10 research outputs found

    An Indirect Comparison of Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate and Abacavir/Lamivudine + Dolutegravir in Initial Therapy

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    <div><p>Objectives</p><p>The objective of this analysis is to perform an indirect comparison of elvitegravir, cobicistat, emtricitabine and tenofovir DF (E/C/F/TDF) to abacavir/lamivudine and dolutegravir (ABC/3TC + DTG) by using 2 trials evaluating each of these regimens in comparison to efavirenz, emtricitabine and tenofovir DF (EFV/FTC/TDF).</p><p>Methods</p><p>An indirect comparison was performed by using a generalization of Bucher's methodology to calculate risk differences. Two phase III clinical trials (GS-US-236-0102 and SINGLE—described above) were used.</p><p>Results</p><p>Results of the indirect comparison showed no statistically significant risk difference of the efficacy endpoint of achieving HIV RNA < 50 copies/mL between E/C/F/TDF and ABC/3TC + DTG for the ITT population at weeks 48, 96 and 144: respectively -3.7% (CI95% = [-10.8%; 3.4%]), -5.2% (CI95% = [-13.2%; 2.8%]) and -3.1% (CI<sub>95%</sub> = [-12.0%; 5.7%]). There was no statistically significant differences in the risk difference for serious adverse events (5.7% (CI95% = [-2.2%; 12.3%])), drug related adverse event (2.7% (CI95% = [-7.0%;12.4%])), drug related serious adverse event (0.8% (CI95% = [-1.6%;3.2%])) and death (0.5% (CI95% = [-0.8%;1.8%])), respectively, between E/C/F/TDF and ABC/3TC + DTG. A significant difference was found for discontinuation due to adverse events with a higher rate for E/C/F/TDF (difference = 8.6% (CI95% = [3.3%; 13.9%])). There was also no statistically significant risk difference of the viral resistance of 1.2% (CI95% = [-1.2; 3.7]) between E/C/F/TDF and ABC/3TC + DTG at week 48, 1.7% at week 96 (CI95% = [-1.1; 4.5]) and 2.2% (CI95% = [-1.0; 5.4]) at week 144.</p></div

    Resistance—Indirect treatment comparison—E/C/F/TDF vs. ABC/3TC + DTG.

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    <p>To the right of zero favors E/C/F/TDF (If the risk difference percentage is higher (lower) than 0, this means that the proportion is higher (lower) for ABC/3TC + DTG in comparison to E/C/F/TDF).</p

    Efficacy,—Indirect treatment comparison—E/C/F/TDF vs. ABC/3TC + DTG.

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    <p>To the right of zero favors ABC/3TC/DTG (If the risk difference percentage is higher (lower) than 0, this means that the proportion is higher (lower) for ABC/3TC + DTG in comparison to E/C/F/TDF).</p

    Safety—Indirect treatment comparison—E/C/F/TDF vs. ABC/3TC + DTG.

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    <p>To the right of zero favors E/C/F/TDF (If the risk difference percentage is higher (lower) than 0, this means that the proportion is higher (lower) for ABC/3TC + DTG in comparison to E/C/F/TDF).</p
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