Five-year follow up of once-daily therapy with emtricitabine, didanosine and efavirenz (Montana ANRS 091 trial).
BACKGROUND
Once-daily combination therapy with emtricitabine, didanosine and efavirenz has been highly effective in clinical trials but its long-term efficacy and safety has not been previously reported.


METHODS
This multicentre, single-arm, open-label trial enrolled 40 antiretroviral-naive HIV-1-infected patients who received a once-daily regimen of emtricitabine, didanosine and efavirenz. The objective was to assess the long-term effects of this combination on plasma HIV RNA levels, CD4+ T-cell counts, safety and tolerability.


RESULTS
After 5 years, 73% and 68% of patients had plasma HIV RNA levels < 400 and < 50 copies/ml, respectively, in an intent-to-treat, missing-equals-failure analysis. Genotypic resistance on treatment emerged in six patients. There was a significant increase in CD4+ T-cell count of 294 x 10(6) cells/l. Only six patients discontinued study treatment, because of non-severe adverse events. Lipodystrophy was infrequent, and lipid and glucose profiles were favourable with a significant increase in high-density lipoprotein cholesterol.


CONCLUSIONS
A convenient once-daily regimen of emtricitabine, didanosine and efavirenz provided durable antiretroviral response and was well tolerated through 5 years of therapy.
Molina
Jean-Michel
JM
Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Department of Infectious Diseases, University of Paris 7, France. maladies.infectieuses@sls.aphp.fr
Journot
Valérie
V
Furco
André
A
Palmer
Pierre
P
De Castro
Nathalie
N
Raffi
François
F
Morlat
Philippe
P
May
Thierry
T
Rancinan
Corinne
C
Chêne
Geneviève
G
D000328:Adult; D000480:Alkynes; D023241:Antiretroviral Therapy, Highly Active; D000998:Antiviral Agents / Q000627:therapeutic use*; D048588:Benzoxazines / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002784:Cholesterol / Q000097:blood; D003521:Cyclopropanes; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016049:Didanosine / Q000627:therapeutic use*; D004361:Drug Tolerance; D000068679:Emtricitabine; D005260:Female; D005602:France; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008055:Lipids / Q000097:blood; D008074:Lipoproteins / Q000097:blood; D008297:Male; D012367:RNA, Viral / Q000097:blood; D013997:Time Factors; D016896:Treatment Outcome
D000480:Alkynes; D000998:Antiviral Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D008055:Lipids; D008074:Lipoproteins; D012367:RNA, Viral; C030104:lipoprotein cholesterol; D003841:Deoxycytidine; D002784:Cholesterol; D000068679:Emtricitabine; C098320:efavirenz; D016049:Didanosine