No Hep B reactivation for resolved infection treated with direct-acting antivirals for Hep C

No Hep B reactivation for resolved infection treated with direct-acting antivirals for Hep C

Full Text Article Available Online @ Alimentary Pharmacology & Therapeutics

Following summary published @ GastroHep.com

Published ahead of print, the Alimentary Pharmacology & Therapeutics reports no evidence of hepatitis B virus reactivation in patients with resolved infection treated with direct-acting antivirals for hepatitis C in a large real-world cohort.

Hepatitis B virus (HBV) reactivation has been observed following interferon-based treatment in HBV/hepatitis C virus (HCV) co-infected patients.

Recent reports suggest that reactivation may also occur in both hepatitis B surface antigen (HBsAg)-positive and HBsAg-negative patients during HCV treatment with direct-acting antivirals.

Dr Vermehren and colleagues from Germany investigated the rate of patients with HBV reactivation during interferon-based and interferon-free HCV treatment in a large real-world cohort.

A total of 848 patients with chronic hepatitis C were treated with different combinations of direct-acting antivirals.

Among patients with available outcome and HBV data, there were 272 patients hepatitis B core antibody (HBcAb)-positive, and 536 were HBcAb-negative.

All HBcAb-positive patients were tested for HBV DNA at the end of direct-acting antiviral therapy and alanine transaminase (ALT) levels were frequently measured during therapy and follow-up.

The team found that 73% of HBsAg-negative/HBcAb-positive patients had elevated ALT levels at baseline, which declined to normal values in all but 18 patients, and no HBV reactivation was observed.

There were 8 patients that had detectable but not quantifiable HBV DNA at end of treatment, but none were associated with elevated ALT.

The research team observed that 5 of 9 HBsAg-positive/HBcAb-positive patients experienced transient or permanent HBV reactivation, 3 of whom required nucleotide treatment during or after direct-acting antiviral therapy.

Dr Vermehren's team concludes, "HBV reactivation was not observed in HBsAg-negative/HBcAb-positive patients but common in HBsAg-positive/HBcAb-positive patients treated with different combinations of direct-acting antivirals for HCV."

Aliment Pharmacol Ther 2017: Early view DOI: 10.1111/apt.14177

Kentucky - Syringe exchanges coupled with drug therapy, treatment could virtually eliminate hepatitis C

Syringe exchanges coupled with drug therapy, treatment could virtually eliminate hepatitis C

By Melissa Patrick
Kentucky Health News

Kentucky leads the nation in new infections of hepatitis C, a liver disease now driven mainly by intravenous drug use. It could be virtually eliminated, but that would require a committed strategy to increase syringe exchanges, medication-assisted therapies, and cutting treatment restrictions such as a ban on treating active intravenous drug users.

That was the overarching message to almost 300 people who attended the fourth annual Viral Hepatitis Conference in Lexington July 27. They also heard that Kentucky is working on all three fronts, but not going as far as some experts want when it comes to treating drug users.

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Reining in Drug Prices: Easier Said than Done

Encouraging generics, ditching 'pay for delay,' easing regulations suggested

by Joyce Frieden, News Editor, MedPage Today August 01, 2017

WASHINGTON -- Some of the so-called solutions for reducing the price of prescription drugs are not as easy as they seem, experts said at a panel here hosted by the Alliance for Health Policy.

Ideas such as having the federal government negotiate drug prices or allowing importation of prescription drugs from other countries "sound good, but they're probably not going to work, or get through Congress," former House member Henry Waxman (D-Calif.) said at the event on Friday. "So we need to look at the problem in a more narrow way in order to get bipartisan support."

Steve Miller, MD, chief medical officer of Express Scripts, a pharmacy benefit manager, gave an example of his company's use of paying for value. "We started the price war for hepatitis C drugs; we were able to get the price down to an [incredible] extent," he said (The hepatitis C treatment Solvadi cost close to $100,000 in 2014). "The old treatment for hepatitis C was ribavirin and interferon; that used to be $35,000. We now have the price of the current crop of hepatitis C treatments at $35,000, which is cheaper than they are in Europe."

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The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"  

Direct-acting antivirals successfully treating hepatitis C, says Public Health England

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The Pharmaceutical Journal

Hepatitis C in the UK - 2017 report

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Direct-acting antivirals successfully treating hepatitis C, says Public Health England

A new report suggests early detection of the disease is key as treatment with direct-acting antiviral therapy in the initial stages has the best results.

Public Health England (PHE) is urging the public to get tested for hepatitis C after its latest figures revealed a fall in deaths from the disease, which it attributed to the introduction of direct-acting antiviral (DAA) therapy.

PHE’s annual report, published on 28 July 2017, estimated that around 200,000 people in the UK are unknowingly living with chronic hepatitis C, but it said that “revolutionary treatments” can successfully treat the disease in the vast majority of cases, with the best results in the earlier stages of the disease.

