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Contraindications<\/strong><\/p>\n\n\n\n<\/div>\n\n\n\n
PIFELTRO is contraindicated when coadministered<\/span> with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John\u2019s wort (Hypericum perforatum<\/em>)), as significant decreases in PIFELTRO plasma concentrations may occur, which may decrease the effectiveness of PIFELTRO.<\/p>\n\n\n\n<\/div>\n\n\n\n
Warnings and Precautions<\/strong><\/p>\n\n\n\n<\/div>\n\n\n\n
Severe Skin Reactions<\/em><\/strong><\/p>\n\n\n\nSevere skin reactions, including Stevens-Johnson syndrome (SJS)\/toxic epidermal necrolysis (TEN), have been reported during the postmarketing experience with doravirine-containing regimens. Discontinue PIFELTRO, and other medications known to be associated with severe skin reactions, immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Clinical status should be closely monitored, and appropriate therapy should be initiated.<\/p>\n\n\n\n
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Immune Reconstitution Syndrome<\/strong><\/em><\/p>\n\n\n\nImmune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.<\/p>\n\n\n\n
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Drug Interactions<\/strong><\/em><\/p>\n\n\n\nCoadministration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended.<\/p>\n\n\n\n
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If coadministered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart).<\/p>\n\n\n\n
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Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions.<\/p>\n\n\n\n
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Adverse Reactions<\/strong><\/p>\n\n\n\nThe most common adverse reactions with PIFELTRO (incidence \u22655%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%).<\/p>\n\n\n\n
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By week 96 in DRIVE-FORWARD, 2% of adult participants in the PIFELTRO group and 3% in the DRV+r group had adverse events leading to discontinuation of study medication.<\/p>\n\n\n\n
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By week 96 in DRIVE-AHEAD, 3% of adult participants in the doravirine (DOR)\/lamivudine (3TC)\/tenofovir disoproxil fumarate (TDF) group and 7% in the efavirenz (EFV)\/emtricitabine (FTC)\/TDF group had adverse events leading to discontinuation of study medication.<\/p>\n\n\n\n
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In DRIVE-FORWARD, mean changes from baseline at week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C)<\/span> were pre-specified. LDL-C: -4.6 mg\/dL in the PIFELTRO group vs 9.5 mg\/dL <\/span>in the DRV+r group. Non-HDL-C: -5.4 mg\/dL in the PIFELTRO group vs 13.7 mg\/dL<\/span> in the DRV+r group. The clinical benefits of these findings have not been demonstrated.<\/p>\n\n\n\n<\/div>\n\n\n\n
In DRIVE-AHEAD, mean changes from baseline at week 48 in LDL-C and non-HDL-C<\/span> were pre-specified. LDL-C: -2.1 mg\/dL<\/span> in the DOR\/3TC\/TDF group vs 8.3 mg\/dL<\/span> in the EFV\/FTC\/TDF group. Non-HDL-C:<\/span> -4.1 mg\/dL in the DOR\/3TC\/TDF group vs 12.7 mg\/dL in the EFV\/FTC\/TDF group. The clinical benefits of these findings have not been demonstrated.<\/p>\n\n\n\n<\/div>\n\n\n\n
In DRIVE-SHIFT, mean changes from baseline at week 24 in LDL-C and non-HDL-C<\/span> were pre-specified. LDL-C: -16.3 mg\/dL<\/span> in the DOR\/3TC\/TDF group vs -2.6 mg\/dL in the PI + ritonavir group. Non-HDL-C<\/span>: -24.8 mg\/dL in the DOR\/3TC\/TDF group vs -2.1 mg\/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated.<\/p>\n\n\n\n<\/div>\n\n\n\n
In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified<\/span> categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult participants in the DOR\/3TC\/TDF group and 26% in the EFV\/FTC\/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DOR\/3TC\/TDF group and 37% in the EFV\/FTC\/TDF group reported dizziness; and 4% in the DOR\/3TC\/TDF group and 8% in the EFV\/FTC\/TDF group reported altered sensorium.<\/p>\n\n\n\n<\/div>\n\n\n\n
The safety of DOR\/3TC\/TDF in virologically-suppressed<\/span> adults was based on week 48 data from participants in the DRIVE-SHIFT trial. Overall, the safety profile in virologically-suppressed adult participants was similar to that in participants with no ARV treatment history.<\/p>\n\n\n\n<\/div>\n\n\n\n
Pregnancy\/Breastfeeding<\/strong><\/p>\n\n\n\nThere is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.<\/p>\n\n\n\n
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Inform individuals with HIV-1 infection of the potential risks of breastfeeding, including: (1) HIV-1 transmission (in HIV-1\u2013negative infants), (2) developing viral resistance (in HIV-1\u2013positive infants), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults.<\/p>\n\n\n\n
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Specific Populations<\/strong><\/p>\n\n\n\n<\/div>\n\n\n\n
Renal Impairment<\/em><\/strong><\/p>\n\n\n\nNo dosage adjustment is necessary with participants with mild, moderate, or severe renal impairment. PIFELTRO has not been adequately studied in patients with end-stage renal disease and has not been studied in dialysis patients.<\/p>\n<\/div><\/details><\/div>\n\n\n\n
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