ライフサイエンスコーパス: cabotegravir

1 -acting cabotegravir PrEP (ie, DCP including cabotegravir).

2 fumarate plus emtricitabine; 266 injectable cabotegravir).

3 bine) and $4471-6785 (long-acting injectable cabotegravir).

4 $13.2 million (11.6-14.8) for DCP including cabotegravir.

5 her assumed uptake of long-acting injectable cabotegravir.

6 first time, a long-acting injectable agent, cabotegravir.

7 tegravir, and 71% (35-83) with DCP including cabotegravir.

8 and moderately resistant to dolutegravir and cabotegravir.

9 andomly allocated in a 1:1:1:1 ratio to oral cabotegravir 10 mg once a day, 30 mg once a day, 60 mg o

10 care group) or switch to receive daily oral cabotegravir 30 mg and rilpivirine 25 mg for at least 4

11 esults lend support to our selection of oral cabotegravir 30 mg once a day for further assessment.

12 background combination ART and received oral cabotegravir 30 mg once daily and oral rilpivirine 25 mg

13 infected with HIV-1 initially received oral cabotegravir 30 mg plus abacavir-lamivudine 600-300 mg o

14 Participants received oral cabotegravir 30 mg tablets or matching placebo once dail

15 o long-acting therapy at baseline received a cabotegravir (30 mg) plus rilpivirine (25 mg) once daily

16 long-acting therapy had a choice to receive cabotegravir (30 mg) plus rilpivirine (25 mg) once daily

17 for at least 4 weeks followed by long-acting cabotegravir 400 mg and rilpivirine 600 mg, administered

18 g plus rilpivirine 900 mg) or every 4 weeks (cabotegravir 400 mg plus rilpivirine 600 mg) to treatmen

19 rilpivirine at 4-week intervals (long-acting cabotegravir 400 mg plus rilpivirine 600 mg; two 2 mL in

20 ion and could choose to continue long-acting cabotegravir (400 mg) plus rilpivirine (600 mg) every 4

21 d at week 48, and 137 (76%; 69-82) receiving cabotegravir (41 [68%; 57-80], 45 [75%; 64-86], and 51 [

22 -6 weeks, followed by long-acting injectable cabotegravir 600 mg (3 mL) and long-acting injectable ri

23 administered intramuscularly every 8 weeks (cabotegravir 600 mg plus rilpivirine 900 mg) or every 4

24 injections) or 8-week intervals (long-acting cabotegravir 600 mg plus rilpivirine 900 mg; two 3 mL in

25 ar gluteal injection (long-acting injectable cabotegravir 600 mg) at weeks 5, 9, 17, 25, and 33.

26 (1:1) to continue oral therapy or switch to cabotegravir (600 mg) and rilpivirine (900 mg) intramusc

27 sex at birth and BMI, to either long-acting cabotegravir (600 mg) plus rilpivirine (900 mg) dosed in

28 hree intramuscular injections of long-acting cabotegravir 800 mg or saline placebo at 12 week interva

29 mly assigned (3:1) to long-acting injectable cabotegravir (800 mg given three times at 12 week interv

30 Long-acting injectable cabotegravir, a drug taken every 2 months, has been show

31 e participant stopped long-acting injectable cabotegravir after three injections due to pregnancy.

32 ears: $8.6 million (7.7-9.4) for DCP without cabotegravir and $13.2 million (11.6-14.8) for DCP inclu

33 e ratios of 0.89 (0.67-1.17) for DCP without cabotegravir and 0.64 (0.44-0.97) for DCP including cabo

34 1.22-6.19) and 1.15 mug/mL (<0.025-5.29) for cabotegravir and 52.9 ng/mL (31.9-148.0) and 39.1 ng/mL

35 ear (95% CI 16 700-20 100) for DCP including cabotegravir and 56 400 DALYs per year (52 300-60 500) f

36 concentrations, at week 2 for oral dosing of cabotegravir and at week 16 for intramuscular dosing of

37 isk reduction between long-acting injectable cabotegravir and daily oral tenofovir disoproxil fumarat

38 ed PrEP and PEP choice including long-acting cabotegravir and enabling risk-informed use could reduce

39 We compressed cabotegravir and excipients into cylindrical pellets and

40 ere to confirm doses for oral and injectable cabotegravir and for injectable rilpivirine in adolescen

41 the promise of longer-acting agents, such as cabotegravir and lenacapavir.

