DESCRIPTION: Aptivus (tipranavir) was approved by the FDA based on 24-week results from two international studies: RESIST-1 and RESIST-2. New data involve volunteers in both studies followed for 48 weeks. Volunteers, all of whom had tried and failed at least two protease inhibitors in the past, were randomized to receive Aptivus 500 mg twice daily and Norvir (ritonavir) 200 mg twice daily or an available Norvir-boosted PI. All volunteers also took other approved HIV drugs for a complete regimen.
FINDINGS: During the 48-week study, approximately 30% of volunteers receiving Aptivus/Norvir were able to reduce their viral loads below 400, compared with almost 14% of patients receiving another Norvir-boosted PI. In these two studies, Aptivus/Norvir worked best when it was combined with at least one HIV drug that the patient’s virus was still sensitive to. In most cases, Fuzeon (enfuvirtide) was the best addition. The most common side effects in volunteers taking Aptivus/Norvir were diarrhea, nausea, fatigue, headache, vomiting and elevated liver enzymes and triglycerides.
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