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1 luding darunavir, atazanavir, raltegravir or dolutegravir.
2 ncentration of the viral integrase inhibitor dolutegravir.
3 d a phase 2 trial comparing bictegravir with dolutegravir.
4 ribed DRMs that emerge in patients receiving dolutegravir.
5 the second generation INST inhibitor (INSTI) dolutegravir.
6 se subtypes can influence resistance against dolutegravir.
7 een reported for naive patients treated with dolutegravir.
8 plified practical dosing and rapid access to dolutegravir.
9 luded darunavir, atazanavir, raltegravir, or dolutegravir.
10 itch to elvitegravir or raltegravir, but not dolutegravir.
11 weight gain was highest among PLWH starting dolutegravir.
12 atic neutropenia) were considered related to dolutegravir.
14 LWH, 351 initiated INSTI-based regimens (135 dolutegravir, 153 elvitegravir, and 63 raltegravir), 86%
15 rted (>/=10%) adverse events were diarrhoea (dolutegravir 41 [17%] patients vs darunavir plus ritonav
16 curred with ritonavir-boosted lopinavir than dolutegravir (44 [14%] of 310 with ritonavir-boosted lop
18 emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine
19 re randomly assigned (1:1) to receive either dolutegravir 50 mg once daily or darunavir 800 mg plus r
20 ks were randomized (2:1) to monotherapy with dolutegravir 50 mg once daily or to continuation of cART
21 ough) of 0.83 mg/L (26%) in fasted adults on dolutegravir 50 mg once-daily; in children weighing 25 k
22 Patients were randomly assigned (1:1) to dolutegravir 50 mg or darunavir 800 mg plus ritonavir 10
23 alafenamide 25 mg (the bictegravir group) or dolutegravir 50 mg with co-formulated emtricitabine 200
24 e 200 mg, and tenofovir alafenamide 25 mg or dolutegravir 50 mg with coformulated emtricitabine 200 m
25 mg (the bictegravir group) or co-formulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300
26 tenofovir alafenamide 25 mg or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300
27 tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300
28 nd emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; once-daily oral fixed-dose combinati
29 nd emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; or once-daily oral fixed-dose combin
30 central randomisation system to receive oral dolutegravir (50 mg once daily) or ritonavir-boosted lop
31 ety and efficacy data of regimens containing dolutegravir (50 mg twice daily) in antiretroviral-exper
33 to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-
34 00 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate
35 nd tenofovir alafenamide than in those given dolutegravir, abacavir, and lamivudine (10% [n=32] vs 23
36 itabine, and tenofovir alafenamide than with dolutegravir, abacavir, and lamivudine (26% [n=82] vs 40
37 enofovir alafenamide (n=316) or coformulated dolutegravir, abacavir, and lamivudine (n=315), of whom
40 gher incidence of drug-related nausea in the dolutegravir, abacavir, and lamivudine group (5% [n=17]
41 and 93.0% of patients (n=293 of 315) in the dolutegravir, abacavir, and lamivudine group (difference
42 lafenamide group and 265 (84%) of 315 in the dolutegravir, abacavir, and lamivudine group (difference
43 enamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1),
44 abine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine) and 645 in study
45 nd tenofovir alafenamide was non-inferior to dolutegravir, abacavir, and lamivudine, with 276 (88%) o
46 adults and was non-inferior to coformulated dolutegravir, abacavir, and lamivudine, with no treatmen
50 ivirine was noninferior to oral therapy with dolutegravir-abacavir-lamivudine with regard to maintain
52 r alafenamide as a fixed-dose combination to dolutegravir administered with coformulated emtricitabin
55 ded in the analysis (242 assigned to receive dolutegravir and 242 assigned to receive ritonavir-boost
57 verse transcriptase inhibitors (NNRTI), with dolutegravir and bictegravir associated with more weight
58 erse transcriptase inhibitors (NNRTIs), with dolutegravir and bictegravir associated with more weight
59 ze the mode of action of the advanced INSTIs dolutegravir and bictegravir at near-atomic resolution.
