Fosalvudine is a type of medicine called a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs block reverse transcriptase, a protein that HIV needs to make more copies of itself.
HIV/AIDS-Related Uses
Fosalvudine is an investigational medicine that is not yet approved by the FDA for use outside of clinical trials. It is being studied for the treatment of HIV infection.This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
Dosage Form/Administration
Fosalvudine is taken by mouth and is being studied in doses of 10 to 40 mg.
Contraindications
Individuals should tell a doctor about any medical problems before taking this medicine.
Possible Side Effects
Along with its desired effects, fosalvudine can cause some unwanted effects. Although not all of these effects are known, nausea, vomiting, diarrhea, and headache have been reported in an early study of fosalvudine in HIV-infected individuals. Individuals should tell a doctor if they have side effects.
Drug and Food Interactions
A doctor should be notified of any other medications being taken, including prescription, nonprescription (over-the-counter), or herbal medications.
Clinical Trials
Click here to search ClinicalTrials.gov for trials that use Fosalvudine.
Manufacturer Information
Fosalvudine
Heidelberg Pharma
Schriesheimer Strasse 101
D-68526 Ladenburg
Baden-Wurttemberg,
Germany
Last Updated: September 8, 2008
Drug Description
Fosalvudine, also known as fosalvudine tidoxil, is a prodrug of alovudine, a nucleoside reverse transcriptase inhibitor. [1]
References
[1] Heidelberg Pharma News: HEIDELBERG PHARMA AG starts second clinical phase II study with FOSALVUDINE [Press Release], November 12, 2007. Available at: http://www.heidelberg-pharma.com/news/popup/20071112.html. Accessed 09/08/08.
HIV/AIDS-Related Uses
Fosalvudine is being evaluated in Phase II clinical trials for the treatment of HIV-1 infection in patients who have multiple-NRTI-resistant HIV-1 infection. [1] [2]
References
[1] Heidelberg Pharma News: HEIDELBERG PHARMA AG starts second clinical phase II study with FOSALVUDINE [Press Release], November 12, 2007. Available at: http://www.heidelberg-pharma.com/news/popup/20071112.html. Accessed 09/08/08.
[2] Heidelberg - Products Pipeline: Fosalvudine. Available at: http://www.heidelberg-pharma.com/products/fosalvudine.html. Accessed 09/08/08.
Dosing Information
Mode of Delivery
Oral. [1]
Dosage Form
Fosalvudine 5, 10, 20, and 40 mg have been studied in Phase I and II clinical trials. Fosalvudine 10- to 40-mg doses are being studied in ongoing Phase II trials. [2] [3]
References
[1] Heidelberg Pharma News: HEIDELBERG PHARMA AG starts second clinical phase II study with FOSALVUDINE [Press Release], November 12, 2007. Available at: http://www.heidelberg-pharma.com/news/popup/20071112.html. Accessed 09/08/08.
[2] IAS Conf HIV Pathogen, Treat, Prevent- 4th, 2007 Abstract WEPEB114LB.
[3] Heidelberg Pharma News: HEIDELBERG PHARMA AG starts second clinical phase II study with FOSALVUDINE [Press Release], November 12, 2007. Available at: http://www.heidelberg-pharma.com/news/popup/20071112.html. Accessed 09/08/08
Pharmacology
Fosalvudine is an enhanced prodrug (through addition of a single phosphate group) of alovudine, a thymidine-anologue nucleoside reverse transcriptase inhibitor. Fosalvudine is covalently linked to a specific lipid-moiety, which should reduce adverse effects associated with alovudine treatment. Fosalvudine is expected to have altered pharmacokinetics and distribution compared with alovudine. [1] [2]
In vitro, fosalvudine inhibits the replication of HIV group M subtypes A through G. In a murine tissue study, low concentrations of fosalvudine were distributed to fat and bone marrow, which suggests a low potential for hematopoetic toxicity. [3]
Fosalvudine is being studied in Phase II trials in treatment-naïve and treatment-experienced patients infected with HIV-1. In a 14-day, dose-finding, Phase II study in treatment-naïve patients, fosalvudine exhibited dose-dependent efficacy across 10- to 40-mg doses. Mean viral load reduction at day 15 was 60% for the 5-mg dose, nearly 80% for the 10-mg dose, 85% for the 20-mg dose, and 90% for the 40-mg dose compared with placebo (nearly 0% change in viral load). Fosalvudine is currently being studied in a Phase II trial in treatment-experienced patients. [4]
References
[1] IAS Conf HIV Pathogen, Treat, Prevent- 4th, 2007 Abstract WEPEB114LB.
[2] IAS Conf - 16th, 2006 Abstract ThPE0025.
[3] IAS Conf - 16th, 2006 Abstract ThPE0025.
[4] Heidelberg HEIDELBERG PHARMA AG starts second clinical phase II study with FOSALVUDINE [Press Release], November 12, 2007. Available at: http://www.heidelberg-pharma.com/news/popup/20071112.html. Accessed 09/08/08.
Adverse Events/Toxicity
Fosalvudine doses of 5 to 40 mg were well tolerated in treatment-naïve, HIV-infected patients for 14 days. Adverse effects were infrequent and included grade 1 nausea, vomiting, and diarrhea and grade 2 headache. [1]
References
[1] IAS Conf HIV Pathogen, Treat, Prevent- 4th, 2007 Abstract WEPEB114LB.
Clinical Trials
Click here to search ClinicalTrials.gov for trials that use .
Chemistry
Further Reading
CahnP., et al. A phase-II study of 14 days monotherapy with the nucleoside-analogue Fosalvudine Tidoxil in treatment-naïve HIV-1 infected adults. Poster exhibition: 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention: Abstract no. WEPEB114LB. Available at: http://aids2008.org/Abstracts/A200705533.aspx. Accessed 09/08/08.
Manufacturer Information
Fosalvudine
Heidelberg Pharma
Schriesheimer Strasse 101
D-68526 Ladenburg
Baden-Wurttemberg,
Germany
Last Updated: September 8, 2008