FDA Hepatitis Update/ VIEKIRA XR - DOSAGE AND ADMINISTRATION

FDA Hepatitis Update
On July 22, 2016 FDA approved VIEKIRA XR extended release tablets. VIEKIRA XR is a fixed dose combination tablet of previously approved antiviral drugs containing dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor, indicated for the treatment of adult patients with chronic hepatitis C virus (HCV):

• genotype 1b infection without cirrhosis or with compensated cirrhosis
• genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

VIEKIRA XR differs from VIEKIRA Pak in that all of the HCV antiviral drugs are now combined in one fixed dose combination tablet for once daily dosing. The daily mg dose of dasabuvir is higher, and dasabuvir is administered once daily as part of the fixed dose combination.

The recommended dosage of VIEKIRA XR is three tablets taken orally once daily. VIEKIRA XR must be taken with a meal.

The approval of VIEKIRA XR is based on comparability of bioavailability for each of the components in VIEKIRA XR compared to that of the previously approved formulations in VIEKIRA Pak. A clinical trial to evaluate the efficacy and safety of Viekira XR FDC was not required because the efficacy and safety of the components of VIEKIRA XR were established previously in six clinical trials enrolling 2,308 Chronic Hepatitis C patients with and without cirrhosis.

DOSAGE AND ADMINISTRATION
Testing Prior to Initiation of VIEKIRA XR
Prior to initiation of VIEKIRA XR, assess for laboratory and clinical evidence of hepatic decompensation.

Recommended Dosage in Adults
VIEKIRA XR is a 4-drug fixed-dose combination, extended-release tablet containing 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. The recommended dosage of VIEKIRA XR is three tablets taken orally once daily.

  • VIEKIRA XR must be taken with a meal because administration under fasting conditions may result in reduced virologic response and possible development of resistance.
  • Swallow tablets whole. Splitting, crushing, or chewing tablets may compromise the extended-release performance, efficacy, and/or safety of VIEKIRA XR.
  • For optimal release of dasabuvir, alcohol should not be consumed within 4 hours of taking VIEKIRA XR.   
VIEKIRA XR is used in combination with ribavirin (RBV) in certain patient populations (see Table 1). When administered with VIEKIRA XR, the recommended dosage of RBV is based on weight: 1000 mg/day for subjects

For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in Table 1.
Table 1 shows the recommended VIEKIRA XR treatment regimen and duration based on patient population.

Table 1. Treatment Regimen and Duration by Patient Population (Treatment-Naïve or Interferon-Experienced)

Patient Population
Treatment*
Duration
Genotype 1a,
without cirrhosis
VIEKIRA XR + ribavirin
12 weeks
Genotype 1a,
with compensated cirrhosis (Child-Pugh A)
VIEKIRA XR + ribavirin
24 weeks**
Genotype 1b,
with or without compensated cirrhosis (Child-Pugh A)
VIEKIRA XR
12 weeks
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
**VIEKIRA XR administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history

Use in Liver Transplant Recipients
In liver transplant recipients with normal hepatic function and mild fibrosis (Metavir fibrosis score 2 or lower), the recommended duration of VIEKIRA XR with ribavirin is 24 weeks, irrespective of HCV genotype 1 subtype. When VIEKIRA XR is administered with calcineurin inhibitors in liver transplant recipients, dosage adjustment of calcineurin inhibitors is needed.

Hepatic Impairment
VIEKIRA XR is contraindicated in patients with moderate to severe hepatic impairment (Child Pugh B and C)
The complete label for VIEKIRA XR is available at Drugs@FDA.

VIEKIRA XR full Prescribing Information, including the Medication Guide.
VIEKIRA PAK full Prescribing Information, including the Medication Guide.

AbbVie Press Release
AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C



Know your hepatitis status – increasing access to testing for a hidden infection.

25 July 2016 – A staggering 95% of people infected with hepatitis B or C do not know they are infected, often living without symptoms for many years. Ahead of World Hepatitis Day, 28 July 2016, WHO and its partner, Social Entrepreneurship for Sexual Health (SeSH), recently launched a global contest to find innovative ways to reach different populations and encourage testing for hepatitis

Know your hepatitis status – increasing access to testing for a hidden infection.
July 2016 

Do you know if you could be infected with hepatitis B or C? What that could mean for your health?

A staggering 95% of people infected with hepatitis B or C around the world do not know they are infected. One reason for this is that people can live without symptoms for many years. When they find out they have hepatitis, it is often too late for treatment to be fully effective. As a result, liver damage becomes cirrhosis or liver cancer.