42 Long-acting injectable cabotegravir and long-acting injectable rilpivirine, adm

43 Long-acting cabotegravir and long-acting rilpivirine constitute a co

44 Combined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the

45 botegravir and until week 16 for long-acting cabotegravir and long-acting rilpivirine, and pharmacoki

46 qualified by comparing the DDI between oral cabotegravir and oral rilpivirine with rifampicin.

47 opriateness of delivering on-label 2-monthly cabotegravir and rilpivirine (CAB + RPV) injections for

48 Long-acting injectable cabotegravir and rilpivirine (LAI cabotegravir and rilpi

49 esults showed non-inferiority of long-acting cabotegravir and rilpivirine administered every 8 weeks

50 Long-acting cabotegravir and rilpivirine administered monthly or eve

51 5 definitions for virological failure on LAI cabotegravir and rilpivirine and nine for treatment disc

52 ontinuation for long-acting injectable (LAI) cabotegravir and rilpivirine antiretroviral therapy are

53 Cabotegravir and rilpivirine are 2 long-acting (LA) anti

54 Cabotegravir and rilpivirine are antiretroviral drugs in

55 Long-acting (LA) intramuscular cabotegravir and rilpivirine are prone to drug-drug inte

56 Resistance levels were similar for LAI cabotegravir and rilpivirine as a switching option for t

57 bese individuals were predicted to have both cabotegravir and rilpivirine Cmin below the target conce

58 irm the 48-week results, showing long-acting cabotegravir and rilpivirine continued to be non-inferio

59 ce levels were care disengagement rates, LAI cabotegravir and rilpivirine coverage, and INSTI mutatio

60 .6% INSTI PDR and 11.3% INSTI TDR at 30% LAI cabotegravir and rilpivirine coverage, compared with 14.

61 tudies showed non-inferiority of long-acting cabotegravir and rilpivirine dosed every 4 weeks compare

62 non-inferiority of long-acting intramuscular cabotegravir and rilpivirine dosed every 4 weeks to oral

63 Long-acting cabotegravir and rilpivirine dosed every 8 weeks had non

64 The fold change in LA cabotegravir and rilpivirine exposures (area under the c

65 By 2045, using LAI cabotegravir and rilpivirine for both switching and ART

66 PDR and 26.0% rilpivirine PDR when using LAI cabotegravir and rilpivirine for both switching and ART

67 Long-acting injectable cabotegravir and rilpivirine have demonstrated safety, a

68 of recent clinical trials for LA parenteral cabotegravir and rilpivirine highlight the emergence of

69 HIV in the past 6 months, had prescribed LAI cabotegravir and rilpivirine in clinical trials or clini

70 ified against available clinical data for LA cabotegravir and rilpivirine in normal weight/ overweigh

71 the test and treat approach, and long-acting cabotegravir and rilpivirine in the public health system

72 Rilpivirine resistance under the LAI cabotegravir and rilpivirine initiation and switch strat

73 A course of oral ART after LAI cabotegravir and rilpivirine interruption (oral bridging

74 Intramuscular injection of long-acting cabotegravir and rilpivirine is a novel, long-acting ant

75 Long-acting injectable cabotegravir and rilpivirine is being rolled out in the

76 vestigating whether switching to long-acting cabotegravir and rilpivirine is non-inferior to daily do

77 cted the theoretical effect of rifampicin on cabotegravir and rilpivirine LA intramuscular formulatio

78 Cabotegravir and rilpivirine long-acting therapy produce

79 acy, and acceptability of dosing long-acting cabotegravir and rilpivirine monthly and every 2 months

80 ve performance of the PBPK model to simulate cabotegravir and rilpivirine pharmacokinetics after oral

81 386 LAI cabotegravir and rilpivirine prescribers across 28 count

82 LAI cabotegravir and rilpivirine roll-out in South Africa sh

83 Cabotegravir and rilpivirine were given alone and in com

84 sus definition was as follows: people on LAI cabotegravir and rilpivirine who have missed two consecu

85 injectable cabotegravir and rilpivirine (LAI cabotegravir and rilpivirine) is recommended as maintena

86 with intramuscular injections of long-acting cabotegravir and rilpivirine, administered every 8 weeks

87 esults support the durability of long-acting cabotegravir and rilpivirine, over an almost 2-year-long

88 participant who reported use of long-acting cabotegravir and rilpivirine.

