Week 48 results from a randomized clinical trial of rilpivirine/ emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/ tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults

AIDS

Volumn 28, Issue 7, 2014, Pages 989-997

  Cohen, Calvin ^a   Wohl, David ^b   Arribas, Jose R ^c   Henry, Keith ^d   Van Lunzen, Jan ^e   Bloch, Mark ^f   Towner, William ^g   Wilkins, Edmund ^h   Ebrahimi, Ramin ⁱ   Porter, Danielle ⁱ   White, Kirsten ⁱ   Walker, Ivan ⁱ   Chuck, Susan ⁱ   De Oertel, Shampa ⁱ   Fralich, Todd ⁱ  

^a Boston Community Research Initiative of New England   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

^c HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^d HENNEPIN COUNTY MEDICAL CENTER   (United States)

^e UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^f Holdsworth House Medical Practice   (Australia)

^g LOS ANGELES MEDICAL CENTER   (United States)

^h NORTH MANCHESTER GENERAL HOSPITAL   (United Kingdom)

ⁱ GILEAD SCIENCES   (United States)

Author keywords

antiretroviral therapy; efavirenz; HIV 1; rilpivirine; single tablet regimens; treatment naive

Indexed keywords

EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; EMTRICITABINE PLUS RILPIVIRINE PLUS TENOFOVIR DISOPROXIL; HIGH DENSITY LIPOPROTEIN; LIPID; LOW DENSITY LIPOPROTEIN; TRIACYLGLYCEROL; VIRUS RNA; ANTIRETROVIRUS AGENT;

ABNORMAL DREAMING; ABNORMAL LABORATORY RESULT; ADULT; ANXIETY; ARTICLE; CAUSE OF DEATH; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; CROSS RESISTANCE; DEPRESSION; DIZZINESS; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOLLICULITIS; HEADACHE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; INSOMNIA; LIPID BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MENTAL DISEASE; MULTICENTER STUDY; NEUROLOGIC DISEASE; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SKIN DISEASE; SOMNOLENCE; SUBCUTANEOUS TISSUE; TABLET; TRIACYLGLYCEROL BLOOD LEVEL; VIRUS MUTATION; VIRUS RESISTANCE; ADVERSE DRUG REACTION; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; INTERNATIONAL COOPERATION; ISOLATION AND PURIFICATION; MIDDLE AGED; PROCEDURES; TREATMENT OUTCOME; VIRUS LOAD;

ADULT; ANTI-RETROVIRAL AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; INTERNATIONAL COOPERATION; MALE; MIDDLE AGED; RNA, VIRAL; TREATMENT OUTCOME; VIRAL LOAD;

EID: 84897493853     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0000000000000169     Document Type: Article

References (26)

