Reports from the Field: Once-daily drug fights HIV
December 1, 2000 2 minutes read
Reports from the Field: Once-daily drug fights HIV
French researchers presented one-year results of a pilot study indicating that a once-a-day HAART (highly active antiretroviral therapy) regimen combining emtricitabine, didanosine, and efavirenz as a first-line therapy in treatment-naive HIV-infected patients was well-tolerated and effective.
Speaking at the 38th Annual Meeting of the Infectious Disease Society of America in New Orleans, researchers reported that at 48 weeks, 95% of patients on the regimen had a viral load below 400 copies/mL.
"The results showed that the once-daily HAART regimen containing Coviracil (emtricitabine) was generally well-tolerated and demonstrated strong antiviral and immunologic effects lasting for the 48-week duration of the study," notes Franck S. Rousseau, MD, executive vice president of medical affairs and chief medical officer of Triangle Pharmaceuticals in Durham, NC, developers of Coviracil. "In fact, 95% of patients maintained plasma HIV RNA levels below 400 copies/mL through 48 weeks, showing that the long-term potency of this once-a-day regimen is very impressive," he says.
"The durability of this regimen to successfully suppress viral load over a 48-week period is very encouraging," adds Jean-Michel Molina, MD, one of the French researchers from the Centre de Recherche sur le SIDA outside Paris. "Patient adherence is emerging as a major challenge as HIV treatment regimens become more complicated. Once-a-day dosing might improve patient adherence that we know is correlated to better virologic suppression."
The 48-week open-label pilot study was designed to examine the antiviral activity and safety of a once-a-day HAART regimen. Forty HIV-infected patients received once-daily doses of Coviracil (200 mg), didanosine (400 mg for patients 60 kg or more in weight and 250 mg for patients under 60 kg), and efavirenz (600 mg). The patients had median baseline HIV RNA levels of 4.77 log10 copies/mL and median baseline CD4 counts of 373 cells/mm3. At 48 weeks, CD4 count increased by a median of 159 and 205 cells/mm3.
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