The Body PRO Covers: The 8th Conference on Retroviruses and Opportunistic Infections

Clinical Trials of HIV-1 Reverse Transcriptase Inhibitors

February 6, 2001

  • Efficacy and Safety of Switch to 3TC 300mg QD vs. Continued 3TC 150mg BID in Subjects with Virologic Suppression on Stable 3TC/d4T/PI Therapy (COLA4005): Final 24-Week Results (Poster 317)
    Authored by M. Sension, N. Bellos, J. Johnson, G. Sepulveda, J. Santana, M. Ames, and D. Goodwin
    View the original abstract

There is a pressing need for regimens that are simple and easy to take. Clinical trials (abstracts 320 and 321) have shown the benefit of once-daily regimens in three-drug combination therapy. Patients are asking for simpler potent regimens, and this trial examined the use of 150mg 3TC (Epivir) traditionally given twice daily now used as two pills (300mg) once daily. The clinical trials presented at this meeting supported the use of once-daily administration 3TC in a small study by Maggiolo, where he used 300mg of 3TC, 300mg of ddI, and 600mg of efavirenz, achieving viral suppression below 50 copies in 78.3% of a 75 treatment-naive patients. This trial represented the longest follow-up of this regimen in clinical practice and is also useful in directly observed therapy, as all the pills are taken at one sitting.

Sension's trial evaluated the benefit of once-daily 3TC vs. twice-daily by following patients who were taking a base regimen of d4T, a protease inhibitor (either nelfinavir or indinavir), and 3TC. After six months of stable therapy and viral suppression (<400 copies/ml) patients were switched to the once-daily 3TC version or the customary twice-daily dosage. The results showed equivalency between the two regimens with an 82% viral suppression success rate at <50 copies/ml and a 95% success at <400 copies/ml. This study has prompted a large-scale study to change the indication for the use of 3TC and represents a clear movement toward providing simpler effective regimens while maintaining potency.

Other trials (320, 321, and 491) demonstrated the effectiveness of once-daily regimens. The use of ddI EC, NNRTIs, a new protease (15), research to use abacavir once daily, stavudine extended release, and now once-daily 3TC as once-daily regimens give hope to simplifying regimens -- to taking less pills less times a day -- a welcome change.

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