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PIFELTRO is a brand name for Doravirine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
1 Adverse Reaction Overview The safety assessment of PIFELTRO® in antiretroviral treatment-naïve, HIV-1-infected subjects, is based on the analyses of data through 48- and 96 Weeks from two Phase 3, randomized, international, multicenter, double-blind, active-controlled trials (DRIVE-FORWARD (Protocol 018) and DRIVE-AHEAD (Protocol 021)).
In subjects receiving PIFELTRO®, the serious adverse reactions of nausea, vomiting, asthenia, insomnia, and nightmares were reported, and these reactions were reported by <1% subjects. The most frequently reported adverse reaction with doravirine was nausea (6 %).
There were no adverse reactions of moderate to severe intensity with an incidence of greater than or equal to 2%. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug.
Clinical Trials in Antiretroviral Treatment-Naïve Adults In DRIVE-FORWARD, 766 adult subjects received either PIFELTRO® 100 mg (n=383) or darunavir 800 mg + ritonavir 100 mg (DRV+r) (n=383) once daily in a double-blind design, each in combination with emtricitabine/tenofovir DF (FTC/TDF) or abacavir/lamivudine (ABC/3TC).
1% in the DRV+r group had adverse events leading to discontinuation of study medication. In DRIVE-AHEAD, 728 adult subjects received either DELSTRIGO® (doravirine/lamivudine/tenofovir DF) (n=364) or efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) once daily (n=364).
6% in the EFV/FTC/TDF group had adverse events leading to discontinuation of study medication. Adverse reactions reported in greater than or equal to 2% of subjects in any treatment group in adults with no antiretroviral treatment history in DRIVE-FORWARD and DRIVE-AHEAD are presented in Table 2.
PIFELTRO® (doravirine) Page 10 of 42 Table 2 - Adverse ReactionsÞ (All Grades) Reported in >2%† of Subjects in Any Treatment Group in Adults with No Antiretroviral Treatment History in DRIVE-FORWARD and DRIVE-AHEAD (Week 48) DRIVE-FORWARD DRIVE-AHEAD PIFELTRO® +2 NRTIs Once Daily DRV+r +2 NRTIs Once Daily DELSTRIGO® Once Daily EFV/FTC/TDF Once Daily N=383 N=383 N=364 N=364 Gastrointestinal Disorders Abdominal pain upper Diarrhea Nausea Vomiting 2% 5% 7% 2% <1% 13% 8% 1% <1% 3% 5% 2% <1% 5% 7% 3% General Disorders and Administration Site Conditions Fatigue 5% 2% 4% 3% Nervous System Disorders Dizziness Headache Sleep disorder Somnolence 3% 6% 2% 0% 2% 3% <1% <1% 7% 4% <1% 3% 32% 4% 2% 7% Psychiatric Disorders Abnormal dreams Insomnia Nightmare 1% 1% <1% <1% 2% <1% 5% 4% 2% 9% 5% 4% Skin and Subcutaneous Disorders Rash <1% <1% 2% 9% Þ Frequencies of adverse reactions are based on all adverse events attributed to trial drugs by the investigator.
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†No adverse reactions of Grade 2 or higher (moderate or severe) occurred in ≥ 2% of subjects treated with doravirine. NRTIs = nucleoside reverse transcriptase inhibitors NRTIs = FTC/TDF or ABC/3TC. Overall, the clinical adverse experiences at Week 96 were consistent with those observed at Week 48.
Clinical Trials in Virologically-Suppressed Adults The safety of PIFELTRO® in virologically-suppressed adults was based on Week 48 data from 670 subjects in the DRIVE-SHIFT trial (see Virologically-Suppressed Adult Subjects). Overall, the safety profile in virologically-suppressed adult subjects was similar to that in subjects with no antiretroviral treatment history.
1 Clinical Trial Adverse Reactions – Pediatrics The safety of doravirine as a component of DELSTRIGO® was evaluated in 45 HIV-1-infected virologically- suppressed or treatment-naïve pediatric patients 12 to less than 18 years of age through Week 24 in an open-label trial (IMPAACT 2014 (Protocol 027)) (see Pediatric Subjects).
The safety profile in pediatric subjects was similar to that in adults. There were no serious or Grade 3 or 4 adverse reactions. No subjects discontinued due to an adverse event. 3 Less Common Clinical Trial Adverse Reactions Other adverse reactions reported in <2% of patients in the DRIVE-FORWARD, DRIVE-AHEAD or DRIVE- SHIFT trials through Week 96 and Week 48 respectively are listed below.
Blood and Lymphatic Systems Disorders: lymph node pain, neutropenia. Cardiac Disorders: palpitations. Ear and Labyrinth Disorders: motion sickness, vertigo. Eye Disorders: vision blurred. Gastrointestinal Disorders: abdominal discomfort, abdominal distension, abdominal pain, abnormal feces, change in bowel habits, constipation, dry mouth, dyspepsia, dysphagia, epigastric discomfort, feces soft, flatulence, frequent bowel movements, gastritis, gastrointestinal motility disorder, gastroesophageal reflux disease, irritable bowel syndrome, rectal tenesmus.
General Disorders and Administration Site Conditions: asthenia, chest discomfort, chest pain, chills, generalized oedema, malaise, pain, pyrexia, thirst. Hepatobiliary Disorders: hepatitis, hepatocellular injury, hyperbilirubinemia.
Immune System Disorders: immune reconstitution inflammatory syndrome. Infections and Infestations: acute sinusitis, angular cheilitis, conjunctivitis, folliculitis, gastroenteritis, lymphogranuloma venereum, oral herpes, nasopharyngitis, rash pustular.
Investigations: alanine aminotransferase increased*, amylase increased, aspartate aminotransferase increased, blood creatinine phosphokinase increased, blood triglycerides increased, bone density decreased, gastric pH decreased, hemoglobin decreased, lipase increased, weight decreased, neutrophil count decreased, weight increased.
Metabolism and Nutrition Disorders: alcohol intolerance, decreased appetite, hypertriglyceridemia, hypomagnesemia, hypophosphatemia, obesity, vitamin D deficiency. […]