{"id":3592,"date":"2024-03-19T09:17:09","date_gmt":"2024-03-19T09:17:09","guid":{"rendered":"https:\/\/www.merckconnect.com\/doravirine\/?page_id=3592"},"modified":"2025-06-12T11:35:09","modified_gmt":"2025-06-12T11:35:09","slug":"delstrigo-clinical-efficacy","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/doravirine\/delstrigo-clinical-efficacy\/","title":{"rendered":"Efficacy"},"content":{"rendered":"<link rel='stylesheet' id='vivid360-heading-css-css' href='https:\/\/www.merckconnect.com\/doravirine\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/heading\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"vivid360-heading\" id=\"a3251a56c-37f4-4913-b9c7-b6670908ad1a\"><h1 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:30px;--tabletFontSize:30px;--mobileFontSize:22px;--desktopLineHeightSize:45px;--tabletLineHeightSize:45px;--mobileLineHeightSize:\" id=\"top\"><strong>Efficacy data for DELSTRIGO<strong><sup>\u00ae<\/sup><\/strong> (doravirine\/lamivudine\/tenofovir disoproxil fumarate)<\/strong><\/h1><\/div>\n\n\n<link rel='stylesheet' id='vivid360-spacer-css-css' href='https:\/\/www.merckconnect.com\/doravirine\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/spacer\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div style=\"background-color:transparent;--desktop-spacer:24px;--tablet-spacer:24px;--mobile-spacer:24px;height:24px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<p class=\"has-black-color has-text-color has-regular-font-size\">Learn about:<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n<link rel='stylesheet' id='vivid360-list-css-css' href='https:\/\/www.merckconnect.com\/doravirine\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/list\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"vivid-block-list content-width  default-list block-73f79d99-6efd-44f3-8d07-ddffa202bbd0 custom-colored-hyperlink\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-73f79d99-6efd-44f3-8d07-ddffa202bbd0\"><ul class=\"first-level\"><li><a href=\"#driveshift\">Efficacy in virologically suppressed adults, DRIVE-SHIFT<\/a><\/li><li><a href=\"#efficacy\">Efficacy in treatment-na\u00efve adults, DRIVE-AHEAD<\/a><\/li><\/ul><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:24px;--tablet-spacer:24px;--mobile-spacer:24px;height:24px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div class=\"paragraph-wrapper\"><div class=\"_f3ca6372-0ec0-44da-860a-9bca0cb09170 \" id=\"driveshift\"><p class=\"has-black-color has-text-color\"><strong>DRIVE-SHIFT:<\/strong>&nbsp;In a 48-week study of virologically suppressed adults with HIV-1 who changed regimens:<\/p><\/div><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"ad218b689-b158-47da-b206-62074915e72d\"><h2 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>DELSTRIGO demonstrated powerful virologic suppression<sup>1<\/sup><\/strong><\/h2><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n<link rel='stylesheet' id='vivid360-image-css-css' href='https:\/\/www.merckconnect.com\/doravirine\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/image\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"wp-block-vivid360-image img-container\"><figure class=\"wp-block-vivid360-image is-style-default size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/DE_CEfficacy_001.svg\" alt=\"Graph Showing Efficacy Outcome Data in the Percentage of Virologically Suppressed Patients in the DELSTRIGO\u00ae (Doravirine\/Lamivudine\/Tenofovir Disoproxil Fumarate) Immediate Switch Group (ISG) at Week 48 vs the Delayed Switch Group (DSG) at Week 24 In the DRIVE-SHIFT Study\" class=\"wp-image-3603  style-noshadow\" width=\"753\" height=\"444\" style=\"height:auto;width:auto\" srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2024\/03\/DE_CEfficacy_001.svg 650w, https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2024\/03\/DE_CEfficacy_001.svg?resize=300,177 300w\" sizes=\"auto, (max-width: 753px) 100vw, 753px\" \/><\/figure><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-primary-dark-color has-text-color\"><a