61 dicines Agency issued warnings on the use of dolutegravir and darunavir/cobicistat for treatment of p
62 the 90% maximal inhibitory concentration for dolutegravir and HIV viral loads were less than 40 copie
64 some non-B HIV subtype viruses treated with dolutegravir and will aid in the inhibition of such a vi
66 containing either InSTI (i.e., raltegravir, dolutegravir, and elvitegravir/cobicstat) or efavirenz (
70 metabolizers in the efavirenz arm and in the dolutegravir arm, suggesting that impaired weight gain a
72 gravir treatment at conception than with non-dolutegravir ART at conception (difference, 0.20 percent
73 nd 0.68% of those among women exposed to non-dolutegravir ART at conception (difference, 0.27 percent
74 .10%) in which the mother was taking any non-dolutegravir ART at conception, 3 among 7959 (0.04%) in
76 , supporting WHO's strong recommendation for dolutegravir as a preferred drug for ART initiators.
77 tase inhibitors (NNRTI) and transitioning to dolutegravir as part of a more affordable and standardis
78 eeded pediatric deaths added with EFV unless dolutegravir-associated NTD risk was 1.5% or greater.
79 n 0.95% of deliveries among women exposed to dolutegravir at conception and 0.68% of those among wome
80 83 deliveries in which the mother was taking dolutegravir at conception, 5 neural-tube defects were f
81 risk of neural tube defects in women taking dolutegravir at time of conception, as well as the effec
83 red-flag DDI, and the use of raltegravir or dolutegravir-based antiretroviral therapy was associated
84 red-flag DDI, and the use of raltegravir- or dolutegravir-based antiretroviral therapy was associated
85 osis prophylaxis to patients with HIV taking dolutegravir-based antiretroviral therapy, without dose
88 ents with confirmed virological failure on a dolutegravir-based regimen can pose challenges because o
89 regimen in women intending pregnancy, and a dolutegravir-based regimen in others, and a dolutegravir
90 The policy involving ART initiation with a dolutegravir-based regimen in women intending pregnancy
91 benefits, a policy of ART initiation with a dolutegravir-based regimen rather than an efavirenz-base
93 dolutegravir-based regimen in others, and a dolutegravir-based regimen, including in women intending
94 found that a policy of ART initiation with a dolutegravir-based regimen, including in women intending
95 reduced risk of resistance acquisition with dolutegravir-based regimens and reduced use of expensive
96 f ART initiation with efavirenz- rather than dolutegravir-based regimens due to PrEP undermining ART
99 after at least 8 weeks of efavirenz-based or dolutegravir-based regimens were recruited in three cons
100 ad strata (mHR: 0.7, 95% CI: 0.6-0.8) and in dolutegravir-based therapy (mHR: 1.2, 95% CI: 1.0-1.4).
103 tfed infants was observed following maternal dolutegravir cessation (3-15 days postpartum), which wan
106 r efficacy and similar safety profile of the dolutegravir combined regimen compared with the atazanav
107 two antiretroviral first-line combinations (dolutegravir combined with emtricitabine and either teno
108 s could explain the increased weight gain on dolutegravir compared with efavirenz observed in ADVANCE
109 logical suppression before giving birth with dolutegravir compared with efavirenz, when initiated dur
113 tenofovir alafenamide was non-inferior to a dolutegravir-containing regimen in treatment-naive peopl
119 We describe the pharmacokinetics (PK) of dolutegravir (DTG) 50 mg once daily in PLWH aged 60 and
122 n immunodeficiency virus (HIV) infection are dolutegravir (DTG) and tenofovir alafenamide fumarate (T
123 4%) infants of women receiving preconception dolutegravir (DTG) antiretroviral therapy (ART) vs 14 of
124 odeficiency virus (HIV) type 1 RNA decay and dolutegravir (DTG) concentrations in the semen of HIV-in
128 anda and South Africa were randomised 1:1 to dolutegravir (DTG) or efavirenz (EFV)-containing ART unt
130 pilot phase IIb VIKING study suggested that dolutegravir (DTG), a human immunodeficiency virus (HIV)
132 d drugs, raltegravir (RAL), elvitegravir and dolutegravir (DTG), act as interfacial inhibitors during
133 ibit reduced sensitivity to the IN inhibitor Dolutegravir (DTG), demonstrating that they confer a glo
137 protease inhibitor (PI/r)-based regimen to a dolutegravir (DTG)-based regimen may improve lipid profi
143 nts, to 5 INSTIs (bictegravir, cabotegravir, dolutegravir, elvitegravir, and raltegravir) at the viro
144 d be an integrase strand transfer inhibitor (dolutegravir, elvitegravir, or raltegravir), a nonnucleo
145 lafenamide group and 273 (84%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide g
146 ir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide g
147 icitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide).
