{"id":29,"date":"2023-08-18T13:22:54","date_gmt":"2023-08-18T13:22:54","guid":{"rendered":"https:\/\/www.merckconnect.com\/doravirine\/?page_id=29"},"modified":"2025-05-27T10:37:33","modified_gmt":"2025-05-27T10:37:33","slug":"delstrigo-dosing-administration","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/doravirine\/delstrigo-dosing-administration\/","title":{"rendered":"Dosing for DELSTRIGO"},"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=\"abbc8cdfe-2855-4732-8cf8-5de92f4e1bfb\"><h1 class=\"has-black-color content-width fontWeightRegular\" style=\"--desktopFontSize:30px;--tabletFontSize:30px;--mobileFontSize:22px;--desktopLineHeightSize:45px;--tabletLineHeightSize:45px;--mobileLineHeightSize:\" id=\"\"><strong>Dosing for DELSTRIGO<sup>\u00ae<\/sup> (doravirine\/lamivudine\/<span class=\"no-wrap-text\">tenofovir<\/span> 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><strong>Recommended dosage:<\/strong> As a fixed-dose combination product containing 100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF). The recommended dosage in adults is one tablet taken orally once daily with or without food.<\/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-black-color has-text-color\">DELSTRIGO 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 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=\"a12121c61-3c90-4e4d-b299-1db2926cf259\"><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>I<strong>n virologically suppressed PLWH, DELSTRIGO provides a complete regimen with convenient dosing.<\/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<div class=\"wp-block-columns is-not-stacked-on-mobile mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:20%\"><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\/2024\/03\/delstrigo_dosing_once_daily_icon.svg?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_once_daily_icon.svg?w=1440\"\/><img decoding=\"async\" data-src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_once_daily_icon.svg\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_once_daily_icon.svg\" alt=\"\"\/><\/picture><figcaption class=\"caption-align-left noCaptionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><\/p><\/figcaption><\/figure><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"vivid360-heading\" id=\"ab925aad3-4c3b-47ff-bacd-2d485afe307d\"><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=\"\"><strong>Once daily<\/strong><\/h3><\/div>\n<\/div>\n<\/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=\"wp-block-columns is-not-stacked-on-mobile mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:20%\">\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_Icon_Food_Restrictions_DELSTRIGO_RGB.webp?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_Icon_Food_Restrictions_DELSTRIGO_RGB.webp?w=1440\"\/><img decoding=\"async\" data-src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/CAT_Icon_Food_Restrictions_DELSTRIGO_RGB.webp\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2025\/05\/CAT_Icon_Food_Restrictions_DELSTRIGO_RGB.webp\" alt=\"\"\/><\/picture><figcaption class=\"caption-align-left noCaptionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><\/p><\/figcaption><\/figure><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"vivid360-heading\" id=\"a714fbaf2-dad5-476c-9af5-b9239b849558\"><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=\"\"><strong>No food restrictions<\/strong><\/h3><\/div>\n<\/div>\n<\/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=\"wp-block-columns is-not-stacked-on-mobile mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:20%\">\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\/2024\/03\/delstrigo_dosing_booster_free_icon.svg?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_booster_free_icon.svg?w=1440\"\/><img decoding=\"async\" data-src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_booster_free_icon.svg\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_booster_free_icon.svg\" alt=\"\"\/><\/picture><figcaption class=\"caption-align-left noCaptionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><\/p><\/figcaption><\/figure><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"vivid360-heading\" id=\"a0658f7ad-4706-488d-bdf9-2ef09d23803c\"><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=\"\"><strong>Booster free<\/strong><\/h3><\/div>\n<\/div>\n<\/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=\"wp-block-columns is-not-stacked-on-mobile mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:20%\">\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\/2024\/03\/delstrigo_dosing_use_with_ppi_icon.svg?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_use_with_ppi_icon.svg?w=1440\"\/><img decoding=\"async\" data-src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_use_with_ppi_icon.svg\" src=\"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_use_with_ppi_icon.svg\" alt=\"\"\/><\/picture><figcaption class=\"caption-align-left noCaptionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><\/p><\/figcaption><\/figure><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"vivid360-heading\" id=\"a25b7eb58-348a-4fe9-a7de-4f6c4ff83d16\"><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=\"\"><strong>Can be used with a PPI<\/strong><\/h3><\/div>\n<\/div>\n<\/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=\"acdcae9a9-c064-4d21-93a0-2f894402d2a2\"><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=\"\"><strong>B<strong>ecause DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in PLWH with estimated creatinine clearance less than 50 mL\/min.