href=\"#DriveStudyDesign\">View DRIVE-SHIFT study design<\/a><\/p>\n\n\n\n<div style=\"background-color:transparent;height:32px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-32\"><\/div>\n\n\n\n<p><strong>DRIVE-SHIFT:<\/strong> In a 144-week extension phase (week 48 to week 144):<\/p>\n\n\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"a47fb7625-1fe5-4a11-b7af-7d2aeee219a3\"><h2 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong><strong>Virologic suppression was assessed<sup>2<\/sup><\/strong><\/strong><\/h2><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-black-color has-text-color\">Participants who completed the week-48 visit were eligible to continue receiving open-label DELSTRIGO for an additional 96 weeks, up to week 144.<sup>1,2<\/sup> <\/p>\n\n\n\n<div class=\"wp-block-vivid360-image img-container\"><figure class=\"wp-block-vivid360-image is-style-default has-mobile-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"650\" height=\"337\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/DE_CEfficacy_002_0125v3.svg\" alt=\"\" class=\"wp-image-3607  style-noshadow\" style=\"height:auto;width:auto\" srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2024\/03\/DE_CEfficacy_002_0125v3.svg 650w, https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2024\/03\/DE_CEfficacy_002_0125v3.svg?resize=300,156 300w\" sizes=\"auto, (max-width: 650px) 100vw, 650px\" \/><img decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/DE_CEfficacy_002_0125v3.svg\" alt=\"Graph Showing Efficacy Outcome Data in the Percentage of Virologically Suppressed Patients in the DELSTRIGO\u00ae (Doravirine\/Lamivudine\/Tenofovir Disoproxil Fumarate) Immediate Switch Group (ISG) vs the Baseline Regimen Delayed Switch Group (DSG) at Week 144 in the DRIVE-SHIFT Extension Phase Study\" class=\"wp-image-3607  style-noshadow mobile-image\" width=\"auto\" height=\"auto\" title=\"\" style=\"height:auto;width:auto\" srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2024\/03\/DE_CEfficacy_002_0125v3.svg 650w, https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2024\/03\/DE_CEfficacy_002_0125v3.svg?resize=300,156 300w\" sizes=\"(max-width: 650px) 100vw, 650px\" \/><figcaption class=\"caption-align-left\"><sup>a<\/sup>Participants had no virologic data at 144 weeks primarily due to treatment discontinuation for reasons other than adverse events or death.<sup>2<\/sup><\/figcaption><figcaption class=\"caption-align-left mobile-caption\"><sup>a<\/sup>Participants had no virologic data at 144 weeks primarily due to treatment discontinuation for reasons other than AEs or death.<\/figcaption><\/figure><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Limitation:<\/strong> No formal statistics testing was planned for this updated analysis and, therefore, no statistical conclusions can be drawn.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<p class=\"has-primary-dark-color has-text-color\"><a href=\"#DriveStudyDesign\">View DRIVE-SHIFT study design<\/a><\/p>\n\n\n\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<div class=\"paragraph-wrapper\"><div class=\"_5515deac-c2f3-4fd7-9a47-5f7023b6142c \" id=\"efficacy\"><p class=\"has-black-color has-text-color\"><strong>DRIVE-AHEAD:<\/strong>&nbsp;A 96-week study evaluating the efficacy of DELSTRIGO in treatment-na\u00efve adult participants with HIV-1 demonstrated:<\/p><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:4px;--tablet-spacer:4px;--mobile-spacer:4px;height:4px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"a05e5d53e-0363-482a-9644-320e516664c6\"><h2 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong><strong>Durable virologic suppression<\/strong><sup><strong>3,4<\/strong><\/sup><\/strong><\/h2><\/div>\n\n\n\n<div class=\"wp-block-vivid360-image img-container\"><figure class=\"wp-block-vivid360-image is-style-default has-mobile-image size-large is-resized\"><img decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/DEL_DriveAhead_Efficacy_96Wk_0d9192.svg\" alt=\"Graph Showing Percentage of Participants With HIV-1 RNA <50 Copies\/ML for