"The first trial is designed to provide clinical data on the use of VICTRELIS (boceprevir), an oral HCV NS3/4A protease inhibitor, in combination with mericitabine (RO5024048), Roche's investigational oral HCV NS5B nucleoside polymerase inhibitor, Pegasys® (pegylated interferon alfa-2a) and Copegus® (ribavirin), in adult patients with chronic HCV genotype 1 infection who had a null response to prior peginterferon alfa and ribavirin therapy (less than a 2 log HCV-RNA decline at treatment week 12). The Phase II study, called DYNAMO 1, plans to recruit patients at 25 sites globally."
Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection
WHITEHOUSE STATION, N.J., Dec. 15, 2011 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Merck, in collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY), has initiated the first of a series of planned clinical trials to examine novel combinations of marketed and investigational medicines to expedite the availability of potential new treatment regimens for patients with chronic hepatitis C virus (HCV) genotype 1 infection. Clinical development collaboration is part of the overarching strategic agreement between Merck and Roche to improve treatment, diagnosis and awareness of chronic HCV in developed and emerging markets.
"VICTRELIS is the first in a new class of medicines for the treatment of chronic HCV genotype 1 infection, and when used in combination with peginterferon alfa, can significantly increase a patient's chance of achieving undetectable levels of the virus," said Eliav Barr, M.D., vice president, Infectious Diseases Project Leadership and Management, Merck Research Laboratories. "The start of this new study is an important milestone in our collaboration with Roche as we work to build on the innovative platform VICTRELIS provides by evaluating it in combination therapy with new investigational medicines for the treatment of chronic HCV genotype 1 infection, and also emphasizes our ongoing commitment to seeking novel treatment options for patients with chronic HCV."
The first trial is designed to provide clinical data on the use of VICTRELISTM (boceprevir), an oral HCV NS3/4A protease inhibitor, in combination with mericitabine (RO5024048), Roche's investigational oral HCV NS5B nucleoside polymerase inhibitor, Pegasys® (pegylated interferon alfa-2a) and Copegus® (ribavirin), in adult patients with chronic HCV genotype 1 infection who had a null response to prior peginterferon alfa and ribavirin therapy (less than a 2 log HCV-RNA decline at treatment week 12). The Phase II study, called DYNAMO 1, plans to recruit patients at 25 sites globally.
For further details of the clinical trial please visit http://www.clinicaltrials.gov/ , or contact (888) 662-6728 (U.S. only) or Genentechclinicaltrials@drug info.com .
Indications and usage for VICTRELIS
VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011 for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (P/R), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:
VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log viral load decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
Important safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and neutropenia have been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations compared to peginterferon alfa and ribavirin alone and/or may result in worsening of neutropenia associated with peginterferon alfa and ribavirin therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
Complete blood counts (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previous treatment-failure patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis care.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.
For more information, visit http://www.merck.com/ and connect with us on Twitter, Facebook and YouTube.
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site
Merck and Roche have started clinical trials to investigate combinations of their hepatitis C drugs.
The first trial is designed to test Merck’s new oral hepatitis C drug Victrelis, in combination with Roche’s established treatments Pegasys and Copegus, alongside its investigational oral treatment HCV NS5B.
The four drugs will aim to treat adult patients with chronic HCV genotype 1 infection who had a poor response to treatment with Pegasys and Copegus. Roche’s HCV NS5B is a nucleoside polymerase inhibitor, and has a similar mechanism of action to Victrelis.
The Phase II study, called DYNAMO 1, plans to recruit patients at 25 sites across the globe. Eliav Barr, vice president of infectious diseases at Merck, said: “Victrelis is the first in a new class of medicines for the treatment of chronic HCV genotype 1 infection, and when used in combination with peginterferon alfa, can significantly increase a patient's chance of achieving undetectable levels of the virus.
“The start of this new study is an important milestone in our collaboration with Roche as we work to build on the innovative platform Victrelis provides, by evaluating it in combination therapy with new investigational medicines for the treatment of chronic HCV genotype 1 infection, and also emphasises our ongoing commitment to seeking novel treatment options for patients with chronic HCV.”
This forms part of a co-promotion deal signed between the two firms in May this year.As well as conducting clinical trials to assess the efficacy of combination therapies, the pair said they were also looking to raise awareness of the disease in emerging markets. The current US licence for Victrelis stipulates that it must be used in combination with Pegasys and Copegus.
