1. The benefits of early initiation for treatment-naïve patients
2. What DHHS and IAS-USA guidelines are saying about the benefits of early treatment initiation
3. Considerations for treatment-naïve patients
| 1. The benefits of early initiation for treatment-naïve patients
2. What DHHS and IAS-USA guidelines are saying about the benefits of early treatment initiation
3. Considerations for treatment-naïve patients
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| | According to DHHS, Initiating HIV Treatment Early
May Result in Better Clinical Outcomes1,2 | |
| | | According to DHHS, Initiating HIV Treatment Early May
Result in Better Clinical Outcomes1,2 | |
|
| | | | Dear 1. Dr.
2. Mr.
3. Mrs.
4. Ms.
5.
{{accFname}} {{accLname}}, 1. MD,
2. DO,
3. PharmD,
4. PA,
5. NP,
6.
| 1. Thank you for making time to meet with me.
2. Sorry I missed you.
3. I’m glad we had the opportunity to discuss early treatment initiation as the DHHS and IAS-USA guidelines describe.
4. I’d like to discuss how early treatment initiation may help your patients.
5. Hope we can schedule some time to talk about early treatment initiation as the DHHS and IAS-USA guidelines describe.
| 1. Below you will find some information that I hope will be helpful to you.
2. To continue our discussion, let’s review the benefits of early treatment initiation.
3. I wanted to remind you of some key points about early treatment initiation.
4. Please take a look at the information below ahead of our meeting.
5. I’m eager to share information about early treatment initiation.
| | DHHS and IAS-USA guidelines support HIV treatment initiation as soon as possible, regardless of CD4 cell count1-4 | | According to DHHS, early treatment may: | | | ‣ | Reduce HIV-related morbidity and mortality at all stages of infection | | ‣ | Help patients achieve undetectable status sooner, thereby reducing transmission risk | | ‣ | When initiating therapy, it is important to educate patients on the benefits and considerations of treatment and adherence | | ‣ | On a case-by-case basis, ARV therapy may be deferred because of clinical and/or psychosocial factors |
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 | In 2016, 23% of patients who knew that they had HIV, but weren't getting treatment, accounted for 43% of new HIV transmissions5* | |
| | |
| | | DHHS-recommended BIKTARVY can be initiated immediately in appropriate patients1,6 |
| | | | | | ‣ | Resistance, CD4, and viral load testing should be performed at treatment initiation; however, you do not have to wait for the results before starting patients on BIKTARVY | | ‣ | Once test results are received, evaluate the appropriateness of continuing treatment | | ‣ | BIKTARVY is not indicated for patients with resistance to any component of BIKTARVY |
| | |
| | | | BIKTARVY is not recommended in patients with severe renal impairment (estimated CrCI
<30 mL/min) or severe hepatic impairment (Child-Pugh Class C). | |
| | A free trial of BIKTARVY may be available for your appropriate patients | | | |  | |
Talk to your Gilead Sales Representative for more information, including important steps to getting started with
BIKTARVY TODAY™ |
| | | Talk to your Gilead Sales Representative for more information, including important steps to getting started with BIKTARVY TODAY™ |
|
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| | | | INDICATION | | | | BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥25 kg who have no antiretroviral (ARV) treatment history. | | |
| IMPORTANT SAFETY INFORMATION | | |
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
| | | | ‣ | 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 BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. |
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| Contraindications | | ‣ | Coadministration: Do not use BIKTARVY with dofetilide or rifampin. |
| | |
| Warnings and precautions | | ‣ | Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. | | ‣ | Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. |
| | |
| | | | | | | Please see below for additional Important Safety Information for BIKTARVY. |
| |
|
| | | | INDICATION | | | | BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥25 kg who have no antiretroviral (ARV) treatment history. | | |
| IMPORTANT SAFETY INFORMATION | | |
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
| | | | ‣ | 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 BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. |
| | |
|
| | | | | | | Please see below for additional Important Safety Information for BIKTARVY. |
|
| | | | | | | | Dear 1. Dr.
2. Mr.
3. Mrs.
4. Ms.
5.
{{accFname}} {{accLname}}, 1. MD,
2. DO,
3. PharmD,
4. PA,
5. NP,
6.
| 1. Thank you for making time to meet with me.
2. Sorry I missed you.
3. I’m glad we had the opportunity to discuss early treatment initiation as the DHHS and IAS-USA guidelines describe.
4. I’d like to discuss how early treatment initiation may help your patients.
5. Hope we can schedule some time to talk about early treatment initiation as the DHHS and IAS-USA guidelines describe.
| 1. Below you will find some information that I hope will be helpful to you.
