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Learn more about Study 109 data!
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THE STRENGTH TO
POWER THEIR
TOMORROW
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Dear {{customText[Dr.|]}} {{accFname}} {{accLname}},
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I'm looking forward to connecting with you.
I'm looking forward to speaking with you this week.
I appreciate you taking the time to speak with me.
Thanks so much for taking the time out of your day to meet.
It was great to connect with you earlier.
I hope this message finds you well.
I'd like to introduce myself and connect sometime in the future.
I'm writing to share some information that might be helpful to your practice.
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I have some information to discuss with you this week that I think you will find useful.
Thank you again for scheduling time out of your busy week to talk with me. I have included some information I think you will find helpful to your practice.
As a follow-up to our call, I wanted to share some additional information about GENVOYA that I think you'll find interesting.
I'd love to keep in touch and provide you and your office staff with information and educational resources you may be interested in.
I'd like to keep you updated and answer any questions you may have about GENVOYA data.
I've included updated information on Study 109, and would love to discuss in more detail.
I'm hoping to connect and offer you and your office staff some data that may interest you.
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Please click here to view full Prescribing Information for GENVOYA® and DESCOVY®, including BOXED WARNINGS.
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THE #1 PRESCRIBED REGIMEN FOR TREATING HIV-1
Source: Ipsos Healthcare US Virology Scope Q4 2016.
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INDICATION
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GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV) regimen in patients 12 years and older (≥35 kg) who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen for ≥6 months with no history of treatment failure and no known resistance to any component of GENVOYA.
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IMPORTANT SAFETY INFORMATION
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BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
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GENVOYA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of GENVOYA have not been established in patients coinfected with HIV-1 and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue GENVOYA. If appropriate, anti-hepatitis B therapy may be warranted.
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GENVOYA DEMONSTRATED POWERFUL VIROLOGIC SUPPRESSION1,2
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93% of virologically suppressed adults who switched to GENVOYA maintained virologic suppression at Week 961
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VS
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89% of those who remained on their baseline FTC/TDF backbone regimen1
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2% of adults who received GENVOYA and 2% of those who remained on their baseline FTC/TDF regimen were classified as virologic failures at Week 961
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97% of virologically suppressed adults who switched to GENVOYA maintained virologic suppression at Week 482
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VS
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93% of those who remained on their baseline FTC/TDF backbone regimen2
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1% of adults who received GENVOYA and 1% of those who remained on their baseline FTC/TDF regimen were classified as virologic failures at Week 482
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Through Week 96, the most common treatment-emergent ARs (incidence ≥10%; all grades) in adults switching to GENVOYA were upper respiratory tract infection (18%), diarrhea (11%), and nasopharyngitis (10%)3
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Additional ARs observed included suicidal ideation and behavior and suicide attempt (<1% combined); these events were serious and occurred in subjects with a history of depression or psychiatric illness1
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Common ARs (incidence ≥5%; all grades) in clinical studies of treatment-naïve adults were nausea (10%), diarrhea (7%), headache (6%), and fatigue (5%)1
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1% of adults who received GENVOYA discontinued treatment due to ARs compared with 3% of those who remained on their baseline FTC/TDF backbone regimen2
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Contraindications |
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Coadministration: Do not use with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Do not use with drugs that strongly induce CYP3A as this may lead to loss of efficacy and possible resistance to GENVOYA. Do not use with alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, or St. John's wort.
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Study design: Study 109 was a phase 3, randomized, open-label, multicenter, international, active-controlled study in 1436 virologically suppressed adults (HIV-1 RNA <50 copies/mL for ≥6 months) that evaluated the efficacy and safety of switching to an FTC/TAF backbone regimen (n=959) vs staying on a baseline FTC/TDF backbone regimen (n=477) of EFV/FTC/TDF (as an STR), COBI- or RTV-boosted ATV + FTC/TDF, or EVG/COBI/FTC/TDF (as an STR). Of the patients who switched to an FTC/TAF backbone regimen (n=959), the mean age was 41 years; 89% were male; 67% were white, 19% were black; mean baseline CD4+ cell count was 697 cells/µL. The primary endpoint was noninferior viral suppression (HIV-1 RNA <50 copies/mL) at Week 48. Secondary endpoints included efficacy, safety, and tolerability at Week 96.1,2
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IMPORTANT SAFETY INFORMATION (CONT'D) |
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Warnings and precautions |
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Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during GENVOYA therapy and monitor for adverse reactions. |
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Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. |
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New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of GENVOYA, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate GENVOYA 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 GENVOYA in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: In all patients, monitor serum creatinine, serum phosphorus, CrCl, urine glucose, and urine protein prior to initiating and during therapy as clinically appropriate. If serum creatinine increases >0.4 mg/dL from baseline, closely monitor for renal safety.
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Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue GENVOYA if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
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Adverse reactions |
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Common adverse reactions (incidence ≥5%; all grades) in clinical studies were nausea (10%), diarrhea (7%), headache (6%), and fatigue (5%).
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Drug interactions |
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Prescribing information: Consult the full prescribing information for GENVOYA for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
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Metabolism: GENVOYA can increase the concentration of drugs metabolized by CYP3A, CYP2D6, P-gp, BCRP, OATP1B1, or OATP1B3. Drugs that inhibit CYP3A, P-gp, or BCRP can increase the concentrations of components of GENVOYA. Drugs that induce CYP3A or P-gp can decrease the concentrations of components of GENVOYA.
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Drugs affecting renal function: Coadministration of GENVOYA 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.
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Dosage and administration |
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Dosage: Patients 12 years and older who weigh ≥35 kg: 1 tablet taken orally once daily with food.
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Renal impairment: Not recommended in patients with CrCl <30 mL/min.
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Hepatic impairment: Not recommended in patients with severe hepatic impairment.
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Testing prior to initiation: Test patients for HBV infection.
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Testing prior to initiation and during treatment: Assess serum creatinine, serum phosphorus, CrCl, urine glucose, and urine protein as clinically appropriate.
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Pregnancy and lactation |
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Pregnancy: There is insufficient human data on the use of GENVOYA during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
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Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
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Please click here to view full Prescribing Information for GENVOYA and DESCOVY, including BOXED WARNINGS.
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Looking forward to speaking with you.
I look forward to answering any questions you may have.
Please let me know if there is anything you would like to discuss in advance of our call.
Feel free to reach out - have a good week!
It was nice speaking with you - please reach out if you'd like more information.
Great seeing you again - please don't hesitate to reach out.
Hoping to connect soon at your convenience.
If you have any questions or are looking for other educational materials, don't hesitate to reach out to set up an appointment.
Great seeing you again - thanks for all that you do for your patients.
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Best,
Best regards,
Regards,
Sincerely,
Thanks,
Thank you,
Cheers,
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{{userName}}
{{userEmailAddress}}
{{customText(25)}}
{{customText(25)}}
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ARs, adverse reactions; ATV, atazanavir; COBI, cobicistat; EFV, efavirenz; EVG, elvitegravir; FTC, emtricitabine; RTV, ritonavir; STR, single-tablet regimen; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
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References: 1. GENVOYA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017. 2. Mills A, Arribas JR, Andrade-Villanueva J, et al; for the GS-US-292-0109 Study Team. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016;16(1):43-52. 3. Data on file. Gilead Sciences, Inc.
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Learn more at www.genvoya.com/hcp.
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© 2017 Gilead Sciences, Inc. All rights reserved. GENP0229 6/17
333 Lakeside Drive, Foster City, CA 94404 |
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