{"id":3608,"date":"2024-03-19T09:24:31","date_gmt":"2024-03-19T09:24:31","guid":{"rendered":"https:\/\/www.merckconnect.com\/doravirine\/?page_id=3608"},"modified":"2025-06-12T10:42:49","modified_gmt":"2025-06-12T10:42:49","slug":"pifeltro-resistance-data","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/doravirine\/pifeltro-resistance-data\/","title":{"rendered":"Resistance profile of PIFELTRO"},"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=\"a22d9bda7-0855-427d-8659-e78c37418f0d\"><h1 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:30px;--tabletFontSize:30px;--mobileFontSize:22px;--desktopLineHeightSize:45px;--tabletLineHeightSize:45px;--mobileLineHeightSize:\" id=\"top\"><strong>Resistance profile of PIFELTRO<strong><sup>\u00ae<\/sup><\/strong> (doravirine)<\/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;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\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>Learn about:<\/p>\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-8dcbe037-5734-4c37-a4c2-4d25b98e141a 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-8dcbe037-5734-4c37-a4c2-4d25b98e141a\"><ul class=\"first-level\"><li><a href=\"#DriveShift\">Resistance in virologically suppressed adults, DRIVE-SHIFT<\/a><\/li><li><a class=\"\" href=\"#DriveForward\">Resistance in treatment-na\u00efve adults, DRIVE-FORWARD<\/a><\/li><\/ul><\/div>\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<div class=\"paragraph-wrapper\"><div class=\"_7829e80f-0419-4685-929e-2f77f50290b4 \" id=\"DriveShift\"><p><strong>DRIVE-SHIFT:&nbsp;<\/strong>In a 48-week study of virologically suppressed adults, which evaluated doravirine-based FDC<sup>a<\/sup>&nbsp;(n=656):<\/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=\"a98866572-6b02-4f41-8a02-f2843f2e3c5c\"><h2 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong> Zero cases of doravirine resistance in two participants in the Immediate Switch Group (ISG) <span class=\"no-wrap-text\">at 48 weeks<\/span><\/strong><sup><span class=\"no-wrap-text\">1<\/span><\/sup><\/h2><\/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\"><div class=\"img-container mr-0 mb-0 ml-0\"><figure class=\"wp-block-vivid360-image is-style-default has-mobile-image aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/01\/CAT_PIFELTRO_resistance_48week_chart_RGB_MC.svg\" alt=\"Graphic Showing Virologic Outcomes After Switch to DOR\/3TC\/TDF in Patients Who Entered 48-Week DRIVE-SHIFT Study\" class=\"wp-image-4073  style-noshadow\" width=\"764\" height=\"544\" style=\"height:544px;width:764px\"\/><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/01\/CAT_PIFELTRO_resistance_48week_chart_RGB_MC.svg\" alt=\"Graphic Showing Virologic Outcomes After Switch to DOR\/3TC\/TDF in Patients Who Entered 48-Week DRIVE-SHIFT Study\" class=\"wp-image-4073  style-noshadow mobile-image\" width=\"245\" height=\"180\" title=\"Graphic Showing Virologic Outcomes After Switch to DOR\/3TC\/TDF in Patients Who Entered 48-Week DRIVE-SHIFT Study\" style=\"height:180px;width:245px\"\/><figcaption class=\"caption-align-left\"><sup>a<\/sup>Doravirine-based FDC (fixed-dose combination) = doravirine 100 mg\/lamivudine <span class=\"no-wrap-text\">300 mg<\/span>\/tenofovir disoproxil fumarate <span class=\"no-wrap-text\">300 mg<\/span> tablets.<br><sup>b<\/sup>Protocol-defined virologic failure is defined as two consecutive measurements of HIV-1 RNA \u226550 copies\/mL at least one week apart.<sup>1<\/sup><br><sup>c<\/sup>Neither of the two participants developed detectable genotypic or phenotypic resistance to doravirine, lamivudine, or tenofovir during treatment with a doravirine-based FDC.<br><sup>d<\/sup>This participant developed the RT M184M\/I substitution and phenotypic resistance to FTC and 3TC during treatment with their baseline regimen.<\/figcaption><figcaption class=\"caption-align-left mobile-caption\"><sup>a<\/sup>Doravirine-based FDC (fixed-dose combination) = doravirine 100 mg\/lamivudine 300 mg\/tenofovir disoproxil fumarate 300 mg tablets.