ALLY-2: Daclatasvir/Sovaldi render high SVR rates in HIV/HCV patients
SEATTLE — A treatment regimen of daclatasvir and Sovaldi for 12 weeks produced high rates of sustained virologic response among patients with HIV and hepatitis C virus infection, according to data presented at CROI 2015.
“Our objective was to explore the association between time to first occurence of HCV RNA viral suppression and achievement of SVR in patients with HCV/HIV-1 coinfection compared to HCV monoinfection following treatment with 3 direct-acting antivirals with or without ribavirin,” David Wyles, MD, of UC San Diego, said during his presentation.
In this phase 3 clinical trial, Wyles and colleagues randomly assigned 151 treatment-naive and 52 treatment-experienced patients coinfected with HIV/HCV to three cohorts: one cohort of treatment-naive patients (n = 101) received 30 mg, 60 mg or 90 mg daclatasvir (Bristol-Myers Squibb) plus 400 mg Sovaldi (sofosbuvir, Gilead Sciences) once a day for 12 weeks, a second cohort of treatment-naive patients (n = 50) received the same doses and combination for 8 weeks, and the treatment-experienced cohort (n = 52) received the same combination and regimen of daclatasvir and sofosbuvir for 12 weeks. Follow-up was until 24 weeks after treatment.
Overall, 97% of patients treated with the combination regimen for 12 weeks achieved an SVR at 12 weeks (149/153), and 76% (38/50) of patients treated for 8 weeks achieved SVR at 12 weeks.
Ninety-six percent of treatment-naive patients with HCV genotype 1 and 100% of patients with HCV genotypes 2, 3 or 4 achieved SVR at 12 weeks, according to the presentation. No patient discontinued therapy due to an adverse event, and no serious adverse events related to daclatasvir or sofosbuvir were observed or reported.
"High SVR12 rates were achieved in patients with or without cirrhosis regardless of time to initial suppression of HCV RNA," Wyles concluded. "Higher baseline viral load was associated with logner time to first viral suppression, although this did not affect achievement of SVR12."
Wyles added: "Traditional negative predictors such as cirrhosis, black race, prior peg-IFN/RBV null response and unfavorable IL28B genetic background did not influence time to viral suppression."
Wyles DL, et al. Abstract 151LB. Presented at: CROI 2015; Feb. 23-26, 2015; Seattle.
Disclosure: Wyles is a consultant/adviser for AbbVie, Bristol-Myers Squibb, Gilead and Janssen, and has received grants and research funds (paid to UC Regents) from AbbVie, Bristol-Myers Squibb, Gilead, Merck and Tacere. The study was funded by Bristol-Myers Squibb.