149 ects was slightly higher in association with dolutegravir exposure at conception than with other type
150 was previously reported in association with dolutegravir exposure from the time of conception, which
151 of transition to tenofovir, lamivudine, and dolutegravir for all substantially outweighed the risks.
152 th the atazanavir regimen support the use of dolutegravir for HIV-1 infection in treatment-naive wome
153 containing efavirenz to regimens containing dolutegravir formulations in adult ART initiators is pre
154 s or stopping criteria was less frequent for dolutegravir (four [2%] patients) than for darunavir plu
156 common in the bictegravir group than in the dolutegravir group (57 [18%] of 320 vs 83 [26%] of 325,
157 ictegravir group and 281 (86%) of 325 in the dolutegravir group (difference -2.3%, 95% CI -7.9 to 3.2
158 ictegravir group and 302 (93%) of 325 in the dolutegravir group (difference -3.5%, 95.002% CI -7.9 to
159 ed, 499 were randomly assigned to either the dolutegravir group (n=250) or the atazanavir group (n=24
160 reened and 627 were randomly assigned to the dolutegravir group (n=312) or the ritonavir-boosted lopi
161 per mL compared with 31 (93.9%) of 33 in the dolutegravir group (weighted difference 2.9%, 95% CI -8.
162 liter) was observed in 3 participants in the dolutegravir group (with none acquiring drug-resistance
163 eek 48, 261 (84%) of 312 participants in the dolutegravir group achieved viral suppression compared w
164 versus 283 (90%) of 315 participants in the dolutegravir group achieving HIV-1 RNA less than 50 copi
165 x participants (three since 48 weeks) in the dolutegravir group and 13 (four) in the darunavir plus r
166 t 96 weeks, 194 (80%) of 242 patients in the dolutegravir group and 164 (68%) of 242 in the ritonavir
167 ed in 137 of 207 participants (66.2%) in the dolutegravir group and in 123 of 200 participants (61.5%
168 ed in 231 of 310 participants (74.5%) in the dolutegravir group and in 209 of 303 participants (69.0%
170 eek 48, 203 (82%) of 248 participants in the dolutegravir group compared with 176 (71%) of 247 in the
172 ictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), a
173 he tenofovir alafenamide, emtricitabine, and dolutegravir group had fewer changes in bone density tha
175 in the bictegravir group versus four in the dolutegravir group occurred between weeks 48 and 96.
176 320 in the bictegravir group and 325 in the dolutegravir group received at least one dose of study d
180 t common were nausea (46 [19%] of 248 in the dolutegravir group vs 49 [20%] of 247 in the atazanavir
181 e events were diarrhoea (23/242 [10%] in the dolutegravir group vs 57/242 [24%] in the darunavir plus
182 bictegravir group vs 51 [16%] of 325 in the dolutegravir group) and headache (51 [16%] of 320 vs 48
183 vir plus abacavir and lamivudine once a day (dolutegravir group) or a three-tablet combination of rit
184 bictegravir group vs 76 [24%] of 315 for the dolutegravir group), diarrhoea (48 [15%] vs 50 [16%]), a
185 abacavir 600 mg, and lamivudine 300 mg (the dolutegravir group), each with matching placebo, once da
186 200 mg and tenofovir alafenamide 25 mg (the dolutegravir group), each with matching placebo, once da
188 pulmonary embolism, and one lymphoma in the dolutegravir group); none were considered to be treatmen
189 safety analysis, and 250 mothers (125 in the dolutegravir group, 125 in the efavirenz group) and thei
190 he tenofovir alafenamide, emtricitabine, and dolutegravir group, 275 (78%) of 351 participants in the
191 he tenofovir alafenamide, emtricitabine, and dolutegravir group, 351 to the tenofovir disoproxil fuma
192 ovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 2.3 kg [7.0] in the tenofovir di
193 ovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 258 (74%) of 351 participants in
194 ovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 351 to the tenofovir disoproxil
195 ant HIV infections were detected, all in the dolutegravir group, and were considered likely to be in-
201 he tenofovir alafenamide, emtricitabine, and dolutegravir group; 4.3 kg [6.7] in the tenofovir disopr
202 n the bictegravir group and five (2%) in the dolutegravir group; one of these events in the bictegrav
209 HO guidelines recommending the transition to dolutegravir in first-line ART for all adults, regardles
210 a small previous trial of such therapy with dolutegravir in healthy, HIV-negative adults was halted
211 pected gains from widespread introduction of dolutegravir in low-income and middle-income countries.