<br \/>\n<sup>b<\/sup>Protocol-defined virologic failure is defined as two consecutive measurements of HIV-1 RNA \u226550 copies\/mL at least one week apart.<sup>1<\/sup><br \/>\n<sup>c<\/sup>Neither of the two participants developed detectable genotypic or phenotypic resistance to doraviririne, lamivudine, or tenofovir during treatment with a doravirine-based FDC.<br \/>\n<sup>d<\/sup>This participant developed the RT M184M\/I substitution and phenotypic resistance to FTC and 3TC during treatment with their baseline regimen.<\/figcaption><\/figure><\/div><\/div>\n\n\n\n<p class=\"has-primary-dark-color has-text-color\"><a href=\"#ShiftstudyDgn\">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 style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<p><strong>DRIVE-SHIFT: <\/strong>144-week extension phase evaluating doravirine-based FDC vs baseline regimen. In the <span class=\"no-wrap-text\">144-week<\/span>&nbsp;extension phase (week 48 to week 144), there were:<\/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;--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=\"af2b9145c-b796-47d7-bf3d-27a9e40e9083\"><h2 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>Zero cases of resistance to doravirine in the four participants with samples available at 144 weeks<sup>2,3,e<\/sup><\/strong><\/h2><\/div>\n\n\n\n<div class=\"wp-block-vivid360-image\"><div class=\"img-container mr-0 mb-0 ml-0\"><figure class=\"wp-block-vivid360-image is-style-default has-mobile-image aligncenter size-large is-resized\"><img decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/PIF_Resistance_144Wk_a5fde8.svg\" alt=\"Graphic Showing Virologic Outcomes After Switch to DOR\/3TC\/TDF in Patients Who Entered 144-Week Extension Phase in the DRIVE-SHIFT Study\n\" class=\"wp-image-7072  style-noshadow\" height=\"590\" style=\"height:590px;width:auto\"\/><img decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/PIF_Resistance_144Wk_a5fde8.svg\" alt=\"Graphic Showing Virologic Outcomes After Switch to DOR\/3TC\/TDF in Patients Who Entered 144-Week Extension Phase in the DRIVE-SHIFT Study\" class=\"wp-image-7072  style-noshadow mobile-image\" width=\"auto\" height=\"200\" title=\"Graphic Showing Virologic Outcomes After Switch to DOR\/3TC\/TDF in Patients Who Entered 144-Week Extension Phase in the DRIVE-SHIFT Study\" style=\"height:200px;width:auto\"\/><figcaption class=\"caption-align-left\"><sup>e<\/sup>None of these 4 participants had resistance to doravirine, lamivudine, or tenofovir disoproxil fumarate.<sup>3<\/sup><br><sup>f<\/sup>Protocol-defined virologic failure is defined as two consecutive measurements of HIV-1 RNA \u226550 copies\/mL at least one week apart.<sup>2<\/sup><\/figcaption><figcaption class=\"caption-align-left mobile-caption\"><sup>e<\/sup>None of these 4 participants had resistance to doravirine, lamivudine, or tenofovir.<br \/>\n<sup>f<\/sup>Protocol-defined virologic failure is defined as two consecutive measurements of HIV-1 RNA \u226550 copies\/mL at least one week apart.<sup>2<\/sup><\/figcaption><\/figure><\/div><\/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: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=\"#ShiftstudyDgn\">View DRIVE-SHIFT 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:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<div class=\"paragraph-wrapper\"><div class=\"_84afcd56-644d-41b2-aa75-dc410b208ef1 \" id=\"DriveForward\"><p><strong>DRIVE-FORWARD and DRIVE-AHEAD:&nbsp;<\/strong>Two studies of treatment-na\u00efve adults (n=747) demonstrated a:<\/p><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:4pxpx;--tablet-spacer:4pxpx;--mobile-spacer:4pxpx;height:4pxpx\" 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=\"a9007c732-6103-4f87-a2fe-8a93f40bb3af\"><h2 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>Low rate of resistance across clinical trials<\/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>Of the 36 participants in the resistance analysis subset, 10 participants (28%) developed genotypic and\/or phenotypic resistance to the other drugs (abacavir, emtricitabine, lamivudine, or tenofovir) in the regimens of the <span class=\"no-wrap-text\"><strong>DRIVE-FORWARD<\/strong><\/span> and <strong>DRIVE-AHEAD<\/strong> trials.