There have currently been no trials to show how well the drug works in combination with other oral polymerase inhibitors, such as Roche’s HCV NS5B.Ben Adams
Stay Updated: Get Updates For HCV New Drugs Delivered By Email
HCV In The News
Hepatitis C New Drug Research And Liver Health
RSS Feed: Website Updates
Sovaldi (Sofosbuvir) Is Now FDA Approved
Hepatitis C- Gilead's Sovaldi (Sofosbuvir) Is Now FDA Approved
Gilead’s Sovaldi™ (Sofosbuvir)
U.S. Patient Assistance Program Gilead is committed to ensuring that people with hepatitis C can access Sovaldi and has launched Support Path™ (www.MySupportPath.com) to provide assistance to patients who are uninsured, underinsured or who need financial assistance to pay for the medicine
Gilead said Friday it would price the drug at $84,000 for one 12-week supply. Patients with a less common subtype of the disease may need to take the drug for 24 weeks, raising the cost to $168,000 for one course of treatment. Drugs already on the market run between $25,000 and $50,000 for a course of treatment.
U.S. Patient Assistance Program
Gilead is committed to ensuring that people with hepatitis C can access Sovaldi and has launched Support Path™ (www.MySupportPath.com) to provide assistance to patients who are uninsured, underinsured or who need financial assistance to pay for the medicine. - See more at: http://hepatitiscnewdrugresearch.com/index.html#sthash.xblNW8ba.dpuf
Sofosbuvir for Hepatitis C: Simpler, Shorter, Safer?
Prescribing and patient information, FDA articles, videos and important updates
Simeprevir Approved In The United States
OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C
Johnson & Johnson's protease inhibitor OLYSIO (Simeprevir) is approved for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
Simeprevir was approved in Japan this past September , and in Canada on November 20th.
*Updated December 5
HCV Drug Olysio (simeprevir) - The New Kid On The Block
OLYSIO (Simeprevir) Cost? - Janssen has priced Olysio at a wholesale acquisition price of $22,120 per bottle of 28 capsules (150 mg capsules), which is an approximately one-month supply. That's roughly $66,360 for a three-month course.
Lessons Learned - An important lesson we learned from these drugs may serve as a reminder for future DDAs, that is, once telaprevir and boceprevir were used in larger groups of patients, or in "real-life" settings - outside clinical trials, new response rates and adverse effects began to emerge.
Simeprevir drug–drug interactions - Simeprevir has a list of medications that can cause drug–drug interactions Other medications can interfere with the way DDAs are metabolized. The drug–drug interactions can either increase drug concentrations which may cause toxicity and lead to side effects, or decrease drug concentrations leading to a loss of efficacy.
Off Label Use - Simeprevir and Sofosbuvir? - Paul Sax, Editor-in-Chief at NEJM Journal Watch wrote an article this past summer on the possibility of combining simeprevir and sofosbuvir with or without ribavirin, to create an off label interferon-free regimen....
J & J Patient Financial Assistance Program
Important Safety Information
OLYSIO (simeprevir) - Resistant Variant Q80K polymorphism
Olysio-simeprevir/Dosing & Uses, Drug Interactions, Adverse Effects
On November 22nd the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), supported Sovaldi® (sofosbuvir) for the Treatment of Chronic Hepatitis C
The CHMP opinion supports the approval of Sovaldi for the treatment of HCV in combination with other agents. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union (EU).
For detailed information please download the FDA review package for sofosbuvir and simeprevir.
FDA Updates For Sofosbuvir
FDA Updates For Simeprevir
Quick Links - Hepatitis C Investigational Drugs
News, Research And Clinical Trials
See **Clinical Trials @ HCV Advocate For Enrollment Information
AbbVie is a new, independent biopharmaceutical company composed of Abbott’s former proprietary
News and Research
ABT-450/r - ABT-267 - ABT-333-non- nucleoside
r = ritonavir
**Clinical Trials @ HCV Advocate-AbbVie
News and Research
**Clinical Trials @ HCV Advocate-Achillion
News and Research
Faldaprevir/ (BI 201335)
**Clinical Trials @ HCV Advocate-Boehringer Ingelheim
News and Research
GS-7977 now Sofosbuvir/BMS-790052 now Daclatasvir,
**Clinical Trials @ HCV Advocate-Bristol-Myers Squibb (BMS)
News and Research
GS-0938 and Sofosbuvir
**Clinical Trials @ HCV Advocate-Gilead
News and Research
**Clinical Trials @ HCV Advocate-Idenix
News and Research
**Clinical Trials @ HCV Advocate-Tibotec / Janssen
News and Research
**Clinical Trials @ HCV Advocate-Merck
News and Research
**ClinicalTrials.gov - Danoprevir
News and Research
**ClinicalTrials.gov - Miravirsen
News and Research
**Clinical Trials @ HCV Advocate-Vertex
To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
ClinicalTrials.gov: updated in the last 30 days
- ► 2013 (922)
- ► 2012 (1293)
- Hepatitis C - Looking Ahead to 2012
- Metformin Hikes B12 Deficiency in Type 2 Diabetes
- HCV News Ticker-Cirrhosis Tied to Increased Risk o...
