Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0042963 (vomiting)
 31,883 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Fosamprenavir (GW433908, Lexiva, Telzir) is an oral prodrug of the protease inhibitor (PI) amprenavir, with a reduced daily pill burden. Fosamprenavir, in combination with other antiretroviral agents, is indicated for the treatment of patients with HIV infection, particularly those who have not previously received antiretroviral therapy. Viral load reductions were at least as great with fosamprenavir-based regimens as those achieved with nelfinavir-based regimens in two large, 48-week, randomised, multicentre trials in antiretroviral therapy-naive patients with HIV infection. In the NEAT study, more patients receiving twice-daily fosamprenavir in combination with abacavir and lamivudine achieved HIV RNA levels <400 copies/mL than those receiving a similar nelfinavir-based regimen. Results of the SOLO study showed similar reductions in viral load among patients who received once-daily ritonavir-boosted fosamprenavir and those treated with twice-daily nelfinavir, both in combination with twice-daily abacavir and lamivudine. In both trials, virological failure rates were at least twice as high with the nelfinavir-based regimen as they were with the fosamprenavir-based regimen. Fosamprenavir was generally well tolerated in clinical trials. The most common adverse events among patients treated with fosamprenavir, with or without ritonavir, plus abacavir and lamivudine were diarrhoea, nausea, vomiting, abdominal pain, drug hypersensitivity and skin rash. The incidence of diarrhoea was significantly lower with fosamprenavir-based therapy than with nelfinavir-based therapy in the NEAT and SOLO trials. The resistance profile of fosamprenavir is consistent with that of amprenavir. Amprenavir-resistant viral isolates from patients experiencing treatment failure with fosamprenavir-based therapy in the NEAT study showed little or no cross-resistance to several other PIs, and protease mutations commonly selected for by various other PIs were not observed. In the SOLO study, protease resistance mutations were not observed in viral isolates from patients experiencing treatment failure with ritonavir-boosted fosamprenavir-based therapy. In conclusion, fosamprenavir-based regimens have shown good antiviral efficacy and are generally well tolerated in antiretroviral therapy-naive patients with HIV infection. Available data on the resistance profile of the drug suggest that it may be used early in the course of therapy without compromising a range of future treatment options. The relatively low pill burden and lack of food restrictions with fosamprenavir may improve adherence to therapy. Further studies are needed to compare fosamprenavir with other PIs and to establish the long-term efficacy of fosamprenavir-based regimens. In conclusion, fosamprenavir appears to be a promising agent for the treatment of antiretroviral therapy-naive patients with HIV infection.
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PMID:Fosamprenavir: a review of its use in the management of antiretroviral therapy-naive patients with HIV infection. 1534 7

Oritavancin is a lipoglycopeptide with bactericidal activity against Gram-positive organisms. Its rapid concentration-dependent bactericidal activity and long elimination half-life allow single-dose treatment of acute bacterial skin and skin structure infections (ABSSSI). SOLO I and SOLO II were randomized, double-blind studies evaluating the efficacy and safety of a single 1,200-mg intravenous (i.v.) dose of oritavancin versus twice-daily i.v. vancomycin for 7 to 10 days in ABSSSI patients. Safety data from both studies were pooled for safety analysis. The database comprised pooled safety data for 976 oritavancin-treated patients and 983 vancomycin-treated patients. The incidences of adverse events, serious adverse events, and discontinuations due to adverse events were similar for oritavancin (55.3, 5.8, and 3.7%, respectively) and vancomycin (56.9, 5.9, and 4.2%, respectively). The median time to onset (3.8 days versus 3.1 days, respectively) and the duration (3.0 days for both groups) of adverse events were also similar between the two groups. The most frequently reported events were nausea, headache, and vomiting. Greater than 90% of all events were mild or moderate in severity. There were slightly more infections and infestations, abscesses or cellulitis, and hepatic and cardiac adverse events in the oritavancin group; however, more than 80% of these events were mild or moderate. Subgroup analyses did not identify clinically meaningful differences in the incidence of adverse events attributed to oritavancin. A single 1,200-mg dose of oritavancin was well tolerated and had a safety profile similar to that of twice-daily vancomycin. The long elimination half-life of oritavancin compared to that of vancomycin did not result in a clinically meaningful delay to the onset or prolongation of adverse events. (This study has been registered at ClinicalTrials.gov under registration no. NCT01252719 and NCT01252732.).
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PMID:Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies. 2935 92