<\/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 the DRV\/r treatment arm of <strong>DRIVE-FORWARD<\/strong> (n=383) through week 96, no participants showed the emergence of darunavir resistance-associated substitutions among 15 participants with resistance data and 2 of the participants had emergent genotypic or phenotypic resistance to lamivudine or tenofovir.<\/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 the EFV\/FTC\/TDF treatment arm of <strong>DRIVE-AHEAD<\/strong> (n=364) through week 96, 15 participants showed the emergence of efavirenz resistance-associated substitutions among 25 (60%) participants in the resistance analysis subset and genotypic resistance to emtricitabine or tenofovir developed in 5 evaluable participants; emergent resistance-associated substitutions were RT K65R (n=1), D67G\/K70E (n=1), L74V\/V75M\/V118I (n=1), M184I or V (n=5), and K219K\/E (n=1).<\/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<link rel='stylesheet' id='vivid360-image-module-css-css' href='https:\/\/www.merckconnect.com\/doravirine\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/image-module\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div id=\"\" class=\"wp-block-vivid360-image-module ratio-50-50 content-above one-col full-page-width\"><div class=\"vivid360-block-image-module__content-wrapper content-align-left\" id=\"contentDiv\"><\/div><figure class=\"vivid360-block-image-module__image-container\"><picture><source media=\"(max-width: 767px)\" data-srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/CAT_resistance_infographic_image_for_PIFELTRO_RGB-1.svg?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/CAT_resistance_infographic_image_for_PIFELTRO_RGB-1.svg?w=1440\"\/><img decoding=\"async\" data-src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/CAT_resistance_infographic_image_for_PIFELTRO_RGB-1.svg\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/CAT_resistance_infographic_image_for_PIFELTRO_RGB-1.svg\" alt=\"DRIVE-FORWARD and DRIVE-AHEAD Week-96 Graphic Showing Breakdown of Subjects in the Doravirine Treatment Arms That Showed Doravirine Resistance-Associated Substitutions\"\/><\/picture><figcaption class=\"caption-align-left captionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><sup>g<\/sup>There were 36 participants in the resistance analysis subset (HIV-1 RNA >400 copies per mL at virologic failure or early study discontinuation and having post-baseline resistance samples) from the doravirine treatment arms of 2 clinical trials evaluating a doravirine-based regimen (N=747) through week 96.<br><sup>h<\/sup>Most participants had at least a 100-fold reduction in doravirine susceptibility.<br><sup>i<\/sup>Participants had only amino acid mixtures of NNRTI resistance substitutions.<br><sup>j<\/sup>Doravirine-based FDC (fixed-dose combination) = doravirine 100 mg\/lamivudine 300 mg\/tenofovir disoproxil fumarate 300 mg tablets.<br><\/p><\/figcaption><\/figure><\/div>\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=\"#DrivestudyDgn\">View DRIVE-FORWARD 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<p class=\"has-primary-dark-color has-text-color\"><a href=\"#DrivestudyAhd\">View DRIVE-AHEAD 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=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"a5f905f2a-c6d3-4dec-b630-3be1da3490cb\"><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=\"a00b01e4a-40b6-4e8c-8714-fceab7388f08\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"ShiftstudyDgn\"><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>A randomized, multicenter, active-controlled, non-inferiority, open-label, phase 3 trial of adult participants with virologically suppressed <span class=\"no-wrap-text\">HIV-1<\/span> for <span class=\"no-wrap-text\">\u22656<\/span> 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 a doravirine-based FDC <span class=\"no-wrap-text\">(100 mg<\/span> <span class=\"no-wrap-text\">DOR\/300 mg<\/span> <span class=\"no-wrap-text\">3TC\/300 mg<\/span> <span class=\"no-wrap-text\">TDF)<\/span> on day 1 of the <span class=\"no-wrap-text\">48-week<\/span> trial (Immediate Switch Group [ISG; n=447]) or continued their baseline regimen and switched after 24 weeks (Delayed Switch Group [DSG; n=223]) to a <span class=\"no-wrap-text\">doravirine-based FDC.