High Cure Rates in HIV/HCV Coinfected Patients Taking Ledipasvir/Sofosbuvir
March 13, 2015
The fixed-dose combination of ledipasvir/sofosbuvir (Harvoni) was approved by the FDA in October 2014 for treating HCV in genotype 1 mono-infected persons, but not for the HIV/HCV co-infected. Although some very compelling evidence shows this treatment is effective in co-infected persons -- an NIH study of 50 non-cirrhotic co-infected patients had an SVR rate of 98% -- the numbers were too small to draw any conclusions regarding its efficacy in larger groups. Results from the ION-4 Study of 335 co-infected patients showed an SVR12 of 96%, offering compelling evidence that co-infected persons can be treated for HCV with a once daily regimen.
ION-4 is a phase 3, multicenter, open label study of co-infected patients with HCV GT1 and 4. The study was open to both HCV treatment naive and experienced patients, and 20% of participants had compensated cirrhosis. Patients were on variousHIV regimens that included emtricitabine and tenofovir disproxil fumerate plus efavirenz, raltegravir or rilpivirine, and all had HIV RNA <50 copies/mL and CD4 cell count >100 cells/mm3. Of the 335 patients, 276 (82%) were male, 115 (34%) were African American, 56 (17%) were Latino/a, and the average age was 52. The vast majority were GT1 (327, 98%), and 185 (55%) were HCV treatment experienced.
The study results showed high SVR rates, no impact on HIV disease severity or treatment, and minimal side effects. Overall, 321 of 335 patients, or 96%, achieved an SVR12. There were 10 viral relapses and 2 on-treatment failures (both had poor adherence to the regimen), while one person was lost to follow-up and another died of non-treatment related causes (injection drug related fatality). A breakdown of the SVR rates is found below:
Although LDV/SOF has been FDA approved for HIV/HCV co-infection, these results will further support patients and providers who wish to treat HCV off-label. The results of the ION-4 study are very promising for patients with co-infection and show that a once-daily regimen of LDV/SOF can cure people at very high rates with minimal side effects, and no impact on their HIV care.
This article was provided by Project Inform. It is a part of the publication The 22nd Conference on Retroviruses and Opportunistic Infections (CROI 2015). Visit Project Inform's website to find out more about their activities, publications and services.
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