<\/strong><\/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>Prior to or when initiating DELSTRIGO, test patients for HBV infections. <\/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, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.<\/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-78014ee6-a55f-4579-b7b0-c41543328572\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-78014ee6-a55f-4579-b7b0-c41543328572\"><ul class=\"first-level\"><li>DELSTRIGO is contraindicated when co-administered 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.<\/li><\/ul><\/div>\n\n\n\n<div class=\"vivid-block-list content-width  default-list block-3324dace-69ba-4919-86ee-04d7c862f535\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-3324dace-69ba-4919-86ee-04d7c862f535\"><ul class=\"first-level\"><li>DELSTRIGO can be used with many common medications: aluminum hydroxide\/magnesium hydroxide\/simethicone containing antacid, ketoconazole, metformin, rifabutin,<sup>a<\/sup> midazolam, elbasvir\/grazoprevir, ledipasvir\/sofosbuvir, sofosbuvir\/velpatasvir,<sup>b<\/sup> methadone, ethinyl estradiol, levonorgestrel, pantoprazole, or atorvastatin. Co-administration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures. When possible, avoid use of sorbitol-containing medicines with lamivudine-containing medicines.<sup>c<\/sup><\/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 class=\"has-black-color has-text-color has-small-font-size\"><sup>a<\/sup>If DELSTRIGO is co-administered with rifabutin, one tablet of doravirine (PIFELTRO) should be taken 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 class=\"has-black-color has-text-color has-small-font-size\"><sup>b<\/sup>If co-administered with ledipasvir\/sofosbuvir or sofosbuvir\/velpatasvir, monitor for adverse reactions associated with 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 class=\"has-black-color has-text-color has-small-font-size\"><sup>c<\/sup>The interaction between doravirine and rifabutin was evaluated in a clinical study. All other drug-drug interactions shown are anticipated based on the known metabolic and elimination pathways.<\/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=\"aabcce0f3-b856-4e0d-a63d-1a8bd37b45d6\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>Acronyms<\/strong><\/h3><\/div>\n\n\n\n<p>HBV, hepatitis B virus; PLWH, person(s) living with HIV; PPI, proton pump inhibitor; RNA, ribonucleic acid.<\/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=\"_b0bc04f7-6ccb-429b-b851-e3a340aca483 \" 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 affbcb418-f91f-420d-8d3e-86ff52cbda81 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>Recommended dosage: As a fixed-dose combination product containing 100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of&#8230;<\/p>\n","protected":false},"author":704,"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":[289],"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-29","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Dosing for DELSTRIGO\u00ae (doravirine\/lamivudine\/tenofovir disoproxil fumarate)<\/title>\n<meta name=\"description\" content=\"Review the dosing information for DELSTRIGO\u00ae (doravirine\/lamivudine\/tenofovir disoproxil fumarate). 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DELSTRIGO provides a complete regimen with convenient dosing.","og_url":"https:\/\/www.merckconnect.com\/doravirine\/delstrigo-dosing-administration\/","og_site_name":"doravirine","article_modified_time":"2025-05-27T10:37:33+00:00","og_image":[{"url":"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_once_daily_icon.svg"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"9 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.merckconnect.com\/doravirine\/delstrigo-dosing-administration\/","url":"https:\/\/www.merckconnect.com\/doravirine\/delstrigo-dosing-administration\/","name":"Dosing for DELSTRIGO\u00ae (doravirine\/lamivudine\/tenofovir disoproxil fumarate)","isPartOf":{"@id":"https:\/\/www.merckconnect.com\/doravirine\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.merckconnect.com\/doravirine\/delstrigo-dosing-administration\/#primaryimage"},"image":{"@id":"https:\/\/www.merckconnect.com\/doravirine\/delstrigo-dosing-administration\/#primaryimage"},"thumbnailUrl":"https:\/\/www.merckconnect.com\/doravirine\/wp-content\/uploads\/sites\/129\/2024\/03\/delstrigo_dosing_once_daily_icon.svg","datePublished":"2023-08-18T13:22:54+00:00","dateModified":"2025-05-27T10:37:33+00:00","description":"Review the dosing information for DELSTRIGO\u00ae (doravirine\/lamivudine\/tenofovir disoproxil fumarate). 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