According to the report, Hepatitis C in the UK, people infected with the disease need to be found and treated as quickly as possible to sustain the recent nationwide drop in deaths from the condition.

The majority of cases in the UK are considered to be from marginalised and under-served groups in society, such as people who inject drugs.

Current data from PHE shows an estimated 10% reduction in mortality from hepatitis C-related end-stage liver disease and cancer in 2016, and the introduction of DAA drugs has resulted in a 50% reduction in need for liver transplantation for chronic hepatitis C infection.

Commenting on the report, Duncan Selbie, chief executive of PHE, said: “The recent fall in UK deaths looks likely to be the result of increased treatment with new direct-acting antiviral drugs, with an increase of nearly 50% over the past year, and of nearly 90% when compared with earlier years.
Sustaining increase in treatment

“Our ability to sustain this increase in treatment will ultimately be limited by our capacity to find and treat those who remain undiagnosed, and to help those who are diagnosed but untreated to engage with accessible treatment services.”

Helen Harris, clinical scientist at PHE’s Immunisation, Hepatitis and Blood Safety Department, said: “We strongly encourage anyone who may have been at risk of hepatitis C infection to get tested, whether or not they have any symptoms.

“We are hopeful that the increased access to improved treatments over recent years has contributed to the latest fall in deaths from severe hepatitis C-related liver disease. This, combined with interventions to prevent infection in the first place, can help us to achieve our vision of eliminating hepatitis C as a major public health threat in the UK.”

In June the Hepatitis C Trust criticised the results of a study carried out by the Cochrane Hepato-Biliary Group that cast doubt on the effectiveness of DAA drugs against hepatitis C.

Citation: The Pharmaceutical Journal, PJ July 2017 online, online | DOI: 10.1211/PJ.2017.20203312

http://www.pharmaceutical-journal.com/news-and-analysis/news/direct-acting-antivirals-successfully-treating-hepatitis-c-says-public-health-england/20203312.article

FDA Approves Expanded Labeling for Epclusa® for Hepatitis C in Patients Co-Infected with HIV

U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV

- New Data for First Approved Pan-genotypic Once-Daily Single Tablet Regimen for Chronic Hepatitis C Virus Infection -

FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 1, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa^® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV. Epclusa received regulatory approval for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin, in the United States on June 28, 2016.

Epclusa has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV co-infected patients. See below for important safety information.
"HCV co-infection remains a major cause of morbidity in HIV-infected individuals. With this expanded use, Epclusa provides co-infected patients with a much needed one-pill-a-day regimen that works across all HCV genotypes and is compatible with widely-used antiretroviral regimens," said David Wyles, M.D., Chief, Division of Infectious Disease, Denver Health Medical Center; Associate Professor of Medicine, University of Colorado School of Medicine. "With Epclusa, physicians have an important new treatment option for their HCV/HIV co-infected patients."

The supplemental new drug application (sNDA) was supported by data from the open-label, Phase 3 ASTRAL-5 study, which evaluated 12 weeks of treatment with Epclusa in 106 subjects with genotype 1-4 HCV infection who were co-infected with HIV and on stable antiretroviral therapy. In the study, 95 percent (101/106) of patients achieved the primary endpoint of SVR12, defined as an undetectable viral load 12 weeks after completing therapy.

The safety profile of Epclusa in HCV/HIV co-infected patients was similar to that observed in HCV mono-infected patients. The most common adverse events (in at least 10 percent of subjects) were fatigue (22 percent) and headache (10 percent).

"Epclusa has already helped further simplify HCV treatment among mono-infected patients, and we are pleased that HCV/HIV co-infected patients can benefit from this pan-genotypic single tablet regimen," said John F. Milligan, PhD, Gilead's President and Chief Executive Officer. "This approval advances the commitment we've made to the HCV and HIV communities to deliver innovative new treatments that address their unmet medical needs."

U.S. Patient Support Program
To support these patients and their families, Gilead's U.S. Support Path^® program provides information regarding access and reimbursement coverage options to patients in the United States who need assistance with coverage for their medications, including Epclusa. Support Path conducts benefits investigations and provides patients with information regarding their insurance options.
Further, the Epclusa Co-pay Coupon Program offers co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.
To learn more about Support Path for Epclusa, please visit www.MySupportPath.com or call 1-855-7-MYPATH (1-855-769-7284) between 9:00 a.m. and 8:00 p.m. (Eastern), Monday through Friday.

Global Availability
The prevalence of HCV genotypes varies regionally throughout the world. In resource-limited settings genotype testing can often be costly or unreliable, posing yet another barrier to treatment. As a pan-genotypic therapeutic option, Epclusa may help eliminate the need for genotype testing and has the potential to accelerate access to treatment for patients worldwide.
Gilead is committed to helping enable access to Epclusa around the world. Gilead works with a network of regional business partners, generic licensing partners and other stakeholders to expand treatment globally. Epclusa is already licensed to Gilead's 11 Indian manufacturing partners who produce and distribute generic versions of this medicine for 101 developing countries.

