Ledipasvir/Sofosbuvir Improves PRO in HCV/HIV Co-infection

SAN FRANCISCO, CA—Patients with HIV/HCV co-infection treated with a fixed-dose combination of ledipasvir/sofosbuvir show significant improvement in patient-reported outcomes (PRO) scores, a study reported at The Liver Meeting® 2015 has found.

"These PRO improvements are observed during treatment and after sustained virologic response (SVR), both compared to the baseline levels and compared to a ribavirin-containing regimen," noted Zobair Younossi, MD, MPH, from the Inova Fairfax Hospital, Falls Church, VA, and colleagues.

Ledipasvir/sofosbuvir fixed-dose combination tablets are currently approved for the treatment of patients with HCV genotype 1 infection; however the effect of this combination on PROs in patients co-infected with HCV/HIV "has not been reported," Dr. Younossi stated.

To examine the impact of ledipasvir/sofosbuvir on PROs of 335 HIV/HCV co-infected patients treated during the ION-4. Study patients were given 12 weeks of ledipasvir/sofosbuvir; matched historic controls were 223 HIV/HCV co-infected patients treated with sofosbuvir and ribavirin in the PHOTON-1 trial.

Previously reported results showed that treatment with ledipasvir/sofosbuvir significantly improved rates of SVR at 12 weeks compared with ribavirin-containing regimens, 96% vs. 76%, respectively.

All participants completed four PRO questionnaires: the CLDQ-HCV, SF-36, FACIT-F, and WPAI:SHP before, during, and after treatment. 

During treatment, patients receiving ledipasvir/sofosbuvir reported improvement in PRO scores, +6.0% in activity/energy of CLDQ-HCV, +5.0% in fatigue scale of FACIT-F, and +6.8% in physical component of SF-36; all P<0.0001. In contrast, patients receiving sofosbuvir/ribavirin demonstrated a moderate decline in PROs (-3.0% in AE, -4.4% in FS; both P<0.05).

"In contrast, those receiving sofosbuvir and ribavirin showed moderate decline in PROs: -3.0% in activity/energy and -4.4% in fatigue scale (both P<0.05)," they reported.

A greater improvement in PROs was seen in patients achieving SVR12 treated with ledipasvir/sofosbuvir vs. those treated in PHOTON-1, an average of +5.1% across 26 PROs vs. +1.4%.

In multivariate analysis, pre-treatment depression (β= -4.4% to -12.6%) and fatigue (β = -5.1% to -12.7%; P<0.05) were the most consistent predictors of PRO impairment in HIV/HCV coinfected patients, noted Dr. Younossi.

A separate analysis indicated that treatment with sofosbuvir/ribavirin when compared to ledipasvir/sofosbuvir resulted in more PRO impairment (β= -6.1% to -12.1%; P<0.05) during treatment and soon after treatment cessation. 

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