89 ic failure in clinical trials of long-acting cabotegravir and rilpivirine.

90 r and at week 16 for intramuscular dosing of cabotegravir and rilpivirine.

91 ng all adverse events, until week 4 for oral cabotegravir and until week 16 for long-acting cabotegra

92 ng-acting cabotegravir PrEP (ie, DCP without cabotegravir); and (3) introduction of the DCP intervent

93 3) with no DCP, 54% (23-74) with DCP without cabotegravir, and 71% (35-83) with DCP including caboteg

94 tions, second-generation InSTIs bictegravir, cabotegravir, and dolutegravir decreased hESC counts and

95 of a combination of the integrase inhibitor, cabotegravir, and the non-nucleoside reverse transcripta

96 ther investigation of long-acting injectable cabotegravir as an alternative to orally administered pr

97 tegravir than rilpivirine with a decrease in cabotegravir AUC and Cmin of >35% for BMI >35 kg/m2 and

98 In cohort 1C, the week 2 median cabotegravir AUC(0-tau) was 148.5 (range 37.2-433.1) mug

99 we report on an ultra-long-acting injectable cabotegravir/barium sulfate (CAB/BaSO4) in-situ forming

100 -exposure prophylaxis (PrEP) options such as cabotegravir, barriers to widespread adoption and scale-

101 abutin was predicted to reduce the AUC of LA cabotegravir by 16% and rilpivirine by 18%.

102 ecrease the area under the curve (AUC) of LA cabotegravir by 61% and rilpivirine by 38%.

103 Long-acting cabotegravir (CAB LA) is a potential new injectable form

104 ion model to investigate whether long-acting cabotegravir (CAB LA) prevents penile SHIV acquisition i

105 Cabotegravir (CAB) + rilpivirine (RPV) dosed intramuscul

106 ce screening before implementing long-acting cabotegravir (CAB) + RPV.

107 This study examined cabotegravir (CAB) and rilpivirine (RPV) distribution an

108 Long-acting (LA) injectable therapy with cabotegravir (CAB) and rilpivirine (RPV) is currently us

109 The impact of pharmacokinetic variability of cabotegravir (CAB) and rilpivirine (RPV) long-acting (LA

110 the lymphatic uptake of two anti-HIV drugs: cabotegravir (CAB) and rilpivirine (RPV) when delivered

111 G), raltegravir (RAL), bictegravir (BIC), or cabotegravir (CAB) at clinically relevant doses, adminis

112 Participants completed an oral cabotegravir (CAB) lead-in (Step 1), then received intra

113 While cabotegravir (CAB) long-acting injectable (CAB LA), an i

114 A once every eight-week cabotegravir (CAB) long-acting parenteral is more effect

115 d the superiority of long-acting, injectable cabotegravir (CAB) over daily oral tenofovir disoproxil

116 mia and persistent low-level viremia, during cabotegravir (CAB) plus rilpivirine (RPV) long-acting (L

117 084 demonstrated that long-acting injectable cabotegravir (CAB) was superior to daily oral tenofovir

118 ed an antiretroviral (dolutegravir (DTG)) or cabotegravir (CAB)), and a hormonal contraceptive (etono

119 and incorporating dual ARVs, Rilpivirine and Cabotegravir (CAB), for targeted delivery to lymph nodes

120 effects of bimonthly long-acting injectable cabotegravir (CAB)/RPV before and throughout pregnancy.