To help countries build up national hepatitis testing and treatment programmes and to encourage more people globally to get tested, WHO will shortly release new testing guidelines for hepatitis B and C.

To show how the testing guidelines could translate into real action on the ground, WHO and its partner, Social Entrepreneurship for Sexual Health (SeSH) recently launched a contest to find real-world examples of innovative ways to reach different populations across various countries and settings and test for hepatitis.

The #HepTestContest Innovation Contest received 64 contributions from 27 countries. The project selected around 20 of the best approaches to testing for hepatitis, and then whittled down the list to 5 finalists.

A multi-faceted approach

As well as national testing campaigns, approaches include testing in prisons, testing in the workplace and hospital emergency rooms, integrated HIV-hepatitis testing, as well as the use of internet, social media, and electronic medical records to flag higher risk patients for testing in primary care.

“We needed examples of innovations and best practices to help guide and inspire others,” said Philippa Easterbrook from the WHO Global Hepatitis Programme, who co-led the project. “From prisons in Australia, use of an internet-based risk self-assessment tool in the Netherlands, community testing camps for drug users in India, to testing in primary care in Mongolia we learned some great lessons about how to build awareness of this hidden disease, improve testing rates and link those infected to treatment and care.“

In Manipur, a small state in North East India, an estimated 92% to 98% of drug users are estimated to have hepatitis C. Although HIV testing is free here, testing for hepatitis is not. Awareness about the virus is low and treatment expensive.

A community network organization, the Community Network for Empowerment (CoNE) led the campaign: “We organized awareness-raising sessions, and encouraged free voluntary testing for over a month. Of the 1011 people tested, just under half were positive for hepatitis C. We provided post-test counselling and were also able to offer treatment,” described Rajkumar Nalinikanta, the organization’s president.

Community involvement and strategic partnerships

A critical feature of this approach was the strong community involvement and support as well as strategic partnerships to leverage reductions in the price of treatments. “Bringing together pharmaceutical companies, government, research organizations and communities helped negotiate price reductions make hepatitis treatments more affordable,” concluded Dr Easterbrook.”

Thousands of miles away in the Netherlands, another campaign used an internet-based risk assessment to target populations of people infected with hepatitis C who were difficult to identify and hard to reach.

“We used social media and the web to draw in people who might be at risk to undertake a self-assessment in a choice of 7 languages. The anonymity of the internet helped enormously,” said Janke Schinkel of the Public Health Service of Amsterdam. “This was balanced with highly visible and creative public communication campaigns – that reached a cross-section of Dutch society.”

“The contest demonstrated a range of possibilities. It showed that if we can develop acceptable testing approaches to suit different contexts and cultures, then we can increase effective hepatitis testing in more countries and communities,” concluded Dr Easterbrook.

These 2 approaches were among the 5 finalists selected by a panel of experts including representatives from WHO, World Hepatitis Alliance, and Médecins sans Frontières, who reviewed the testing models for innovation, effectiveness, and plans for sustainability.




Why baby boomers need a hepatitis C screening

Why baby boomers need a hepatitis C screening
26-Jul-2016

Electronic medical record alerts contribute to dramatic rise in HepC screening

University of Michigan Health System

Baby boomers, adults born between 1945 and 1965, are five times more likely to have been exposed to the hepatitis C virus (HCV).

As a result, the Centers for Disease Control and Prevention and the U.S. Preventive Service Task Force recommend that all patients in that age group get tested.

But the simple blood test, designed to detect and prevent illness before the virus wreaks havoc, is infrequently performed on baby boomers whose routine medical appointments are often crammed with other preventive measures and tests -- as well as time spent addressing active problems that require a doctor's immediate attention.

Investigators at the University of Michigan Health System recently found an easy way to help primary care physicians ensure that an HCV screening is part of the routine: Electronic medical record alerts.

The automated alert, programmed to appear if a patient was within the at-risk age group, reminds doctors not only to issue the test but also provide educational materials about the virus.

Implemented in fall 2015 in primary care clinics throughout the U-M health system, the strategy contributed to a significant rise in screenings -- an eightfold boost -- in the first six months alone.

"A large part of the success was figuring out how to take the logistical work away, which involves more than looking at a patient's date of birth," says Monica Konerman, M.D., M.Sc., a hepatologist at the University of Michigan who treats patients facing the prospect of hepatitis damaging their liver.

