Trikafta* (elexacaftor/tezacaftor/ivacaftor; ivacaftor) vs Lucaftor (lumacaftor/ivacaftor)

Trikafta and Lumacaftor/Ivacaftor (marketed as Orkambi) are both used to treat cystic fibrosis in patients with specific genetic mutations. Trikafta, a combination of elexacaftor, tezacaftor, and ivacaftor, is approved for patients 6 years and older with at least one F508del mutation in the CFTR gene, and has been shown to improve lung function and reduce pulmonary exacerbations more significantly than previous treatments. Lumacaftor/Ivacaftor is also for patients with two copies of the F508del mutation, but it is generally considered less effective than Trikafta and may be used in cases where Trikafta is not available or suitable for the patient, subject to the prescribing physician's assessment.

Difference between Trikafta* and Lucaftor

Metric	Trikafta* (elexacaftor/tezacaftor/ivacaftor; ivacaftor)	Lucaftor (lumacaftor/ivacaftor)
Generic name	Elexacaftor/tezacaftor/ivacaftor and ivacaftor	Lumacaftor/ivacaftor
Indications	Cystic fibrosis in patients aged 6 years and older with at least one F508del mutation in the CFTR gene	Cystic fibrosis in patients aged 2 years and older with two copies of the F508del mutation in the CFTR gene
Mechanism of action	CFTR modulator therapy; corrects the function of the defective protein made by the CFTR gene	CFTR modulator therapy; improves the function of the defective protein made by the CFTR gene
Brand names	Trikafta	Orkambi
Administrative route	Oral	Oral
Side effects	Headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, increased liver enzymes, flu-like symptoms, sinusitis, increased creatinine	Shortness of breath, chest discomfort, fatigue, increase in blood pressure, liver enzyme elevations, rash, flu-like symptoms, respiratory events
Contraindications	Use of certain drugs (e.g., strong CYP3A inhibitors), liver disease, history of organ transplantation	Use of certain drugs (e.g., strong CYP3A inhibitors), liver disease, history of organ transplantation
Drug class	CFTR modulators	CFTR modulators
Manufacturer	Vertex Pharmaceuticals	Vertex Pharmaceuticals

Efficacy

Efficacy of Trikafta in Cystic Fibrosis

Trikafta, a combination of elexacaftor, tezacaftor, and ivacaftor, is a transformative treatment for cystic fibrosis (CF). This medication is specifically designed for patients with at least one F508del mutation in the CFTR gene, which is the most common mutation causing CF. Clinical trials have demonstrated that Trikafta significantly improves lung function, as measured by the percent predicted forced expiratory volume in one second (ppFEV1). Patients treated with Trikafta have shown an approximate 10-14% improvement in ppFEV1 compared to baseline or placebo, representing a substantial advancement in CF care.

In addition to improvements in lung function, Trikafta has been associated with other health benefits for CF patients. These include a reduction in pulmonary exacerbations, which are acute worsenings of respiratory symptoms requiring treatment, and improvements in body mass index (BMI), a crucial factor given the nutritional challenges faced by individuals with CF. The medication has also been linked to improvements in quality of life scores, underscoring its impact beyond measurable physiological parameters.

Efficacy of Orkambi (lumacaftor/ivacaftor) in Cystic Fibrosis

Orkambi, a combination of lumacaftor and ivacaftor, is another medication used to treat CF in patients who are homozygous for the F508del mutation in the CFTR gene. Clinical trials have shown that Orkambi improves lung function, but to a lesser extent than Trikafta. Patients on Orkambi have experienced an average increase of 2-4% in ppFEV1 compared to placebo. While this improvement is more modest, it is still a significant step forward for patients with limited treatment options.

Orkambi has also been associated with a decrease in pulmonary exacerbations and certain improvements in respiratory symptoms. However, the drug's efficacy in terms of pulmonary exacerbations and symptom improvement is not as pronounced as that observed with Trikafta. Despite this, Orkambi remains an important treatment option for CF patients with the appropriate genetic profile, particularly before the introduction of Trikafta or for those who are not eligible for Trikafta therapy.

Regulatory Agency Approvals

Trikafta*

Food and Drug Administration (FDA), USA

Lucaftor

ANMAT (ARG)

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