- Bavituximab-Peregrine Provides Update on hepatitis...
- Optimization of Comorbidity Therapy to Achieve Sus...
- Recent Trends of Japanese Hepatocellular Carcinoma...
- Tailor-Made Therapy for Viral Hepatitis
- Hospital sued for improper sterilization of equipm...
- Tattoos and Piercings: A Review for the Emergency ...
- Natural Variation in Drug Susceptibility to HCV Po...
- Management of Hepatitis C Infection
- Hepatitis C News Ticker-Following response-guided ...
- Merry Christmas
- Bristol-Myers: Liver cancer drug failed in study
- Incivek and Victrelis Usage as Part of Triple Ther...
- CDC Reports-Transmission of Hepatitis C Virus Thro...
- Hepatitis News Ticker-FDA Okays Raltegravir for Ki...
- Scientists identify an innate function of vitamin ...
- The Role of Pre-Existing Diabetes Mellitus on Hepa...
- Hepatitis C News Ticker-Implications of rapid viro...
- The King is Dead, Long Live the King: Entering A N...
- Hepatitis C News Ticker-Intravenous silibinin as '...
- Excess liver-related morbidity of chronic hepatiti...
- Hepatitis-related Renal Disease
- Entry completed for BI 201335 plus pegIFN/RBV Phas...
- SUGAR BABIES -Compelling documentary that examines...
- HCV News Ticker; Risk factors for hepatocellular c...
- New HCV Clinical Trial To Evaluate Merck’s-VICTREL...
- PSI-7977 plus ribavirin -A 'Newer' Era of HCV Ther...
- Experimental Hepatitis C Drug PSI-938 Halted In Cl...
- Watch-The Coming of Age of Direct Anti-Viral Agent...
- Hepatitis C-Impact of age > 65 years on svr and ...
- HCV News Ticker-Hepatitis C Treatment - Clearing T...
- Irreversible Anterior Ischemic Optic Neuropathy Co...
- IV User-Worried About HCV ? Check This Out
- Hepatitis News Ticker- Telaprevir and Boceprevir
- Coffee and health: What does the research say?
- Market Update-The Quest For The Ideal Hepatitis C ...
- Australia-Hep C expertise now just a call away
- 'Pep talk' can revive immune cells exhausted by ch...
- Novel Interferon-Free Hepatitis C Regimen Promisin...
- Audio-Interferon-Free Regimens for Hepatitis C: Ar...
- Advanced Liver Disease: What Every Hepatitis C Vir...
- Conventional LFTs May Miss Fibrosis in Type 2 Diab...
- Hepatitis C- Rare case of pegylated IFN-α induced ...
- Dec 2011-Improving the Recognition and Diagnosis o...
- Weekend Reading-Hepatitis C Newsletters, Blogs and...
- Patient Advocate Foundation Announces $9.3 Million...
- Fever-Oral Temperature Changes After Initial Pegin...
- "Liverscore" is predictive of both liver fibrosis ...
- Researchers identify a novel therapeutic approach ...
- Boceprevir: Indication of added benefit for specif...
- Initiation of ALS-2200/ALS-2158 in clinical studie...
- BI 201335-Boehringer announced final patient entry...
- Transesophageal Echocardiogram Appears Safe in Pat...
- Hepatitis News Ticker-New HCV drugs trigger race f...
- The Risk - Contracting Hepatitis C In A Nonhospita...
- Risk Factors for HCV Infections Among Young Adults...
- HCV Infection May Predict Coronary Artery Disease
- Dendreon to sell royalty in Merck hepatitis C drug...
- Telaprevir Effective in Hard-to-Treat Cirrhotic HC...
- Hepatitis News Ticker-Boceprevir Case Study
- Off Topic-Documentary film about a single day on E...
