From the Guidelines
Emtricitabine 200 mg-tenofovir disoproxil fumarate 300 mg is recommended as a first-line option for pre-exposure prophylaxis (PrEP) in individuals at high risk of HIV infection, as evidenced by the 2020 recommendations of the International Antiviral Society-USA panel 1. This combination antiretroviral medication, commonly known by the brand name Truvada, is typically taken as one tablet once daily with or without food. For HIV treatment, it's usually combined with at least one other antiretroviral drug as part of a complete regimen. Some key points to consider when prescribing this medication include:
- The medication works by inhibiting HIV viral replication through two mechanisms: emtricitabine and tenofovir are both nucleoside reverse transcriptase inhibitors that prevent the virus from copying its genetic material.
- Common side effects include nausea, headache, and diarrhea, which often improve over time.
- More serious potential side effects include kidney problems and decreased bone density, so regular monitoring of kidney function is important while on this medication.
- For maximum effectiveness, it's crucial to take this medication exactly as prescribed without missing doses, as inconsistent use can lead to drug resistance or reduced protection against HIV.
- The 2020 recommendations of the International Antiviral Society-USA panel also suggest that tenofovir disoproxil fumarate/emtricitabine once daily is recommended for oral PrEP 1. Other options for PrEP, such as tenofovir alafenamide/emtricitabine, may be considered in certain situations, such as for men who have sex with men (MSM) with or at risk for kidney dysfunction, osteopenia, or osteoporosis 1. However, the emtricitabine 200 mg-tenofovir disoproxil fumarate 300 mg combination remains a preferred option due to its established efficacy and safety profile 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Emtricitabine 200 mg-Tenofovir Disoproxil Fumarate 300 mg Tablet
- The emtricitabine 200 mg-tenofovir disoproxil fumarate 300 mg tablet is a fixed-dose co-formulation of two reverse transcriptase inhibitors, emtricitabine and tenofovir disoproxil fumarate, for once-daily dosing in combination with other antiretrovirals for the treatment of HIV infection 2.
- Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) with demonstrated potent activity against HIV and hepatitis B virus (HBV), while tenofovir disoproxil fumarate is a nucleotide reverse transcriptase inhibitor 2.
- The combination of emtricitabine and tenofovir disoproxil fumarate has been shown to be effective in the treatment of HIV-1 infection, with studies demonstrating its efficacy in both treatment-naive and treatment-experienced patients 3, 4, 5, 6.
Mechanism of Action and Efficacy
- Emtricitabine and tenofovir disoproxil fumarate work by inhibiting the reverse transcriptase enzyme, which is essential for the replication of HIV 2.
- Studies have shown that the combination of emtricitabine and tenofovir disoproxil fumarate is effective in reducing viral load and increasing CD4 cell count in patients with HIV-1 infection 3, 4, 5, 6.
- The combination has also been shown to be effective in preventing HIV-1 infection in high-risk individuals, with a study demonstrating a 44% reduction in the risk of HIV-1 infection in men who have sex with men 4.
Safety and Tolerability
- The emtricitabine 200 mg-tenofovir disoproxil fumarate 300 mg tablet is generally well tolerated, with common side effects including nausea, diarrhea, and headache 2, 3, 4, 5, 6.
- Studies have also shown that the combination is effective in maintaining virological suppression and improving adherence to treatment in patients with HIV-1 infection 5, 6.