Emtricitabine / Tenofovir disoproxil Teva (emtricitabine / tenofovir disoproxil)

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Emtricitabine / Tenofovir disoproxil Teva (emtricitabine / tenofovir disoproxil)

Manufacturer Teva Nederland B.V.
Disease HIV / AIDS
Indication HIV-1 infection or prevention (PrEP)
Mode of Action Antiviral
Approval Status MHRA approved (UK); MEB approved (NL)
CAS Number 945721-28-8
HS Code 29334990
Strength 200 mg / 245 mg

 
Disclaimer: Please note that in some countries the compound emtricitabine / tenofovir disoproxil is protected by patents registered by Gilead Sciences Inc. We cannot deliver emtricitabine / tenofovir disoproxil to a country where there is a valid patent registered. If you are unsure if a patent is registered in your country, please get in touch and we will find out for you.

Who is emtricitabine / tenofovir disoproxil for?

Emtricitabine / Tenofovir disoproxil Teva (emtricitabine / tenofovir disoproxil) is indicated for the treatment of carriers of the human immunodeficiency virus type 1 (HIV-1), the virus that causes acquired immune deficiency syndrome (AIDS). It is used in combination with at least one other antiviral medicine [1][2].
Emtricitabine / tenofovir disoproxil Teva (emtricitabine / tenofovir disoproxil) is also indicated as ‘pre-exposure prophylaxis’ (PrEP) to help prevent sexually transmitted HIV-1 infection in adults who are at high risk of being infected. It is recommended for use in combination with safer sex practices, such as the use of condoms [1][2], which may protect against other sexually transmitted infections (STIs) as well as against HIV infection. Emtricitabine / tenofovir disoproxil can be used for PrEP only in individuals who have been tested to be free of HIV infection. Individuals taking it to prevent HIV-1 infection should be tested at least every 3 months to make sure that they are free of HIV-1 [1][2].
In the case of kidney dysfunction, emtricitabine / tenofovir disoproxil should be used only if the potential benefits are considered to outweigh the potential risks. Prior to initiating emtricitabine / tenofovir disoproxil for the treatment of HIV-1 infection or for use in pre-exposure prophylaxis, it is recommended that creatinine clearance is calculated in all individuals. In individuals without risk factors for renal disease, it is recommended that renal function (creatinine clearance and serum phosphate) is monitored after two to four weeks of use, after three months of use and every three to six months thereafter. In individuals at risk for renal disease more frequent monitoring of renal function is required [1][2].

Recommended dose

Complete information about Emtricitabine / tenofovir disoproxil Teva (emtricitabine / tenofovir disoproxil) dosage and administration can be found here [1][2].
The standard dosage for both treatment and prevention of HIV-1 infection is:
  • 1 tablet 200 mg emtricitabine/ 245 mg tenofovir disoproxil once daily
The kidney function should be monitored in all patients. Patients using emtricitabine / tenofovir disoproxil for PrEP should be tested for HIV infection every 3 months [1][2].
HIV-1 uninfected individuals should be counseled to strictly adhere to the recommended Emtricitabine / Tenofovir disoproxil Teva dosing schedule. The effectiveness of the combination of emtricitabine and tenofovir in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in blood [1][2].
Consult your treating doctor for personalised dosing.

What is emtricitabine / tenofovir disoproxil and how does it work?