- Poor Liver Transplant Outcomes for HIV/HCV Coinfec...
- Study-Low vitamin D levels may contribute to devel...
- Hepatitis C- ACH-2928: Preliminary Phase 1b Proof-...
- Hepatitis C Virus Vertical Transmission and the Ca...
- Prediction of Effect of Pegylated Interferon Alpha...
- Progress in the hunt for hepatitis C cure
- 2 Studies- Limitations in screening for primary li...
- New stem cell method makes lots of liver, pancreas...
- Cost Effectiveness of Fibrosis Assessment Prior to...
- TMC435 phase II combination study with daclatasvir...
- Unlicensed Clinic Investigated for Hepatitis C Out...
- HCV News Ticker-Hepatitis C Treatment Without Inte...
- ▼ December 2011 (75)
Patient Assistance Program
INCIVEK/Telaprevir and VICTRELIS (Boceprevir) Patient Assistance Programs
Prescribing Information for INCIVEK including the Medication Guide.
VICTRELIS™- Boceprevir: Prescribing Information and Medication Guide
Hepatitis C-New Protease Inhibitor (NS3/4A) Drug Resistance Test
LabCorp has begun offering nationwide its hepatitis C GenoSure NS3/4A assay, which is designed to identify NS3 and NS4A mutations and NS3-associated resistance to a pair of recently approved HCV protease inhibitors.
- (Sofosbuvir) now Sovaldi (1)
- 2012 -168 Pages Of HCV FAQs (1)
- a 2013 Conference ID Week (3)
- A 2013 Conference on Retroviruses and Opportunistic Infections (4)
- A Guide 2011-Management Of HCV (2)
- A Guide 2012-Guideline for Nonalcoholic Fatty Liver Disease (1)
- A-2012 EASL-AASLD Special Conference (2)
- A-2012 Update on the Diagnosis and Treatment of Hepatitis C (1)
- A-2012-New guidelines on the management of hepatocellular carcinoma (HCC). (1)
- A-Current status and future directions in the management of chronic hepatitis C (1)
- a-DDW 2011 Meeting (11)
- a-DDW 2012 meeting (21)
- a-DDW 2013 meeting (23)
- A-EASL 2011 Summary (1)
- A-EASL 2012 (79)
- A-EASL 2012 - Guidelines on the Management of Chronic Hepatitis B (1)
- A-EASL 2012 Index (1)
- A-EASL 2012 Internet Symposium (2)
- A-EASL 2012 Summary Of The Meeting (1)
- a-EASL 2013 (51)
- A-EASL 2013 Summary Of The Meeting (1)
- a-EASL 2013-abstract search (1)
- A-List Of Unnecessary Medical Tests (1)
- A-New targets for antiviral therapy (100)
- AASLD 2011 updated hepatitis C practice guidelines (2)
- AASLD 2012-63rd Annual Meeting (73)
- AASLD 2012-STC (1)
- AASLD 2013 (46)
- AASLD 2013 Summary-Symposium (2)
- AASLD Nov 2011 (60)
- AASLD Nov 2011-Pocasts-Videos-Webcasts (2)
- AASLD Nov 2011-Summary (1)
- AASLD Oct2010 (80)
- AASLD Oct2010-summary (1)
- ABT-267 (13)
- ABT-333-non- nucleoside (13)
- ABT-450 (11)
- ABT-450/r (25)
- ABT-450/r and ABT-072 (4)
- ABT-450/r plus ABT-333 (10)
- ABT-450/R/ ABT-267/ABT-333/ribavirin (5)
- Acetaminophen Safety (9)
- ACH-1625 (15)
- ACH-2684 (5)
- ACH-2928 (2)
- ACH-3102 (9)
- acute HCV (4)
- addiction (21)
- Adherence to therapy (13)
- alcohol consumption (17)
- alisporivir (4)
- ALS-2200 (3)
- ALS-2200 (VX-135) (13)
- ALS-2200 and ALS-2158 (3)
- ALS2158 (1)
- ANA598 (5)
- ANA598-setrobuvir (2)
- ANA773 (1)
- ANA958 (1)
- anemia (9)
- antidepressants (5)
- arthritis (5)
- ascites (9)
- Asunaprevir (4)
- autoimmune hepatitis (1)
- Avila Therapeutics™ (1)
- AVL-192 (2)
- bath salts-spice (14)
- Bavituximab (5)
- BCX5191 (2)
- Behind the Headlines (10)
- Behind the Headlines-Vaccine (1)
- Best Hospitals (5)
- BI 201335 and BI 207127 (10)
- BI 207127 (7)
- BILB 1941 (1)
