{"id":581,"date":"2026-08-06T16:30:51","date_gmt":"2026-08-06T16:30:51","guid":{"rendered":"https:\/\/www.merckconnect.com\/idvynso\/?page_id=581"},"modified":"2026-08-20T08:45:58","modified_gmt":"2026-08-20T08:45:58","slug":"adverse-reactions","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/idvynso\/adverse-reactions\/","title":{"rendered":"Adverse reactions"},"content":{"rendered":"\n\n
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Adverse reactions: most common (\u22652%) \u2028across Trial 052 and Trial 051<\/h1>

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Adverse reactions: most common (\u22652%)<\/h2><\/div>\n\n\n\n
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Among participants who received IDVYNSO and experienced at least one adverse event in Trial 052 or Trial 051, 88% experienced only adverse events that were mild (Grade 1) or moderate (Grade 2).<\/p><\/div><\/div>\n\n\n\n

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Adverse Reactionsa<\/sup> (All Grades) Reported in \u22652% of Participants in Any Treatment Group in Trial 052 and Trial 051 in HIV-1<\/span> Virologically Suppressed Adults (Week 48)\u200b<\/strong>
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<\/th>Trial 052 (N=513; double-blinded)<\/span><\/th>TRIAL 051 (N=551; open-label)<\/span><\/th><\/tr>
IDVYNSO<\/span>
(n=342)<\/th>		BIC\/FTC\/TAF
(n=171)<\/th>		IDVYNSO<\/span>
(n=366)<\/th>		Baseline Oral ART (n=185)<\/th><\/tr><\/thead>
Diarrhea<\/span><\/td>1%<\/strong><\/td>1%<\/strong><\/td>3%<\/strong><\/td>0%<\/strong><\/td><\/tr>
Dizziness<\/span><\/td>1%<\/strong><\/td>0%<\/strong><\/td>2%<\/strong><\/td>1%<\/strong><\/td><\/tr>
Fatigueb<\/sup><\/span><\/td>1%<\/strong><\/td>1%<\/strong><\/td>2%<\/strong><\/td>1%<\/strong><\/td><\/tr>
Abdominal Distension<\/span><\/td>1%<\/strong><\/td>0%<\/strong><\/td>2%<\/strong><\/td>0%<\/strong><\/td><\/tr>
Headache<\/span><\/td>1%<\/strong><\/td>0%<\/strong><\/td>2%<\/strong><\/td>1%<\/strong><\/td><\/tr>
Weight Increasedc<\/sup><\/span><\/td><1%<\/strong><\/td>0%<\/strong><\/td>2%<\/strong>d<\/strong><\/sup><\/td>0%<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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a<\/sup>Frequencies based on all adverse reactions attributed to study drugs by the investigator.<\/p><\/div><\/div>\n\n\n\n

b<\/sup>Fatigue includes fatigue and asthenia\u200b.<\/p><\/div><\/div>\n\n\n\n

c<\/sup>The mean change in weight from baseline at Week 48 was -0.03 kg in the IDVYNSO group vs 0.28 kg in the BIC\/FTC\/TAF group in Trial 052, and 0.94 kg in the IDVYNSO group \u2028vs -0.15 kg in the baseline ART group in Trial 051.<\/p><\/div><\/div>\n\n\n\n

d<\/sup>4 of the 6 participants with adverse reactions of weight increase switched from a baseline ART regimen containing efavirenz and\/or tenofovir disoproxil fumarate in Trial 051.<\/p><\/div><\/div>\n\n\n\n

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Review clinical trial data<\/strong><\/h2><\/div>\n\n\n\n
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Review drug interactions ><\/a><\/strong><\/p>\n\n\n\n

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Abbreviations<\/strong><\/h4><\/div>\n\n\n\n
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ART, antiretroviral therapy; BIC, bictegravir; FTC, emtricitabine; PLWH, person(s) living with HIV; TAF, tenofovir alafenamide.<\/p><\/div><\/div>\n\n\n\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Among participants who received IDVYNSO and experienced at least one adverse event in Trial 052 or Trial 051, 88% experienced only adverse…<\/p>\n","protected":false},"author":4249,"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":[247],"ga4_page_birn_id":[],"ga4_page_branding":[264],"ga4_page_businessunit":[],"ga4_page_campaign":[],"ga4_page_content_purpose":[320],"ga4_page_customer_journey_stage":[341],"ga4_page_customer_specialty":[366],"ga4_page_experience":[],"ga4_page_indication":[471],"ga4_page_material_intent":[563],"ga4_page_product":[616],"ga4_page_region":[793],"ga4_page_therapeuticarea":[839],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-581","page","type-page","status-publish"],"yoast_head":"\nAdverse Reactions for IDVYNSO\u2122 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