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Latest questions

ViiV responds to questions from the healthcare professional community.

Q1. What efficacy data is available for dolutegravir?

Dolutegravir has shown superior efficacy versus 4 core agent comparators (EFV, DRV/r, ATV/r and RAL) in studies with treatment-naive or treatment-experienced patients and maintained efficacy in switch setting.

Q2. How does the efficacy of dolutegravir compare to Atripla® in treatment-naïve patients?

In the SINGLE study, n=833, DTG + ABC/3TC was statistically superior to Atripla® with respect to the proportion of patients achieving HIV-1 RNA <50 c/mL (FDA snapshot) at Week 48 (88% vs 81%, respectively; p=0.003).1 71% in the dolutegravir + abacavir/lamivudine arm and 63% in the efavirenz/tenofovir/emtricitabine arm maintained viral loads of < 50 copies/mL through week 144.2

Q3. How does the efficacy of dolutegravir compare with other integrase inhibitors?

SPRING-2 was the first head-to-head, double-blind comparison of efficacy and safety of two INI-based regimens for first-line ART. Once daily dolutegravir was non-inferior to twice daily raltegravir, when co-administered with 2 NRTIs at 48 weeks, in treatment-naive patients. 7

In addition, in the SAILING study, in treatment-experienced, integrase-inhibitor-naive patients, virologic suppression (HIV-1 RNA<50 copies/mL) in the dolutegravir arm (71%) was statistically superior to the raltegravir arm (64%), at week 48 (p=0.03). 8

Q4. Is dolutegravir equally effective when given with either Truvada or Kivexa?

Yes, in the SPRING-2 7 and FLAMINGO 3 studies, DTG demonstrated  comparable or similar efficacy regardless of backbone regimen.

Q5. What are the most common adverse events that have been reported with dolutegravir?

The most commonly seen treatment emergent adverse reactions were nausea (13%), diarrhoea (18%), and headache (13%). 10

Q6. How does the tolerability profile of dolutegravir compare to other antiretroviral agents?

In the SINGLE study, dolutegravir + ABC/3TC was generally better tolerated vs. Atripla® with fewer discontinuations. 1 In both SPRING-2 (treatment naive) and SAILING (treatment experienced) studies, dolutegravir had a similar tolerability profile to raltegravir. 7 8

References:

  1. Walmsley S, Antela A, Clumeck N, et al, for the SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807-1818.
  2. Walmsley S, Baumgarten A, Berenguer J et al; Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results from the SINGLE Randomized CLinical Trial; J Acquir immune Defic Syndrome, 2015 Dec 15; 70(5); 515-9.
  3. Clotet B, Feinberg J, van Lunzen J, et al, on behalf of the ING114915 Study Team. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014;383(9936):2222-2231.
  4. Molina JM, 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 Apr;2(4):e127-36.
  5. Orrell C, Hagins DP, Belonosova E, et al, for the ARIA study team. 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. Lancet HIV 2017; published online July 17. http://dx.doi.org/10.1016/S2352-3018(17)30095-4.
  6. Raffi F, Rachlis A, Stellbrink HJ, et al; on behalf of the SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43.
  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. 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.
  9. Trottier B, Lake JE, Logue K, et al. Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study. Antivir Ther. 2017 Apr 12. doi: 10.3851/IMP3166.
  10. TIVICAY (dolutegravir) Summary of Product Characteristics.

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