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Simon Collins, HIV i-Base<\/strong><\/p>\n These summaries cover selected studies on new ART.<\/strong><\/p>\n All abstracts, posters and webcasts for the studies reported below are now available online and hyperlinked in the references. <\/strong><\/p>\n Please see these open resources for full details.<\/strong><\/p>\n L to R: BIC\/LEN, Biktarvy, Triumeq<\/p><\/div>\n Two randomised (2:1) phase 3 switching studies compared a new combination of oral bictegravir\/lenacapavir (BIC\/LEN), formulated as a small daily tablet, to either current complex ART (in ARTISTRY-1<\/a>) or to Biktarvy (in ARTISTRY-2<\/a>). At week 58, both studies reported BIC\/LEN to be non-inferior to the comparator, with high rates of viral suppression and good tolerability. [1, 2, 3]<\/p>\n ARTISTRY-1 was especially notable for being able to simplify complex multidrug combinations in older people who were extremely treatment experienced with a median 28 previous years on ART (IQR: 22 to 32). At baseline, participants were taking a median of 3 drugs (range 2 to 6) and 3 tablets (range 2 to 11) although only n=17 had CD4 <200 cells\/mm3.<\/p>\n i-Base also reported ARTISTRY-1 in detail in a longer report<\/a>. [4]<\/p>\n Four studies presented new results using the once-daily oral combination of doravirine\/islatravir (100 mg\/0.25 mg): an oral presentation of a randomised phase 3 study in treatment naive participants, two posters from phase 2\/3 switch trials and a poster on renal safety study.<\/p>\n Jurgen Rockstroh from the University of Bonn presented the results from the first treatment-naive study with this combination<\/a>. Participants (n=536) were randomised (1:1) to daily oral doravirine\/islatravir (DOR\/ISL) or B\/F\/TAF. This study was notable for enrolling a large percentage of participants with low CD4 (17% <200 cells\/mm3) or high viral load (27% >100,000 and 12% >500,000). [5]<\/p>\n Viral load was <50 copies\/mL at week 48, in >90% participants in each arm with treatment difference 1.2% (95% CI: \u20133.7 to +6.2). There were 6 vs 9 viral failures, finding non-inferiority (based on \u201310% margin), with generally similar tolerability, CD4 responses and discontinuations (6%) in each arm. However, 2\/6 cases of viral failure with NNRTI resistance both had screening viral load > 1.5 million copies\/mL and CD4 counts <200 cells\/mm3, and one had very low adherence.<\/p>\n This compared to 0\/9 cases of drug resistance in those with viral failure in the control arm. Viral load declined more rapidly in the control arm both arms had similar viral suppression by week 16. There were also three cases of incident HBV in the DOR\/ISL arm.<\/p>\n Weight changes were similar in both arms with increases of approximately 4 kgs.<\/p>\n The Q&A discussion<\/a> about this presentation focused on the balance of risks from enrolling people with advanced HIV into experimental\/unproven combinations with the benefits of reflecting the wide range of perhaps half of people living with HIV in Europe still being diagnosed late. This session also included a question from Dr Anton Pozniak that was supported by the audience about whether HBV vaccination should be mandatory for research studies when ART doesn’t also cover HBV, rather than just being offered.<\/p>\n Three posters reported that week-48 responses were generally sustained out to week-96 in two phase 2 switch studies (one blinded<\/a> and one open labe<\/a>l). [6, 7]<\/p>\n Also, a post-hoc analyses of renal function<\/a> from the two large phase 3 switch studies described above. [8]<\/p>\n Among just over 700 participants in the combined studies, 90% had either normal or only mildly impaired renal function at baseline. This study compared changes in renal function over time in those with either eGFR-determined mild (60 to 90) or moderate (30-60) renal function at baseline compared to participants with normal function (>90 mL\/min x 1.73 (2).<\/p>\n Efficacy and safety of DOR\/ISL was similar irrespective of baseline eGFR with no renal changes over 48 weeks after switching to DOR\/ISL.<\/p>\n Two posters at CROI 2026 presented 96-week results on 97 participants enrolled in a randomised open-label phase 2 switch study comparing once-weekly oral ISL+LEN (2 mg + 300 mg) to remaining on B\/F\/TAF standard of care.<\/p>\n This study<\/a> included an immediate vs deferred design and at week-48, all participants with viral load <50 copies\/mL (94% in ISL+LEN) had the option to use ISL+LEN. There were no new viral failures at week-96 (or at earlier discontinuation). Tolerability was good (low level side effects in 12 participants) with only two discontinuations (both in ISL+LEN) due to side effects not related to study drugs. There were no significant changes in weight, BMI or CD4 count which were similar in all groups. [9]<\/p>\n The second poster<\/a> reported no development of drug resistance in the same phase 2 study, focussing on five participants who were later found to have had NNRTI-associated drug mutations at baseline (three in the ISL+LEN arm and two in the B\/F\/TAF to ISL+LEN arm). [10]<\/p>\n All five remained <50 copies\/mL to week-96, including one participant in each arm with pre-existing M184I\/V. Two participants without baseline mutations in the ISL+LEN arm met viral load criteria for resistance testing (>50 to <500 copies\/mL) bt then resuppressed without changing ART.<\/p>\n These results support the two currently ongoing phase 3 studies (ISLEND-1 and -2).<\/p>\n Once-weekly oral islatravir+ulonivirine (ISL+ULO)\n<\/p> Early data on another once-weekly oral combination pairing islatravir with the investigational NNRTI ulonivirine (ISL+ULO) was presented in a poster<\/a>. [11]<\/p>\n This in vitro study looked at the susceptibility to developing drug resistance when these drugs were used as monotherapy or combined, especially to M184I and V106A. With ULO alone, E138K and M230I\/L emerged instead of V106A with M184I variant. With ISL+ULO, V108I\/M184I and E138K\/M184I were most prevalent with WT and M184I variant, respectively.<\/p>\n Each compound had reduced sensitivity to its related mutations but retained similar sensitivity to wild-type against resistance associated to the partner compound.