Hepatitis C and Telaprevir
Hepatitis C and Telaprevir
Telaprevir
· Safe to use in COMPENSATED liver disease. Do not use in patients which Childs score more than 7.
· It can only be used on Type 1 HCV pts
Contraindications
· Cannot use in men or women who are planning pregnancy
· Must use 2 contraceptives while on treatment and for 6 months after treatment
· 2 contraceptives needed because the drug decreases BCP efficacy
· After 2 weeks of stopping Telaprevir, you can switch to one form of contraception
· Solid organ transplant patients
· HIV and HBV co infected patients
· Nursing mothers.
· Age more than 65 – use with caution.
· Renal impairment.
Caution and Drug Interactions
· It is contraindicated in pts on drug metabolized by CYP3A for metabolism
· Eg include rifampin, atorvastatin, lovastatin, simvastatin, sildenafil, tadalafil, midazolam, triazolam, St. Johns wort, ergot derivatives, alfuzosin. Pimozide
· Long list of drugs for which it is not recommended and use with caution. It includes methadone, seboxon, etc.
Response Guided Therapy
· This is a new term used for treatment. Basically it means that treatment duration depends on how the patient responds initially to treatment.
Dose
· Telaprevir needs fat for better absorbption. Take food (not low fat food) with the medicine
· Dose MUST be given every 8 hours (range 7-9 hours)
· Dose is 375 mg . Take 2 tablets three times a day.
· The dose MUST NOT be reduced or interrupted.
Treatment Regimen
· If HCV RNA > 1000 at week 4 – STOP treatment
· If HCV RNA > 1000 at week 12 – stop treatment
· If patients have cirrhosis and are negative at week 12, treat for 48 weeks
· If patients are prior relapsers, partial or null responders and are negative at week 12, treat for 48 weeks.
· If patient is less than 1000 at week 12, check at 24. If neg, treat till 48 weeks. (basically 36 after undetectable).
Monitoring
· Use CMP, CBC, TSH uric acid every 2 weeks, week 4, week 8 and week 12
· Check PCR at weeks 4 and 12.
Studies
· Advance, Illuminate and Realize.
· 2/3 treatment naïve patients will need treatment only for 24 weeks.
· Response rate in compensated cirrhosis is 62%
· Response rate in AA is 62%
· Overall response rate is 79%
· Response rate for Hispanics is 74%
· Relapse rate overall is 4%
· Results for prior relapsers is 86%, partial responders is 59% and for null responders 32%. Treatment in this group was for 48 weeks.
Side Effects
· Rash, fatigue, pruritis, nausea, anemia, diarrhea, vomiting, hemorrhoids, anorectal discomfort, dysgeusia and anal pruritis
· Rash occurs in first 4 weeks. Occurs in 56% of patients
· Difficult to differentiate between rash of ribavirin or Telaprevir.
· DRESS – drug related eosinophilia and systemic symptoms (may develop hepatitis, nephritis, facial edema and may or may not have eosinophilia)
· Steven Johnsons syndrome and TEN can occurs in 1%
· General care includes – no fragrances, Dove soap, no sun exposure, High SPF (>45), oral antihistamines (zyrtec, Benadryl, Claritin) topical steroids.
· Rashes – mild (local or just one area), moderate (diffuse) severe (diffuse plus systemic)
· Hb usually decreases at week 4. Lowest Hb is at week 12.
· Anorectal symptoms – treat analpram cream, tucks.
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