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Experimental Treatment Shows Effectiveness Across Genotypes

An experimental combination drug manufactured by Gilead Sciences Inc shows promise in treatment for all hepatitis C genotypes. The combination treatment of Sovaldi and NS5A inhibitor velpatasvir is a single once per a day tablet.

In four Phase III trials, the 12 week treatment showed a high rate of success. Out of the 1,035 patients with genotype 1-6 who underwent treatment in the first three trials, 98% reached sustained virologic rate (SVR12). Of the patients who did not achieve SVR12, 13 patients experienced virologic failure and seven did not follow up with an SVR12 visit. No patients with genotypes 2, 4, 5 and 6 experienced virologic failure.

In the fourth trial, SVR12 rates were higher for more advanced patients with decompensated cirrhosis who also received ribavirin at 94% compared to without ribavirin at 86% after 24 weeks of treatment and 83% after 12 weeks.

Gilead also has two other treatments available: Sovaldi and Harvoni. Harvoni is also a combination treatment and targets genotype 1 patients, the most common genotype in the United States.

The most common side effects from treatment reported were headaches, fatigue, and nausea. Two patients stopped treatment during the first three trials due to side effects. In the forth trial, 31% of patients who were also treated with ribavirin reported anemia, while only 3-4% of patients treated without ribavirin experienced anemia. Nine patients died during treatment; the majority of which had advanced liver disease.

The ability to treat all genotypes might eliminate the need for genotype testing especially in areas outside of the United States where this type of testing is less possible. The Food and Drug Administration (FDA) has given the combination treatment a Breakthrough Therapy designation. This designation is given to treatments that may offer advanced results over current options.1-3

For more information, visit Gilead’s press release.

  1. Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating a Once-Daily, Fixed-Dose Combination of Sofosbuvir (SOF) and Velpatasvir (VEL) (GS-5816) for the Treatment of All Six Hepatitis C Genotypes. Gilead Sciences Inc. Published September 21, 2015. Accessed September 21, 2015.
  2. Carroll J. Gilead's new pangenotype hep C combo scores stellar results in PhIII. Fierce Biotech. Published September 21, 2015. Accessed September 21, 2015.
  3. Grover N. UPDATE 2-Gilead experimental drug fights all forms of hep C: data. Reuters. Published September 21, 2015. Accessed September 21, 2015.