{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T14:00:47Z","timestamp":1784815247582,"version":"3.55.0"},"reference-count":12,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T00:00:00Z","timestamp":1770681600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100010877","name":"ViiV Healthcare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010877","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100015756","name":"SEIMC","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100015756","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The effect of archived lamivudine resistance mutations in the efficacy of dolutegravir plus lamivudine (DTG\/3TC) remains unclear. We evaluated whether proviral-DNA M184V\/I detection is associated with virological outcomes in the VOLVER-GESIDA 11820 study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This open-label, single-arm, multicenter phase IIa trial (NCT04880785) enrolled virologically suppressed adults with documented or suspected historical lamivudine resistance if the M184V\/I mutation was not detected in baseline proviral DNA population sequencing. Participants switched to DTG\/3TC and were followed through week 96. Proviral-DNA M184V\/I was assessed retrospectively by next-generation sequencing (NGS) of peripheral blood mononuclear cells at baseline and week 96.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 121 participants, 94% had documented historical M184V\/I. Proviral-DNA NGS detected M184V\/I at \u22655% frequency in 37 (30.6%; 32 M184V, 5 M184I) at baseline and\/or week 96: 12 only at baseline, 13 only at week 96, and 12 at both timepoints. Two virological failures occurred within the first 48 weeks; none were observed thereafter. No treatment-emergent resistance was detected. In the ITT-e population (Snapshot analysis), HIV-1 RNA &amp;lt;50 copies\/mL at week 96 was maintained in 85.7% (72\/84) with no detection of M184V\/I, 66.7% (8\/12) with detection only at baseline, and 100% with detection only at week 96 (13\/13) or both time points (12\/12). Among those with M184V\/I at both time points, the proportion of proviral sequences carrying the mutation increased from 30% to 45% (P = .0037)<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Proviral-DNA M184V\/I detection was not associated with virological outcomes in participants receiving DTG\/3TC supporting its limited clinical value in this specific setting.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciag060","type":"journal-article","created":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T12:39:11Z","timestamp":1770122351000},"page":"149-157","source":"Crossref","is-referenced-by-count":0,"title":["Impact of Proviral-DNA M184V\/I on 96-Week Outcomes of DTG\/3TC Maintenance Therapy: Results From the VOLVER Clinical 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