Oncolgoic side effect of entecavir

[cyrus131]

Hi all,

Just come across this :

Oncologic

Oncologic side effects have included malignant neoplasms occurring at a rate of 8.4 per 1000 patient-years. Hepatocellular carcinoma has been reported in 6% of entecavir-treated patients with hepatic decompensation.

Do you think the risk of taking the entecavir outweigh this severe (though remote) side effect?  Do you think there is a need to switch to tenofovir?  I have taken entecavir 0.5mg for more than 6 years.  Many thanks.

Regards,

Cyrus

[stef2011]

because of a cirrhosis baseline so death risk if hbv reactivates and no drugs working, because i have the mutation q415s which lowers response to lam, adv and theorically tdf, so to stay safe i made combo since also etv was not able to fully suppress hbvdna to zero

[cyrus131]

Dear Stefano,

May I know why you still keep the etv while on tnf?

Regards,

Cyrus

[stef2011]

My point is if tenofovir has same potency as entecavir but without this risk (no matter how small), it is worthwhile to consider switching to tenofovir.  

tenofovir has not same potency as entecavir, it has more potency and if you consider no resistance at all i d say much more potency than etv

[StephenCastlecrag]

A fair point. This is from a 2006 discusion:
"Altogether, the data demonstrate that there is no early safety signal for an increased rate of human cancer as a result of treatment with ETV. However, the observational period is too limited to exclude a carcinogenicity risk and close monitoring in long-term follow-up studies is required."

[cyrus131]

While HCC is definitely a risk, I am more concerned about other kinds of malignant neoplasms.  My point is if tenofovir has same potency as entecavir but without this risk (no matter how small), it is worthwhile to consider switching to tenofovir.  

[StephenCastlecrag]

I think you must read the Oncologic side effects in context. I believe the results are from clinical trials of ETV submitted to FDA when seeking approval. A wide selection of patients was included in these trials, including patients with decompensated cirrhosis. So is this 6% HCC due to ETV or is it normal for this special population of HBV patients?

I think there is an ongoing phase 4 studies of ETV to monitor any events related to HCC. So far, FDA has not issued any warning.

[stef2011]

i was also worried about the reports of tumors in animal labs and the fact that it was discussed if to stop etv development at that time.

i am on etv+tdf combo and my plans are make hbv as weak as possible by intf add on and after that continue with tdf mono.

the other long term side i am worried about is mitocondrial toxicity and tdf is better for this too

[imdrew]

There is always a risk for everything. A famous artist in my country died of a heart attack at the age of 34 while doing a treadmill in a local gym. Age 34!! And no previous medical problems.

If you're really worried then do a full check twice a year, 6 months apart.

Wow 6 years! Any sides so far? Mind sharing your lab report?