A population in need

It isn't entire clear why hepatitis C rates are higher in baby boomers -- although many, according to the CDC, are believed to have become infected during the 1970s and 80s when rates were highest (and before screenings of donated blood and organs became available in 1992).

Hepatitis C, likewise, can be asymptomatic for decades. Many patients could have been exposed to risk factors years ago but never sought testing or treatment.

A universal one-time HCV screening based on age, then, can bypass the discomfort of having to talk about potentially embarrassing topics such as prior drug use or sharing needles.

It also helps democratize preventive care. Prior to launching the alert, HCV screening was higher in men, Asian and African Americans, and in patients with Medicaid insurance. Screening rates also varied greatly by clinic site (ranging from 20 to 32 percent).

After the alert was adopted, however, screenings increased equally among genders, races, insurance plans and UMHS clinic sites.

Why screening matters

The screening test for hepatitis C is the virus antibody. If the hepatitis C antibody is detected, a confirmation test for the virus' RNA (genetic material) is recommended to confirm chronic infection.

Of the 16,773 baby boomers targeted for screening via electronic alert at UMHS, fewer than 1 percent tested positive for the hepatitis C antibody.

Despite that low rate, the alert system nonetheless helped identify people who would benefit from curative hepatitis C treatment, says Konerman, who presented the findings in May at the Digestive Disease Week conference in San Diego.

After all, a new era in hepatitis treatment began in 2013 with the approval of interferon-free oral combination therapy that was demonstrated in clinical trials studies led by the U-M to cure hepatitis C in 95 percent of patients. If treated and the body responds, patients can get rid of the virus before liver damage and liver failure occur.

Which is why the new alert technology is crucial for a population that could benefit most from HCV screening.

"The availability of direct-acting antiviral agents has been a game-changer," says Konerman. "Previously, many providers thought screening had low utility: (that) the treatment was terrible and didn't work well. Today, short courses of all oral treatments are highly effective and can prevent progressive liver disease."

http://www.med.umich.edu

Children Exposed To Hepatitis C May Be Missing Out On Treatment

Public Health

Children Exposed To Hepatitis C May Be Missing Out On Treatment
July 26, 20165:00 AM ET
Elana Gordon

Several times a month, Jessica Wen, a pediatrician specializing in liver diseases, has a teenager show up at her clinic at the Children's Hospital of Philadelphia with an unexpected diagnosis: hepatitis C.

Hepatitis C virus, or HCV, is the most common bloodborne infection in the U.S. and a leading cause of liver failure and cancer. Injection drug use is a common risk factor, as is receiving a blood transfusion before 1992. But some of the teens Wen sees picked up the illness another way: at birth, from their mothers.

"I have diagnosed moms after diagnosing the kids," Wen says, referring to mothers who have hepatitis C, didn't know it and then passed it to their babies during childbirth. Wen estimates that about 1 or 2 of every 1,000 young children have chronic hepatitis C.

A study by the Philadelphia Department of Health points to what Wen and others in the medical profession see as a worrisome trend: Children with hepatitis C may be unaware of their diagnosis and the potential need for treatments down the road in order to prevent long-term liver damage.

Using city surveillance data, the study found that as many as 8 in 10 children at high risk for hepatitis C exposure in Philadelphia were never screened for the condition. More specifically, of the approximately 500 moms-to-be who were registered as having hepatitis C between 2011 and 2013, only 84 of their newborns, or about 16 percent, were tested for the virus by 20 months of age.

"Sixteen percent is really low," says Danica Kuncio, lead author of the study. "When you think about children, you hope that the number would be 100 percent, that it should be in the interest of every provider to be doing the best they can to get information to the next provider."

Kuncio, an epidemiologist with the city, worries that people who don't know they contracted hepatitis C as babies won't get the health care they need or realize they could spread the virus to others through blood-to-blood contact. It's a concern intensified by a rise in both injection drug use and hepatitis C among women of childbearing age, she said.

"It's a call to arms to figure out how we can do this better," said Dr. Michael Narkewicz, who specializes in pediatric liver diseases and hepatitis C at the University of Colorado School of Medicine.

Not so long ago, the lack of drugs to cure hepatitis C made screening less of a priority. But in 2013, the Food and Drug Administration approved the first of several drugs that effectively eliminate the virus. Now, with access to these expensive medicines, the condition has gone from chronic and debilitating to curable.

Narkewicz and others say the next frontier is to prove these treatments are safe and effective in children. Clinical trials are underway, and he thinks the drugs could become available for children in the next year or two.