<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 <span class=\"no-wrap-text\">48-week<\/span> visit were eligible to continue receiving an open-label<span class=\"no-wrap-text\"> doravirine-based<\/span> FDC for an additional 96 weeks, up to week <span class=\"no-wrap-text\">144.<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>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 the <span class=\"no-wrap-text\">doravirine-based<\/span> FDC vs <span class=\"no-wrap-text\">1%<\/span> for the baseline regimen. Difference <span class=\"no-wrap-text\">(95% CI):<\/span> <span class=\"no-wrap-text\">0.7<\/span> <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 <span class=\"no-wrap-text\">24:<\/span> <span class=\"no-wrap-text\">91%<\/span> for the <span class=\"no-wrap-text\">doravirine-based<\/span> FDC vs <span class=\"no-wrap-text\">95%<\/span> 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=\"a98aac3c2-282a-4e31-8f2e-fc17896efc13\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"DrivestudyDgn\"><strong>DRIVE-FORWARD 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 PIFELTRO <span class=\"no-wrap-text\">100 mg<\/span> once daily <span class=\"no-wrap-text\">(n=383)<\/span> vs darunavir <span class=\"no-wrap-text\">800 mg<\/span> <span class=\"no-wrap-text\">+ ritonavir<\/span> <span class=\"no-wrap-text\">100 mg<\/span> once daily <span class=\"no-wrap-text\">(n=383),<\/span> each in combination with 2 NRTIs, <span class=\"no-wrap-text\">FTC\/TDF<\/span> or <span class=\"no-wrap-text\">ABC\/3TC<\/span> selected by the investigator, in <span class=\"no-wrap-text\">treatment-na\u00efve<\/span> 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>4,5<\/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 &lt;50 <span class=\"no-wrap-text\">copies\/mL<\/span> at week 48 for PIFELTRO + 2 NRTIs vs <span class=\"no-wrap-text\">DRV\/r +<\/span> 2 NRTIs: 84% vs 80%. Difference <span class=\"no-wrap-text\">(95% CI):<\/span> 3.9 <span class=\"no-wrap-text\">(-1.6, 9.4).<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>Secondary efficacy end point:<\/strong> Percentage of participants with <span class=\"no-wrap-text\">HIV-1<\/span> RNA &lt;50 <span class=\"no-wrap-text\">copies\/mL<\/span> at week 96 for PIFELTRO + 2 NRTIs vs <span class=\"no-wrap-text\">DRV\/r +<\/span> 2 NRTIs: 72% vs 65%. Difference <span class=\"no-wrap-text\">(95% CI):<\/span> 7.5 <span class=\"no-wrap-text\">(1.0, 14.1).<sup>5<\/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> 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>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<div class=\"vivid360-heading\" id=\"a0a4b5537-1e67-4ed5-b496-b22065a355bf\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"DrivestudyAhd\"><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 a <span class=\"no-wrap-text\">doravirine-based<\/span> FDC <span class=\"no-wrap-text\">(100 mg<\/span> <span class=\"no-wrap-text\">DOR\/300 mg<\/span> <span class=\"no-wrap-text\">3TC\/300 mg<\/span> <span class=\"no-wrap-text\">TDF)<\/span> 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 <span class=\"no-wrap-text\">treatment-na\u00efve<\/span> 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>6,<\/sup><\/span><sup>7<\/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 &lt;50 <span class=\"no-wrap-text\">copies\/mL<\/span> at week 48 for the <span class=\"no-wrap-text\">doravirine-based<\/span> FDC 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).<\/span><sup>6<\/sup><\/p>\n\n\n\n<p><strong>Secondary safety end point:<\/strong> Percentage of participants with <span class=\"no-wrap-text\">HIV-1<\/span> RNA &lt;50 <span class=\"no-wrap-text\">copies\/mL<\/span> at week 96 for the doravirine-based FDC 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>7<\/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 <span class=\"no-wrap-text\">week 48.