1 INDICATIONS AND USAGE
TRUVADA is a combination of EMTRIVA and VIREAD, both nucleoside analog HIV-1 reverse transcriptase inhibitors.
TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. (
1)
TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. (
1)
1.1	Treatment of HIV-1 Infection
TRUVADA
, a combination of EMTRIVA
and VIREAD
, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg
[see
Dosage and Administration (2) and
Clinical Studies (14)]
.
The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:
It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen.
TRUVADA should not be coadministered with ATRIPLA
, COMPLERA
, EMTRIVA, GENVOYA
, ODEFSEY
, STRIBILD
, VIREAD or lamivudine-containing products
[see
Warnings and Precautions (5.4)]
.
In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history
[see
Microbiology (12.4)]
.
1.2	Pre-Exposure Prophylaxis
TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples
[see
Clinical Studies (14.2,
14.3)]
.
When considering TRUVADA for pre-exposure prophylaxis the following factors may help to identify individuals at high risk:
has partner(s) known to be HIV-1 infected, or
engages in sexual activity within a high prevalence area or social network and one or more of the following:
inconsistent or no condom use
diagnosis of sexually transmitted infections
exchange of sex for commodities (such as money, food, shelter, or drugs)
use of illicit drugs or alcohol dependence
incarceration
partner(s) of unknown HIV-1 status with any of the factors listed above
When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:
prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection
[see
Warnings and Precautions (5.9)]
;
counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials
[see
Warnings and Precautions (5.9)]
;
confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
[see
Warnings and Precautions (5.9)]
; and
screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP.