Raltegravir

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Articles

Medicine Compliance Aid Stability

Isentress · Merck Sharp & Dohme Ltd

Merck Sharp & Dohme Ltd
Isentress
Tablets 400mg
G1 · Green 1 · Stability data indicates that the drug is suitable for CAs and there are no theoretical concerns with the product.
No special precautions for storage
Manufacturer confirms stability.
5th August 2015

Isentress · Merck Sharp & Dohme Ltd

Merck Sharp & Dohme Ltd
Isentress
Tablets chewable 25mg, 100mg
R1 · Red 1 · Stability data indicates that the drug is not suitable for CAs.
Unsuitable
Chewable tablets stored with dessicant in original pack.
5th August 2015

Lactation Safety Information

Specialist drug/complex disease area for which expert advice is recommended
21st September 2020

New Medicines

Isentress (EU), Isentress HD (US) · HIV infection in adults and children weighing at least 40kg, in combination with other anti-retrovirals - 600mg tablet formulation

Information

Isentress (EU), Isentress HD (US)
New formulation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Launched
Launched
Launched
September 2017
Feb 18 · Has been approved in US for treatment of HIV-1 infection in newborns weighing at least 2kg, in combination with other antiretroviral agents [9].
Sep 17 · Launched in the UK. Cost for 60 x 600 mg film-coated tablets is £471.41 [7].
Jul 17 · Approved in EU [6].
May 17 · Approved in the US. Approval is supported by data from PIII ONCEMRK trial [4].
May 17 · CHMP adopt positive opinion [5].
Feb 17 · Will be filed via the EU centralised route [2].

Category

Integrase strand transfer inhibitor. 600mg tablet formulation. Dosed once daily.
In 2013, a total of 6,000 persons (4,500 men and 1,500 women) were newly diagnosed with HIV in the UK. The number of newly diagnosed heterosexual men and women has dropped over the years from 4,890 in 2004 to 2,490 in 2013) due to fewer diagnoses among people born in sub-Saharan Africa [1].
HIV infection in adults and children weighing at least 40kg, in combination with other anti-retrovirals - 600mg tablet formulation
Oral

Trial or other data

Sep 17 · Results of NCT02131233 published in The Lancet [8].
Jul 17 · Week 96 results from PIII ONCEMRK study shows once-daily raltegravir met primary efficacy endpoint of non-inferiority to twice-daily regimen. 81.5% of 531 patients on once-daily regimen (2 x 600 mg) achieved viral suppression <40 copies/mL HIV-1 RNA, vs. 80.1% of 266 patients taking 400mg BD, both in combination with emtricitabine plus tenofovir disoproxil fumarate [6].
May 17 · Data from pivotal PIII ONCEMRK trial show that at Week 48, 89% (n=531) of patients receiving ISENTRESS HD 1200 mg (2 x 600 mg) once a day achieved viral suppression of HIV-1 RNA 100,000 copies/mL) [4].
Sep 16 · PIII onceMRK has completed recruitment [3].
May 14 · PIII onceMRK study (NCT02131233) starts. The study will evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in 802 HIV-1 infected, treatment-naive adults. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48. The study is expected to complete Dec 16 [3].

Evidence based evaluations

SMC