DELSTRIGO\u00ae (Doravirine\/Lamivudine\/Tenofovir Disoproxil Fumarate) vs EFV\/FTC\/TDF at Week 48 and Week 96 in the DRIVE AHEAD: 96-Week Study Evaluating the Efficacy of DELSTRIGO In Treatment-Na\u00efve Patients with HIV-1\" class=\"wp-image-4218  style-noshadow\" height=\"590\" style=\"height:590px;width:auto\" srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2025\/05\/DEL_DriveAhead_Efficacy_96Wk_0d9192.svg 650w, https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2025\/05\/DEL_DriveAhead_Efficacy_96Wk_0d9192.svg?resize=300,160 300w\" sizes=\"(max-width: 650px) 100vw, 650px\" \/><img decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/DEL_DriveAhead_Efficacy_96Wk_0d9192.svg\" alt=\"Graph Showing Percentage of Participants With HIV-1 RNA <50 Copies\/ML for DELSTRIGO\u00ae (Doravirine\/Lamivudine\/Tenofovir Disoproxil Fumarate) vs EFV\/FTC\/TDF at Week 48 and Week 96 in the DRIVE AHEAD: 96-Week Study Evaluating the Efficacy of DELSTRIGO In Treatment-Na\u00efve Patients with HIV-1\" class=\"wp-image-4218  style-noshadow mobile-image\" width=\"auto\" height=\"auto\" title=\"\" style=\"height:auto;width:auto\" srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2025\/05\/DEL_DriveAhead_Efficacy_96Wk_0d9192.svg 650w, https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/\/2025\/05\/DEL_DriveAhead_Efficacy_96Wk_0d9192.svg?resize=300,160 300w\" sizes=\"(max-width: 650px) 100vw, 650px\" \/><\/figure><\/div>\n\n\n\n<p class=\"has-medium-font-size\">21% of adult participants at baseline had HIV-1 RNA &gt;100,000 <span class=\"no-wrap-text\">copies\/mL.<\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-primary-dark-color has-text-color\"><a href=\"#driveaheadStudy\">View DRIVE-AHEAD study design<\/a><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"a0ed9bb55-3a2a-4036-9e9d-4e41d111f634\"><h2 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>Study designs<\/strong><\/h2><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:4px;--tablet-spacer:4px;--mobile-spacer:4px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"a7739c1e9-e8cb-4b67-8c9a-e7fa98f428e4\"><h3 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"DriveStudyDesign\"><strong>DRIVE-SHIFT study design<\/strong><\/h3><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-black-color has-text-color\">A randomized, multicenter, active-controlled, non-inferiority, open-label, phase 3 trial of adult participants with virologically suppressed HIV-1 for \u22656 months on 2 NRTIs with a PI plus either ritonavir or cobicistat, elvitegravir plus cobicistat, or an NNRTI, with no history of virologic failure. Participants were either immediately switched to DELSTRIGO on day 1 of the 48-week trial (Immediate Switch Group [ISG; n=447]) or continued their baseline regimen and switched after 24 weeks (Delayed Switch Group [DSG; n=223]) to DELSTRIGO.<span class=\"no-wrap-text\"><sup>1,2<\/sup><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Extension study:<\/strong> Participants who completed the 48-week visit were eligible to continue receiving open-label DELSTRIGO for an additional 96 weeks, up to week 144.<sup>1,2<\/sup><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Primary efficacy end point:<\/strong> Percentage of participants with <span class=\"no-wrap-text\">HIV-1<\/span> RNA <span class=\"no-wrap-text\">\u226550<\/span> <span class=\"no-wrap-text\">copies\/mL<\/span> in the ISG at week 48 vs the DSG at week 24: 2% for DELSTRIGO vs 1% for the baseline regimen. Difference <span class=\"no-wrap-text\">(95% CI):<\/span> 0.7 <span class=\"no-wrap-text\">(-1.3, 2.6).<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Additional efficacy end point:<\/strong> Percentage of participants with <span class=\"no-wrap-text\">HIV-1<\/span> RNA <span class=\"no-wrap-text\">&lt;50<\/span> <span class=\"no-wrap-text\">copies\/mL<\/span> in the ISG at week 48 vs the DSG at week 24: 91% for DELSTRIGO vs 95% for the baseline <span class=\"no-wrap-text\">regimen.