214 ding switching to tenofovir, lamivudine, and dolutegravir in those currently on ART, regardless of cu
217 ation health of postponing the transition to dolutegravir increases substantially with higher prevale
218 asma HIV-2 RNA (pVL) was assessed at time of dolutegravir initiation (baseline), month 3, and month 6
227 a policy in which tenofovir, lamivudine, and dolutegravir is used in all people on ART, including swi
228 mtricitabine/tenofovir alafenamide, abacavir/dolutegravir/lamivudine, raltegravir, rilpivirine, ataza
229 vir-boosted lopinavir vs 11 [4%] of 314 with dolutegravir), mainly driven by gastrointestinal disorde
231 bacavir/lamivudine/dolutegravir or switch to dolutegravir (MONCAY trial), or to continue tenofovir/em
232 mized, 68 were assigned to simplification to dolutegravir monotherapy and 33 to continuation of cART.
234 67/67 (100%) had virological response in the dolutegravir monotherapy group vs 32/32 (100%) in the cA
238 tudy at 48 weeks showed that patients taking dolutegravir once daily had a significantly higher virol
241 ndomized 1:1 to continue abacavir/lamivudine/dolutegravir or switch to dolutegravir (MONCAY trial), o
242 ter were randomly assigned to receive either dolutegravir or the reference treatment of low-dose efav
244 might reduce effectiveness and durability of dolutegravir, particularly if there is scarce access to
245 n on the genetic correlates of resistance to dolutegravir, particularly in patients infected with HIV
247 Groups 1A (n=12) and 1B (n=18) had intensive dolutegravir pharmacokinetic sampling at week 8 (before
248 reated with the same schedule and had sparse dolutegravir pharmacokinetic sampling at weeks 8, 11, an
249 g 25 kg to less than 40 kg, we also assessed dolutegravir pharmacokinetics within-subject on film-coa
251 d darunavir (19.8%); the most common 3DR was dolutegravir plus 2 nucleoside reverse transcriptase inh
252 months were randomly assigned (1:1) to 50 mg dolutegravir plus 25 mg rilpivirine orally once daily (e
253 to receive either a single-tablet regimen of dolutegravir plus abacavir and lamivudine once a day (do
254 ine, and tenofovir alafenamide compared with dolutegravir plus co-formulated emtricitabine and tenofo
255 combination [bictegravir group] and 330 with dolutegravir plus emtricitabine and tenofovir alafenamid
256 afenamide group versus 22 (67%) of 33 in the dolutegravir plus emtricitabine and tenofovir alafenamid
257 emtricitabine and tenofovir alafenamide and dolutegravir plus emtricitabine and tenofovir alafenamid
258 ne and tenofovir alafenamide and 33 received dolutegravir plus emtricitabine and tenofovir alafenamid
260 efficacy and similar tolerability profile of dolutegravir plus lamivudine to a guideline-recommended
261 513 participants were randomly assigned to dolutegravir plus rilpivirine (ie, the early-switch grou
262 rd ART regimen, 477 of whom then switched to dolutegravir plus rilpivirine at week 52 (ie, the late-s
263 regimen for 52 weeks before switching to the dolutegravir plus rilpivirine combination (ie, the late-
265 owed that switching to a two-drug regimen of dolutegravir plus rilpivirine was non-inferior to contin
267 were adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics, assessed in pa
269 men was achieved and was non-inferior to the dolutegravir regimen in previously untreated adults.
270 egimen and 325 participants who received the dolutegravir regimen were included in the primary effica
275 lenges because of uncertainty around whether dolutegravir resistance has actually developed and switc
278 ub-nM activity against a clinically relevant dolutegravir resistant mutant virus suggesting potential
279 ighing 20 kg to less than 25 kg, we assessed dolutegravir's pharmacokinetics in children given once d
281 ng policy makers on approaches to the use of dolutegravir that are likely to lead to the highest popu
284 -tube defects was higher in association with dolutegravir treatment at conception than with non-dolut
285 ong 3840 (0.03%) in which the mother started dolutegravir treatment during pregnancy, and 70 among 89
288 s and investigators to treatment assignment: dolutegravir was administered as single-entity tablets (
296 was greater than 0%, then we concluded that dolutegravir was superior to ritonavir-boosted darunavir
298 be higher with dolutegravir than efavirenz, dolutegravir will lead to many fewer deaths among women,
299 e oral once-daily 75 mg bictegravir or 50 mg dolutegravir with matching placebo plus the fixed-dose c
300 virological failure to raltegravir received dolutegravir with optimized background antiretroviral co