What is Truvada?
Truvada is a drug containing the two active substances emtricitabine (200 mg) and tenofovir disoproxil (245 mg). It is available in blue capsule-shaped tablets.
What is Truvada used for?
Truvada is an antiviral drug. It is indicated in combination with at least one other antiviral drug for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How is Truvada used?
Treatment with Truvada should be started by a doctor with experience in the field of HIV infection. The recommended dose of Truvada is one tablet once a day, taken with food. Patients with kidney problems may need to take the tablets less frequently. Truvada is not recommended in patients with severe kidney problems or in patients requiring hemodialysis (a blood clearance technique). In exceptional cases, patients who have difficulty swallowing can crush and dissolve the tablet in about 100 ml of water, orange juice or grape juice and drink the liquid immediately. If the patient should stop taking emtricitabine or tenofovir or change the dose, medicines containing emtricitabine or tenofovir disoproxil should be taken separately. For more information, see the package leaflet.
How does Truvada work?
Truvada contains two active ingredients: emtricitabine, a nucleoside reverse transcriptase inhibitor, and tenofovir disoproxil, a tenofovir "prodrug". Tenofovir is a nucleoside reverse transcriptase inhibitor. Both drug groups are known as NRTIs. Both emtricitabine and tenofovir act in the same way, blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and reproduce. Truvada, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level. Truvada does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Both active substances are available in the European Union (EU) since the early 2000s: emtricitabine obtained marketing authorization under the name Emtriva in 2003, while tenofovir disoproxil obtained authorization to place it in commerce under the name of Viread in 2002.
What studies have been carried out on Truvada?
The main studies evaluated the effects of the active ingredients of Truvada, emtricitabine and tenofovir disoproxil, in 683 treatment-naïve HIV-1 infected patients (never previously treated for treatment of HIV infection). The first study compared the combination of emtricitabine and tenofovir disoproxil with the combination of lamivudine and zidovudine (other antiviral drugs), both taken in combination with efavirenz (another antiviral drug) in 487 patients. In the second study, the effects of emtricitabine and tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral drugs), were examined in 196 patients. The main measure of effectiveness was the percentage of patients whose levels of HIV in the blood (viral load) fell below 400 or 50 copies / ml, remaining below these thresholds up to the 48th week of treatment. The company also looked at how the single tablet was absorbed by the body compared to separate medicines.
What benefit has Truvada shown during the studies?
The active ingredients of Truvada, taken in combination with other antiviral drugs, have reduced the viral load in most patients and are more effective than the comparator medicines. In the first study, 84% of 244 patients treated with Truvada achieved and maintained, within 48 weeks of starting treatment, a viral load of less than 400 copies / ml compared to 73% of 243 patients treated with the comparator medicines . About two thirds of the patients who participated in the second study achieved and maintained a viral load below 50 copies / ml after 48 weeks of treatment. The unique tablet was absorbed by the body just like the separate drugs.
What is the risk associated with Truvada?
The most common side effects that may occur when taking Truvada (seen in more than 1 patient in 10) are hypophosphataemia (low blood phosphate levels), headache, dizziness, diarrhea, vomiting, nausea and an increase in creatine kinase levels in the blood (enzyme found in muscles). For the full list of all side effects reported with Truvada, see the Package Leaflet.
Truvada should not be used in people who may be hypersensitive (allergic) to emtricitabine, tenofovir, tenofovir disoproxil fumarate or any of the other substances.
As with other anti-HIV drugs, patients receiving Truvada may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the reactivation of the immune system ). Patients with liver problems (including hepatitis B or C) may be at an increased risk of developing liver damage if treated with Truvada. Like all other NRTIs, Truvada can also cause lactic acidosis (accumulation of lactic acid in the body) and, in the children of mothers treated during pregnancy, mitochondrial dysfunction (injuries to cellular constituents that produce energy that can cause blood problems).
Why has Truvada been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Truvada's benefits are greater than its risks in combination antiretroviral therapy for the treatment of HIV-1 infected adults. He noted that the benefit of Truvada has only been shown in patients not previously treated for HIV infection, but that the simplified dosing regimen offered by the once-daily tablet can help patients stick to treatment. The Committee therefore recommended that it be given marketing authorization.
More information on Truvada:
The European Commission granted a marketing authorization valid throughout the European Union for Truvada to Gilead Sciences International Limited on 21 February 2005.
For the full EPAR for Truvada click here.
Last update of this summary: 03-2007.