<\/p>\n The study concluded that these results would support further development into this joint combination.<\/p>\n Lotivibart is a bNAb given by infusion every four months that is being studied in combination with monthly cabotegravir-LA by ViiV Healthcare.<\/p>\n CROI 2026 included updated 6-monthly results<\/a> from an open-label randomised (2:2:1) phase 2b switch study. The EMBRACE study randomised 125 people suppressed on ART and sensitive to the bNAb to either IV or SC lotivibart or continue with their oral ART. [12]<\/p>\n At 12-months, viral suppression was 94%, 82% and 88% in the IV, SC and control arms respectively. This remained largely similarly to 6-month results of 94%, 88% and 92% in the primary endpoint reported last year at CROI. Viral failure >50 copies\/mL was reported in 6%, 10% and 4% of participants this year compared to 4%, 6% and 0 at month-6, respectively.<\/p>\n Six participants met protocol defined viral failure of two consecutive results >200 copies\/mL: 2 in the IV group, 3 in the SC group and one in the control arm.<\/p>\n Resistance to lotivibart was reported in two IV and one SC participant and resistance to CAB-LA was reported for two participants in the SC group who both had high viral load at failure of >3000,000 and >100,000 respectvely, although both retained sensitivity to dolutegravir.<\/p>\n Side effects, including injection site reactions, were more frequent in the SC arm which included 3-related discontinuations (compared to none in the IV arm. Pain scores relating to injections remained low in all groups over 12 months.<\/p>\n The IV formulation has been selected for further development of lobivibart in stage 2 of this study.<\/p>\n Last year at CROI, 26-week safety and efficacy results were presented from a phase 2 open label study that randomised (2:1) 80 participants on suppressed ART to either lenacapavir with two bNAbs or continue ART. These results, also recently published in the Lancet Microbe, included one case of viral failure in the experimental arm, with missing data for two participants (one in each arm).<\/p>\n This year, CROI 2026 included two posters with week-52 data on drug resistance analyses and participant-reported outcomes.<\/p>\n In the first of these posters<\/a>, 3 (5.7%) vs 0 participants in the active vs standard ART arm met the criteria for resistance testing. [13]<\/p>\n One participant developed resistance to both LEN (Q67H) and ZAB (IC90<\/sub> >50 \u00b5g\/mL) at week 24, with low plasma LEN concentrations. A second participant only developed resistance to ZAB at week 50 with low levels of both bNAbs. Both these cases quickly resuppressed viral load after switching to oral ART. The third case continued to have persistent low-level viremia after restarting oral ART, with no resistance or viral evolution suggesting clonal expansion of the viral reservoir (ie unrelated to ART), but did suppress after six months.<\/p>\n In the second poster<\/a>, at both weeks 26 and 52 participants reported a strong preference for six-monthly treatment and a good or excellent treatment-related quality of life (although these are all people who actively recruited to this study because of a preference for injectable ART). [14]<\/p>\n References<\/p>\n Simon Collins, HIV i-Base These summaries cover selected studies on new ART. All abstracts, posters and webcasts for the studies reported below are now available online and hyperlinked in the references. Please see these open resources for full details. Daily …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[346],"class_list":["post-53695","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-croi-2026"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53695","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=53695"}],"version-history":[{"count":10,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53695\/revisions"}],"predecessor-version":[{"id":53738,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53695\/revisions\/53738"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=53695"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=53695"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=53695"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Daily oral bictegravir\/lenacapavir (BIC\/LEN)<\/h2>\n
![\"\"](\"https:\/\/i-base.info\/htb\/wp-content\/uploads\/2026\/03\/comparative-pill-sizes-2-300x217.png\")
Once-daily oral doravirine\/islatravir<\/h2>\n
Once-weekly oral islatravir + lenacapavir (ISL+LEN)<\/h2>\n
Four-monthly lotivibart + monthly CAB-LA<\/h2>\n
Six-monthly injections of lenacapavir + dual long-acting bNAbs<\/h2>\n
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\nhttps:\/\/www.croiconference.org\/abstract\/2302-2026<\/a> (abstract)
\nhttps:\/\/www.croiwebcasts.org\/console\/player\/55172<\/a> (webcast)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/1325-2026<\/a> (abstract and poster)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/2367-2026<\/a> (abstract, poster and webcast)<\/li>\n
\nhttps:\/\/i-base.info\/htb\/53317<\/a><\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/2279-2026<\/a> (abstract)
\nhttps:\/\/www.croiwebcasts.org\/console\/player\/55168<\/a> (webcast)
\nhttps:\/\/watch.croiwebcasts.org\/2026croi\/ap\/56220<\/a> (Q&A discussion)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/2391-2026<\/a> (abstract and poster)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/2380-2026<\/a> (abstract and poster)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/649-2026<\/a> (abstract and poster)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/1910-2026<\/a> (abstract, poster and short webcast)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/541-2026<\/a> (abstract and poster)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/1246-2026\/<\/a><\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/1946-2026<\/a> (abstract and webcast)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/1163-2026<\/a> (abstract and poster)<\/li>\n
\nhttps:\/\/www.croiconference.org\/abstract\/1166-202<\/a>6 (abstract and poster)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"