- Bioartificial Liver (3)
- biological "devices" to program cells (1)
- Biopump (1)
- BioScience (2)
- biosimilars (6)
- BIT225 (2)
- BL-8020 (2)
- blood safety (3)
- blood scandal (3)
- bms-650032 (6)
- BMS-650032 (Asunaprevir) BMS-790052 (Daclatasvir) (10)
- BMS-650032 and BMS-790052 (5)
- bms-790052 (18)
- bms-790052-declatasvir (10)
- BMS-986094-INX 189 halted (8)
- BMS-986094-INX 189 on hold (7)
- boceprevir (98)
- Boceprevir FDA Transcript (1)
- boceprevir patient guide (1)
- boceprevir-drug assistance program (3)
- boceprevir-Medication Guide-Prescribing Info (1)
- boceprevir-victrelis (194)
- boceprevir-victrelis-Cost (1)
- boceprevir-victrelis-mericitabine w-SOC (1)
- Bowel (1)
- Brain (7)
- Caleco Pharma (1)
- Canada (3)
- cancer (15)
- cancerous growths gallbladder and/or the bile duct (1)
- CDC (5)
- CDC- World Hepatitis Day 2011 (1)
- CDC- World Hepatitis Day 2012 (4)
- CDC- World Hepatitis Day 2013 (2)
- children treating HCV (15)
- chronic disease (2)
- chronic fatigue (16)
- chronic liver failure (2)
- chronic pain (3)
- cirrhosis (190)
- cirrhosis-complications (13)
- cirrhosis-Vibrio vulnificus-raw oysters (2)
- clinical trials (128)
- clinical trials-Pro-Con (4)
- coffee (31)
- Colloidal silver (2)
- colonoscopy (2)
- compensated cirrhosis (11)
- Complementary and Alternative Medicine (30)
- Counterfeit drugs (8)
- covalent inhibitor (2)
- Creating Functional Hepatic Tissue (1)
- Cryoglobulinemia (5)
- CTS-1027 (5)
- Cyclophilin Inhibitors (1)
- Daclatasvir (9)
- daclatasvir-peg/riba (4)
- Daclatasvir/Asunaprevir (7)
- daclatasvir/asunaprevir/BMS-791325 (5)
- Daily Consensus Interferon (1)
- Danoprevir (17)
- Danoprevir/Mericitabine (3)
- DEB025 (2)
- DEB025- alisporivir (4)
- decompensated cirrhosis (18)
- Dental (4)
- Depression (17)
- diabetes (106)
- diabetes-insulin resistance (8)
- Digestion (2)
- Direct-acting Antivirals (11)
- disease progression (13)
- donation (16)
- drug alerts (1)
- Drug Assistance Programs (5)
- Drug Resistance Test (1)
- drug shortages (1)
- dry eye (3)
- dyspepsia (1)
- EASL (59)
- Economic Burden HCV (2)
- ELAD® Bioartificial Liver (1)
- encephalopathy (28)
- endoscopy (1)
- Epidemic HCV (10)
- Epogen (4)
- ESLD (1)
- faldaprevir (20)
- faldaprevir w-PPI-668/deleobuvir(BI207127) (3)
- faldaprevir/ (BI 201335) (24)
- faldaprevir/BI 207127 (2)
- faldaprevir/DELEOBUVIR (4)
- fatigue (8)
- Fatigue-Cognitive Function-Sleep Quality (3)
- Fatty Liver (126)
- Fatty Liver-RP103 (1)
- FDA (83)
- fibromyalgia (9)
- Fluvastatin (3)
- Foodborne illness (18)
- G7128 (1)
- gallbladder (1)
- gallstones (10)
- gastritis (1)
- Gastroenterologist (2)
- geno1 (104)
- geno2 (57)
- geno3 (65)
- geno4 (32)
- geno5 (6)
- geno6 (11)
- genotype test (1)
- genotypes;All (14)
- green tea (2)
- GS-0938 and Sofosbuvir (1)
- GS-5885 (4)
- GS-7977 now Sofosbuvir (124)
- GS-7977 now Sofosbuvir and simeprevir (TMC435) (8)
- GS-7977 now sofosbuvir / GS-5885 now ledipasvir (20)
- GS-7977 now Sofosbuvir off label use (1)
- GS-7977 now Sofosbuvir Plus Riba (3)
- GS-7977 now Sofosbuvir-FDA Review (11)
- GS-7977 now Sofosbuvir/BMS-790052 now Daclatasvir (11)
- GS-7977 Plus Peg/Riba (3)
- GS-9190 (7)
- GS-9256 (6)
- GS-9451 (2)
- GSK2336805 (4)
- Gut Bacteria (1)
- H pylori (1)
- HALL OF SHAME (44)
- HALT-C (8)
- hav (8)
- hav vaccine (2)
- hbv (113)
- hbv vaccine (4)
- HCV Australia (7)
- hcv abstracts (236)
- HCV agents/drug interactions (1)