Important U.S. Safety Information for Epclusa

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV CO-INFECTED PATIENTS
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Epclusa. HBV reactivation has been reported in HCV/HBV co-infected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV co-infected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Contraindications

• If Epclusa is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions

• Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Epclusa due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
• Risk of Reduced Therapeutic Effect Due to Concomitant Use of Epclusa with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John's wort, and carbamazepine are not recommended for use with Epclusa as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

Adverse Reactions

• The most common adverse reactions (=10%, all grades) with Epclusa were headache and fatigue; and when used with RBV in decompensated cirrhotics were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

Drug Interactions

• Coadministration of Epclusa is not recommended with topotecan due to increased concentrations of topotecan.
• Coadministration of Epclusa is not recommended with proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.

Consult the full Prescribing Information for Epclusa for more information on potentially significant drug interactions, including clinical comments.

About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing Epclusa for the treatment of adults with chronic HCV infection, for expanded use in patients co-infected with HIV. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. Full Prescribing Information for Epclusa, including BOXED WARNING, is available at www.gilead.com.

Epclusa is a registered trademark of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Really Rapid Review — Paris IAS 2017

HIV and ID Observations
An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.

Really Rapid Review — Paris IAS 2017
Paul E. Sax, MD

Last week, the International AIDS Society meeting returned to Paris for the first time since 2003.

Here’s a Really Rapid Review® of some of the conference highlights, roughly ordered by “cure”, prevention, treatment, and complications....

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Hepatitis C: analysis of cures versus new infections in 91 countries

Review

The road to elimination of hepatitis C: analysis of cures versus new infections in 91 countries
Andrew M Hill, Sanjay Nath, Bryony Simmons 

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Published July, 2017

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Abstract
Background

Hepatitis C (HCV) can only be eradicated if annual rates of cure (SVR) are consistently and significantly higher than new HCV infections, across many countries. In 2016, the WHO called for a 90% reduction in new HCV infection by 2030. Direct-acting antivirals (DAA) can cure the majority of those treated, at around 90% in most populations, at potentially very low prices. We compared the net annual change in epidemic size across 91 countries using data on SVR, new HCV infections, and deaths. In a further 109 countries, we projected this figure using regional averages of epidemic size.

Methods

Epidemiological data for 2016 were extracted from national reports, publications and the Polaris Observatory. There were 91/210 countries with data on SVR, HCV-related deaths and new infections available for analysis; 109 countries had net change in epidemic size projected from the regional prevalence of HCV, extrapolated to their population size. ‘Net cure’ was defined as the number of people with SVR, minus new HCV infections, plus HCV-related deaths in 2016.

Results

For the 91 countries analysed, there were 57.3 million people with chronic HCV infection in 2016. In the remaining 109 countries, the projected epidemic size was 12.2 million, giving a global epidemic size of 69.6 million. Across the 91 countries, there was a fall from 57.3 to 56.9 million people in 2017, a 0.7% reduction. The projected global net change was from 69.6 to 69.3 million, a 0.4% reduction. Ten countries had at least five times more people reaching SVR than new HCV infections, including Egypt and USA. In 47/91 countries, there were more HCV infections than SVR in 2016.

Conclusion

Very few countries are on target to achieve elimination of HCV as a public health problem by 2030. While the North American, North African/Middle East and Western European regions have shown small declines in prevalence, the epidemic is growing in sub-Saharan Africa and Eastern Europe. Far higher rates of DAA treatment are required for worldwide elimination of HCV.

Full text article online

New At Hepatitis C Online: Vosevi and Mavyret

Hepatitis C Online is a free educational, web-based service that functions as a comprehensive resource for diagnosing, monitoring and managing the Hepatitis C virus infection. The service is produced at the University of Washington, through a partnership with the International Antiviral Society-USA, and funded by a grant from the Center for Disease Control and Prevention.

Although Hepatitis C Online is aimed at clinicians, a wealth of information is provided for people living with HCV as well. This interactive site offers easy to follow modules about the natural history of HCV, staging liver fibrosis, managing cirrhosis and treating the virus, click here to browse materials.

Updates At Hepatitis C Online

Information on Gilead's newly FDA approved Vosevi and AbbVie's Mavyret  was recently added, however, make sure to check the website in the future for additional updates. The clinical trial data is not new information, but now its easier to review.

Here are a few links to get you started:

Summary

Start Here: Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi)

Links

View clinical trial data in either slide decks, in your browser or download PDF.

Key Drug Interactions

For complete information on sofosbuvir-velpatasvir-voxilaprevir-related drug interactions, see the Drug Interactions section in the Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi) Prescribing Information.

Begin here.....

Summary

Start Here: Glecaprevir-Pibrentasvir (Mavyret)

Prescribing information: last updated August 4, 2017 (provided by AbbVie Inc.)

Data: All Clinical Trials

Slide Deck 

Begin here.........