New all-oral, direct-acting antiviral agents were well tolerated and showed encouraging signs of virological efficacy in a study of cirrhotic patients coinfected with HIV and hepatitis C virus, according to research presented at the 2015 International Liver Congress.
“Cirrhotic HIV-HCV coinfected patients have long been considered as difficult-to-treat patients with a high mortality rate,” Philippe Sogni, MD, of the Université Paris Descartes, and colleagues wrote. “Real-life efficacy and tolerance data with sofosbuvir-based combinations in cirrhotic HIV-coninfected patients are scarce and urgently needed.”
The ANRS CO13 HEPAVIH cohort study included 106 patients (median age, 54 years; 80% men) who initiated a Sovaldi (sofosbuvir, Gilead Sciences)-based regimen between 2014 and 2015. Of these, 104 were on continuous ART. Twenty-eight percent were treatment-naive, 57% had experienced treatment failure with pegylated-interferon plus ribavirin (PR), and 11% had experienced treatment failure with PR plus a first-generation protease inhibitor. Thirty-two percent of participants had HCV genotype 1a, 12% had genotype 1b, 4% had genotype 2, 19% had genotype 3, and 23% had genotype 4.
Four treatment regimens were used:
- sofosbuvir plus ribavirin (n =22);
- sofosbuvir plus Daklinza (daclatasvir, Bristol-Myers Squibb), with or without ribavirin (n = 75);
- Harvoni (ledipasvir/sofosbuvir, Gilead Sciences; n = 3); and
- sofosbuvir plus Olysio (simeprevir, Janssen Therapeutics; n = 6).
Virologic response was observed in 52% of patients at week 4 and 100% at the end of treatment. SVR4 and SVR12 were 100% and 93%, respectively, for patients reaching this endpoint, the researchers said.
Adverse events, including anemia (36%), asthenia (14%), digestive problems (5%) and other complications (45%), were reported in 22 patients. Ribavirin was stopped in three patients and dose-adjusted in nine.
During treatment and posttreatment periods, clinical events in relation with cirrhosis were reported in 8% of patients — including hepatocellular carcinoma in two cases and decompensation in five cases — and with HIV in 4% of the patients. – by David Jwanier
Sogni P, et al. Abstract LP20. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Sogni reports no relevant financial disclosures.