Harvoni Provides Added Benefit for Certain Hepatitis C Patient Groups

Historical comparison shows advantage in virologic response for patients with genotype 1 hepatitis C.

Historical comparison shows advantage in virologic response for patients with genotype 1 hepatitis C.

The use of Harvoni (ledipasvir and sofosbuvir) was found to provide an added benefit over the appropriate competitor therapy during an evaluation by the German Institute for Quality and Efficiency in Health Care (IQWiG).

The institute found a hint of a non-quantifiable additional benefit in 2 of 7 patient groups: those with genotype 1 hepatitis C virus (HCV) infection following unsuccessful prior therapies, and in patients who were previously untreated and had not developed cirrhosis of the liver yet. The results of the analysis indicated an advantage in sustained virologic response (SVR), as nearly all of the patients were free of the virus following treatment.

The IQWiG evaluated the added benefit separately for 7 different patient groups categorized according to genotype of the virus (1, 3, or 4), stage of the disease, and prior treatment. The manufacturer did not offer direct comparative studies, but provided historical comparisons with data from different studies where at least one of the competitor treatments were evaluated.

In general, conclusions on the added benefit can only be derived when the differences of the effect are large enough that they cannot be explained by bias alone. In light of the reduced certainty of conclusions, however, only a hint of the added benefit can be derived from historical data, with no indication or proof, the analysis noted.

In 3 patient groups with genotype 1 HCV, more than 20 studies showed a dramatic effect on SVR. Following treatment with Harvoni, the virus was no longer detectable in nearly 100% of patients, including treatment-experienced and treatment-naive patients with and without cirrhosis. Meanwhile, the success rate of comparator therapies was between nearly 35% and 75%.

“The difference between the treatments was so large that an advantage of the new drug combination could be derived from it,” the authors wrote. “It remained unclear, however, how large this difference is exactly because these were only historical comparisons.”

Increased harm from side effects could not be excluded in treatment-naive patients with cirrhosis of the liver. The IQWiG noted a hint of an added benefit in just 2 of 3 genotype 1 patient groups, specifically in treatment-experienced and treatment-naive patients without cirrhosis of the liver.

The extent of the added benefit, however, is non-quantifiable, as it was unclear how many patients had an undetectable viral load and whether liver cancer can be prevented. There was no added benefit of Harvoni found in the other 4 patient groups, as the dossier either contained no data or no comparative data.