HIV Treatment Considerations

The Importance of Starting HIV Treatment Early

Initiating HIV treatment early may result in better clinical outcomes^1,2

DHHS and IAS-USA guidelines support HIV treatment initiation immediately (or as soon as possible), regardless of CD4 cell count. According to DHHS, early treatment may:

Increase the uptake of ART and linkage to care
Decrease the time to virologic suppression for individual patients
Improve the rate of virologic suppression among persons with HIV

Additional treatment initiation guidance from DHHS¹

When initiating therapy, it is important to educate patients on the benefits and considerations of treatment and adherence

In 2016, 23% of all people living with HIV who knew that they had HIV, but weren't actively in care, accounted for 43% of new HIV transmissions^3,*

*According to the US Centers for Disease Control and Prevention.

How do you discuss starting treatment early with your patients?

Listen to Dr. Joel Gallant and Dr. Calvin Cohen as they reflect on the importance of early treatment initiation and how it changed the conversation with their patients.

Early and Effective HIV Treatment Is Crucial^1,3-6

According to the CDC, starting people living with HIV (PLWH) on HIV treatment as soon as possible so they may reach undetectable status is critical³

Each year, ~35,000 NEW HIV INFECTIONS are diagnosed in the US^5,†

^†2019 data.

Icon of virus representing 8 in 10 new HIV infections from PLWH not in care.

8 in 10 NEW HIV TRANSMISSIONS come from PLWH not in care³

The NIH recommends starting PLWH on treatment early, while their CD4 counts may still be high, in order to reduce their risk of developing AIDS or other serious illnesses.

When starting PLWH on ARV therapy, consider the benefits of initiating treatment as soon as possible

Only half of the >1.2 million PLWH in the US are retained in care, and just over half were virologically suppressed, according to 2019 CDC data.⁷

1 in 5 TRANSMISSIONS were transmitted from PLWH who were in care but not virologically suppressed^3,‡

^‡2016 data.

According to DHHS guidelines, when people with HIV achieve and maintain an undetectable viral load for at least 6 months, it prevents sexual transmission of HIV to their partners¹

How do you identify barriers that may affect your patients’ treatment goals?

Explore some of the key factors that Dr. Joel Gallant and Dr. Calvin Cohen considered to achieve durable viral suppression.

A Treatment With a High Barrier to Resistance Is Key^1,8-12

Drug-resistant mutations may develop depending on a medicine's barrier to resistance and during periods when drug levels are suboptimal

HIV is one of the fastest-mutating pathogens and can mutate millions of times per day⁸

Mutations can affect ARV target proteins, resulting in potential drug resistance¹¹

1 in 5 patients resistance to >=1 ARV graphic.

In an analysis of HIV sequences reported to NHSS from 2014 to 2018,

1 IN 5 TREATMENT-NAÏVE PATIENTS IN THE US (n=9616/50747) DEMONSTRATED RESISTANCE TO ≥1 ARV¹³

One particular concern is cross-resistance, an HIV mutation that confers resistance to drugs in the same ARV class, rendering them ineffective—thus limiting treatment options²

How important is resistance to your treatment decisions?

Early clinical developments working to achieve viral suppression often had their own challenges. Resistance was top among them, and it remains a crucial concern when treating patients living with HIV.

Resistance Summary

Early Treatment Initiation

Please see full Prescribing Information for BIKTARVY^® and DESCOVY^®, including BOXED WARNINGS.

ART, antiretroviral therapy; ARV, antiretroviral; CD4, cluster of differentiation 4; CDC, Centers for Disease Control and Prevention; DHHS, US Department of Health and Human Services; IAS-USA, International Antiviral Society–USA; NHSS, National HIV Surveillance System.