But unlike HIV, which has safe and effective treatments that can dramatically reduce transmission of the virus from mother to child, "for hepatitis C, there are no treatments to prevent transmission in a mom or in a newborn," said Narkewicz.

Hepatitis C in children may be lacking attention for another reason: perinatal transmission rates are a lot lower for Hepatitis C compared to hepatitis B and HIV. For every 100 babies born to women with HCV, five to seven will contract the virus. Of those who do get it, 30 to 40 percent will clear it on their own before the age of two, said Narkewicz. That's why the current protocols for children exposed to HCV call for monitoring and then screening them at 18 months with an antibody test.

But up to 15 percent of those born with HCV will develop a more aggressive form of the disease during adolescence, said Narkewicz, which can result in advanced fibrosis or liver scarring that can progress over time. "It's a small percentage, but it's still a real number," he said.

The medical community really hasn't done a good job of projecting the costs and benefits of early identification and treatment in children, according to Dr. Rhavi Javeri, a pediatrician at UNC Children's Hospital in Chapel Hill, N.C.

"A lot of these other issues related to mom-to-infant transmission, it really all fallen by the wayside," Javeri says. "[The conversation] still falls on, we don't have resources to treat patients that are the priority right now."

Having new drugs to treat hepatitis C in children will be a game-changer, according to Dr. Regino Gonzalez-Peralta, a pediatrician at the University of Florida Health System in Gainesville.

"The old dogma was, why screen mothers if there's nothing to be done?" says Gonzalez-Peralta, who has also been studying gaps in identifying children infected with HCV.

He says that while drugs to prevent transmission are not yet available, there are promising developments. "Now we've got drugs that potentially might be useful in preventing maternal-fetal transmission. This is going to become a hotter area," he says.

Another issue under debate is universal screening for the virus. Dr. Damien Croft, an obstetrician at Hahnemann University Hospital in Philadelphia, doesn't advocate it for everyone in the country. But he thinks it might be a good idea for his pool of patients. "There [are] enough women who are high risk for hepatitis C in Philadelphia that maybe we should consider doing that."

Croft also thinks it's important to improve communication between obstetricians and pediatricians so the pediatrician will know which children are at higher risk for having hepatitis C and can recommend screening.

In the meantime, Philadelphia's health department has begun working with health care providers and at-risk mothers in the city to improve the testing of infants born to women with hepatitis C, and when necessary, linking mother or child to specialists.

This story is part of a reporting partnership with NPR, WHYY's health show The Pulse and Kaiser Health News.
http://www.npr.org

Also See;
Earlier Identification of HCV in Young Women, Babies Needed​


Shared Drug Snorting Straws May Transmit Hepatitis C Virus
FRIDAY, July 22, 2016 (HealthDay News) -- Sharing snorting straws for noninjection drug use may be a source for hepatitis C virus (HCV) transmission, according to research published in the August issue of Obstetrics & Gynecology.
Here is the report; Sharing of snorting straws and hepatitis C virus infection in pregnant women

FDA approves a New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir)

Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal. VIEKIRA XR fixed-dose formulation is given once-daily as three oral tablets and must be taken with a meal. 

VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for people with decompensated cirrhosis.

VIEKIRA XR full Prescribing Information, including the Medication Guide.
VIEKIRA PAK full Prescribing Information, including the Medication Guide.

FDA Hepatitis Update
On July 22, 2016 FDA approved VIEKIRA XR extended release tablets. VIEKIRA XR is a fixed dose combination tablet of previously approved antiviral drugs containing dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor, indicated for the treatment of adult patients with chronic hepatitis C virus (HCV):

• genotype 1b infection without cirrhosis or with compensated cirrhosis
• genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

VIEKIRA XR differs from VIEKIRA Pak in that all of the HCV antiviral drugs are now combined in one fixed dose combination tablet for once daily dosing. The daily mg dose of dasabuvir is higher, and dasabuvir is administered once daily as part of the fixed dose combination.

The recommended dosage of VIEKIRA XR is three tablets taken orally once daily. VIEKIRA XR must be taken with a meal.

The approval of VIEKIRA XR is based on comparability of bioavailability for each of the components in VIEKIRA XR compared to that of the previously approved formulations in VIEKIRA Pak. A clinical trial to evaluate the efficacy and safety of Viekira XR FDC was not required because the efficacy and safety of the components of VIEKIRA XR were established previously in six clinical trials enrolling 2,308 Chronic Hepatitis C patients with and without cirrhosis.

DOSAGE AND ADMINISTRATION
Testing Prior to Initiation of VIEKIRA XR
Prior to initiation of VIEKIRA XR, assess for laboratory and clinical evidence of hepatic decompensation.

