{"id":523,"date":"2026-08-06T11:58:02","date_gmt":"2026-08-06T11:58:02","guid":{"rendered":"https:\/\/www.merckconnect.com\/idvynso\/?page_id=523"},"modified":"2026-08-20T09:14:28","modified_gmt":"2026-08-20T09:14:28","slug":"trial-052-efficacy-data","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/idvynso\/trial-052-efficacy-data\/","title":{"rendered":"Trial 052 – Efficacy data"},"content":{"rendered":"\n\n
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In Trial 052, IDVYNSOTM<\/sup> (doravirine\/islatravir) demonstrated non-inferiority to Biktarvy<\/em>\u00ae (BIC\/FTC\/TAF)<\/h1>

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Trial 052 efficacy data<\/strong><\/h2><\/div>\n\n\n\n
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IDVYNSO demonstrated non-inferiority to Biktarvy<\/em>\u00ae (BIC\/FTC\/TAF)a<\/sup> in this double-blinded trial as assessed by the proportion of participants with HIV-1<\/strong> RNA \u226550 copies\/mL<\/span> at week 48.<\/strong><\/p><\/div><\/div>\n\n\n\n

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In Trial 052, 342 participants were switched from BIC\/FTC\/TAF to IDVYNSO.<\/p><\/div><\/div>\n\n\n\n

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Virologic outcomes at week 48 in virologically suppressed adults who were switched to IDVYNSO<\/strong><\/h3><\/div>\n\n\n\n
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Virologic outcomes at week 48 in virologically-suppressed adults who were switched to IDVYNSO.<\/title>Bar charts for virologic outcomes at week 48 in virologically suppressed adults in Trial 052 (N=513), who were switched to IDVYNSO (n=342) compared with BIC\/FTC\/TAF (n=171). The bars for IDVYNSO group are fuchsia pink and the bars for BIC\/FTC\/TAF group are striped in dark gray. Primary endpoint was the proportion of participants with HIV-1 RNA at or above 50 copies per mL and it was 1% in IDVYNSO group and 1% in BIC\/FTC\/TAF group. The primary endpoint showed a treatment difference of 0.9% with a 95% confidence interval of negative 1.9% to 2.9%. The proportion of participants with HIV-1 RNA below 50 copies per mL was 92% in IDVYNSO group and 94% in BIC\/FTC\/TAF group. There were no virologic data in 7% of participants in IDVYNSO group and 5% in BIC\/FTC\/TAF group.<\/desc><\/rect><\/rect><\/rect><\/rect><\/rect><\/rect><\/rect><\/path><\/path><\/path><\/path><\/path><\/path><\/path><\/path><\/path><\/path><\/rect><\/rect><\/rect><\/rect><\/path><\/path><\/rect><\/path><\/rect><\/rect><\/rect><\/path><\/rect><\/rect><\/rect><\/rect><\/path><\/path><\/path><\/path><\/rect><\/path><\/rect><\/rect><\/rect><\/path><\/rect><\/path><\/rect><\/rect><\/rect><\/rect><\/path><\/path><\/use><\/use><\/use><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/g><\/pattern><\/defs><\/svg> <\/div><\/div>
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Virologic outcomes at week 48 in virologically-suppressed adults who were switched to IDVYNSO.<\/title>Bar charts for virologic outcomes at week 48 in virologically suppressed adults in Trial 052 (N=513), who were switched to IDVYNSO (n=342) compared with BIC\/FTC\/TAF (n=171). The bars for IDVYNSO group are fuchsia pink and the bars for BIC\/FTC\/TAF group are striped in dark gray. Primary endpoint was the proportion of participants with HIV-1 RNA at or above 50 copies per mL and it was 1% in IDVYNSO group and 1% in BIC\/FTC\/TAF group. The primary endpoint showed a treatment difference of 0.9% with a 95% confidence interval of negative 1.9% to 2.9%. The proportion of participants with HIV-1 RNA below 50 copies per mL was 92% in IDVYNSO group and 94% in BIC\/FTC\/TAF group. There were no virologic data in 7% of participants in IDVYNSO group and 5% in BIC\/FTC\/TAF group.<\/desc><\/rect><\/rect><\/rect><\/rect><\/rect><\/rect><\/rect><\/path><\/path><\/path><\/path><\/path><\/path><\/path><\/path><\/path><\/path><\/rect><\/rect><\/rect><\/rect><\/path><\/path><\/rect><\/path><\/rect><\/rect><\/rect><\/path><\/rect><\/rect><\/rect><\/rect><\/path><\/path><\/path><\/path><\/rect><\/path><\/rect><\/rect><\/rect><\/path><\/rect><\/path><\/rect><\/rect><\/rect><\/rect><\/path><\/path><\/use><\/use><\/use><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/g><\/pattern><\/defs><\/svg> <\/div><\/div><\/div>\n\n\n
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a<\/sup>Biktarvy is a registered trademark of Gilead Sciences Ireland UC.<\/p><\/div><\/div>\n\n\n\n

b<\/sup>CIs were calculated based on the unstratified Miettinen and Nurminen method for Trial 052; non-inferiority (NI) was assessed using an NI margin of 4%.<\/p><\/div><\/div>\n\n\n\n

c<\/sup>Includes participants who discontinued because of AE or death if this resulted in no virologic data on treatment during the Week 48 window.<\/p><\/div><\/div>\n\n\n\n

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