Reference: 1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Updated May 26, 2023. Accessed June 26, 2023. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf 2. Gandhi RT, Bedimo R, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2022 recommendations of the International Antiviral Society—USA Panel. JAMA. 2023;329(1):63-84. 3. Centers for Disease Control and Prevention. Ending the HIV epidemic. Updated March 18, 2019. Accessed March 16, 2022. https://www.cdc.gov/vitalsigns/end-HIV/ 4. Li Z, Purcell DW, Sansom SL, Hall HI. Vital signs: HIV transmission along the continuum of care—United States, 2016. MMWR Morb Mortal Wkly Rep. 2019;68(11):267-272. 5. U.S. Statistics. HIV.gov. Updated June 2, 2021. Accessed March 16, 2022. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics 6. Starting antiretroviral treatment early improves outcomes for HIV-infected individuals. Department of Health and Human Services. National Institutes of Health News Releases. Released May 2015. Accessed June 14, 2020. https://www.nih.gov/news-events/news-releases/starting-antiretroviral-treatment-early-improves-outcomes-hiv-infected-individuals 7. Centers for Disease Control and Prevention. Monitoring selected HIV prevention and care objectives by using surveillance data—United States and 6 dependent areas, 2019. HIV Surveillance Supplemental Report, 2019; vol 26(2). Published May 2021. Accessed March 26, 2022. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-vol-26-no-2.pdf 8. Sanjuán R, Domingo-Calap P. Mechanisms of viral mutation. Cell Mol Life Sci. 2016;73(23):4433-4448. 9. Clavel F, Hance AJ. HIV drug resistance. N Engl J Med. 2004;350(10):1023-1035. 10. Perelson AS, Neumann AU, Markowitz M, Leonard JM, Ho DD. HIV-1 dynamics in vivo: virion clearance rate, infected cell life-span, and viral generation time. Science. 1996;271(5255):1582-1586. 11. Perelson AS. Modelling viral and immune system dynamics. Nat Rev Immunol. 2002;2(1):28-36. 12. Wensing AM, Calvez V, Günthard HF, et al. 2017 update of the drug resistance mutations in HIV-1. Top Antivir Med. 2017;24(4):132-133. 13. McClung RP, Oster AM, Ocfemia MCB, et al. Transmitted drug resistance among human immunodeficiency virus (HIV)-1 diagnoses in the United States, 2014-2018. Clin Infect Dis. 2022;74(6):1055-1062.

INDICATION

BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of BIKTARVY.

INDICATION

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.

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.
New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. 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.

Adverse reactions

Most common adverse reaction (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

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.

Dosage and administration

Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For these pediatric patients, who are unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, 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.

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.

Please see full Prescribing Information for BIKTARVY^® and DESCOVY^®, including BOXED WARNINGS.

The information contained on this site is intended for healthcare provider audiences in the United States only. The content on this site may not apply to non-US audiences as regulatory control, legal requirements, and/or medical practices may vary in other countries.

BIKTARVY, BIKTARVY ANYWHERE, the BIKTARVY Logo, the BIKTARVY Tablet, BIKTARVY TODAY, ADVANCING ACCESS, DESCOVY, FOR TODAY, TOMORROW, AND THE DAYS TO COME, GILEAD, the GILEAD Logo, GSI, and 9883 are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

HIV Treatment Considerations

The Importance of Starting HIV Treatment Early

Initiating HIV treatment early may result in better clinical outcomes1,2

Additional treatment initiation guidance from DHHS1

How do you discuss starting treatment early with your patients?

Early and Effective HIV Treatment Is Crucial1,3-6

How do you identify barriers that may affect your patients’ treatment goals?

A Treatment With a High Barrier to Resistance Is Key1,8-12

Drug-resistant mutations may develop depending on a medicine's barrier to resistance and during periods when drug levels are suboptimal

1 IN 5 TREATMENT-NAÏVE PATIENTS IN THE US (n=9616/50747) DEMONSTRATED RESISTANCE TO ≥1 ARV13

How important is resistance to your treatment decisions?

INDICATION

INDICATION

Important Safety Information

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pregnancy and lactation

INDICATION

Important Safety Information

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pregnancy and lactation

Initiating HIV treatment early may result in better clinical outcomes^1,2

Additional treatment initiation guidance from DHHS¹

Early and Effective HIV Treatment Is Crucial^1,3-6

A Treatment With a High Barrier to Resistance Is Key^1,8-12

1 IN 5 TREATMENT-NAÏVE PATIENTS IN THE US (n=9616/50747) DEMONSTRATED RESISTANCE TO ≥1 ARV¹³