Recommended Dosage in Adults
VIEKIRA XR is a 4-drug fixed-dose combination, extended-release tablet containing 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. The recommended dosage of VIEKIRA XR is three tablets taken orally once daily.

  • VIEKIRA XR must be taken with a meal because administration under fasting conditions may result in reduced virologic response and possible development of resistance.
  • Swallow tablets whole. Splitting, crushing, or chewing tablets may compromise the extended-release performance, efficacy, and/or safety of VIEKIRA XR.
  • For optimal release of dasabuvir, alcohol should not be consumed within 4 hours of taking VIEKIRA XR.   
VIEKIRA XR is used in combination with ribavirin (RBV) in certain patient populations (see Table 1). When administered with VIEKIRA XR, the recommended dosage of RBV is based on weight: 1000 mg/day for subjects

For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in Table 1.
Table 1 shows the recommended VIEKIRA XR treatment regimen and duration based on patient population.

Table 1. Treatment Regimen and Duration by Patient Population (Treatment-Naïve or Interferon-Experienced)

Patient Population
Treatment*
Duration
Genotype 1a,
without cirrhosis
VIEKIRA XR + ribavirin
12 weeks
Genotype 1a,
with compensated cirrhosis (Child-Pugh A)
VIEKIRA XR + ribavirin
24 weeks**
Genotype 1b,
with or without compensated cirrhosis (Child-Pugh A)
VIEKIRA XR
12 weeks
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
**VIEKIRA XR administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history

Use in Liver Transplant Recipients
In liver transplant recipients with normal hepatic function and mild fibrosis (Metavir fibrosis score 2 or lower), the recommended duration of VIEKIRA XR with ribavirin is 24 weeks, irrespective of HCV genotype 1 subtype. When VIEKIRA XR is administered with calcineurin inhibitors in liver transplant recipients, dosage adjustment of calcineurin inhibitors is needed.

Hepatic Impairment
VIEKIRA XR is contraindicated in patients with moderate to severe hepatic impairment (Child Pugh B and C)
The complete label for VIEKIRA XR is available at Drugs@FDA.

AbbVie Press Release
AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

Jul 25, 2016

- New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of VIEKIRA PAK® for adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection

- The approval marks another milestone in AbbVie's ongoing commitment to therapeutic innovation for people living with GT1 HCV

NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for people with decompensated cirrhosis.

VIEKIRA XR is the first co-formulated three direct-acting antiviral (DAA) treatment for adult patients with GT1 HCV. VIEKIRA XR is given once-daily as three oral tablets and must be taken with a meal. It is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients. The approval is supported by Phase 3 clinical trials for VIEKIRA PAK which include data that demonstrated 100 percent sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients with 12 weeks of therapy without ribavirin and 95 percent SVR12 in GT1a patients when used with ribavirin for 12 or 24 weeks of therapy.

"AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie. "The approval of VIEKIRA XR provides a new treatment option for genotype 1 hepatitis C patients in the U.S. with clinical trial data using the components of VIEKIRA XR demonstrating 100 percent cure rates in genotype 1b patients."

There are six major HCV genotypes (GT1-6) and GT1 is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases.1 Hepatitis C continues to be an important public health issue, with the Centers for Disease Control and Prevention (CDC) estimating that in the U.S. approximately 2.7 million people are chronically infected with HCV.2

The approval of VIEKIRA XR is supported by data from seven Phase 3 clinical trials in more than 2,300 patients who received VIEKIRA PAK with or without RBV for 12 or 24 weeks and two bioavailability studies comparing the formulations.

About Clinical Studies

The components of VIEKIRA XR (administered twice daily with a meal) have been studied in seven Phase 3 clinical trials where 1076 subjects (including 181 with compensated cirrhosis) received the recommended regimen of VIEKIRA +/? RBV for 12 weeks, or for 24 weeks in GT1a patients with compensated cirrhosis. Ninety-five to 100 percent achieved SVR12, which means the hepatitis C virus is not detectable in the blood three months after treatment ends. Cure rates varied by the subtype of hepatitis C and whether or not the person had cirrhosis. Individual results may vary.

USE

VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets/VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) (VIEKIRA) are prescription medicines used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection.

VIEKIRA can be used in people who have compensated cirrhosis.

VIEKIRA is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking VIEKIRA.

IMPORTANT SAFETY INFORMATION

When taking VIEKIRA in combination with ribavirin, people should read the Medication Guide that comes with ribavirin, especially the important pregnancy information.

