therapy-experienced adults - week 48 results [CONFIDENTIAL internal manufacturer’s report]. Brentford, UK: ViiV Healthcare and the GlaxoSmithKline Group; 2013
Aug
13.
- 13.
Cahn
P, Fourie
J, Grinsztejn
B, Hodder
S, Molina
JM, Ruxrungtham
K, et al. Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients. AIDS. 2011
Apr
24;25(7):929–39. [
PubMed: 21346512]
- 14.
Ortiz
R, DeJesus
E, Khanlou
H, Voronin
E, van Lunzen
J, Andrade-Villanueva
J, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS. 2008
Jul
31;22(12):1389–97. [
PubMed: 18614861]
- 15.
Steigbigel
RT, Cooper
DA, Kumar
PN, Eron
JE, Schechter
M, Markowitz
M, et al. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med [Internet]. 2008
Jul
24;359(4):339–54. [
PubMed: 18650512]
- 16.
Eron
JJ, Cooper
DA, Steigbigel
RT. Final 5-year results of the BENCHMARK studies: sustained antiretroviral effect of raltegravir, and exploratory analysis of late outcomes based on early virologic response. Abstract presented at: XIX International AIDS Conference; 2012 Jul 22–27; Washington (DC).
- 17.
Rockstroh
JK, DeJesus
E, Saag
M. Lonf-term safety and efficacy of raltegravir (RAL)-based versus efavirenz (EFV)-based combination therapy in treatment-naïve HIV-1 infected patients: final 5-year double-blind results from STARTMRK. Abstract presented at: XIX International AIDS Conference; 2012 Jul 22–27; Washington (DC).
- 18.
Eron
JJ, Cooper
DA, Steigbigel
RT, Clotet
B, Gatell
JM, Kumar
PN, et al. Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials. Lancet Infect Dis. 2013
Jul;13(7):587–96. [
PMC free article: PMC6083850] [
PubMed: 23664333]
- 19.
Mellors
JW, Muñoz
A, Giorgi
JV, Margolick
JB, Tassoni
CJ, Gupta
P, et al. Plasma viral load and CD4
+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med. 1997
Jun
15;126(12):946–54. [
PubMed: 9182471]
- 20.
D’Arminio
MA, Sabin
CA, Phillips
A, Sterne
J, May
M, Justice
A, et al. The changing incidence of AIDS events in patients receiving highly active antiretroviral therapy. Arch Intern Med. 2005
Feb
28;165(4):416–23. [
PubMed: 15738371]
- 21.
Cole
SR, Hernan
MA, Robins
JM, Anastos
K, Chmiel
J, Detels
R, et al. Effect of highly active antiretroviral therapy on time to acquired immunodeficiency syndrome or death using marginal structural models. Am J Epidemiol. 2003
Oct
1;158(7):687–94. [
PubMed: 14507605]