<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Safety end point:<\/strong> For participants whose baseline regimen included a PI plus ritonavir: Mean change from baseline to week 24 in fasting LDL-C and <span class=\"no-wrap-text\"><span class=\"no-wrap-text\">non-HDL-C.<sup>1<\/sup><\/span><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"ad353a41b-9228-4f31-b14f-f128502a289c\"><h3 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"driveaheadStudy\"><strong>DRIVE-AHEAD study design<\/strong><\/h3><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>A randomized, multicenter, double-blind, active-controlled, non-inferiority, phase 3 trial comparing DELSTRIGO once daily <span class=\"no-wrap-text\">(n=364)<\/span> vs <span class=\"no-wrap-text\">600 mg<\/span> <span class=\"no-wrap-text\">EFV\/200 mg<\/span> <span class=\"no-wrap-text\">FTC\/300 mg<\/span> TDF once daily <span class=\"no-wrap-text\">(n=364)<\/span> in treatment-na\u00efve adult participants with <span class=\"no-wrap-text\">HIV-1<\/span> RNA <span class=\"no-wrap-text\">\u22651000<\/span> <span class=\"no-wrap-text\">copies\/mL.<sup>3,4<\/sup><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Primary efficacy end point:<\/strong> Percentage of participants with <span class=\"no-wrap-text\">HIV-1<\/span> RNA <span class=\"no-wrap-text\">&lt;50<\/span> <span class=\"no-wrap-text\">copies\/mL<\/span> at week 48 for DELSTRIGO vs <span class=\"no-wrap-text\">EFV\/FTC\/TDF:<\/span> 84% vs 81%. Difference <span class=\"no-wrap-text\">(95% CI):<\/span> 3.5 <span class=\"no-wrap-text\">(-2.0, 9.0).<sup>3<\/sup><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Secondary efficacy end point:<\/strong> Percentage of participants with <span class=\"no-wrap-text\">HIV-1<\/span> RNA <span class=\"no-wrap-text\">&lt;50<\/span> <span class=\"no-wrap-text\">copies\/mL<\/span> at week 96 for DELSTRIGO vs <span class=\"no-wrap-text\">EFV\/FTC\/TDF:<\/span> 77% vs 74%. Difference <span class=\"no-wrap-text\">(95% CI):<\/span> 3.8 <span class=\"no-wrap-text\">(-2.4, 10.0).<sup>4<\/sup><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Primary safety end point:<\/strong> Percentage of participants with three <span class=\"no-wrap-text\">pre-specified<\/span> neuropsychiatric events (dizziness, sleep disorders\/disturbances, and altered sensorium) at week <span class=\"no-wrap-text\">48.<sup>3,a,b<\/sup><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid-block-list content-width  default-list block-569232fe-e034-452c-bdf6-6d19e4ca72c2\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-569232fe-e034-452c-bdf6-6d19e4ca72c2\"><ul class=\"first-level\"><li>Dizziness: 9% for DELSTRIGO vs 37% for <span class=\"no-wrap-text\">EFV\/FTC\/TDF.<\/span> Difference <span class=\"no-wrap-text\">(95% CI):<\/span> -28.3 <span class=\"no-wrap-text\">(-34.0, -22.5);<\/span> <span class=\"no-wrap-text\"><em>P<\/em>&lt;0.001<\/span><\/li><li>Sleep disorders and disturbances<sup>c<\/sup>: 12% for DELSTRIGO vs 26% for <span class=\"no-wrap-text\">EFV\/FTC\/TDF.<\/span> Difference <span class=\"no-wrap-text\">(95% CI):<\/span> -13.5<span class=\"no-wrap-text\"> (-19.1, -7.9); <em>P<\/em>&lt;0.001<\/span><\/li><li>Altered sensorium<sup>d<\/sup>: 4% for DELSTRIGO vs 8% for <span class=\"no-wrap-text\">EFV\/FTC\/TDF.<\/span> Difference <span class=\"no-wrap-text\">(95% CI):<\/span> -3.8 <span class=\"no-wrap-text\">(-7.6, -0.3);<\/span> <span class=\"no-wrap-text\"><em>P<\/em>=0.033<\/span><\/li><\/ul><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Safety end point:<\/strong> Mean change from baseline to week 48 in fasting <span class=\"no-wrap-text\">LDL-C<\/span> and <span class=\"no-wrap-text\">non-HDL-C.<sup>3<\/sup><\/span><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-small-font-size\"><sup>a<\/sup>n=364 for each treatment group.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-small-font-size\"><sup>b<\/sup>The 95% CIs were calculated using Miettinen and Nurminen&#8217;s method.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-small-font-size\"><sup>c<\/sup>Predefined using MedDRA preferred terms, including: abnormal dreams, hyposomnia, initial insomnia, insomnia, nightmare, sleep disorder, and somnambulism.