121 People who use long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP)

122 exposure prophylaxis (PrEP) with long-acting cabotegravir (CAB-LA) had a better bone safety profile t

123 e formulation of the HIV integrase inhibitor cabotegravir (CAB-LA) is currently in clinical developme

124 Long-acting, injectable cabotegravir (CAB-LA) is more effective than daily oral

125 who inject drugs (WWID) selected long-acting cabotegravir (CAB-LA) over oral PrEP, and 51/55 received

126 up to 88% increased efficacy of long-acting cabotegravir (CAB-LA) versus continuous oral tenofovir d

127 ial, demonstrated superiority of long-acting cabotegravir (CAB-LA) versus daily oral tenofovir disopr

128 HPTN 083 trial demonstrated that long-acting cabotegravir (CAB-LA) was superior to tenofovir-disoprox

129 cted generic production costs of long-acting cabotegravir can be realised, it is likely to be cost-ef

130 If lenacapavir + cabotegravir can be sourced at a cost of around $ 80 per

131 After 4-6 weeks of oral cabotegravir (cohort 1C) or rilpivirine (cohort 1R), par

132 ime from the last injection to the time when cabotegravir concentration decreased below the LLOQ was

133 (23%) of 40 male participants had detectable cabotegravir concentrations and at week 76, four (13%) o

134 (13%) of 30 male participants had detectable cabotegravir concentrations compared with 52 (63%) of 82

135 Cabotegravir concentrations did not differ by gender aff

136 Long-acting injectable cabotegravir could potentially substantially change HIV

137 There were no long-acting injectable cabotegravir discontinuations due to intolerability.

138 erienced patients, to 5 INSTIs (bictegravir, cabotegravir, dolutegravir, elvitegravir, and raltegravi

139 gimen consisting of their randomly allocated cabotegravir dose plus oral rilpivirine 25 mg or continu

140 If long-acting injectable cabotegravir drug costs were equal to those of tenofovir

141 ntification (LLOQ) of long-acting injectable cabotegravir during the injection phase (defined as the

142 arate (F/TAF), or intramuscular injection of cabotegravir every 2 months, for PrEP (after a 180-day w

143 Infection within 6 months of cabotegravir exposure was associated with diagnostic del

144 roup 24 weeks after the final injection when cabotegravir exposure was well below the protein-binding

145 rticipants preferring long-acting injectable cabotegravir for future use) were assessed in all partic

146 would consider using long-acting injectable cabotegravir for HIV prevention in the future.

147 Intramuscular cabotegravir for long-acting injectable HIV pre-exposure

148 P), dapivirine vaginal rings, and injectable cabotegravir for PrEP, are becoming more widely availabl

149 ir subcutaneous implant capable of releasing cabotegravir for several months.

150 0 person-years (0.07-1.95) in the injectable cabotegravir group (hazard ratio 0.34 [95% CI 0.08-1.56]

151 idence 1.0% [95% CI 0.73-1.40]); four in the cabotegravir group (HIV incidence 0.2 cases per 100 pers

152 ction occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years

153 as higher in participants in the long-acting cabotegravir group (n=75 [80%]) than in those in the pla

154 up during the injection phase and one in the cabotegravir group 24 weeks after the final injection wh

155 6, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 part

156 , we enrolled 3224 participants (1614 in the cabotegravir group and 1610 in the TDF-FTC group).

157 87 (82%) participants in the cabotegravir group and 20 (95%) participants in the plac

158 reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC

159 e reactions, which were more frequent in the cabotegravir group than in the TDF-FTC group (577 [38.0%

160 er active cabotegravir with TDF-FTC placebo (cabotegravir group) or active TDF-FTC with cabotegravir

161 mtricitabine group and two in the injectable cabotegravir group); overall incidence was 1.19 per 100

162 were the main reasons for withdrawal in the cabotegravir group.

163 24, 149 (82%; 95% CI 77-88) patients in the cabotegravir groups (48 [80%; 70-90], 48 [80%; 70-90], a

164 nd treated, 156 (86%) of 181 patients in the cabotegravir groups (52 [87%] of 60, 51 [85%] of 60, and

165 Six (3%) patients in the cabotegravir groups (one [2%], one [2%], and four [7%] p

166 After patients in the cabotegravir groups were changed over from dual NRTIs to

167 tand the factors associated with long-acting cabotegravir (GSK1265744 LAP) pharmacokinetic variabilit

168 Cabotegravir (GSK1265744) is an HIV-1 integrase strand t

169 he HIV-1 integrase strand transfer inhibitor cabotegravir (GSK1265744) was well tolerated, both alone

170 not involve daily regimens (eg, long-acting cabotegravir) holds potential to facilitate medication a

171 LYs per year (52 300-60 500) for DCP without cabotegravir in 10 million adults.

172 inetics and safety of long-acting injectable cabotegravir in participants included in the HPTN 077 tr

173 ug/day (median value per implant, N = 41) of cabotegravir in rhesus macaques.

