FTC (emtricitabine, Emtriva) approved in Europe

On 28 October 2003 the European Commission granted Marketing Authorisation for FTC (emtricitabine, Emtriva) 200 mg hard capsules and 10 mg/mL oral solution in all 15 member states of the European Union. FTC will be available in individual European countries as local reimbursement approvals are obtained.

FTC is a nucleoside reverse transcriptase inhibitor (NRTI) for the treatment of HIV infection, and is dosed as a single capsule taken once a day as part of combination therapy.

FTC is indicated for the treatment of HIV-infected adults and children in combination with other antiretroviral agents. This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control. There is no experience with the use of FTC in patients who are failing their current regimen or who have failed multiple regimens. When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.

FTC is dosed once daily and can be taken with or without food. More than 2,000 HIV-infected adults have been treated with FTC for periods of 10 days to 200 weeks in phase I, II and III clinical trials. Assessment of adverse drug reactions is based on data from three studies in adults (n=1,479) and two paediatric studies (n=114). In the adult studies, 1,039 treatment-naïve and 440 treatment-experienced patients received FTC (n=814) or comparator medicinal product (n=665) for 48 weeks in combination with other antiretroviral medicinal products. In the paediatric studies, treatment-naïve (n=83) and treatment-experienced (n=31) paediatric patients aged four months to 18 years were treated with Emtriva in combination with other antiretroviral agents.

The most common adverse reactions observed in the studies described above include headache, diarrhoea, nausea and elevations in creatine kinase. Additionally, as outlined in the US prescribing information, skin discoloration was observed at a higher frequency in FTC versus control groups. Skin discoloration, manifested by hyperpigmentation (excess pigmentation) on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance of this adverse event are unknown.

FTC is available as a 200 mg capsule for use in adults and as a 10 mg/mL oral solution for use in infants older than four months, children and patients who are unable to swallow hard capsules and patients with renal insufficiency who require dose reduction. Please refer to the Summary of Product Characteristics for Emtriva 10 mg/mL oral solution.

Comment

Potential advantages of FTC include a longer plasma and intracellular half-life that might provide a safer window period in the event of a missed Q24H dose.

Whether people will be able to benefit from this in the UK will depend on the negotiated price in different health trusts, although the list price for FTC is set just under the list price for 3TC. Use of GSK’s once-daily formulation of 3TC is very low because of the relatively small additional cost over the BID 3TC formulation.

As with 3TC, doctors should be aware of anti-HBV activity of FTC, and people coinfected with HIV and HBV should follow cautions for stopping FTC that are included in the summary of product characteristics.