- HCV Awareness (84)
- HCV Awareness-screening strategies (36)
- HCV Baby Boomers (41)
- HCV cardiovascular disease (1)
- HCV diet (8)
- HCV Forum (1)
- HCV generics (1)
- HCV hypertension (1)
- HCV natural compounds (1)
- HCV neurocognitive function (1)
- HCV News (1705)
- HCV News-monthly rewind (1)
- HCV News-weekly rewind (20)
- HCV pregnancy (9)
- HCV Protease Inhibitors in Active Drug Users (1)
- HCV replication (3)
- HCV research (97)
- HCV Self-management (1)
- HCV symptoms (3)
- HCV tests (25)
- HCV tests-endoscope (1)
- HCV transmission FAQ (1)
- HCV Vaccine (26)
- HCV vaccine GI-5005 (7)
- HCV Vaccine-TG4040 (MVA-HCV) (2)
- HCV Worldwide (35)
- HCV Worldwide Asia Australia Egypt (2)
- HCV Worldwide-Egypt (1)
- HCV Worldwide-Europe Canada Israel (1)
- HCV Your Health (3)
- HCV-autoimmune diseases (1)
- HCV-Breast Cancer (1)
- HCV-Breast Cancer Risk (1)
- HCV-Editorial (12)
- HCV-Education (76)
- HCV-elderly (5)
- HCV-Insulin resistance (13)
- HCV-Statins (8)
- HCV-TARGET (1)
- HCV/HBV/HIV special populations (1)
- Health Reform (3)
- Health Reform-Insurance (4)
- Healthy you (47)
- hemochromatosis (1)
- HepaFat™ (1)
- Hepatitis-related Renal Disease (1)
- hepatocyte cell transplantation (1)
- hepatologist (2)
- hepatoSys Virtual Liver Network (1)
- herb (36)
- herb-kava (2)
- HEV (4)
- History of HCV (4)
- HIV (120)
- HIV-children (3)
- hiv/hbv-coinfection (1)
- HIV/HCV (80)
- hot topic (9)
- HTAs-host-targeting agents (1)
- human genome (6)
- human interferon alpha lozenges (2)
- Idenix Reports Positive Interim Data for Hepatitis C Drug (1)
- IDX184 (21)
- IDX184-Discontinued (1)
- IDX19368-Discontinued (1)
- IDX19368-hold (2)
- IDX20963/FDA Request More Data (2)
- IDX719 (9)
- if I had.. (9)
- IFNL 4 (1)
- IL-7(CYT 107) (1)
- IL28B (64)
- IL28B Test (2)
- immune system (10)
- IMO-2125 (6)
- Inflammation (3)
- Inflammation Liver (2)
- Inflammatory Bowel Disease (1)
- INFRADURE Biopump (1)
- Inspirational (28)
- Insurance (1)
- Insurance medicare (1)
- interferon (5)
- Interferon Free Combinations (151)
- Interferon lambdas (1)
- Investment News HCV Drugs (22)
- INX 189 (13)
- IP-10 (1)
- ITX-5061 (1)
- IV drug use (1)
- Joint pain (1)
- Just for fun (5)
- JX594/TG6006 (2)
- Lambda (7)
- ledipasvir (GS-5885) (5)
- Lichen Planus (5)
- List Peer-Reviewed Journals (2)
- Liver Abscess (2)
- liver biopsy (14)
- liver biopsy-necessary in all genotypes? (1)
- liver cancer (260)
- Liver cancer CF102 (2)
- Liver Cancer Treatment (77)
- liver cancer treatment-radiofrequency ablation (RFA) (2)
- Liver Cancer-HEAT Study of ThermoDox(R) (3)
- liver cancer-MCT-465 and MCT-485 (1)
- liver cancer/sorafenib (4)
- Liver Cysts (1)
- liver disease (26)
- Liver Fibrosis (114)
- liver function tests (13)
- liver health (82)
- Liver Injury Dietary Supplements (11)
- Liver Injury-Shark liver oil (1)
- Liver Pain (6)
- liver surgery (3)
- liver/anatomy (1)
- Locteron/interferon (3)
- lymphoma (3)
- M11-602 (1)
- marijuana (30)
- marijuana-based prescription drug (1)
- MBX-700 and MBX-701 (formerly SCH 900942 and SCH 900188) (1)
- Mediterranean diet (2)
- Men and HCV (4)
- microspheres (3)
- Milk thistle (24)
- Miracle Mineral Solution-MMS (1)
- Miravirsen (9)
- miRNAs (1)
- MK-5172 (15)
- MK-5172/peg/riba (1)
- MK-5172/Vaniprevir(MK-7009) (1)
- MK-7009 (4)
- MK-8742 (4)
- monoclonal antibody GS-6624 (1)
- Morbidity-SVR (7)
- Mortality (16)
- nanoparticles (3)
