Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses.
BACKGROUND
We analyzed the 96-week results in the overall population and in prespecified subgroups from the ongoing STARTMRK study of treatment-naive HIV-infected patients.


METHODS
Eligible patients with HIV-1 RNA (vRNA) levels >5000 copies per milliliter and without baseline resistance to efavirenz, tenofovir, or emtricitabine were randomized in a double-blind noninferiority study to receive raltegravir or efavirenz, each combined with tenofovir/emtricitabine.


RESULTS
At week 96 counting noncompleters as failures, 81% versus 79% achieved vRNA levels <50 copies per milliliter in the raltegravir and efavirenz groups, respectively [Delta (95% confidence interval) = 2% (-4 to 9), noninferiority P < 0.001]. Mean change in baseline CD4 count was 240 and 225 cells per cubic millimeter in the raltegravir and efavirenz groups, respectively [Delta (95% confidence interval) = 15 (-13 to 42)]. Treatment effects were consistent across prespecified baseline demographic and prognostic subgroups. Fewer drug-related clinical adverse events (47% versus 78%; P < 0.001) occurred in raltegravir than efavirenz recipients. Both regimens had modest effects on serum lipids and glucose levels and on body fat composition.


CONCLUSIONS
When combined with tenofovir/emtricitabine in treatment-naive patients, raltegravir exhibited durable antiretroviral activity that was noninferior to the efficacy of efavirenz through 96 weeks of therapy. Subgroup analyses were generally consistent with the overall findings. Both regimens were well tolerated.
Lennox
Jeffrey L
JL
Emory University School of Medicine, Atlanta, GA, USA.
Dejesus
Edwin
E
Berger
Daniel S
DS
Lazzarin
Adriano
A
Pollard
Richard B
RB
Ramalho Madruga
Jose Valdez
JV
Zhao
Jing
J
Wan
Hong
H
Gilbert
Christopher L
CL
Teppler
Hedy
H
Rodgers
Anthony J
AJ
Barnard
Richard J O
RJ
Miller
Michael D
MD
Dinubile
Mark J
MJ
Nguyen
Bach-Yen
BY
Leavitt
Randi
R
Sklar
Peter
P
D000328:Adult; D000368:Aged; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D048588:Benzoxazines / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D011760:Pyrrolidinones / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D011760:Pyrrolidinones; D012367:RNA, Viral; D000068898:Raltegravir Potassium; C098320:efavirenz
AIDS. 2008 Jul 11;22(11):1382-4
18580624
J Acquir Immune Defic Syndr. 2009 Nov 1;52(3):350-6
19648823
Lancet. 2009 Sep 5;374(9692):796-806
19647866
J Infect Dis. 2008 Oct 15;198(8):1113-22
18783318
J Acquir Immune Defic Syndr. 2008 Jul 1;48(3):281-8
18545156
JAMA. 2008 Aug 6;300(5):555-70
18677028
J Infect Dis. 2009 Nov 15;200(10):1503-8
19835478
AIDS. 2006 Nov 14;20(17):2193-7
17086059
Stat Med. 1985 Apr-Jun;4(2):213-26
4023479
N Engl J Med. 2008 Jul 24;359(4):355-65
18650513
N Engl J Med. 2001 Mar 15;344(11):824-31
11248160
AIDS. 2008 Sep 12;22(14):1890-2
18753871
AIDS. 2004 Jul 2;18(10):1393-401
15199315
N Engl J Med. 2008 Jul 24;359(4):339-54
18650512
J Infect Dis. 2008 Mar 15;197(6):867-70
18269317
Clin Infect Dis. 2008 Aug 1;47(3):421-4
18558886
J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):125-33
17721395
J Acquir Immune Defic Syndr. 2007 Mar 1;44(3):329-35
17179768
Clin Infect Dis. 2008 Jul 15;47(2):266-85
18549313