3rd IAS Conference on HIV Pathogenesis and Treatment
July 24 - 27, 2005, Rio de Janerio, Brazil
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Salvage Therapy in Different Clinical Settings By Lloyd Bailey, MD Two of the five presentations in this session reported the results of original studies which evaluated novel treatment approaches in the setting of salvage therapy. The first of these two was the final 48 week data from the E-184V Study. The E-184V study took 58 patients failing an HAART regimen with the 184V mutation and a CD4 count at time of entry of > 500 who wished to interrupt therapy for personal reasons. They were randomized in a 1:1 fashion to either fully interrupt ARV treatment or continue only 3TC 300mg QD. The protocol defined that patients would be put back on HAART if the CD4 count declined to below 350 cells or if the patient developed a CDC B or C AIDS-defining event. At 48 weeks, 41% experienced protocol defined failure in the 3TC arm and needed to be restarted on HAART whereas 69% of subjects in the treatment interruption arm needed to be restarted on HAART. Similar results favoring the 3TC treatment arm were seen when examining VL changes. An average 1.11 log increase in HIV viral load was seen in the treatment interruption arm whereas only an average 0.57log increase was seen in the 3TC arm. CD4 cell count declines were also greater in the treatment interruption group averaging 215 versus an average decline of 141 in the 3TC group. Not surprisingly, neither group showed any further increase in the number of resistance mutations. Bioject 2000 The other original research presentation in this session discussed the preliminary results of a study evaluating the Bioject B2000 as a needleless delivery system for the subcutaneous administration of enfuvirtide (Fuzeon). The goal of this study was to assess the incidence and severity of injection site reactions (ISR) with this novel delivery system and also to assess the ease of use of the Bioject device. The study took 32 individuals who were either naïve to enfuvirtide use or currently using a needle for enfuvirtide drug delivery. They were followed for a median of 12 weeks using the Bioject B2000 (range <1 week to 24 weeks). Of the 32 subjects, 20 (63%) remain on enfuvirtide and are using the Bioject device (though 3 of these 20 subjects use the Bioject device interchangeably with a standard needle). Of the 12 subjects no longer using the Bioject device for enfuvirtide subcutaneous administration: 2 were lost to follow-up, 4 subjects were taken off all ARVs for reasons unrelated to the injection device, 4 subjects stopped enfuvirtide <1 week after starting due to injection site reactions (of these four, one is now back on ENF with a standard needed delivery system), and 2 (6%) stopped ENF at >4 weeks due to adverse events that were specific to the Bioject device. These two patients with adverse events specific to the Bioject device had problems with nerve bundle pain during and following problematic injections. There were a total of four of these adverse events occurring in three patients. One patient injected at the right buttock on one occasion and had immediate pain in the front of his thigh followed by numbness in this region for two weeks. Later a similar episode occurred in this patient at the left leg. In patient #2, immediate pain at the left forearm was noted after an injection above the elbow. This was followed by numbness in this area for one month. Patient #3 injected at the top of the left anterior thigh and noted immediate pain down to the knee lasting for several days. This same patient has ongoing numbness, tingling and dysesthesia at this region now at three months after the event. The reason for these reactions is unclear, but the presenter speculated it could be related to lack of subcutaneous tissue and injecting near joints. Despite these events, ISRs were significantly reduced with the use of the Bioject B2000 and the patients in the study found the device easier to use than standard needles. Pre-dose trough and and 1 hour post dose ENF plasma levels achieved using the Bioject device was equivalent to those levels found using standard syringes and needles. Longer term safety and efficacy evaluation of the Bioject B2000 is ongoing. 08/05/05 References All references are to the Program and Abstracts of the 3rd IAS Conference on HIV Pathogenesis and Treatment. July 24-27, 2005. Rio de Janeiro. Steven Deeks (USA). Switching therapy: strategic approaches. Abstract WeFo0201 (oral). United States. I Sanne (South Africa). Sequencing therapy in resource-limited settings. Abstract WeFo0202 (oral). South Africa. Julio Montaner (Canada). Options for deep salvage therapy: now and the near future. Abstract WeFo0202 (oral). A Castagna and others (Italy). E-184V Study: Lamivudine monotherapy vs treatment interruption in failing HIV-1 infected subjects, harbouring the M184V mutation: 48-week final results. Abstract WeFo0204 (oral). J Montaner and others (Canada; USA). Enfuvirtide (T20) plasma levels and injection site reactions (ISRs) using a novel needle-free gas-powered injection system (Biojector) for subcutaneous administration of T20 in treatment-experienced HIV+ patients. Abstract WeFo0205 (oral).
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