Start your HIV-1 patients on their DELSTRIGO® or PIFELTRO® journey

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DELSTRIGO®: A complete regimen

DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients 12 years of age and older and weighing at least 35 kg without past or present evidence of viral resistance to doravirine, lamivudine, or tenofovir.¹

Antiretroviral treatment-naïve patients

Virologically-suppressed patients

See efficacy results for DELSTRIGO®in antiretroviral treatment-naïve patients

See efficacy results for DELSTRIGO® in virologically-suppressed patients

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PIFELTRO®: An NNRTI

PIFELTRO® (doravirine) is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine.²

Antiretroviral treatment-naïve patients

See efficacy results for PIFELTRO® in antiretroviral treatment-naïve patients

Learn more about the Resistance/cross-resistance profile of PIFELTRO®

NNRTI=non-nucleoside reverse transcriptase inhibitor
References: 1. DELSTRIGO® Product Monograph. Merck Canada Inc. December 10, 2024. 2. PIFELTRO® Product Monograph. Merck Canada Inc. December 10, 2024.

CA-DOR-00155

IMPORTANT SAFETY INFORMATION

DELSTRIGO®IMPORTANT SAFETY INFORMATION

Indications and clinical use:
DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients 12 years of age and older and weighing at least 35 kg without past or present evidence of viral resistance to doravirine, lamivudine, or tenofovir. The safety and efficacy of DELSTRIGO®in pediatric patients 12 years of age and older and weighing at least 35 kg receiving DELSTRIGO®once daily have been established. The safety and efficacy of DELSTRIGO®have not been established in patients younger than 12 years of age and weighing less than 35 kg. Limited data on use in patients ≥ 65 years.

Contraindications:

Use with drugs that are strong CYP3A enzyme inducers, including but not limited to the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and St. John’s wort (Hypericum perforatum)

Most serious warnings and precautions:

Chronic HBV infection: Not approved for treatment of chronic HBV infection, and safety and efficacy not established in coinfected patients. Severe acute exacerbations of HBV have been reported in coinfected HBV/HIV-1 patients who discontinued lamivudine or tenofovir DF, two of the components of DELSTRIGO®. Monitor closely with clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, initiate anti-hepatitis B therapy, especially in patients with advanced liver disease or cirrhosis, since post-treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure
Nephrotoxicity: Renal impairment including cases of acute renal failure and Fanconi syndrome has been reported with the use of tenofovir disoproxil fumarate (TDF)
Breastfeeding: Mothers should not breastfeed if they are receiving DELSTRIGO®

Other relevant warnings and precautions:

Do not administer with other antiretroviral drugs, with adefovir dipivoxil, or with single-agent doravirine unless doravirine dose adjustment required
Has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy
Should not be used in antiretroviral-experienced patients with resistance mutations to doravirine, lamivudine, or tenofovir or with suspected such mutations if no genotype is available
Bone loss and mineralization defects associated with TDF
Avoid driving and operating machinery if fatigue, dizziness, and somnolence occur
Avoid concomitant use with moderate CYP3A inducers, or if coadministration cannot be avoided, 1 tablet of doravirine 100 mg (PIFELTRO®) should be taken approximately 12 hours after the dose of DELSTRIGO®
Increased TDF exposure when used with certain HCV regimens
Consider measurement of serum lipids and blood glucose
Very rare occurrences of pure red cell aplasia reported with lamivudine use
Lactic acidosis/severe hepatomegaly with steatosis, including fatal cases, have been reported
Immune reconstitution inflammatory syndrome
Angioedema has been reported in patients taking TDF
New onset or worsening renal impairment with TDF
Physicians are encouraged to report pregnancy cases to the Antiretroviral Pregnancy Registry: http://www.apregistry.com/
Severe skin reactions, including toxic epidermal necrolysis, and hypersensitivity reactions
Discontinue DELSTRIGO® immediately if a painful rash with mucosal involvement or a progressive severe rash or hypersensitivity reactions develop
Special care advised in patients ≥ 65 years of age due to age-associated changes e.g., decreases in renal function
Not recommended in patients with estimated creatinine clearance <50 mL/min
Not studied in patients with severe hepatic impairment, therefore caution is advised
Emergence of lamivudine-resistant HBV
Patients coinfected with HIV-1 and HBV or HCV are at increased risk for severe hepatic adverse events

For more information:
Please consult the Product Monograph at merck.ca/static/pdf/DELSTRIGO-PM_E.pdf for important information relating to contraindications, warnings and precautions, adverse reactions, drug interactions, and dosing information, which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-567-2594.

Reference: DELSTRIGO® Product Monograph. Merck Canada Inc. December 10, 2024.

PIFELTRO® IMPORTANT SAFETY INFORMATION

Indications and clinical use:
PIFELTRO® (doravirine) is indicated, in combination with other antiretroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older and weighing at least 35 kg without past or present evidence of viral resistance to doravirine. The safety and efficacy of PIFELTRO® in pediatric patients ≥12 years of age and weighing at least 35 kg receiving doravirine 100 mg once daily has been established. Safety and efficacy of PIFELTRO® have not been established in patients younger than 12 years of age weighing less than 35 kg. There are limited data available on the use of doravirine in patients aged 65 years and over.

Contraindications:

Use with drugs that are strong CYP3A enzyme inducers, including but not limited to the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and St. John’s wort (Hypericum perforatum)

Most serious warning and precaution:

Breastfeeding: Mothers should not breastfeed if they are receiving PIFELTRO®

Other relevant warnings and precautions:

Has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy
Should not be used in antiretroviral-experienced patients with NNRTI resistance mutations which may confer resistance to doravirine or with suspected NNRTI resistance in virologically suppressed patients if no genotype is available
Avoid driving and operating machinery if fatigue, dizziness, and somnolence occur
Caution when coadministering with drugs that may reduce doravirine exposure
Consider measurement of serum lipids and blood glucose
Immune reconstitution inflammatory syndrome
Physicians are encouraged to report pregnancy cases to the Antiretroviral Pregnancy Registry: http://www.apregistry.com/
Severe skin reactions, including toxic epidermal necrolysis, and hypersensitivity reactions
Discontinue PIFELTRO® immediately if a painful rash with mucosal involvement or a progressive severe rash or hypersensitivity reactions develop
No human data on the effect of doravirine on fertility are available
Not studied in end-stage renal disease or dialysis
Not studied in patients with severe hepatic impairment

For more information:
Please consult the Product Monograph at merck.ca/static/pdf/PIFELTRO-PM_E.pdf for important information relating to contraindications, warnings and precautions, adverse reactions, drug interactions, and dosing information, which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-567-2594.

Reference: PIFELTRO® Product Monograph. Merck Canada Inc. December 10, 2024.

CYP3A=cytochrome P450, family 3, subfamily A; HBV=hepatitis B virus; HIV=human immunodeficiency virus; DF=disoproxil fumarate; TDF=tenofovir disoproxil fumarate; HCV=hepatitis C virus; NNRTI=non-nucleoside reverse transcriptase inhibitors