- Nanotechnology (3)
- Natural leukocyte interferon alpha (Alfaferone) (1)
- Neutropenia HCV Treatment (5)
- new drugs (5)
- new hcv drugs (55)
- newly diagnosed (10)
- newsletters (53)
- Nitazoxanide (2)
- noni juice (1)
- noninvasive tests for fibrosis (42)
- nonresponders (9)
- NS5A inhibitor (2)
- NSAID (7)
- nucleoside inhibitors (1)
- null responders (10)
- occult hepatitis C virus infection (1)
- Off Topic (34)
- online pharmacy (1)
- Oral interferon (1)
- organ harvesting (11)
- organ trafficking (5)
- organ trafficking- U.S (1)
- organ-imported tainted tissue (1)
- Origin Of Hepatitis (2)
- Other Conditions Related To HCV (51)
- Other Conditions Related To HCV-Vasculitis (5)
- Other Health News (121)
- OTHER INFECTIOUS DISEASE (20)
- outsourcing clinical trials (3)
- outsourcing drugs (7)
- partial responders (3)
- Pediatric liver disease (3)
- Pegasys (10)
- Peginterferon (77)
- PegIntron (4)
- Peripheral Neuropathy (2)
- PF-05095808 (1)
- Pharmaceuticals (146)
- Pink eye-Sty-and other eye conditions (1)
- platelets (4)
- polymerase inhibitor (16)
- Porphyria Cutanea Tarda (PCT) (2)
- Post Treatment Symptoms (1)
- PPI-383 (1)
- PPI-461 (3)
- PPI-668 (3)
- primary biliary cirrhosis (PBS) (1)
- probiotics (2)
- procrit (4)
- prognostic test:response to therapy (1)
- promacta (1)
- prostate cancer (1)
- protease inhibitor (33)
- protease inhibitor- (NS3/4A) Drug Resistance Test (2)
- PSI-7977 (24)
- PSI-7977 and PSI-938 (1)
- PSI-7977-TMC435 (3)
- PSI-7977/ Daclatasvir-(BMS-790052) (1)
- PSI-938 (6)
- PSI-938-Halted (1)
- Pulmonary fibrosis (1)
- Q80K polymorphism (1)
- Quackery (10)
- Questions About HCV (4)
- rash (10)
- recall (25)
- regeneration (6)
- regenerative Medicine (17)
- relapse (8)
- resistance to protease inhibitors (17)
- response-guided therapy (4)
- RG7128 (9)
- ribavirin (27)
- Ritonavir (1)
- rituximab (2)
- salt (5)
- SB 9200 (1)
- scientists grow human livers in laboratory (7)
- SCY-635 (5)
- SCY-641 (1)
- Seasonal Flu Vaccine (10)
- selenium (2)
- setrobuvir (1)
- side effects (71)
- side effects-direct-acting antivirals (19)
- side effects-eyes (8)
- side effects-telaprevir (4)
- silibinin (4)
- silymarin (4)
- Simeprevir (42)
- Simeprevir now Olysio (11)
- Simeprevir now Olysio FDA Approved (5)
- Simeprevir off label use (1)
- Simeprevir/Samatasvir (IDX719) (1)
- Simeprevir/TMC647055/ Samatasvir (IDX719 (1)
- SIR-Spheres microspheres (3)
- Small fiber neuropathy (2)
- sofosbuvir and ABT-450 (1)
- Sorafenib (6)
- sovaprevir (6)
- Sovaprevir (Formerly ACH-1625) (7)
- Sovaprevir/ACH-3102 (2)
- sphincter of Oddi (3)
- spleen (6)
- SPONTANEOUS CLEARANCE (13)
- Standardization of Terminology of Virological Response (1)
- Starting HCV Treatment (75)
- STAT-C (3)
- stem cell lawsuit (2)
- stem cell tourism (7)
- stem cell-diabetes (1)
- stem cells (82)
- stem cells-pluripotent (2)
- stem-cell-derived liver tissue model (1)
- stigma (1)
- supplements (22)
- support (48)
- support-hotline (5)
- Surgery in liver disease (3)
- svr (81)
- svr durability (4)
- svr-pitavastatin (Livalo) (1)
- svr-rapid response (1)
- SVR24-SVR12-SVR4 (9)
- Tattoos (2)
- telaprevir (125)
- Telaprevir FDA Transcript (1)
- telaprevir medication guide (1)
- telaprevir patient assistance (3)
- telaprevir prescribing information (1)
- telaprevir with VX-222 (20)
- telaprevir-incivek (235)
- telaprevir-incivek-Cost (3)
- Tenofovir (2)