2. To continue our discussion, let’s review the benefits of early treatment initiation.
3. I wanted to remind you of some key points about early treatment initiation.
4. Please take a look at the information below ahead of our meeting.
5. I’m eager to share information about early treatment initiation.
| | DHHS and IAS-USA guidelines support HIV treatment initiation as soon as possible, regardless of CD4 cell count1-4 | | According to DHHS, early treatment may: | | | ‣ | Reduce HIV-related morbidity and mortality at all stages of infection | | ‣ | Help patients achieve undetectable status sooner, thereby reducing transmission risk | | ‣ | When initiating therapy, it is important to educate patients on the benefits and considerations of treatment and adherence | | ‣ | On a case-by-case basis, ARV therapy may be deferred because of clinical and/or psychosocial factors |
| | |
|
| |
| In 2016, 23% of patients who knew that they had HIV, but weren't getting treatment, accounted for 43% of new HIV transmissions5* | |
| | |
| | | DHHS-recommended BIKTARVY can be initiated immediately in appropriate patients1,6 |
| | | | | | ‣ | Resistance, CD4, and viral load testing should be performed at treatment initiation; however, you do not have to wait for the results before starting patients on BIKTARVY | | ‣ | Once test results are received, evaluate the appropriateness of continuing treatment | | ‣ | BIKTARVY is not indicated for patients with resistance to any component of BIKTARVY |
| | |
| | | | BIKTARVY is not recommended in patients with severe renal impairment (estimated CrCI
<30 mL/min) or severe hepatic impairment (Child-Pugh Class C). | |
| | A free trial of BIKTARVY may be available for your appropriate patients | | | | | |
Talk to your Gilead Sales Representative for more information, including important steps to getting started with
BIKTARVY TODAY™ |
| | | Talk to your Gilead Sales Representative for more information, including important steps to getting started with BIKTARVY TODAY™ |
|
| | | |
|
|
| | |
| | | IMPORTANT SAFETY INFORMATION (cont’d) | | |
| | Contraindications | | ‣ | Coadministration: Do not use BIKTARVY with dofetilide or rifampin. |
| | |
| | Warnings and precautions (cont’d) | | ‣ | 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 BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY 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 BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. | | ‣ | Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. |
| | |
| | Warnings and precautions | | ‣ | Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. | | ‣ | Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. | | ‣ | 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 BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY 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 BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. | | ‣ | Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY 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 | | ‣ | Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). |
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| | Drug interactions | | ‣ | Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. | | ‣ | Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. | | ‣ | Drugs affecting renal function: Coadministration of BIKTARVY 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 | | ‣ | Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food. | | ‣ | Renal impairment: Not recommended in patients with CrCl <30 mL/min. | | ‣ | Hepatic impairment: Not recommended in patients with severe hepatic impairment. | | ‣ | Prior to or when initiating: Test patients for HBV infection. | | ‣ | Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. |
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| | Pregnancy and lactation | | ‣ | Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. 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. | | ‣ | 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 to view full Prescribing Information for BIKTARVY, including BOXED WARNING. | |
| | 1. Please let me know if you would like any additional materials before we meet.
2. Looking forward to our upcoming conversation. Please feel free to reach out if you have any questions.
3. It was great to see you. Let me know if I can provide any additional information about starting treatment early.
4. There’s much more to discuss about BIKTARVY—please let me know when a good time would be to continue the conversation.
5. I hope we can meet in the near future. Please let me know when we can connect at your earliest convenience.
6. Please reach out if you have any questions or if there’s other information about BIKTARVY that I can provide.
| | | | 1. Best,
2. Best regards,
3. Regards,
4. Sincerely,
5. Thanks,
6. Thank you,
7. Cheers,
| | | | {{userName}} | | | | {{userEmailAddress}} | | | | {{customText(25)}} | | | | {{customText(25)}} | | | | | | | |
| | | References: 1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Updated July 10, 2019. Accessed August 1, 2019. 2. Department of Health and Human Services. National Institutes of Health News Releases. Starting antiretroviral treatment early improves outcomes for HIV-infected individuals. https://www.nih.gov/news-events/news-releases/starting-antiretroviral-treatment-early-improves-outcomes-hiv-infected-individuals. Released May 2015. Accessed June 21, 2019. 3. Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society–USA Panel. JAMA. 2018;320(4):379-396. 4. Department of Health and Human Services. HIV.gov. Ending the HIV epidemic: a plan for America. https://www.hhs.gov/sites/default/files/ending-the-hiv-epidemic-fact-sheet.pdf. Released February 2019. Accessed July 17, 2019. 5. Centers for Disease Control and Prevention. Vital Signs. Ending the HIV Epidemic. https://www.cdc.gov/vitalsigns/end-HIV/. Accessed June 21, 2019. 6. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2019. |
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