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Fortsett

Tilbake

Why DTG + RPV? 

Dolutegravir and Rilpivirine

Like traditional 3-drug regimens, dolutegravir + rilpivirine inhibits the viral life cycle at 2 different targets1,2,11

Juluca
Juluca

*Efficacy measured as proportion of participants with HIV viral load <50 copies/ml.

  • At week 48, 88% (364/414) of participants on DTG/ABC/3TC and 81% (338/419) of participants on Atripla had HIV-1 RNA level of <50 copies/ml (difference in response 8.3%, 95% CI: 2.0%-14.6%, P=0.010). Insomnia was reported more frequently with DTG/ABC/3TC, whereas rash and neuropsychiatric events (including abnormal dreams, anxiety, dizziness, and somnolence) were more common with Atripla.3 
  • At week 96, 80% (194/242) of participants on dolutegravir and 68% (164/242) of participants on darunavir/r had HIV-1 RNA level of <50 copies/ml (adjusted difference 12.4%, 95% CI: 4.7%-20.2%, P=0.002). The most common drug-related adverse events were diarrhoea (23/242 [10%] in the dolutegravir group vs 57/242 [24%] in the darunavir plus ritonavir group), nausea (31/242 [13%] vs 34/242 [14%]), and headache (17/242 [7%] vs 12/242 [5%]).4 
  • At week 48, 82% (203/248) of participants on dolutegravir and 71% (176/247) of participants on atazanavir/r had HIV-1 RNA level of <50 copies/ml (mean difference 10.5%, 95% CI: 3.1%-17.8%, P=0.005). Adverse events were similar between the dolutegravir and atazanavir groups; the most common were nausea (19% [46/248] in the dolutegravir group vs 20% [49/247] in the atazanavir group) and headache (11% [28/248] vs 13% [32/247]).5 
  • At week 48, 71% (251/354) of participants on dolutegravir and 64% (230/361) of participants on raltegravir had HIV-1 RNA level of <50 copies/ml (adjusted difference 7.4%, 95% CI: 0.7%-14.2%, P=0.03). Occurence of adverse event were similar across groups; the most commonly reported events for dolutegravir versus raltegravir were diarrhoea (20% [71/357] vs 18% [64/362]), upper respiratory tract infection (11% [38/357] vs 8% [29/362]), and headache (9% [33/357/] vs 9% [31/362]).6 

Referanser

  1. TIVICAY preparatomtale 
  2. Edurant preparatomtale
  3. Walmsley SL, Antela A, Clumeck N et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807-1818.
  4. Molina J-M. Clotet B, van Lunzen J. et al; on behalf of the FLAMINGO study team. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised. open-label, phase 3b study. Lancet HIV. 2015;2(4):e127-e136. doi: 10.1016/S2352-3018(15)00027-2.
  5. Orrell C, Hagins DP, Belonosova E, et al. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study. Published online July 17, 2017. Lancet HIV. doi: 10.1016/S2352-3018(17)30095-4. 
  6. Cahn P, Pozniak AL, Mingrone H, et al; on behalf of the extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382(9893):700-708. 
  7. Raffi F, Jaeger H, Quiros-Roldan E, et al; on behalf of the extended SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naïve adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013;13(11):927-935. 
  8. TRIUMEQ preparatomtale
  9. Pozniak AL, Morales-Ramirez J, Katabira E, et al; TMC 278-C 204 Study Group. Efficacy and safety of TMC 278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase llb randomized trial. AIDS. 2010:24:55-65. 
  10. Mills AM, Antinori A, Clotet B, et al; on behalf of the ECHO and THRIVE study groups. Neurological and psychiatric tolerability of rilpivirine (TMC278} vs. efavirenz in treatment-naïve, HIV-1-infected patients at 48 weeks. HIV Med. 2013;14:391-400. 
  11. JULUCA▼ preparatomtale