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-small-font-size\"><sup>d<\/sup>Predefined using MedDRA preferred terms, including: altered state of consciousness, lethargy, somnolence, and syncope.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"a8a42dcbf-300c-4c9f-9453-23042d88b792\"><h3 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:18px;--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:27px;--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>Acronyms<\/strong><\/h3><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-black-color has-text-color\">EFV, efavirenz; FTC, emtricitabine; HDL-C, high-density lipoprotein-cholesterol; LDL-C, low-density lipoprotein-cholesterol; MedDRA, Medical Dictionary for Regulatory Activities; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTIs, nucleoside reverse transcriptase inhibitors; PI, protease inhibitor; RNA, ribonucleic acid; TDF, tenofovir disoproxil fumarate.<\/p>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:24pxpx;--tablet-spacer:24pxpx;--mobile-spacer:24pxpx;height:24pxpx\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"ae90d231b-162c-469a-bb7d-6d79cbeed532\"><h3 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:18px;--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:27px;--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>References<\/strong><\/h3><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid-block-list content-width  block-6bbeaba4-39f1-4a8a-9731-926275c57777\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#000\" data-client-id=\"block-6bbeaba4-39f1-4a8a-9731-926275c57777\"><ol class=\"first-level default-order\"><li>Johnson M, Kumar P, Molina JM, et al; for the DRIVE-SHIFT Study Group. Switching to doravirine\/lamivudine\/tenofovir disoproxil fumarate (DOR\/3TC\/TDF) maintains <span class=\"no-wrap-text\">HIV-1<\/span> virologic suppression through 48 weeks: results of the DRIVE-SHIFT trial. <em>J Acquir Immune Defic Syndr<\/em>. 2019;81(4):463-472. doi:10.1097\/QAI.0000000000002056.<\/li><li>Kumar P, Johnson M, Molina JM, et al; for the DRIVE-SHIFT Study Group. Switching to DOR\/3TC\/TDF maintains HIV-1 virologic suppression through week 144 in the DRIVE-SHIFT trial.<span class=\"no-wrap-text\"> <em>J Acquir Immune Defic Syndr<\/em>.<\/span> 2021;87(2):801- 805. doi:10.1097\/QAI.0000000000002642.<\/li><li>Orkin C, Squires KE, Molina JM, et al; for the DRIVE-AHEAD Study Group. Doravirine\/lamivudine\/tenofovir disoproxil fumarate is non-inferior to efavirenz\/ emtricitabine\/tenofovir disoproxil fumarate in treatment-naive adults with human immunodeficiency virus-1 infection: week 48 results of the DRIVE-AHEAD trial. <em>Clin Infect Dis<\/em>. 2019;68(4):535-544. doi: 10.1093\/cid\/ciy540.<\/li><li>Orkin C, Squires KE, Molina JM, et al. Doravirine\/lamivudine\/tenofovir disoproxil fumarate (TDF) versus efavirenz\/emtricitabine\/TDF in treatment-naive adults with human immunodeficiency virus type 1 infection: week 96 results of the randomized, double-blind, phase 3 DRIVE-AHEAD noninferiority trial. <em>Clin Infect Dis<\/em>. 2021;73(1):33-42. doi: 10.1093\/cid\/ciaa822.<\/li><\/ol><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p class=\"has-primary-dark-color has-text-color\"><a href=\"#top\">Back to top<\/a><\/p>\n\n\n<link rel='stylesheet' id='vivid360-modal-css-css' href='https:\/\/www.merckconnect.com\/doravirine\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/modal\/css\/style.min.css?ver=1770643873' media='all' \/>\n\n<div class=\"wp-block-vivid360-modal\"><div><div class=\"vivid360-modal-block-container is-style-passive-modal\"><div class=\"vivid360-modal-trigger-container\"><span data-design-module=\"modal\" data-design-category=\"modal-page-load\" class=\"vivid360-modal-trigger-pageload\" data-page-load-parameter=\"safety_overlay\"><\/span><\/div><div class=\"vivid360-modal-container vivid360-modal-blurredBgBlack\"><div class=\"vivid360-modal larger_modal\"><div class=\"vivid360-modal-content-area\"><a class=\"vivid360-modal-close-modal-span\" role=\"button\" aria-label=\"modal popup close\"><i class=\"icon-close\"><\/i><\/a><div class=\"modal-flex-container\"><div class=\"vivid360-modal-label-container  title-left\" style=\"--titleColor:#12838e\"><h2>Selected Indications<\/h2><\/div><div class=\"vivid360-modal-content-container has-regular-font-size\">\n<p>PIFELTRO\u00ae (doravirine) is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>DELSTRIGO\u00ae (doravirine\/lamivudine\/tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.