Reverset Shows Potent Anti-HIV-1 Activity Against Resistant Virus

BANGKOK (Reuters Health) - Reverset, a cytidine analog inhibitor of HIV reverse transcriptase, appears to be effective and tolerable in both naïve and treatment-experienced patients with HIV infection, according to a report presented this week at the XV International AIDS Conference.

In a 10-day escalation study, Dr. Robert L. Murphy of Northwestern University in Chicago and colleagues studied 30 treatment-naïve HIV-infected patients who received 50 mg to 200 mg of Reverset. Baseline CD4 cell counts were less than 50 cells per µL and HIV RNA levels were greater than 500,000 copies/mL.

There was a considerable effect on HIV RNA levels. "At the highest dose tested, the median log drop in 10 days was 1.77," Dr. Murphy said. "Nearly every patient had a log drop of at least 1."

Dr. Murphy also reported on 10 treatment-experienced patients, eight of whom received 200 mg of Reverset. One of the two patients who received placebo dropped out of the study.

All were highly experienced with antiretroviral drugs. "Half of the patients had three or four thymidine analogue mutations (TAM), five of the eight patients were receiving tenofovir and five of the eight patients were receiving 3TC," he continued. Reverset was added while the patients continued on their failing antiretroviral regimen.

"After the 10 days of dosing, there was a 0.8 log reduction, with a return towards baseline after the subjects' stopped the Reverset." During treatment, four of the eight patients had HIV RNA levels of less than 400 copies/mL "and one of them when down to less than 50."

Moreover, "it didn't seem to make any difference whether patients were on 3TC or on tenofovir or not -- virtually every patient had a response," he said. No treatment-related mutations were noted and the drug was very well tolerated and there were no serious adverse events.

In this 200-mg pilot study, Dr. Murphy concluded, "Reverset was effective against multiple-resistant strains of virus, including those with multiple thymidine analogue mutations,"

Further analyses are currently underway, he added, and a phase IIb study of the drug has just begun in the US, Germany and France.

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