Interferon-free regimen effective in HCV, HIV coinfection

The first interferon-free treatment regimen to be tested in patients with hepatitis C virus and HIV coinfection was associated with high sustained virologic response rates at 12 weeks and 24 weeks, findings from the PHOTON-1 study indicate.

Susanna Naggie, MD, MHS, of Duke Clinical Research Institute, presented final data from the study, which assessed sofosbuvir plus ribavirin in 223 patients HCV genotypes 1, 2 and 3, and HIV coinfection of varying treatment status, at the 2014 Conference on Retroviruses and Opportunistic Infections.

Overall, sustained virologic response at 12 weeks (SVR¹²) ranged from 70% to 90% depending on HCV genotype with SVR rates in most cases “exactly the same as mono-infected patients,” according to Naggie.

Study treatment consisted of 400 mg once-daily sofosbuvir plus 1,000 mg to 1,200 mg weight-based ribavirin for 24 weeks among 114 treatment-naïve patients with HCV genotype 1. HIV infection was well controlled in all patients; none had been previously treated for HCV.  

The researchers also assessed 68 treatment-naive and 41 treatment-experienced patients with HCV genotypes 2 and 3. Previously untreated patients received sofosbuvir and ribavirin for 12 weeks and prior non-responders were treated for 24 weeks.

Among treatment- naïve genotype 1 patients, 76% achieved SVR¹². One person had detectable HCV again after completing treatment – giving a sustained-virologic response rate at week 24 (SVR²⁴) of 75%.

The SVR¹² and SVR²⁴ rates were 88% (for both groups) among treatment-naive patients with HCV genotype 2. However, SVR¹² and SVR²⁴ rates decreased to 67% for treatment-naive patients with HCV genotype 3. 

Among previously treated patients SVR²⁴ rates were  92% for genotype 2 and 94% for genotype 3. The most common adverse events included fatigue, insomnia, headache and nausea.

“Overall, this regimen was very well-tolerated and was dosed with multiple ARTs. It appeared safe with HIV viral breakthrough occurring in only one patient who reported nonadherence to their ART,” Naggie said.