Gilead Sciences announced that the FDA has approved Truvada (Emtricitabine 200mg and Tenofovir disoproxil fumarate 300mg tablets), for pre-exposure prophylaxis (PrEP) in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. This approval was based on data from two large placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx) and Partners PrEP that found that Truvada reduced the risk of acquiring HIV infection by 42% and 75%, respectively.
As part of the approval, Gilead worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use of Truvada for PrEP as part of a comprehensive prevention strategy. Gilead has developed FDA-approved materials to educate and inform healthcare providers and uninfected individuals about Truvada for PrEP.
PHARMACOLOGICAL CLASS FOR TRUVADA
Nucleoside/nucleotide analogue (reverse transcriptase inhibitors)
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Emtricitabine Tenofovir disoproxil fumarate
INDICATIONS FOR TRUVADA
HIV-1 infection.
ADULT DOSE FOR TRUVADA
≥18yrs (CrCl ≥50mL/min): 1 tab once daily. Renal impairment: CrCl 30–49mL/min: 1 tab every 48 hrs; CrCl <30mL/min, hemodialysis: not recommended.
CHILDREN'S DOSING FOR TRUVADA
Not recommended for <18 years
INTERACTIONS FOR TRUVADA
Avoid concomitant drugs that contain Emtricitabine, Tenofovir, Lamivudine, or Adefovir dipivoxil. Potentiates didanosine toxicity (>60kg; reduce dose of didanosine); discontinue didanosine if toxicity develops. Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, Adefovir dipivoxil, Cidofovir, Acyclovir, Valacyclovir, Ganciclovir, Valganciclovir). Avoid concomitant or recent use of nephrotoxic agents. Potentiated by Lopinavir/Ritonavir, Atazanavir; monitor for toxicity. Concomitant Atazanavir: must give with Ritonavir. Caution with triple nucleoside-only regimen (high rate of early viral non-response); monitor and consider alternative therapy. See literature for dosing of concomitant didanosine or ritonavir.
WARNINGS/PRECAUTIONS FOR TRUVADA
Suspend if lactic acidosis or hepatotoxicity occurs. Renal impairment: monitor CrCl and serum phosphorus. Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity.
Not for treating chronic hepatitis B; test for HBV before starting therapy and monitor patients co-infected with HIV-1 and HBV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection).
History or risk of fractures or osteopenia: monitor bone mineral density (BMD); consider Vit. D and calcium supplementation. Elderly.
Pregnancy (Category B).
Nursing mothers: not recommended.
As part of the approval, Gilead worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use of Truvada for PrEP as part of a comprehensive prevention strategy. Gilead has developed FDA-approved materials to educate and inform healthcare providers and uninfected individuals about Truvada for PrEP.
These materials highlight the importance of strict adherence to the dosing regimen, emphasize that Truvada must be considered as only one part of a comprehensive prevention strategy to reduce the risk of HIV-1 infectionm, and convey that Truvada for PrEP should only be used in individuals who are confirmed HIV negative. HIV-1 screening should be repeated at least every three months while taking Truvada for PrEP.
DISCLAIMER: All information on this website is for educational purposes only and is not intended to provide medical advice nor medical decision.
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