174 ug/day (median value per implant, N = 41) of cabotegravir in rhesus macaques.

175 The cost per long-acting cabotegravir injection needed to be less than twice that

176 ability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk

177 Long-acting injectable cabotegravir is a novel integrase inhibitor currently in

178 Our results suggest that injectable cabotegravir is a safe and effective pre-exposure prophy

179 Long-acting injectable cabotegravir is a safe, tolerable, and acceptable option

180 ized mice with long-acting ester prodrugs of cabotegravir, lamivudine, and abacavir in combination wi

181 HIV biomedical prevention options including cabotegravir long-acting injectable in a flexible model

182 Among cabotegravir long-acting injectable initiators, 118 (43%

183 1) randomisation group; the option to choose cabotegravir long-acting injectable was added for interv

184 (56%) of 485 intervention participants used cabotegravir long-acting injectable, 255 (53%) used oral

185 P) or post-exposure HIV prophylaxis (PEP) or cabotegravir long-acting injectable, with the option to

186 of-care access to oral PrEP and PEP, but not cabotegravir long-acting injectable.

187 n of follow-up covered by oral PrEP, PEP, or cabotegravir long-acting injectable; primary outcome) an

188 t least one injection and had at least three cabotegravir measurements higher than the LLOQ after the

189 h high HIV incidence, long-acting injectable cabotegravir must be reasonably priced.

190 andomly assigned 127 participants to receive cabotegravir (n=106) or placebo (n=21); 126 (99%) partic

191 ificance of the long pharmacokinetic tail of cabotegravir observed in female participants compared wi

192 ough concentration (Ctrough, 28th day) of LA cabotegravir of 41%-46% for the first maintenance dose c

193 in HIV-uninfected individuals randomized to cabotegravir or a placebo.

194 allocated to receive long-acting injectable cabotegravir or daily oral tenofovir disoproxil fumarate

195 d for 96 weeks, but not to the assignment of cabotegravir or efavirenz.

196 ticipants received intramuscular long-acting cabotegravir or long-acting rilpivirine every 4 weeks or

197 Study data support using long-acting cabotegravir or long-acting rilpivirine, given every 4 w

198 central randomisation schedules, to receive cabotegravir or placebo.

199 ceive sequential doses of either long-acting cabotegravir or rilpivirine and 52 received at least two

200 cceptability and tolerability of long-acting cabotegravir or rilpivirine injections suggests that the

201 andomly assigned (1:1) to receive injectable cabotegravir or tenofovir disoproxil fumarate plus emtri

202 s (brand F/TDF: OR, 0.36; 95% CI, 0.36-0.37; cabotegravir: OR, 0.52; 95% CI, 0.49-0.55; F/TAF: OR, 0.

203 Four cabotegravir pellets were sealed in the membrane, with a

204 Four cabotegravir pellets were sealed in the membrane, with a

205 (cabotegravir group) or active TDF-FTC with cabotegravir placebo (TDF-FTC group).

206 Five implants generated an average cabotegravir plasma concentration of 373 ng/ml in rhesus

207 Cabotegravir plasma levels in macaques dropped below det

208 After a 20-week induction period on oral cabotegravir plus abacavir-lamivudine, patients with vir

209 0 mg; two 3 mL injections) or continued oral cabotegravir plus abacavir-lamivudine.

210 tramuscular dosing regimens relative to oral cabotegravir plus abacavir-lamivudine.

