Direct-acting Antivirals Treat HIV/HCV Coinfection in Real-world Study

Real-world outcomes indicate that direct-acting antiviral (DAA) agents induce high rates of 12-week viral eradication in patients infected with both human immunodeficiency virus (HIV) and hepatitis C virus (HCV), particularly in patients without decompensated cirrhosis, according to a new study.

About one-third of HIV patients are coinfected with HCV, and therefore liver disease is a major source of morbidity and mortality in these patients, said Juan J. Gonzalez-Garcia, MD, PhD, of Hospital La Paz/IdiPaz in Madrid, Spain. DAAs have been assessed in HIV/HCV coinfected persons in clinical trials, but more data are needed to determine their effectiveness and safety under real-world conditions, he said at the American Association for the Study of Liver Diseases annual meeting (Abstract 78).

Gonzalez-Garcia and colleagues evaluated data from a prospective registry of HIV/HCV-coinfected patients receiving DAA-based HCV therapy. They used the Madrid Coinfection Registry, a prospective registry of coinfected patients age 18 years and older treated with DAAs for HCV infection in hospitals from the Madrid Regional Health Service. The researchers assessed HCV virologic responses at 12 and 24 weeks after completion of therapy of 1,242 HIV/HCV-coinfected patients, median age 51 years.

The most commonly used DAA-based regimens were sofosbuvir/ledipasvir, which accounted for more than 60% of the DAA regimens, and sofosbuvir/daclatasvir with or without ribavirin. Other DAA regimens included ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, simeprevir and sofosbuvir with or without ribavirin, and sofosbuvir plus ribavirin.

The vast majority of patients (93.6%) were on combination antiretroviral therapy; 659 patients (53%) had liver cirrhosis (533 patients with compensated cirrhosis and 126 patients with decompensated cirrhosis), and 7.5% had severe extrahepatic HCV manifestations. Slightly more than half (57.5%) of the patients had not received HCV therapy.

The study suggests that coinfected patients do not have different responses from non-HIV infected patients to DAA therapy...

There were 17 liver-transplant recipients and 7 patients were on a transplant waiting list. The patients had a wide range of HCV genotypes, including G1a 493 patients (39.7%), G4 270 patients (21.7%), G1b 210 patients (16.9%), G3 184 patients (14.8%), non-subtyped G1 53 patients (4.3%), G2 14 patients (1.1%), mixed 17 patients (1.4%), and undetermined 1 patient (0.1%).

A total of 1,123 patients (90.4%) achieved sustained virologic response at 12 weeks after completion of treatment (SVR12); 69 patients (5.6%) relapsed, 19 patients (1.5%) died, 8 patients (0.6%) discontinued due to adverse events, 4 patients (0.3%) experienced break through, and 19 patients (1.5%) discontinued due other reasons.

SVR12 rates were somewhat lower (80.2%) in patients with decompensated cirrhosis, but not for those with compensated cirrhosis (90.4%). This indicates that earlier treatment may be preferable before cirrhosis patients become decompensated, Gonzalez-Garcia said.

Other factors independently associated with treatment failure were male sex and the combination of sofosbuvir plus simeprevir with or without ribavirin.

In conclusion, Gonzalez-Garcia said: “The results of this large prospective cohort of HIV/HCV-coinfected patients -- the majority of them with liver cirrhosis -- showed a high effectiveness of DAA-based HCV therapy.” The study suggests that coinfected patients do not have different responses from non-HIV infected patients to DAA therapy and that DAA therapy is safe in coinfected patients, with about 1% discontinuing therapy due to adverse events.

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