For patients who are all of
- GT1
- Treatment naive
- No cirrhosis
- Taking Harvoni
- Viral load < 6,000,000
The guidelines suggest 8 weeks treatment is ok. But is it really?
In this VA study of 4,365 patients they concluded:
Conclusions: In this real-world cohort, SVR rateswith LDV/SOF6RBV nearly matched the rates reported in clinical trials and were consistently high across all sub-groups; those without cirrhosis but with HCV RNA<6,000,000 IU/mL were less likely to achieve SVR with 8 weeks compared to 12 weeks of therapy, although the numeric difference in SVR rates was small.
https://www.researchgate.net/publication/301671429_Real_World_Effectiveness_of_LedipasvirSofosbuvir_in_4365_Treatment-Naive_Genotype_1_Hepatitis_C_Infected_Patients
Hmm, small. What’s small?
Small is 96.6% SVR at 12 weeks compared to 93.2% at 8 weeks.
Putting that in failure terms:
3.4% failure at 12 weeks compared to 6.8% failure at 8 weeks.
So if you fit the criteria, and only do 8 weeks you have DOUBLE the failure rate.
DOUBLE is not small to me. Double is big.
I don’t know about you, but I would be wanting that extra 3.4%
Also note this. The same study shows (as did we with generics) that patients who are detectable at the 4 week test (that’s detectable at all and includes <15 detected) are 2.5 times more likely to fail, compared to patients who are undetected at this point.
So the only reason that I personally would do only 8 weeks would be if that was all I could get. If I was still detected at the 4 week mark I would be very nervous.
If you are female, if you have low fibrosis, if you are undetected at 4 weeks these are all good, but still - DOUBLE THE FAILURE RATE
Double is not small.
.
