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|Gilead Announces New Data on the Impact of Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) for Pre-Exposure Prophylaxis (PrEP) on the Number of HIV Diagnoses in the United States|
– Data Show That States with Highest Use of Truvada for PrEP® Had Significant Declines in New HIV Infections –
Truvada for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. To take Truvada for PrEP, individuals must be confirmed to be HIV-negative and be tested for HIV immediately prior to initiating and at least every 3 months while taking Truvada for PrEP. Truvada has a boxed warning in its product label regarding the risks of drug resistance with the use of Truvada for PrEP in undiagnosed early HIV infection and post treatment acute exacerbation of hepatitis B. Further important safety information, adverse drug reactions and prescribing considerations are included below.
In the analysis, states with the highest utilization of Truvada for PrEP
during this five year period (2012 to 2016) had significant declines in
the average number of HIV diagnoses, while there was an average increase
for the states with the lowest use. The impact of Truvada for PrEP use
occurred even after controlling for the effect of antiretroviral therapy
use in those living with HIV, known as treatment as prevention (TasP),
in a subset of 38 states and
“These data further validate the potential for significant public health
impacts of Truvada for PrEP to help reduce HIV transmission in the
The analysis of state-level data was based on National HIV Surveillance
System and national pharmacy data on HIV diagnoses and prevalence of use
of Truvada for PrEP from 2012 to 2016. Across all 50 states and
In the ten states with the highest prevalence of Truvada for PrEP use, the pooled unadjusted estimated annual percent change (EAPC) of HIV diagnoses was -4.7 percent. In the group of ten states with the lowest prevalence of Truvada for PrEP use, the EAPC of HIV diagnoses was +0.9 percent.
To evaluate the independence of the effect of Truvada for PrEP uptake
from the effect of TasP, researchers analyzed data from a subset of 38
“Since 2012, Truvada for PrEP has been an important component of HIV
prevention strategies. We are pleased to share these additional data at
AIDS 2018, correlating its uptake with declines in new diagnoses,” said
Truvada for PrEP — in combination with safer sex practices — was
approved in 2012 by the
Truvada does not prevent other sexually transmitted infections or cure HIV infection or AIDS.
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR TRUVADA for PrEP
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions: Comprehensive risk reduction strategies
Warnings and precautions
Pregnancy and lactation
Dosage and administration
Truvada for PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation
Individuals at risk for sexually acquired HIV-1 may include those:
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that physicians may not see the benefits of prescribing Truvada for PrEP
and the possibility of unfavorable results from additional studies
involving Truvada for PrEP. These risks, uncertainties and other factors
could cause actual results to differ materially from those referred to
in the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are described
in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
Truvada, Truvada for PrEP, and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.
For more information on
Gilead Sciences, Inc.
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