New data demonstrate once daily Videx EC ® (didanosine) is as effective as alternative multi-dosed HIV therapies

Convenience of VIDEX EC could improve patient adherence

Results from a study presented today at the Eighth Conference on Retroviruses and Opportunistic Infections in Chicago demonstrate that VIDEX EC® (didanosine) capsules are safe and effective when included in a combination regimen.

A large randomized, multinational study (BMS AI454-152, Abstract #319) of 511 treatment naïve HIV patients compares the safety and efficacy of VIDEX EC capsules taken once-daily with stavudine and nelfinavir to a regimen of Combivir and nelfinavir. Interim results of this study, by the protocol – specified analysis, show that after 48 weeks, the proportion of patients with HIV RNA levels below 400 copies/ml was equivalent in each treatment arm (VIDEX EC capsules 57%, Combivir 55%). Additionally, median CD4+ T-cell count, which are a measure of improvements in a patient’s immune function, increased similarly in both regimens. These results show that VIDEX EC capsules given once-daily as part of a triple regimen demonstrates similar anti-viral activity compared to that of a reference regimen.

“VIDEX EC offers patients a more tolerable, one-capsule, once-a-day antiretroviral therapy for the treatment of HIV,” said Joseph Gathe, M.D., Plaza Medical Center, Houston, Texas. “More important, the new encapsulated formulation of VIDEX with enteric coated beadlets may reduce undesirable gastrointestinal side effects.”

Patients in the VIDEX EC arm versus those in the Combivir arm experienced less gastrointestinal side effects including nausea (21% vs. 35%) and vomiting (13% vs. 18%). GI side effects have been thought to be related to the buffer found in many anti-HIV therapies. Peripheral neurological symptoms were reported more frequently in patients taking VIDEX EC capsules (17%) compared to Combivir (8%), while the discontinuation of treatment because of side effects were similar in each treatment arm, occurring early in the Combivir arm and later in the VIDEX EC arm.

“We are very happy that more HIV medicines are becoming easier and more convenient for patients,” said patient advocate L. Joel Martinez, The Center for AIDS: Hope and Remembrance, Houston, Texas. “We expect that the new one capsule once-a-day formulation of VIDEX EC will make taking VIDEX much easier for many patients.”