- Terry's nails (1)
- TG4040 (2)
- Thalidomide (1)
- The natural history of hepatitis C (3)
- TheraSphere (2)
- Thrombocytopenia (4)
- Thrombocytopenia-Promacta (1)
- thrombosis (3)
- thyroid (11)
- Timeline Hepatiits (1)
- Timeline Hepatitis (1)
- TMC435 (26)
- TMC435 (Simeprevir) (36)
- TMC435-BMS-790052 (3)
- TMC647055 (3)
- TMC647055 and IDX719 (1)
- TMC649128 (4)
- toxicity (28)
- transmission (72)
- Transmission clinical setting (93)
- Transmission clinical setting-Government Report 2012 (1)
- Transmission of HCV Through Transplanted Organs (2)
- transmission-needlestick (3)
- transplant (182)
- transplant tourism (7)
- Transplant- Telaprevir/Boceprevir (3)
- transplant-certican (1)
- Transplant-GS-7977 now Sofosbuvir (1)
- transplant-MELD (8)
- Triad Prep Pads (16)
- TT-034 (1)
- tylenol (17)
- upper abdominal pain (2)
- varices (14)
- video (269)
- viral load (11)
- Virtual Liver (1)
- virus research (3)
- vitamin A (6)
- vitamin B12 (3)
- vitamin D (40)
- vitamin E (7)
- Vitamin E-TE/TCP supplements (1)
- vitamin k (1)
- vitamins (11)
- weekend reading (53)
- wellness (52)
- women (13)
- Xifaxan (1)
- XIX International AIDS Conference (4)
- zalbin (1)
- zinc (2)
Click here to order a FREE Home Access Hepatitis C Test Kit
How Soon Should I Get Tested After Exposure ?
After the exposure (especially if the blood exposure involved another person known to have the hepatitis C virus), it is recommended that testing for the hepatitis C antibody be performed at 4 to 6 months after the exposure OR that testing for the hepatitis C virus itself (a test often called an HCV PCR or hepatitis C viral load test) be performed 4 to 6 weeks after the potential exposure. These tests are done to determine whether or not hepatitis C infection has occurred as a result of the exposure.;
FAIR USE NOTICE:
If this site contains copyrighted material the use of which has not been specifically authorized by the copyright owner, it is being made available in an effort to advance the understanding of the ethics dealing with medical practice, medical care, new drug research, drug trials, science and scientific research, human rights, social justice and, in addition, the law and politics which cover these areas. It is believed that this use constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed to visitors of this “HCV New Drugs Blog” without profit to the blog or to those who by visiting this blog have expressed interest in receiving the included information for research and educational purposes. The material in this site is provided for educational and informational purposes only, and is not intended to be a substitute for a health care provider's consultation. Please consult your own appropriate health care provider about the applicability of any opinions or recommendations with respect to your own symptoms or medical conditions. The information on this site does not constitute legal or technical advice
- New HCV Drugs
- Keeping current on the potential arrival of new improved hepatitis C drugs. As once a hepatitis C patient myself (I successfully treated the virus with standard HCV therapy in 2000) I understand the difficult decisions and overwhelming fear that ensues after being diagnosed with this serious and life-changing disease. This blog serves as a starting point for information on the rapidly evolving number of new agents in development to treat hepatitis C. Tina