Five-year follow up of once-daily therapy with emtricitabine, didanosine and efavirenz (Montana ANRS 091 trial).

Jean-Michel Molina, Valérie Journot, André Furco, Pierre Palmer, Nathalie De Castro, François Raffi, Philippe Morlat, Thierry May, Corinne Rancinan, Geneviève Chêne

Journal: Antiviral therapy 2007;12(3):417-22

PMID: 17591032

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Abstract

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.

CONCLUSION

A convenient once-daily regimen of emtricitabine, didanosine and efavirenz provided durable antiretroviral response and was well tolerated through 5 years of therapy.

Address: Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Department of Infectious Diseases, University of Paris 7, France. [email protected]

Link outs

Free resources

Medical:

https://medlineplus.gov/hivinwomen.html

Research Materials:

https://antibodies.cancer.gov/detail/CPTC-CD4-1

MeSH Terms: Adult, Alkynes, Antiretroviral Therapy, Highly Active, Antiviral Agents, Benzoxazines, CD4 Lymphocyte Count, Cholesterol, Cyclopropanes, Deoxycytidine, Didanosine, Drug Tolerance, Emtricitabine, Female, France, HIV Infections, HIV-1, Humans, Lipids, Lipoproteins, Male, RNA, Viral, Time Factors, Treatment Outcome