<sup>6,a,b<\/sup><\/span><\/p>\n\n\n\n<div class=\"vivid-block-list content-width  default-list block-0ae5d377-928b-4e07-b69e-d55a67314535\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#000\" data-client-id=\"block-0ae5d377-928b-4e07-b69e-d55a67314535\"><ul class=\"first-level\"><li>Dizziness: 9% for <span class=\"no-wrap-text\">doravirine-based<\/span> FDC vs 37% for <span class=\"no-wrap-text\">EFV\/FTC\/TDF.<\/span> Difference <span class=\"no-wrap-text\">(95% CI):<\/span> <span class=\"no-wrap-text\">-28.3<\/span> <span class=\"no-wrap-text\">(-34.0,<\/span> <span class=\"no-wrap-text\">-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 doravirine-based FDC 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);<\/span> <span class=\"no-wrap-text\"><em>P<\/em>&lt;0.001<\/span><\/li><li>Altered sensorium<sup>d<\/sup>: 4% for doravirine-based FDC 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<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>6<\/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><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><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><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><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=\"ae88eb75d-7a07-4ce9-ab2b-23e62fe9b335\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:18px;--tabletFontSize:18px;--mobileFontSize:18px;--desktopLineHeightSize:27px;--tabletLineHeightSize:27px;--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>3TC, lamivudine; ABC, abacavir; DOR, doravirine; DRV\/r, darunavir\/ritonavir; EFV, efavirenz; FDC, fixed-dose combination; 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 inhibitors; NRTI, nucleoside reverse transcriptase inhibitors; PI, protease inhibitor; RNA, ribonucleic acid; RT, reverse transcriptase; TDF, tenofovir disoproxil fumarate.<\/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=\"a6369928d-34cb-4191-a4b8-ae8bb9353fde\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:18px;--tabletFontSize:18px;--mobileFontSize:18px;--desktopLineHeightSize:27px;--tabletLineHeightSize:27px;--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-61b32eaa-a2c9-463a-b5e8-1fa693c8e91c\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#000\" data-client-id=\"block-61b32eaa-a2c9-463a-b5e8-1fa693c8e91c\"><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 HIV-1 virologic suppression through 48 weeks: results of the <span class=\"no-wrap-text\">DRIVE-SHIFT<\/span> 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>Data available on request from the Merck National Service Center via email at daprequests@merck.com. Please specify information package US-DOV-01680.<\/li><li>Molina JM, Squires K, Sax PE, et al; for the DRIVE-FORWARD Study Group. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial. <em>Lancet HIV<\/em>. 2018;5(5):e211-e220. Epub 2018 Mar 25. doi: 10.1016\/S2352-3018(18)30021-3.<\/li><li>Molina JM, Squires K, Sax PE, et al; for the DRIVE-FORWARD Trial Group. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial. <em>Lancet HIV<\/em>. 2020;7(1):e16-e26. Epub 2019 Nov 15. doi: 10.1016\/S2352-3018(19)30336-4.<\/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=\"_10960778-9ecf-477a-b73d-bde5f813c06c \" 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 af5e04667-1a78-4163-a971-61f8e0204e4b 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>HBV<\/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, which evaluated doravirine-based FDCa&nbsp;(n=656): View DRIVE-SHIFT study design DRIVE-SHIFT: 144-week extension phase&#8230;<\/p>\n","protected":false},"author":699,"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":[321],"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":[624],"ga4_page_region":[951],"ga4_page_therapeuticarea":[969],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-3608","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.7 - 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