211 Cabotegravir plus dual NRTI therapy had potent antiviral

212 f care oral regimen or switch to long-acting cabotegravir plus rilpivirine (283 per group) in the 100

213 Cabotegravir plus rilpivirine (CAB + RPV) is a guideline

214 The long-acting injectable regimen of cabotegravir plus rilpivirine (CAB/RPV) emerged as an al

215 The impact of long-acting injectable cabotegravir plus rilpivirine (CAB/RPV) on rectal human

216 Long-acting injectable cabotegravir plus rilpivirine (LA CAB/RPV) is currently

217 Overall, cabotegravir plus rilpivirine adverse event type, severi

218 ssigned (2:2:1) to intramuscular long-acting cabotegravir plus rilpivirine at 4-week intervals (long-

219 These data support the use of long-acting cabotegravir plus rilpivirine dosed every 2 months as a

220 The SOLAR study aimed to compare long-acting cabotegravir plus rilpivirine every 2 months with contin

221 g combination of all-injectable, long-acting cabotegravir plus rilpivirine every 4 weeks or every 8 w

222 e the current oral therapy or switch to oral cabotegravir plus rilpivirine for 1 month followed by mo

223 The LATTE-2 study evaluated long-acting cabotegravir plus rilpivirine for maintenance of HIV-1 v

224 regimen, long-acting injectable therapy with cabotegravir plus rilpivirine given as infrequently as e

225 253 participants transitioned to long-acting cabotegravir plus rilpivirine in the extension phase (11

226 Cabotegravir plus rilpivirine is the only approved compl

227 These results support the use of cabotegravir plus rilpivirine long-acting administered e

228 to compare the week 48 antiviral efficacy of cabotegravir plus rilpivirine long-acting dosed every 8

229 Cabotegravir plus rilpivirine long-acting every 8 weeks

230 ipants were randomly assigned 1:1 to receive cabotegravir plus rilpivirine long-acting every 8 weeks

231 Cabotegravir plus rilpivirine long-acting every 8 weeks

232 37% (n=391) transitioned from every 4 weeks cabotegravir plus rilpivirine long-acting in ATLAS.

233 en-label, phase 3b, non-inferiority study of cabotegravir plus rilpivirine long-acting maintenance th

234 articipants switching to monthly long-acting cabotegravir plus rilpivirine or continuing with daily d

235 r plus rilpivirine over 96 weeks following a cabotegravir plus rilpivirine oral lead-in.

236 thly long-acting intramuscular injections of cabotegravir plus rilpivirine over 96 weeks following a

237 As a two-drug maintenance therapy, cabotegravir plus rilpivirine provided antiviral activit

238 to the long-acting therapy show long-acting cabotegravir plus rilpivirine remains a durable maintena

239 At month 11-12, long-acting cabotegravir plus rilpivirine showed non-inferior effica

240 in the oral lead-in group) after 24 weeks of cabotegravir plus rilpivirine therapy, and 15 (5%) parti

241 tandard of care oral regimens to long-acting cabotegravir plus rilpivirine via direct-to-injection or

242 Therapy with long-acting cabotegravir plus rilpivirine was noninferior to oral th

243 We assessed cabotegravir plus rilpivirine, as a two-drug oral antire

244 ollowed by monthly injections of long-acting cabotegravir plus rilpivirine.

245 revention efficacy of long-acting injectable cabotegravir pre-exposure prophylaxis (PrEP) compared wi

246 Long-acting injectable cabotegravir pre-exposure prophylaxis (PrEP) is recommen

247 e DCP intervention and including long-acting cabotegravir PrEP (ie, DCP including cabotegravir).

248 laxis (PEP), and condoms without long-acting cabotegravir PrEP (ie, DCP without cabotegravir); and (3

249 Long-acting injectable cabotegravir PrEP retained high efficacy for HIV prevent

250 Addition of long-acting cabotegravir PrEP to DCP was cost-effective (vs DCP with

251 alysis we assumed in our base case a cost of cabotegravir-PrEP drug to be similar to oral PrEP, resul

252 eiving PrEP compared with 1.5% (28%) without cabotegravir-PrEP introduction across 20 years.

253 ars is projected to be 1.7% (0-6.4%) without cabotegravir-PrEP introduction but 13.1% (4.1-30.9%) wit

254 AIDS deaths are predicted to be averted with cabotegravir-PrEP introduction in 99% of setting-scenari

255 ases in integrase-inhibitor drug resistance, cabotegravir-PrEP introduction is likely to reduce AIDS

256 Cabotegravir-PrEP introduction is predicted to lower the

257 redicted to be similar regardless of whether cabotegravir-PrEP is introduced (total mean discounted a

258 Long-acting cabotegravir-PrEP is predicted to be cost-effective if d

259 Reflecting our assumptions on the appeal of cabotegravir-PrEP, its introduction is predicted to lead

260 same period compared with no introduction of cabotegravir-PrEP.

