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European Commission Approves Merck’s DELSTRIGO (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen for the Treatment of HIV-1 in Appropriate Patients

Delstrigo is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Delstrigo contains the active substances doravirine, lamivudine and tenofovir disoproxil. The medicine is not suitable for patients who are infected with HIV that is resistant to lamivudine, tenofovir disoproxil or to medicines in the same class as doravirine (non-nucleoside reverse transcriptase inhibitors or NNRTIs).

Delstrigo is available as tablets, each containing doravirine 100 mg, lamivudine 300 mg and tenofovir disoproxil 245 mg. It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection. The recommended dose is one tablet daily.

The three active substances in Delstrigo, doravirine, lamivudine and tenofovir disoproxil, block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI). Tenofovir disoproxil is a ‘prodrug’ of tenofovir, meaning that it is converted in the body to the active substance tenofovir. Tenofovir is a nucleotide reverse transcriptase inhibitor. Delstrigo keeps the amount of HIV in the blood at a low level. It does not cure HIV infection or AIDS but it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.

Delstrigo is as effective at keeping HIV infection under control as similar HIV combination treatments. In addition, Delstrigo’s side effects are mostly mild. The European Medicines Agency therefore decided that Delstrigo’s benefits are greater than its risks and it can be authorised for use in the EU.

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