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TreatmentUpdate 173Volume 21 Issue 4 2009 May/June I ANTI-HIV AGENTS: E. Darunavir—favourable results after two yearsDarunavir (Prezista) is a powerful anti-HIV drug. When used as part of combination therapy and taken twice daily, darunavir can help raise CD4+ counts and decrease viral load in most treatment-experienced people who have taken this drug in clinical trials. Results from clinical trials suggest that once-daily darunavir (800 mg) together with a small once-daily dose of ritonavir (100) can be an effective part of highly active antiretroviral therapy (HAART) for people starting their first drug regimen. The manufacturer of darunavir, Tibotec, is conducting a long-term clinical trial called Artemis, expected to last up to four years. In this study, 689 HIV positive people who had never been exposed to anti-HIV drugs were recruited and randomly assigned to one of the following combinations:
All participants also received a fixed-dose combination called Truvada, which contains these two anti-HIV drugs:
The average profile of people at the time they enrolled in Artemis was as follows:
Adherence in this study was assessed by means of questionnaires that participants completed from time to time. Results—overallAfter two years the proportion of participants whose viral load was below the 50-copy mark was as follows:
This difference between treatments was statistically significant; that is, not likely due to chance alone. Statistical analysis suggests that the combination of darunavir-ritonavir is superior to lopinavir-ritonavir in this study. Results—adherenceWhen researchers assess the results among participants with excellent adherence there were no significant differences in the ability of either regimen to suppress HIV. However, among participants who had what the research team called “sub-optimal” adherence, better suppression of viral load occurred in volunteers taking darunavir-ritonavir as indicated below:
Results—CD4+ cell countsAfter two years, participants on the study regimens had increased CD4+ cell counts as follows:
This difference was not statistically significant. Results—side effectsMore serious side effects, graded moderate to life threatening in intensity, were more likely to occur in people taking lopinavir-ritonavir (34%) compared to people taking darunavir-ritonavir (23%). Diarrhea was significantly more common in users of lopinavir-ritonavir (11%) than in people taking darunavir-ritonavir (4%). This difference was statistically significant. More people taking darunavir-ritonavir developed a rash (3%) than those taking lopinavir-ritonavir (1%). However, this difference was not statistically significant. For the most part, neither regimen caused abnormal blood test results. However, more volunteers taking lopinavir-ritonavir developed higher-than-normal levels of cholesterol and triglycerides in their blood, also a statistically significant difference from darunavir-ritonavir users. The use of darunavir-ritonavir as part of a once-daily regimen has recently been approved in Canada. REFERENCES:
Created on: 2009 June 9 Author: Hosein SR |
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Decisions about particular medical treatments should always be made in consultation with a qualified medical practitioner who is knowledgeable about HIV-related illness and the treatments in question. MORE | |