Jordi Navarro of University Hospital Vall d’Hebron in Barcelona and colleagues did a prospective
cohort study of 170 people with HIV/HCV co-infection with cirrhosis who started DAA
therapy at 13 Spanish centres during 2015.
About three-quarters were men and the
average age was 51 years. The most common HCV genotypes were 1a (40%), 1b
(12%), 3 (15%) and 4 (28%). Most (75%) had compensated cirrhosis, but 12% were
Child-Pugh class B and 17% had a history of prior decompensation.
Participants were on stable antiretroviral
therapy (ART), most (89%) had undetectable HIV viral load and the median CD4
T-cell count was approximately 500 cells/mm3. About half were
starting hepatitis C treatment for the first time, 38% had been treated before with
pegylated interferon plus ribavirin and about 14% had tried early HCV protease
inhibitors with pegylated interferon/ribavirin.
Most cohort participants were treated
with interferon-free DAA regimens for 12 or 24 weeks, most commonly
sofosbuvir/ledipasvir (Harvoni) plus
ribavirin (25%), sofosbuvir/ledipasvir alone (15%), sofosbuvir and simeprevir (Olysio) plus ribavirin (20%), or
sofosbuvir and daclatasvir (Daklinza)
plus ribavirin (15%).
Overall, 98% of previously untreated and
89% of treatment-experienced participants achieved sustained virological
response, or continued undetectable HCV RNA at 12 weeks post-treatment (SVR12).
Previously treated people with HCV genotype 1a or 4 had somewhat lower response
rates (87% and 83%). Cure rates were 95% or higher for all regimens except
sofosbuvir and simeprevir without ribavirin for 12 weeks (63%).
Treatment was generally safe and well
tolerated. However, 16% had to reduce their ribavirin dose, mostly due to
anaemia. Four people experienced liver decompensation while on treatment. Liver
stiffness, an indicator of fibrosis severity, decreased by an average of 5.6
kPa after treatment.
In another study, Juan Berenguer of Gregorio Maranon
Hospital in Madrid and colleagues looked at real-life outcomes among
people with HIV/HCV co-infection with advanced liver disease in the MADRID-CoRe registry who received interferon-free
DAA therapy between November 2014 and May 2016.
Of the 2662 DAA-treated individuals with co-infection in the registry, 146 – about 5% – fell within the study's definition
of decompensated cirrhosis (having ever had Child-Pugh class B or C or hepatocellular
carcinoma). Of these, 51% were currently classified as Child-Pugh class A, 43%
as class B and 6% as class stage C. The median MELD score was 10, 10% had a
history of hepatocellular carcinoma, one person had received a liver transplant
and seven (5%) were on a transplant waiting list.
Again most participants (70%) were men
and the median age was 52. The most common HCV genotypes were 1a (34%), 1b
(22%), 3 (15%) and 4 (21%). Most were on ART and the median CD4 count was 474
cells/mm3. A majority (60%) had not been treated before for
The most common interferon-free regimens
were sofosbuvir/ledipasvir (50%), sofosbuvir and daclatasvir (25%) or
sofosbuvir and simeprevir (18%). Across all regimens, about half included
ribavirin and half did not.
Looking at the entire MADRID-CoRe
cohort, sustained response rates were 94% for people without cirrhosis, 91% for
those with compensated cirrhosis and 81% for those with decompensated
cirrhosis. Two people with decompensation had to stop treatment due to adverse
The difference was driven by people with
the most severe liver disease: people with Child-Pugh class A and B did well
(87% and 79%), but the SVR12 rate fell to just 44% for class C. Rates were 74%
and 88% for people with MELD scores above and below 10, respectively. Male sex
and Child-Pugh class C were the only significant predictors of treatment