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DOVATO: Comparable and durable efficacy at 144 weeks in treatment-naïve patients and at 96 weeks in experienced patients1,5

Dovato

Download publications behind Dovato clinical data and other DTG studies.

  

LOC_NOCL DOVATO PRINT MAY 19 - DOVATO 48wk Infographic_D2
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HIV treatment has come a long way in the last 25 years, but there's still more to do. See why Dr Annemiek de Ruiter, Senior Global Medical Director of ViiV Healthcare, believes it is important for us to address patients concerns around long-term toxicities of ARVs by providing options that reduce the amount of drugs patients need to effectively control the virus.H

Dovato er tilgjengelig i gjeldende anbud. Se LIS avtaledokument i perioden 01.12.2019 – 30.11.2021 [3]

 
*DTG 50 mg + 3TC 300 mg (bioequivalent to DOVATO) used in the GEMINI studies.1

DOVATO is indicated for the treatment of HIV-infected adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.2

DOVATO was studied in HBV-negative adult HIV patients with viral loads up to 500,000 copies/mL. The GEMINI-1 and GEMINI-2 studies are identically designed, 148-week, treatment-naïve, phase III, randomized, double-blind, parallel-group, multicenter, non-inferiority studies evaluating efficacy, safety and tolerability of once-daily DTG 50 mg +3TC 300 mg versus DTG 50 mg + TDF/FTC 300 mg/200 mg. At week 48, 91% of participants on DTG+3TC and 93% of participants on 3-drug regimen had HIV-1 RNA levels of <50 copies/mL. Adjusted treatment difference -1.7%, 95% CI: -4.4, 1.1.4

At week 144, 82% of participants in DTG+3TC group (n=716) and 84% of participants in DTG+TDF/FTC group (n=717) achieved HIV-1 RNA <50 copies/mL (treatment difference: -1.8%; 95% CI: -5.8; 2.1).2

Adverse events reported at 96 weeks in ≥10% of subjects in either group:1
DOVATO: diarrhea (12,4% ), headache (11,0%), nasopharyngitis (9,9%)
DTG + TDF/FTC: diarrhea (13,0%), headache (12,1%), nasopharyngitis (15,9%)

DOVATO was also studied in HBV-negative adult HIV patients with HIV-1 RNA <50 copies/mL on a tenofovir alafenamide (TAF)-based regimen. The TANGO study was a 144 week, open-label, multicenter, non-inferiority study evaluating efficacy, safety and tolerability of switch to once-daily DTG/3TC fixed-dose combination compared to continued tenofovir alafenamide (TAF)-based regimen. At week 48, 0.3% (1/369) of participants on DTG/3TC and 0.5% (2/372) of participants on continued TAF-based regimen had HIV-1 RNA levels of ≥50 copies/mL. Adjusted treatment difference -0.3%, (95% CI: -1.2, 0.7) meeting non-inferiority criteria.5

At week 96, the proportion of participants with HIV-1 RNA ≥50 c/mL (Snapshot) was 0.3% in the DOVATO group (n=369) and 1.1% in the TAF-based regimen group (n=372) (95% CI for the adjusted treatment difference: -2.0%; 0.4%; ITT E Population)5

Incidences of specific AEs were mostly similar between treatment groups. There was a higher proportion of participants who withdrew because of adverse events in the DTG/3TC group (n=13 [3.5%] vs n=2 [0.5%]), including 1 fatal AE unrelated to study treatment (homicide).5

Dovato is contraindicated with co-administration with substrates of organic cation transporter (OCT)2 with narrow therapeutic windows, including but not limited to fampridine.2

The most severe adverse reaction reported with dolutegravir was a hypersensitivity reaction that included rash and severe liver effects.

Women of childbearing potential should be counselled about the potential risk of neural tube defects with dolutegravir including consideration of effective contraceptive measures. If a women is planning pregnancy, the benefits and risks of continuing treatment with Dovato should be discussed with the patient.2

Reference:

  1. Cahn P, Madero JS, Arribas JS, et al. Durable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment–Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials. J Acquir Immune Defic Syndr. 2019. doi: 10.1097/QAI.0000000000002275.
  2. DOVATO (dolutegravir/lamivudine) Summary of Product Characteristics.
  3. LIS-anbefalinger for ARV behandling av hiv for perioden 01.12.2019 - 30.11.2021. https://sykehusinnkjop.no/Documents/Legemidler/Avtaler og anbefalinger/2020/Anbefalinger LIS hiv.pdf (accessed Oct 20, 2020)
  4. Cahn P, Sierra Madero J, Arribas JR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393(10167):143-155.
  5. van Wyk J, Ajana F, Bisshop F, et al. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose Two-Drug Regimen Versus Continuing a Tenofovir Alafenamide–Based Three-or Four-Drug Regimen for Maintenance of Virologic Suppression in Adults With HIV-1: Phase 3, Randomized, Non-inferiority TANGO Study. Clin Infect Dis. 2020. doi: 10.1093/cid/ciz1243.

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