Peter,
IMO the movement in AGPH is has little to do with short covering or takeover rumors. The stocks strength is the result of positive expectations for presentations that AGPH will make at the 38th Interscience Conference on Microbial Agents. IMO Viracept will continue to replace Crixivan and the Sustiva launch may actually be a major benefit for Viracept. Crixivan's lower activity in combination with Sustiva requires a higher dose of Crixivan, making it even less tolerable and likely to be replaced by Viracept. Protease inhibitors will continue to be the standard of care for the treatment of HIV infection and AIDS. PIs continue to demonstrate important clinical benefits, reduced opportunistic infections, and cost/benefit data. Side effects, such as abnormal fat distribution and diabetes, are being dealt with. According to a Robby Stephens report issued today "In a trial that may or may not be presented
at ICAAC, a four drug therapy of Sustiva in combination with Agouron's Viracept provides strong evidence that a PI is absolutely necessary to gain additional benefit. "
Among the studies that will be released are:
Abstract I-102: discusses the two-drug combination of Viracept and in 63 patients (33 treatment experienced, 30 treatment naive) treated for 16 weeks. The results show that this two-drug combination is essentially as effective as the standard triple drug therapy of two reverse transcriptase inhibitors (NRTIs) and a protease inhibitor (average reduction of 1.6 log in HIV RNA).
Abstract I-195: discusses the use of Viracept and Nevirapine (Boehringer Ingelheim's Viramune) in a "salvage" regimen, i.e., in patients who have become resistant to protease inhibitor therapy. While the study is small (only 19 patients were studied), these patients were heavily pre-treated with anti-retroviral drugs other than NNRTIs. At 23 weeks, four of six evaluable patients had undetectable viral loads.
Abstracts I-216 and I-218: discuss the use of b.i.d. Viracept. Abstract I- 216 compares 1250 mg b.i.d. of Viracept with 750 mg t.i.d. of Viracept and concludes that both regimens are similar in terms of both safety and efficacy. Abstract I-218, while small (only 20 evaluable patients), at 36 weeks 19 of 20 patients had HIV RNA below the level of detection with a less sensitive assay (400 copies/ml of blood) and 13 of 19 patients had HIV RNA
below the level of detection with a more sensitive assay (50 copies/ml of blood). Adverse events were no greater in the b.i.d. dose group versus the t.i.d. dose group.
Abstract I-241: discusses the substitution of Viracept for Crixivan in
patients with undetectable viral loads. While this was a single center
examination of case records of only 11 patients treated with Crixivan, it suggests that patients who are doing well on Crixivan but cannot tolerate some of its infamous side effect may switch to Viracept without risk of clinical deterioration.
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