<\/p>\n\n\n\n<div class=\"paragraph-wrapper\"><div class=\"_33ee7ab0-c983-4d9c-bce6-3dc21a61328c \" id=\"\"><p class=\"has-primary-dark-color has-text-color\" style=\"font-size:24px\">&nbsp;<br><strong>Selected Safety Information<\/strong><\/p><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n<link rel='stylesheet' id='vivid360-card-css-css' href='https:\/\/www.merckconnect.com\/doravirine\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/card\/css\/style.min.css?ver=1773241827' media='all' \/>\n\n<div id=\"\" class=\"wp-block-vivid360-card a2f0f55ed-ec44-4e06-9c34-c125100635ce vivid360-block-card has-text-align-left card-basic full-page-width\" style=\"border-width:3px;border-style:solid;border-radius:0;color:#111 !important\"><div class=\"card-content\"><div class=\"card-content-wrap\"><div class=\"card-desc has-regular-font-size\">\n<p class=\"has-text-align-center has-large-font-size\"><strong>WARNING: POSTTREATMENT ACUTE EXACERBATION OF <strong><strong>HEPATITIS B VIRUS (HBV)<\/strong><\/strong> FOR <em>DELSTRIGO<\/em><\/strong><\/p>\n\n\n\n<p><strong>All patients with HIV-1 should be tested for the presence of <strong><strong><strong>HBV<\/strong><\/strong><\/strong> before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in people with concomitant HIV-1 and HBV who have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with <span class=\"no-wrap-text\">HIV-1<\/span> and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted.<\/strong><\/p>\n<\/div><\/div><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Contraindications<\/strong><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>PIFELTRO and DELSTRIGO are contraindicated when coadministered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John\u2019s wort (<em>Hypericum perforatum<\/em>)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Warnings and Precautions<\/strong><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><em><strong>Severe Skin Reactions<\/strong><\/em><br>Severe skin reactions, including Stevens-Johnson syndrome (SJS)\/toxic epidermal necrolysis (TEN), have been reported during the postmarketing experience with doravirine-containing regimens. Discontinue PIFELTRO or DELSTRIGO, and other medications known to be associated with severe skin reactions, immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Clinical status should be closely monitored, and appropriate therapy should be initiated.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><em><strong>New or Worsening Renal Impairment<\/strong><\/em><br>Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in people living with HIV with risk factors for renal dysfunction who appeared stable on TDF.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL\/min.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><em><strong>Bone Loss and Mineralization Defects<\/strong><\/em><br>In clinical trials in adults living with HIV, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF. The effects of TDF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in adults are unknown.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><em><strong>Immune Reconstitution Syndrome<\/strong><\/em><br>Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><em><strong>Drug Interactions<\/strong><\/em><br>Because DELSTRIGO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>Coadministration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>If DELSTRIGO is coadministered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>If PIFELTRO is coadministered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart).