HIV/HCV coinfected people who take sofosbuvir/ledipasvir (Harvoni) to treat hepatitis C along with boosted protease inhibitor antiretroviral regimens may experience changes in drugs levels, but these are mostly not considered clinically relevant, according to a drug-drug interaction study presented at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) last month in Seattle. However, data on the safety and efficacy of combining sofosbuvir/ledipasvir with boosted protease inhibitors during treatment are lacking, and increased tenofovir exposure may be a concern.
The advent of interferon-free direct-acting antiviral regimens has brought about a revolution in treatment for chronic hepatitis C virus (HCV) infection, including for patients who have traditionally been considered 'difficult to treat', such as those with HIV/HCV coinfection. Clinical trials have seen cure rates for coinfected people equal to those for patients with HCV alone, and current treatment guidelines and product labels indicate that HIV-positive patients can be treated with the same recommended regimens as HIV-negative ones, taking into account potential interactions with antiretroviral therapy (ART).
Polina German of Gilead Sciences reported findings from a phase 1 study to evaluate interactions between sofosbuvir/ledipasvir and ART regimens containing ritonavir-boosted atazanavir (Reyataz) or darunavir (Prezista) plus tenofovir/emtricitabine (Truvada) in healthy HIV-negative volunteers.
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Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.
For more information on how to use this blog, the HCV drug pipeline, and for more information on HCV clinical trials click here
Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.
Alan Franciscus
Editor-in-Chief
HCV Advocate
Tuesday, March 10, 2015
Monday, March 9, 2015
Nepal: Natco Pharma up 4%, launches hepatitis C drug in Nepal
Shares of Natco Pharma gained 4.4 percent intraday on Monday on launching the first generic version of sofosbuvir in Nepal.
Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences Inc., under its brand Sovaldi.
Natco priced its generic medicine at an MRP of Rs 19,900 for a bottle of 28 tablets in Nepal. "Natco markets generic sofosbuvir under its brand HEPCINAT. Natco hopes to launch HEPCINAT in India soon, subject to approval from the Drugs Controller General of India (DCGI)," said the company in its filing to the exchange.
Read more at: http://www.moneycontrol.com/news/buzzing-stocks/natco-pharma4-launches-hepatitis-c-drugnepal_1323547.html?utm_source=ref_article
Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences Inc., under its brand Sovaldi.
Natco priced its generic medicine at an MRP of Rs 19,900 for a bottle of 28 tablets in Nepal. "Natco markets generic sofosbuvir under its brand HEPCINAT. Natco hopes to launch HEPCINAT in India soon, subject to approval from the Drugs Controller General of India (DCGI)," said the company in its filing to the exchange.
Read more at: http://www.moneycontrol.com/news/buzzing-stocks/natco-pharma4-launches-hepatitis-c-drugnepal_1323547.html?utm_source=ref_article
Labels:
generic Sovaldi,
HEPCINAT,
Nepal
Scotland: Scots patients first in UK to hepatitis C ‘cure’
HEPATITIS C sufferers in Scotland are the first patients in the UK to be given access to a new treatment that cures up to 99 per cent of cases in eight or 12 weeks.
The Scottish Medicines Consortium (SMC) has accepted for use Harvoni for the treatment of chronic hepatitis C which affects one in every 100 people in Scotland and causes more than 20 per cent of all liver transplants.
Approximately 50,000 people in Scotland are infected with hepatitis C, which can cause liver cancer or liver failure – equivalent to around 1 per cent of the Scottish population.
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The Scottish Medicines Consortium (SMC) has accepted for use Harvoni for the treatment of chronic hepatitis C which affects one in every 100 people in Scotland and causes more than 20 per cent of all liver transplants.
Approximately 50,000 people in Scotland are infected with hepatitis C, which can cause liver cancer or liver failure – equivalent to around 1 per cent of the Scottish population.
Read more...
Weekly Special Topic: Support Group Handbook & Lessons
Support Group Handbook & Lessons
Emotional and informational support are extrmely important for people with hepatitis C. If you are interested in starting or attending a support group in your area, then check out our recently updated Support Group Handbook and Support Group Lessons:
Important Note: HCV Advocate Website Redesign
Due to the rapid changes in the landscape of hepatitis C we will be conducting a major evaluation and reorganization of our website content over the next few months.
This week will be updating and condensing our Women and HCV fact sheets/guides series.
Additionally, we will be moving our older HCV treatment fact sheet series and guides to a new page titled “HCV Advocate Historical Treatments Page.” We will keep you updated as changes are made.
We hope that these changes will make your visit to our Website easier to use and more enjoyable.
Alan
Bangladesh: $10 Copy of Gilead Blockbuster Sovaldi Appears in Bangladesh
(Bloomberg) -- A $10 version of Sovaldi, the Gilead Sciences Inc. hepatitis C treatment that sells for $1,000 a pill in the U.S., is now available in Bangladesh and could make its way to other parts of the world where the U.S. company doesn’t have patents.
Incepta Pharmaceuticals Ltd. doesn’t have a license from Gilead and its version was launched last month, said Managing Director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.
The generic drugmaker has beaten to the market a number of larger Indian competitors that were licensed by Gilead to produce low-cost versions of Sovaldi for 91 countries that are mostly poor. Nations not covered by Gilead’s license, including Thailand, Malaysia and Morocco, and countries where Sovaldi isn’t patented could benefit from the new source of cheap copies.
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Incepta Pharmaceuticals Ltd. doesn’t have a license from Gilead and its version was launched last month, said Managing Director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.
The generic drugmaker has beaten to the market a number of larger Indian competitors that were licensed by Gilead to produce low-cost versions of Sovaldi for 91 countries that are mostly poor. Nations not covered by Gilead’s license, including Thailand, Malaysia and Morocco, and countries where Sovaldi isn’t patented could benefit from the new source of cheap copies.
Read more...
Canada: Drug cure for hep C comes with $95,000 price for Windsor man
Thirty-three years after a van-motorcycle crash put Mike North in hospital for multiple surgeries, he is suffering the devastating health effects from the hepatitis C virus that snuck into his body via blood transfusions.
The virus has attacked his liver, which is now in the most advanced stage of cirrhosis, and he needs a transplant. But before the transplant he must take a recently approved drug that should cure him of hep C, so the virus won’t attack the new liver. Harvoni boasts a cure rate higher than 95 per cent. But there’s a catch: it costs $95,000 for a 12-week treatment, and North has almost no coverage.
“If I don’t get a liver, I’m done,” said North, 62, a former manager at several local automotive plants, who has some savings (including his share of the settlement paid out to victims of Canada’s tainted blood scandal), but only enough to fund his retirement. So his family and medical staff are scrambling to find a way to get him these $1,130 pills as quickly as they can.
Read more...
The virus has attacked his liver, which is now in the most advanced stage of cirrhosis, and he needs a transplant. But before the transplant he must take a recently approved drug that should cure him of hep C, so the virus won’t attack the new liver. Harvoni boasts a cure rate higher than 95 per cent. But there’s a catch: it costs $95,000 for a 12-week treatment, and North has almost no coverage.
“If I don’t get a liver, I’m done,” said North, 62, a former manager at several local automotive plants, who has some savings (including his share of the settlement paid out to victims of Canada’s tainted blood scandal), but only enough to fund his retirement. So his family and medical staff are scrambling to find a way to get him these $1,130 pills as quickly as they can.
Read more...
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