261 and emtricitabine and long-acting injectable cabotegravir provision to heterosexual adolescents and y

262 ts and investigators were masked to doses of cabotegravir received for 96 weeks, but not to the assig

263 noninferior to oral TDF/FTC, and injectable cabotegravir reduced the risk of HIV infection compared

264 ravir and 0.64 (0.44-0.97) for DCP including cabotegravir, relative to no DCP.

265 Cabotegravir + rilpivirine (CAB + RPV) administered via

266 rs of confirmed virologic failure (CVF) with cabotegravir + rilpivirine long-acting (CAB + RPV LA) we

267 ainst observed data for oral formulations of cabotegravir, rilpivirine, and rifampicin.

268 approaches to the introduction of injectable cabotegravir-rilpivirine are predicted to avert DALYs.

269 ctive unless the cost per year of injectable cabotegravir-rilpivirine is considerably reduced.

270 Our modelling suggests that injectable cabotegravir-rilpivirine offers potential benefits; howe

271 ies involving the introduction of injectable cabotegravir-rilpivirine were predicted to lead to an in

272 first long-acting injectable antiretroviral, cabotegravir/rilpivirine (LA-CAB/RPV), was approved by t

273 ieve viral suppression (VS) with long-acting cabotegravir/rilpivirine (LA-CAB/RPV).

274 Long-acting injectable cabotegravir/rilpivirine (LAI-CAB/RPV) may improve outco

275 re at risk of presenting suboptimal Cmin for cabotegravir/rilpivirine after the first injection but a

276 ifabutin can be overcome by administering LA cabotegravir/rilpivirine monthly together with a daily o

277 LA cabotegravir/rilpivirine should be avoided with strong i

278 ere generated to simulate the exposure of LA cabotegravir/rilpivirine up to a BMI of 60 kg/m2.

279 tabine/tenofovir alafenamide and long-acting cabotegravir/rilpivirine without (n = 4) or with (n = 4)

280 ost-approval of long-acting injectable (LAI) cabotegravir/rilpivirine, nearly two-thirds reported wil

281 extremely limited since the introduction of cabotegravir/rilpivirine, the first LAI for HIV treatmen

282 Across long-acting injectable cabotegravir scenarios, 15-28% more new HIV infections w

283 Cabotegravir sodium (CAB-Na) is a poorly soluble anti- h

284 Obesity was predicted to impact more cabotegravir than rilpivirine with a decrease in caboteg

285 EP to DCP was cost-effective (vs DCP without cabotegravir); the incremental cost-effectiveness ratio

286 treatment, in January 2021, and long-acting cabotegravir, the first LAI for HIV prevention, in Decem

287 ong-acting injectable drugs of lenacapavir + cabotegravir to increase levels of sustained viral suppr

288 e incremental cost of long-acting injectable cabotegravir to the HIV programme was higher than that o

289 ted adverse events were reported by 93 (51%) cabotegravir-treated patients (28 [47%], 32 [53%], and 3

290 n as MK-8591]), long-acting injectables (eg, cabotegravir), vaginal rings, broadly neutralising monoc

291 l cost-effectiveness ratio for DCP including cabotegravir (vs no DCP) was $234 per DALY averted.

292 The annual cost of DCP including cabotegravir was assumed to be $190 per person.

293 infections were eliminated when long-acting cabotegravir was included as an option.

294 083 trial showed that long-acting injectable cabotegravir was more effective than tenofovir disoproxi

295 Injectable cabotegravir was superior to daily oral tenofovir disopr

296 nerally safe, well tolerated, and effective, cabotegravir was superior to TDF-FTC in preventing HIV i

297 derate injection-site reactions, long-acting cabotegravir was well tolerated with an acceptable safet

298 ing dosing of dolutegravir, bictegravir, and cabotegravir when used with the rifamycins for both tube

299 Long-acting cabotegravir with rilpivirine ART has reduced required d

300 ere randomly assigned (1:1) to either active cabotegravir with TDF-FTC placebo (cabotegravir group) o