<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Dosage and Administration\/Specific Populations<\/strong><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><em><strong>Renal Impairment<\/strong><\/em><br>Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL\/min.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Adverse Reactions<\/strong><br>The most common adverse reactions with DELSTRIGO (incidence \u22655%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence \u22655%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%).<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>By week 96 in DRIVE-FORWARD, 2% of adult participants in the PIFELTRO group and 3% in the darunavir+ritonavir (DRV+r) group had adverse events leading to discontinuation of study medication.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>By week 96 in DRIVE-AHEAD, 3% of adult participants in the DELSTRIGO group and 7% in the efavirenz (EFV)\/emtricitabine (FTC)\/TDF group had adverse events leading to discontinuation of study medication.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>In DRIVE-FORWARD, mean changes from baseline at week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg\/dL in the PIFELTRO group vs <span class=\"no-wrap-text\">9.5 mg\/dL<\/span> in the DRV+r group. Non-HDL-C: <span class=\"no-wrap-text\">-5.4 mg\/dL<\/span> in the PIFELTRO group vs <span class=\"no-wrap-text\">13.7 mg\/dL<\/span> in the DRV+r group. The clinical benefits of these findings have not been demonstrated.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>In DRIVE-AHEAD, mean changes from baseline at week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: <span class=\"no-wrap-text\">-2.1 mg\/dL<\/span> in the DELSTRIGO group vs <span class=\"no-wrap-text\">8.3 mg\/dL<\/span> in the EFV\/FTC\/TDF group. Non-HDL-C: <span class=\"no-wrap-text\">-4.1 mg\/dL<\/span> in the DELSTRIGO group vs <span class=\"no-wrap-text\">12.7 mg\/dL<\/span> in the EFV\/FTC\/TDF group. The clinical benefits of these findings have not been demonstrated.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>In DRIVE-SHIFT, mean changes from baseline at week 24 in LDL-C and non-HDL-C were pre-specified. LDL-C: <span class=\"no-wrap-text\">-16.3 mg\/dL<\/span> in the DELSTRIGO group vs <span class=\"no-wrap-text\">-2.6 mg\/dL<\/span> in the PI + ritonavir group. Non-HDL-C: <span class=\"no-wrap-text\">-24.8 mg\/dL<\/span> in the DELSTRIGO group vs <span class=\"no-wrap-text\">-2.1 mg\/dL<\/span> in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult participants in the DELSTRIGO group and 26% in the EFV\/FTC\/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV\/FTC\/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV\/FTC\/TDF group reported altered sensorium.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The safety of DELSTRIGO in <span class=\"no-wrap-text\">virologically-suppressed<\/span> adults was based on week 48 data from participants in the DRIVE-SHIFT trial. Overall, the safety profile in <span class=\"no-wrap-text\">virologically-suppressed<\/span> adult participants was similar to that in participants with no ARV treatment history.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Pregnancy\/Breastfeeding<\/strong><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO or DELSTRIGO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at <span class=\"no-wrap-text\">1-800-258-4263<\/span>.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>Inform individuals with HIV-1 infection of the potential risks of breastfeeding, including: (1) HIV-1 transmission (in HIV-1\u2013negative infants), (2) developing viral resistance (in HIV-1\u2013positive infants), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Specific Populations<\/strong><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong><em>Renal Impairment<\/em><\/strong><\/p>\n\n\n\n<p>No dosage adjustment of PIFELTRO is necessary for patients with mild, moderate, or severe renal impairment. PIFELTRO has not been adequately studied in patients with end-stage renal disease and has not been studied in dialysis patients.