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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:

Overall SVRTreatment NaiveTreatment ExperiencedNo CirrhosisCirrhosis

All patients maintained stable CD4 counts both during and after treatment, and no patient experienced an HIV virologic rebound. The regimen was very well tolerated, with 257 (77%) reporting some side effects, but all were on the mild to tolerable level. Reported side effects included headaches, fatigue, diarrhea, nausea, arthralgia and upper respiratory tract infections. No one stopped HCV treatment due to these side effects.

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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