Emtricitabine / tenofovir disoproxil Teva (emtricitabine / tenofovir disoproxil) is an antiviral medicine used in combination with at least one other antiviral medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), the virus that causes acquired immune deficiency syndrome (AIDS) [1][2]It is also used to help prevent sexually transmitted HIV-1 infection in adults who are at high risk of being infected (PrEP - pre-exposure prophylaxis). When used as PrEP it is recommended for use in combination with safer sex practices, such as the use of condoms [1][2], which may protect against other sexually transmitted infections (STIs) as well as against HIV infection.
Each tablet of emtricitabine / tenofovir disoproxil contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg). Inside the body, tenofovir disoproxil is converted into the active substance tenofovir. Tenofovir and emtricitabine block the activity of the enzyme made by the virus to reproduce itself in the cells it has infected. 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. It does not cure HIV infection or AIDS but it can prevent damages to the immune system and the development of infections and diseases associated with AIDS [1][2].
For the treatment of HIV-1 infection, emtricitabine / tenofovir disoproxil, 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. It does not cure HIV infection or AIDS, but it can prevent damages to the immune system and the development of infections and diseases associated with AIDS [1][2].
For HIV-1 infection prevention (PrEP), it is expected that emtricitabine / tenofovir disoproxil in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus. The effectiveness of the combination of emtricitabine and tenofovir in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in blood [1][2].

What is emtricitabine / tenofovir disoproxil's approval status?

Emtricitabine / tenofovir disoproxil Teva was approved among others by:
  • MHRA (UK) April 19, 2016 [1]
  • CBG (NL) in September 29, 2016 [2]
For treatment of individuals infected with human immunodeficiency virus type 1 (HIV-1), in combination with at least one other antiviral medicine, and as pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.
The approvals of emtricitabine / tenofovir disoproxil for HIV-1 treatment were based on studies that compared emtricitabine and tenofovir disoproxil fumerate with other antiviral medicines in HIV-1-positive treatment-naive adults. The active substances in emtricitabine and tenofovir disoproxil fumerate were more effective than the comparator medicines in reducing the viral load [1][2].
The study GS-01-934 compared the combination of emtricitabine and tenofovir disoproxil with the combination of lamivudine and zidovudine (other antiviral medicines) both taken with another antiviral medicine (efavirenz) by patients with HIV-1 infection. Eighty percent of the patients (total of 511) taking emtricitabine and tenofovir disoproxil achieved and maintained viral loads below 50 HIV-1 copies/ml by 48 weeks, compared with 70 % of the patients taking the comparator medicines [1][2].
The approvals of emtricitabine / tenofovir disoproxil as pre-exposure prophylaxis (PrEP) were based on two main studies which evaluated the addition of emtricitabine / tenofovir disoproxil to standard preventative measures for pre-exposure prophylaxis. This was done by comparing emtricitabine / tenofovir disoproxil with placebo in adults at high risk of sexually transmitted HIV-1 infection. Emtricitabine / tenofovir disoproxil resulted more effective than placebo for preventing HIV-1 infection. In both studies the level of protection depended on how well individuals adhered to the treatment program [1][2].
Study iPrEx involved 2499 HIV-seronegative individuals with evidence of high-risk behaviour for HIV-1 infection [1][2].  In total, the study lasted 4,237 person-years (a person-year is a measurement combining the number of persons and their time contribution in a study [3]). Of the 1,224 people in the emtricitabine/tenofovir disoproxil arm 3.9 % tested positive for HIV-1 infection compared with 6.8 % individuals taking placebo, corresponding to a relative risk reduction of 42 % [1][2].
The second study (Partner PrEP) involved over 4,758 heterosexual couples with discordant HIV-1 infection status. Of the individuals takingemtricitabine/tenofovir disoproxil, 0.8 % tested positive for HIV-1 infection over 1 year compared with 3.3 % of those taking placebo [1][2].
The most common adverse reactions were nausea and diarrhoea [1][2].
References
[1] Summary of Product Characteristics [MHRA]: Emtricitabine / Tenofovir disoproxil Teva (emtricitabine / tenofovir disoproxil), Teva UK Ltd., April, 2016.
http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1495775183909.pdf
[2] Summary of Product Characteristics [MEB]: Emtricitabine / Tenofovir disoproxil Teva (emtricitabine / tenofovir disoproxil), Teva Nederland B.V., Feb, 2017.
https://db.cbg-meb.nl/IB-teksten/h117050.pdf
[3] University of Michigan. Person-Time. Cited on 01/08/2017.
https://practice.sph.umich.edu/micphp/epicentral/person_time.php








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