1. Maggiolo F, Ripamonti D, Arici C, Gregis G, Quinzan G, Camacho GA, et al. Simpler regimens may enhance adherence to antiretrovirals in HIV infected patients. HIV Clin Trials 2002; 5:371-378.
2. Stone VE, Jordan J, Tolson J, Miller R, Pilon T. Perspectives on adherence and simplicity for HIV-infected patients on antiretroviral therapy: self-report of the relative importance of multiple attributes of highly active antiretroviral therapy (HAART) regimens in predicting adherence. J Acquir Immune Defic Syndr 2004; 36:808-816.
3. Molina J-M, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, et al. for the ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised doubleblind active-controlled trial. Lancet 2011; 378:238-246.
4. Cohen CJ, Molina J-M, Cassetti I, Chetchotisakd P, Lazzarin A, Orkin C, et al. Week 96 efficacy and safety of rilpivirine in treatment-na?̈ve, HIV-1 patients in two phase III randomized trials. AIDS 2013; 27:939-950.
5. Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, et al. for the THRIVE study group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, noninferiority trial. Lancet 2011; 378:229-237.
6. Gilead Sciences Inc., Foster City, CA, USA. Complera (emtricitabine/ rilpivirine/tenofovir disoproxil fumarate) tablets, for oral use. Highlights of prescribing information. http://www.gilead. com/pdf/complera-pi.pdf. [Accessed 19 February 2013].
7. Gilead Sciences Ltd, Cambridge, UK. Eviplera Summary of product characteristics. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR- Product-Information/human/002312/WC500118802.pdf. [Accessed 19 February 2013].
8. Rimsky L, Van Eygen V, Vingerhoet J, Thys K, Aerssens J, Stevens M, Picchio G. Similar prevalence of baseline HIV-1 minority variants among responders and virologic failures, as well as increased detection of HIV-1 minority variants at treatment failure, in rilpivirine patients from the ECHOand THRIVE phase III studies [abstract TUAB0302]. In: Program and Abstracts of the XXInternational AIDSConference; 22-27July2012;Washington, DC, USA.
9. Smith F, Hammerstrom T, Soon G, Zhou S, Chen B, Mai Y, et al. A meta-analysis to assess the FDA DAVP's TLOVR algorithm in HIV submissions. Drug Information J 2011; 45:291-300.
10. US Department of Health and Human Services. Guidance for Industry. Antiretroviral drugs using plasma HIV RNA measurements-clinical considerations for accelerated and traditional approval. October 2002. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm 070968.pdf. [Accessed 4 March 2013].
11. Bristol-Myers Squibb Company, Princeton, NJ 08543 USA. Sustiva (efavirenz) capsules for oral use. Sustiva (efavirenz) tablets for oral use. Highlights of prescribing information. http://packageinserts.bms.com/pi/pi- sustiva.pdf. [Accessed 25 March 2013].
12. Porter DP, Kulkarni R, Fralich T, Miller MD, White KL. Characterization of HIV-1 drug resistance development through week 48 in antiretroviral na?̈ve subjects on rilpivirine/emtricitabine/tenofovir DF or efavirenz/emtricitabine/tenofovir DF in the STaR Study (GS-US-264-0110). J Acquir Immune Defic Syndr 2014; [Epub ahead of print].
13. Cohen CJ, Molina JM, Cahn P, Clotet B, Fourie J, Grinsztejn B, et al. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-na?̈ve HIV-1-infected patients: pooled results from the phase 3 double-blind randomized ECHO and THRIVE trials. JAIDS 2012; 60:33-42.
14. Maggiolo F, Ripamonti D, Arici C, Gregis G, Quinzan G, Camacho GA, et al. Simpler regimens may enhance adherence to antiretrovirals in HIV infected patients. HIV Clin Trials 2002; 5:371-378.
15. Stone VE, Jordan J, Tolson J, Miller R, Pilon T. Perspectives on adherence and simplicity for HIV-infected patients on antiretroviral therapy: self-report of the relative importance of multiple attributes of highly active antiretroviral therapy (HAART) regimens in predicting adherence. J Acquir Immune Defic Syndr 2004; 36:808-816.
16. Molina J-M, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, et al. for the ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised doubleblind active-controlled trial. Lancet 2011; 378:238-246.
17. Cohen CJ, Molina J-M, Cassetti I, Chetchotisakd P, Lazzarin A, Orkin C, et al. Week 96 efficacy and safety of rilpivirine in treatment-na?̈ve, HIV-1 patients in two phase III randomized trials. AIDS 2013; 27:939-950.
18. Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, et al. for the THRIVE study group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, noninferiority trial. Lancet 2011; 378:229-237.
19. Gilead Sciences Inc., Foster City, CA, USA. Complera (emtricitabine/ rilpivirine/tenofovir disoproxil fumarate) tablets, for oral use. Highlights of prescribing information. http://www.gilead. com/pdf/complera-pi.pdf. [Accessed 19 February 2013].
20. Gilead Sciences Ltd, Cambridge, UK. Eviplera Summary of product characteristics. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR- Product-Information/human/002312/WC500118802.pdf. [Accessed 19 February 2013].
21. Rimsky L, Van Eygen V, Vingerhoet J, Thys K, Aerssens J, Stevens M, Picchio G. Similar prevalence of baseline HIV-1 minority variants among responders and virologic failures, as well as increased detection of HIV-1 minority variants at treatment failure, in rilpivirine patients from the ECHOand THRIVE phase III studies [abstract TUAB0302]. In: Program and Abstracts of the XXInternational AIDSConference; 22-27July2012;Washington, DC, USA.
22. Smith F, Hammerstrom T, Soon G, Zhou S, Chen B, Mai Y, et al. A meta-analysis to assess the FDA DAVP's TLOVR algorithm in HIV submissions. Drug Information J 2011; 45:291-300.
23. US Department of Health and Human Services. Guidance for Industry. Antiretroviral drugs using plasma HIV RNA measurements-clinical considerations for accelerated and traditional approval. October 2002. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm 070968.pdf. [Accessed 4 March 2013].
24. Bristol-Myers Squibb Company, Princeton, NJ 08543 USA. Sustiva (efavirenz) capsules for oral use. Sustiva (efavirenz) tablets for oral use. Highlights of prescribing information. http://packageinserts.bms.com/pi/pi- sustiva.pdf. [Accessed 25 March 2013].
25. Porter DP, Kulkarni R, Fralich T, Miller MD, White KL. Characterization of HIV-1 drug resistance development through week 48 in antiretroviral na?̈ve subjects on rilpivirine/emtricitabine/tenofovir DF or efavirenz/emtricitabine/tenofovir DF in the STaR Study (GS-US-264-0110). J Acquir Immune Defic Syndr 2014; [Epub ahead of print].
26. Cohen CJ, Molina JM, Cahn P, Clotet B, Fourie J, Grinsztejn B, et al. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-na?̈ve HIV-1-infected patients: pooled results from the phase 3 double-blind randomized ECHO and THRIVE trials. JAIDS 2012; 60:33-42.