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF, both components of DELSTRIGO, cannot be altered, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL\/min.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong><em>Hepatic Impairment<\/em><\/strong><\/p>\n\n\n\n<p>No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. PIFELTRO and DELSTRIGO have not been studied in patients with severe hepatic impairment.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Before prescribing PIFELTRO\u00ae (doravirine), please read the accompanying <a class=\"custom-colored-hyperlink\" href=\"https:\/\/www.merck.com\/product\/usa\/pi_circulars\/p\/pifeltro\/pifeltro_pi.pdf\">Prescribing Information<\/a>. The <a href=\"https:\/\/www.merck.com\/product\/usa\/pi_circulars\/p\/pifeltro\/pifeltro_ppi.pdf\" class=\"custom-colored-hyperlink\">Patient Information<\/a> also is available. <\/strong><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><strong>Before prescribing DELSTRIGO\u00ae (doravirine\/lamivudine\/tenofovir disoproxil fumarate), please read the accompanying <a class=\"custom-colored-hyperlink\" href=\"https:\/\/www.merck.com\/product\/usa\/pi_circulars\/d\/delstrigo\/delstrigo_pi.pdf\">Prescribing Information<\/a>, including the Boxed Warning about posttreatment acute exacerbation of Hepatitis B. The <a class=\"custom-colored-hyperlink\" href=\"https:\/\/www.merck.com\/product\/usa\/pi_circulars\/d\/delstrigo\/delstrigo_ppi.pdf\">Patient Information<\/a> also is available.<\/strong><\/p>\n<\/div><div class=\"vivid360-modal-button-container desktop-container\"><div class=\"vivid360-button-block\"><a class=\"btn primary primary-regular btn-confirm  vivid360-modal-dismiss-button\" role=\"button\" aria-label=\"Button 1\" style=\"font-size:14px\" href=\"#!\" title=\"Button 1\" target=\"_self\" rel=\"noopener\" data-design-category=\"button\" data-design-label=\"Button 1\" data-design-module=\"element\">Button 1<\/a><\/div><div class=\"vivid360-button-block\"><a class=\"btn primary primary-regular btn-dismissive  vivid360-modal-dismiss-button\" role=\"button\" aria-label=\"Button 2\" style=\"font-size:14px\" href=\"#!\" title=\"Button 2\" target=\"_self\" rel=\"noopener\" data-design-category=\"button\" data-design-label=\"Button 2\" data-design-module=\"element\">Button 2<\/a><\/div><\/div><\/div><\/div><div class=\"vivid360-modal-button-container mobile-container \"><div class=\"vivid360-button-block\"><a class=\"btn primary primary-regular btn-confirm  vivid360-modal-dismiss-button\" role=\"button\" aria-label=\"Button 1\" style=\"font-size:14px\" href=\"#!\" title=\"Button 1\" target=\"_self\" rel=\"noopener\" data-design-category=\"button\" data-design-label=\"Button 1\" data-design-module=\"element\">Button 1<\/a><\/div><div class=\"vivid360-button-block\"><a class=\"btn primary primary-regular btn-dismissive  vivid360-modal-dismiss-button\" role=\"button\" aria-label=\"Button 2\" style=\"font-size:14px\" href=\"#!\" title=\"Button 2\" target=\"_self\" rel=\"noopener\" data-design-category=\"button\" data-design-label=\"Button 2\" data-design-module=\"element\">Button 2<\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Learn about: DRIVE-SHIFT:&nbsp;In a 48-week study of virologically suppressed adults with HIV-1 who changed regimens: View DRIVE-SHIFT study design DRIVE-SHIFT: In a&#8230;<\/p>\n","protected":false},"author":389,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[268],"ga4_page_businessunit":[273],"ga4_page_campaign":[],"ga4_page_content_purpose":[295],"ga4_page_customer_journey_stage":[335],"ga4_page_customer_specialty":[359],"ga4_page_experience":[],"ga4_page_indication":[468],"ga4_page_material_intent":[589],"ga4_page_product":[621],"ga4_page_region":[951],"ga4_page_therapeuticarea":[969],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-3592","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ 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