| |
Letter from Gilead - PrEP Study in
Cisgender Women and Adolescent Females
|
| |
| |
Good morning,
As you may know, the U.S. Food and Drug Administration (FDA) recently approved a pre-exposure prophylaxis (PrEP) indication for Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF).
The approval makes available an additional preventive medication option for appropriate individuals at risk for HIV. We are excited about the value that Descovy can bring to HIV prevention efforts for at-risk populations and are dedicated to helping ensure that all appropriate individuals at risk for HIV infection can access PrEP.
Descovy for PrEP™ is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. The indication does not include use of DESCOVY in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated. Please see below for important safety information for Descovy for PrEP, including the Boxed Warning on the risk of drug resistance in undiagnosed early HIV infection and the risk of post-treatment acute exacerbation of hepatitis B.
Gilead is committed to advancing a PrEP study in cisgender women. To that end, and in connection with the recent FDA approval of a PrEP indication for Descovy, we have agreed with FDA to conduct a study evaluating Descovy for PrEP in adult and adolescent cisgender women.
Community voices will be vital to provide input into key elements of the study, such as study design, site selection, recruitment and ongoing study management.
We believe that this study will provide valuable data in relation to the safety and pharmacokinetics of Descovy for PrEP in cisgender women and evaluate the effectiveness of its potential use as a prevention option for individuals at risk from receptive vaginal sex.
We are grateful for the work you do to serve communities living with or at-risk for HIV and share your commitment to helping reduce the number of new HIV infections in support of efforts to end the epidemic. We value our ongoing partnerships and dialogue with community advocates and welcome additional feedback on this study as well as Gilead’s work in HIV prevention and treatment.
Thank you for your unwavering commitment to people living with HIV and those at risk.
Respectfully,
Diana Brainard
Senior Vice President, HIV and Emerging Viruses
Gilead Sciences
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
• DESCOVY FOR PrEP must be prescribed only to patients confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed.
• Severe acute exacerbations of hepatitis B have been reported in patients infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of DESCOVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HBV who discontinue DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted.
Contraindication
• DESCOVY FOR PrEP is contraindicated in patients with unknown or positive HIV status.
Warnings and precautions
• Comprehensive management to reduce risks:
• Use DESCOVY FOR PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
• HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are not limited to: condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network.
• Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner’s HIV-1 viremic status, regular testing for STIs).
• Reduce potential for drug resistance: Only prescribe DESCOVY FOR PrEP to patients confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking DESCOVY, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in patients with undetected HIV-1 infection who are taking only DESCOVY because DESCOVY alone is not a complete regimen for treating HIV-1.
• Some HIV tests may not detect acute HIV infection. Prior to initiating DESCOVY FOR PrEP, ask patients about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection.
• If HIV-1 infection is suspected or if symptoms of acute infection are present while taking DESCOVY FOR PrEP, convert the DESCOVY FOR PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection.
• Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some patients, such as adolescents, may benefit from more frequent visits and counseling.
• New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. Do not initiate DESCOVY in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue DESCOVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients (see Dosage and Administration section).
• Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Adverse reactions
• Most common adverse reactions (≥2%) in the DESCOVY FOR PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain.
Drug interactions
• Prescribing information: Consult the full Prescribing Information for DESCOVY for more information, warnings, and potentially significant drug interactions, including clinical comments.
• Metabolism: Drugs that inhibit P-gp can increase the concentrations of tenofovir alafenamide (TAF), a component of DESCOVY. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy.
• Drugs affecting renal function: Coadministration of DESCOVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.
Dosage and administration
• Dosage: One tablet taken once daily with or without food.
• HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section).
• HBV screening: Test for HBV infection prior to or when initiating DESCOVY.
• Renal impairment and monitoring: Not recommended in patients with creatinine clearance (CrCl) <30 mL/min. Prior to or when initiating DESCOVY, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.
INDICATION
DESCOVY for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1-negative status must be confirmed immediately prior to initiation.
[if !supportLists]
• [endif]Limitation of Use: DESCOVY FOR PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.
U.S. full Prescribing Information for Descovy, including BOXED WARNING, is available at www.gilead.com.
DESCOVY, DESCOVY for PrEP, and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies.
333 Lakeside Drive, Foster City, CA 94404
©2019 Gilead Sciences, Inc. All rights reserved. DVYP0248 10/19
|
|
| |
| |
|
|
|
