Velpanat is a new medication used to treat hepatitis C. It is a combination pill containing sofosbuvir (sold separately as Sovaldi) plus velpatasvir. This hep c treatment is called generic Epclusa in developed nations like US, UK and Europe. The cost of Velpanat in the US, UK and Europe is anywhere from $45,000 to $95,000.
This hep C treatment was approved in the US, UK & Europe in July 2016 for treatment of adults with all genotypes (1, 2, 3, 4, 5 and 6) of chronic hepatitis C.
Velpanat is the first pan-genotypic interferon-free hepatitis C treatment regimen, meaning it works against all hepatitis C genotypes.
It is more effective than the older Harvoni combination (sofosbuvir + ledipasvir) for people with genotype 3.
Some people with harder-to-treat disease may do better if they take Velpanat with ribavirin.
Successful treatment reduces the risk of long-term complications of hepatitis C such as liver cancer or needing a liver transplant.
It contains two direct-acting antiviral drugs that target different steps of the hepatitis C virus (HCV) lifecycle.
Sofosbuvir is a nucleotide analogue HCV polymerase inhibitor, meaning it blocks the polymerase enzyme which the virus must use to reproduce.
Velpatasvir is an HCV NS5A replication complex inhibitor that interferes with another protein HCV uses to reproduce.
This medicine for hepatitis C treatment is approved for use by adults with chronic hepatitis C, meaning infection lasting more than six months.
It is approved for people with HCV genotypes 1, 2, 3, 4, 5 and 6. Genotype 1 is the most common type in Europe. Genotype 3 is considered hardest to treat with direct-acting antivirals.
It can be used by people being treated for hepatitis C for the first time (known as ‘treatment naive’) and for retreatment of people who were not cured with previous therapy (known as ‘treatment experienced’).
This hep c treatment has also been tested in people with HIV and HCV co-infection.
Response rates and side-effects are similar to those seen in HIV-negative people, and it can be used with many HIV medications.
People with HIV and HCV co-infection who want to take this medicine you should do so under the care of a doctor who has experience treating both infections.
This drug can be used by people with all stages of liver disease, including compensated cirrhosis, decompensated cirrhosis (laboratory abnormalities or symptoms of poor liver function) and people who are awaiting or have received a liver transplant.
It is taken as a single pill once daily with or without food. The length of treatment is 12 weeks for people with all HCV genotypes, with or without cirrhosis.
People with decompensated cirrhosis should add ribavirin. Ribavirin may also improve effectiveness for people with genotype 3 and compensated cirrhosis.
People who previously did not respond to earlier treatment with a different NS5A inhibitor may benefit from longer treatment with Velpanat.
Recommended uses for people with HIV and HCV co-infection are the same as for HIV-negative people, but they should be cautious about using antiretroviral medications that can interact with the drugs in Velpanat.
This hepatitis C medicine works better for some people than for others. Several factors predict how well someone will respond, including HCV genotype, extent of liver damage and previous treatment history.
People with advanced liver disease do not respond as well as those with mild or moderate liver fibrosis.
This may be overcome by adding ribavirin, which helps prevent relapse. People who are new to treatment have a better chance of being cured than those who did not respond to prior treatment.
People with sustained virological response, who have undetectable HCV viral load 12 and 24 weeks after finishing treatment (known as ‘SVR12’and ‘SVR24’), are considered cured.
The phase 3 ASTRAL studies showed that the drugs in Velpanat, sofosbuvir plus velpatasvir, are highly effective against all genotypes of HCV.
ASTRAL-1 tested Velpanat without ribavirin in more than 700 previously untreated and treatment-experienced people with HCV genotypes 1, 2, 4, 5 and 6, while ASTRAL-2 focused on people with genotype 2.
In both studies 99% of participants were cured.
ASTRAL-3 enrolled more than 500 people with hard-to-treat genotype 3. The cure rate was 95% for people taking Velpanat for 12 weeks compared to 80% for those taking sofosbuvir plus ribavirin for 24 weeks.
The ASTRAL-4 study showed that Velpanat works for people with decompensated cirrhosis. Cure rates were 83% for those treated with Velpanat alone for 12 weeks and 94% for those who added ribavirin.
ASTRAL-5 showed that people with HIV and HCV co-infection had response rates similar to those of HIV-negative people, ranging from 92% for genotype 3 to 100% for genotypes 2 and 4.
Velpanat’s effectiveness in ‘real world’ use may be somewhat lower than cure rates seen in clinical trials, in part because patients may be sicker or have other conditions that make treatment more complicated.
This pan genotype hep C treatment is generally well-tolerated. The most common side-effects reported in clinical trials were headache, fatigue and nausea.
The drugs in Velpanat have not been tested in pregnant or breastfeeding women, or in children and adolescents with hepatitis C.
Velpanat has not yet been tested in people with advanced decompensated cirrhosis (Child-Pugh C) or people with severe kidney dysfunction or haemodialysis. Ribavirin can cause side-effects including anaemia.
It can also cause birth defects, so it should not be used by pregnant women or their male partners.
Velpatasvir and sofosbuvir can interact with other drugs that are processed by the same enzymes in the liver or intestines.
This can lead to low drug levels that are less effective or high levels that can cause worse side-effects.
People taking other medicines or natural remedies should consult with their doctor before starting treatment with Velpanat.
Notice: Sofosbuvir and velpatasvir can interact with some TB medications, psychiatric drugs, cholesterol-lowering drugs, proton pump inhibitors, the heart medication amiodarone and herbal products containing St John’s wort.
Velpanat can raise levels of the HIV drug tenofovir (Viread, also in several antiretroviral co-formulations), so people taking these drugs together should have their kidney function checked regularly.
Velpanat has been approved by the FDA to treat people with chronic hepatitis C genotypes 1 through 6. Velpanat is generic Epclusa and the license to manufacture this in India was approved by the FDA in 2016.
It is now available globally to treat people with hepatitis C genotypes 1 or 4, and in some cases genotype 3.
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When to start treatment will depend on a number of factors, including severity of liver damage (as determined by FibroScan or a liver biopsy).
Ask your GP or liver specialist if this hepatitis C treatment may be a good option for you, and if it is available in your country.
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