{"id":533,"date":"2026-08-06T13:38:54","date_gmt":"2026-08-06T13:38:54","guid":{"rendered":"https:\/\/www.merckconnect.com\/idvynso\/?page_id=533"},"modified":"2026-08-20T08:42:53","modified_gmt":"2026-08-20T08:42:53","slug":"trial-051-efficacy-data","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/idvynso\/trial-051-efficacy-data\/","title":{"rendered":"Trial 051 – Efficacy data"},"content":{"rendered":"\n\n
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In Trial 051, IDVYNSOTM<\/sup> (doravirine\/islatravir) demonstrated non-inferiority to oral baseline ART<\/h1>

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Trial 051 efficacy data<\/strong><\/h2><\/div>\n\n\n\n
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IDVYNSO demonstrated non-inferiority to oral baseline ART in this open-label trial\u200b as assessed by the<\/strong> proportion of HIV-1 RNA >50 copies\/mL at week 48.<\/strong><\/p><\/div><\/div>\n\n\n\n

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In Trial 051, 366 participants were switched from oral baseline ART regimen 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 who were switched to IDVYNSO (n=366) in Trial 051(N=551), compared with oral baseline ART(n=185). The bars for IDVYNSO are fuchsia pink and the bars for oral baseline ART are hatch marked 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 5% in oral baseline ART group. The primary endpoint showed a treatment difference of negative 3.6% with a 95% confidence interval of negative 7.8% to negative 0.8%. The proportion of participants with HIV-1 RNA below 50 copies per mL was 96% in IDVYNSO group and 92% in oral baseline ART. There were no virologic data in 3% of participants in both groups.<\/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><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/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 who were switched to IDVYNSO (n=366) in Trial 051(N=551), compared with oral baseline ART(n=185). The bars for IDVYNSO are fuchsia pink and the bars for oral baseline ART are hatch marked 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 5% in oral baseline ART group. The primary endpoint showed a treatment difference of negative 3.6% with a 95% confidence interval of negative 7.8% to negative 0.8%. The proportion of participants with HIV-1 RNA below 50 copies per mL was 96% in IDVYNSO group and 92% in oral baseline ART. There were no virologic data in 3% of participants in both groups.<\/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><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/rect><\/g><\/pattern><\/use><\/use><\/use><\/rect><\/rect><\/g><\/pattern><\/defs><\/svg> <\/div><\/div><\/div>\n\n\n

a<\/sup>CIs were calculated based on the stratified Miettinen and Nurminen method with Cochran-Mantel-Haenszel weights for Trial 051 (with baseline ART as stratification factors); non-inferiority (NI) was assessed using an NI margin of 4%.<\/p><\/div><\/div>\n\n\n\n

b<\/sup>Includes participants who discontinued because of AE or death if this resulted in no virologic data on treatment during the Week 48 window. Other reasons include: lost to follow-up, physician decision, and withdrawal by participant.<\/p><\/div><\/div>\n\n\n\n

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