In the Journals

Generic ledipasvir-sofosbuvir achieved SVR12 in HCV genotype 1b

Treatment with generic ledipasvir-sofosbuvir for 8 to 12 weeks was affective in Chinese patients with hepatitis C genotype 1b, according to a recently published study.

“Genotype 1 is the most common in China, as it accounts for 58.4% of all HCV-infected persons, principally genotype 1b,” the researchers wrote. “As an eliminator of HCV and a leader of direct-acting antiviral agents (DAAs), sofosbuvir has revolutionized the treatment of [chronic hepatitis C] since 2013. However, brand name DAAs are unaffordable. Fortunately, Gilead Sciences ... approved generic ledipasvir-sofosbuvir with a very low price in many neighboring countries of China, and patients can go to these countries to purchase the drug and for treatment.”

To determine the safety and efficacy of generic ledipasvir-sofosbuvir compared with brand name agents such as Harvoni (Gilead), the researchers enrolled 192 patients between March 2016 and June 2016 in an open-label study.

Researchers divided the patients into three groups: 63 patients with cirrhotic HCV treated with a once-daily generic tablet of 90 mg ledipasvir and 400 mg sofosbuvir plus ribavirin for 12 weeks (group 1); 65 patients with chronic HCV treated with a once-daily generic tablet plus ribavirin for 8 weeks (group 2); and 64 patients with chronic HCV treated with once-daily ledipasvir-sofosbuvir without ribavirin for 8 weeks (group 3).

Mean patient age was 55.8 years (range, 35-70 years) and 154 were women. Overall, 187 patients completed the full course of therapy.

All 61 patients who completed therapy from group 1 achieved sustained virologic response at week 12 (95% CI, 92.6-99.9). All 63 patients from group 2 who completed treatment also achieved SVR12 (95% CI, 92.8-99.9). Sixty-two of the 64 patients in group 3 completed treatment and achieved SVR12 (95% CI, 90.3-99.9).

The researchers found significant differences in HCV RNA undetectable rates between group 1 and group 3 at week 1 (P < .0001), week 2 (P < .007) and week 3 (P < .027), but not following week 4.

There were no severe adverse events. The most common adverse events were fatigue in 17.7% of patients (95% CI, 12.7-24), diarrhea in 10.9% (95% CI, 7.1-16.4) and headache in 9.9% (95% CI, 6.2-15.2).

“There is controversy regarding the bioequivalence, quality control and assessment between the generics and brand name medications; in other words, the safety and efficacy data of the generic agents are lacking worldwide,” the researchers wrote. “Our current study indicated that generic ledipasvir-sofosbuvir with or without RBV is effective and well-tolerated for genotype 1b patients, although four patients discontinued the therapy due to diarrhea and vomiting. Future validation studies with a larger number of cases and shorter treatment durations are warranted.” – by Talitha Bennett

Disclosure s : The researchers report no relevant financial disclosures.

Treatment with generic ledipasvir-sofosbuvir for 8 to 12 weeks was affective in Chinese patients with hepatitis C genotype 1b, according to a recently published study.

“Genotype 1 is the most common in China, as it accounts for 58.4% of all HCV-infected persons, principally genotype 1b,” the researchers wrote. “As an eliminator of HCV and a leader of direct-acting antiviral agents (DAAs), sofosbuvir has revolutionized the treatment of [chronic hepatitis C] since 2013. However, brand name DAAs are unaffordable. Fortunately, Gilead Sciences ... approved generic ledipasvir-sofosbuvir with a very low price in many neighboring countries of China, and patients can go to these countries to purchase the drug and for treatment.”

To determine the safety and efficacy of generic ledipasvir-sofosbuvir compared with brand name agents such as Harvoni (Gilead), the researchers enrolled 192 patients between March 2016 and June 2016 in an open-label study.

Researchers divided the patients into three groups: 63 patients with cirrhotic HCV treated with a once-daily generic tablet of 90 mg ledipasvir and 400 mg sofosbuvir plus ribavirin for 12 weeks (group 1); 65 patients with chronic HCV treated with a once-daily generic tablet plus ribavirin for 8 weeks (group 2); and 64 patients with chronic HCV treated with once-daily ledipasvir-sofosbuvir without ribavirin for 8 weeks (group 3).

Mean patient age was 55.8 years (range, 35-70 years) and 154 were women. Overall, 187 patients completed the full course of therapy.

All 61 patients who completed therapy from group 1 achieved sustained virologic response at week 12 (95% CI, 92.6-99.9). All 63 patients from group 2 who completed treatment also achieved SVR12 (95% CI, 92.8-99.9). Sixty-two of the 64 patients in group 3 completed treatment and achieved SVR12 (95% CI, 90.3-99.9).

The researchers found significant differences in HCV RNA undetectable rates between group 1 and group 3 at week 1 (P < .0001), week 2 (P < .007) and week 3 (P < .027), but not following week 4.

There were no severe adverse events. The most common adverse events were fatigue in 17.7% of patients (95% CI, 12.7-24), diarrhea in 10.9% (95% CI, 7.1-16.4) and headache in 9.9% (95% CI, 6.2-15.2).

“There is controversy regarding the bioequivalence, quality control and assessment between the generics and brand name medications; in other words, the safety and efficacy data of the generic agents are lacking worldwide,” the researchers wrote. “Our current study indicated that generic ledipasvir-sofosbuvir with or without RBV is effective and well-tolerated for genotype 1b patients, although four patients discontinued the therapy due to diarrhea and vomiting. Future validation studies with a larger number of cases and shorter treatment durations are warranted.” – by Talitha Bennett

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Disclosure s : The researchers report no relevant financial disclosures.