Two Pfizer Medicines Recommended For Use In NHS Wales

Main Category: HIV / AIDS
Article Date: 14 Jun 2009 - 2:00 PDT

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The All Wales Medicine Strategy Group (AWMSG) has today recommended two Pfizer medicines, Celsentri® (maraviroc) and Ecalta® (anidulafungin) for use in NHS Wales.1

Celsentri, an important HIV medicine has been recommended for use in Wales, in accordance with British HIV Association (BHIVA) guidance2. This provides treatment-experienced patients living with HIV and clinicians access to another effective and important treatment option.

Ecalta has been recommended for use within its licensed indication for the treatment of invasive candidiasis (serious fungal infections) in adult non-neutropenic patients in Wales.

Dr Berkeley Phillips, Medical Director at Pfizer UK, said: "Today's recommendation will help improve access to Celsentri and Ecalta. This will increase the options available to clinicians to help them optimise care for patients."

About Celsentri (maraviroc)

- Maraviroc was the first oral class of HIV treatment to be launched in more than a decade and was made available in November 2007 for treatment experienced patients throughout the UK.

- Maraviroc works in an entirely novel way. It is the first in a new class of HIV medicines called CCR5 antagonists (see below) and is licensed for treatment experienced patients infected with only CCR5-tropic HIV-1 (in combination with other antiretroviral medicinal products)3. Maraviroc works by blocking virus entry into human immune (CD4) cells, preventing HIV from entering and replicating4. All other currently available oral HIV medicines work once HIV has entered the immune cells. This development now enables clinicians to target HIV both inside and outside the cell.

- In large clinical trials (MOTIVATE 1 and 2), maraviroc demonstrated significant efficacy, reducing the virus circulating in the blood stream to undetectable levels and increasing the numbers of immune CD4 cells when added to the standard optimised treatment regimen5. In addition, maraviroc demonstrated an acceptable tolerability profile; the most commonly reported adverse reactions were diarrhoea, nausea and headache3

- In September 2008, BHIVA recommended that treatment-experienced patients should be prescribed a treatment regimen containing at least two, or preferably three, active medicines (i.e. medicines to which the patient's virus has not demonstrated resistance)2. BHIVA also stated that the selection of a new drug class is likely to be more effective in reducing the patient's viral load2.

- Resistance is a serious issue for treatment-experienced patients6. New, effective and well-tolerated treatments are urgently needed for the many people living with HIV, whose virus has become resistant to two or more currently available options.

About CCR5 antagonists

- CCR5 antagonists form a class in a broader group of HIV antiretrovirals known as entry inhibitors. Rather than fighting HIV inside CD4 immune cells, CCR5 antagonists are designed to prevent the virus entering uninfected cells via the CCR5 co-receptor4.

About Ecalta (anidulafungin)

- Results from a double-blind pivotal clinical trial of 245 patients with invasive candidasis (mostly candidaemia) showed anidulafungin to achieve superior global success rate compared to fluconazole at the end of IV therapy (primary endpoint at two weeks): 75.6% vs 60.2%, p=0.01 (95% Confidence Interval for the difference 3.9-27.0%).7

- Anidulafungin is given intravenously through infusion once-a-day - 200mg on day one, followed by 100mg daily thereafter. Duration of treatment should be based on the patient's clinical response. In general, antifungal medicines for candidaemia should be given for at least 14 days after the last positive culture. 8

- Anidulafungin requires no dose adjustment in adult special populations (age, gender, race, renal or hepatic insufficiency, or HIV status).8

- Anidulafungin does not have any known drug interactions, although in vitro studies do not exclude in vivo interactions.

- Anidulafungin has demonstrated to be generally well tolerated with a comparable safety profile to fluconazole.7

- In the pivotal clinical study, adverse events leading to discontinuation of the study drug occurred in 27 patients receiving fluconazole and 15 receiving anidulafungin (p=0.02).7

References

1. All Wales Medicines Strategy Group, 2009. Final Appraisal [Online] Available at: http://www.wales.nhs.uk/sites3/home.cfm?orgid=371[Accessed May 2009]

2. Gazzard B et al, British HIV Association guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy. HIV Medicine 2008; 9, 563-608

3. Celsentri Summary of Product Characteristics. Available at: http://www.medicines.org.uk

4. Dorr, P. et al. Maraviroc (UK-427,857), a potent, orally bioavailable, and selective small-molecule inhibitor of chemokine receptor CCR5 with broad-spectrum anti-human immunodeficiency virus Type 1 activity. Antimicrobial Agents Chemotherapy 2005;49:4721-32

5. Gulick, R et al., 2008. Maraviroc for Previously Treated Patients with R5 HIV-1 Infection, New England Journal of Medicine. 359 (14) 1429-1441

6. National Aids Map (2008) Resistance Factsheet (online) Available: http://www.aidsmap.com/cms1044468.asp (accessed May 2009)

7. Reboli AC, et al. Anidulafungin versus fluconazole for invasive candidiasis. New England Journal of Medicine. 2007;356(24):2472-82.

8. Ecalta Summary of Product Characteristics. Available at: http://www.medicines.org.uk.

Source
Pfizer