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A newborn with meconium ileus is found to have an elevated immunoreactive trypsinogen on newborn screening. Sweat chloride is 85 mEq/L. Genetic testing reveals F508del homozygosity.

AR; CFTR (cystic fibrosis transmembrane conductance regulator)

  • F508del (p.Phe508del): ~70% of alleles in Caucasians
  • Variant classes affect treatment eligibility

Variant Classes:

ClassDefectExampleCFTR Modulators
INo protein (nonsense/frameshift)G542XLimited
IITrafficking defectF508delLumacaftor/ivacaftor, elexacaftor/tezacaftor/ivacaftor
IIIGating defectG551DIvacaftor
IVConductance defectR117HIvacaftor
VReduced quantity3849+10kbC>TVariable
  • Pulmonary: Chronic infections (Pseudomonas, Staph), bronchiectasis, respiratory failure
  • GI: Pancreatic insufficiency, meconium ileus, distal intestinal obstruction, hepatobiliary disease
  • Reproductive: Male infertility (CBAVD, 97% of CF males), reduced female fertility
  • Other: Nasal polyps, CF-related diabetes, osteoporosis

CBAVD is the obstructive cause of azoospermia found in 97-98% of males with classic CF and is also a frequent sole presentation of CFTR disease in otherwise asymptomatic men evaluated for infertility: a CFTR-related disorder at the mild end of the phenotypic spectrum, not classic CF.

Genetics of isolated CBAVD:

  • Most isolated CBAVD males carry one severe CFTR variant in trans with one mild variant, most commonly the 5T allele of the intron 9 (now intron 8) polypyrimidine tract (a splicing-efficiency variant that reduces normal CFTR transcript)
  • The 5T allele's penetrance is modulated by the adjacent TG-repeat tract length (TG12 or TG13 in cis with 5T markedly increases the chance of CBAVD)
  • A minority of CBAVD males have two mild variants or one severe + 5T

Counseling implications:

  • Any male with CBAVD should have full CFTR analysis (sequencing + 5T/TG genotyping), not just the standard panel
  • The female partner must be tested with comparable sensitivity before IVF/ICSI; if she carries any CFTR variant, offspring are at risk for classic CF or a CFTR-related disorder
  • Sweat chloride may be normal or borderline in isolated CBAVD; diagnosis is genetic
  • Renal ultrasound is recommended (unilateral renal agenesis can co-occur with unilateral, not bilateral, vas deferens absence, a developmental clue that the etiology is not CFTR)
  • Newborn screening (IRT + DNA or IRT/IRT)
  • Sweat chloride ≥60 mEq/L (diagnostic)
  • CFTR genetic testing

Carrier Screening: Recommended for all reproductive-age individuals

  • CFTR modulators are the disease-modifying mainstay: elexacaftor/tezacaftor/ivacaftor for eligible variants, ivacaftor for gating variants
  • Airway clearance plus inhaled therapies (dornase alfa, hypertonic saline, inhaled antibiotics) and aggressive treatment of pulmonary exacerbations
  • Pancreatic enzyme replacement with fat-soluble vitamin (A, D, E, K) supplementation and high-calorie nutrition
  • Surveillance for CF-related diabetes, hepatobiliary disease, and bone disease; lung transplantation for end-stage disease