What is the most important information to know about VIEKIRA?
VIEKIRA may cause severe liver problems, especially in people with certain types of cirrhosis. These severe liver problems can lead to the need for a liver transplant, or can lead to death.
VIEKIRA can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).
Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with VIEKIRA. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA, and for about 2 weeks after treatment with VIEKIRA ends. A doctor can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
A doctor should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.
A doctor may tell people to stop taking VIEKIRA if signs or symptoms of liver problems develop. A doctor must be notified right away if any of the following symptoms develop or if they worsen during treatment with VIEKIRA: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, color changes in stools, confusion, or swelling of the stomach area.

VIEKIRA must not be taken if people:
have certain liver problems
take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®, TEGRETOL®-XR, TERIL®) • cisapride (Propulsid®) • colchicine (Colcrys®), in patients who have certain kidney or liver problems • dronedarone (Multaq®) • efavirenz (Atripla®, Sustiva®) • ergot-containing medicines, including ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, Medihaler®, Migergot®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines • gemfibrozil (Lopid®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • lurasidone (Latuda®) • midazolam (when taken by mouth) • phenytoin (Dilantin®, Phenytek®) • phenobarbital (Luminal®) • pimozide (Orap®) • ranolazine (Ranexa®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®), when taken for pulmonary artery hypertension (PAH) • simvastatin (Simcor®, Vytorin®, Zocor®) • St. John's wort (Hypericum perforatum) or a product that contains St. John's wort • triazolam (Halcion®)
have had a severe skin rash after taking ritonavir (Norvir®)

What should people tell a doctor before taking VIEKIRA?
If they have: liver problems other than hep C infection, HIV infection, or any other medical conditions.
If they have had a liver transplant.
If they take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), a doctor should check blood levels and, if needed, may change the dose of these medicines or how often they are taken, both during and after treatment with VIEKIRA.
If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA will harm a person's unborn baby or pass into breast milk. A doctor should be consulted about the best way to feed a baby if taking VIEKIRA.
About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA.
A new medicine must not be started without telling a doctor. A doctor will provide instruction on whether it is safe to take VIEKIRA with other medicines.
When VIEKIRA is finished, a doctor should be consulted on what to do if one of the usual medicines taken was stopped or if the dose changed during VIEKIRA treatment.

What are the common side effects of VIEKIRA?
For VIEKIRA used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.
For VIEKIRA used without ribavirin, side effects include nausea, itching, and sleep problems.

These are not all of the possible side effects of VIEKIRA. A doctor should be notified if there is any side effect that is bothersome or that does not go away.

This is the most important information to know about VIEKIRA. For more information, talk to a doctor.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see VIEKIRA XR full Prescribing Information, including the Medication Guide.

Please see VIEKIRA PAK full Prescribing Information, including the Medication Guide.

If people cannot afford their medication, they should contact www.pparx.org for assistance.

About VIEKIRA XR

The components of VIEKIRA XR* have been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naïve to difficult to treat patients, such as those with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV).

The extended-release co-formulation of these components, VIEKIRA XR, consists of 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir per tablet, and is dosed three tablets once daily. VIEKIRA XR must be taken with a meal, and tablets should be swallowed whole. People should not drink alcohol within four hours of taking VIEKIRA XR. VIEKIRA XR is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity. VIEKIRA XR is taken for 12 weeks, except in GT1a patients with cirrhosis and all liver transplant recipients with normal hepatic function and mild fibrosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients and in all patients who have received a liver transplant.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is used in combination with AbbVie's ombitasvir with or without dasabuvir for the treatment of hepatitis C.

*Given as a fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal.

About AbbVie's Patient Assistance Program

AbbVie supports patient assistance programs to help qualified people access their needed AbbVie medication at no cost. In 2015, more than 81,000 U.S. patients received AbbVie's medicines at no cost3. For those who qualify, AbbVie plans to offer a patient assistance program for people taking VIEKIRA XR. Since VIEKIRA PAK's approval in 2014, AbbVie has supported access to medication for those living with chronic HCV and facing financial difficulties.

About AbbVie's HCV Clinical Development Program

AbbVie's HCV clinical development program is intended to advance scientific knowledge and the clinical care of people with chronic HCV infection. AbbVie is investigating a pan-genotypic (genotypes 1-6) regimen and is in Phase 3 of clinical development. For more information on AbbVie Phase 3 HCV studies, visit www.clinicaltrials.gov (NCT02243293).

About HCV

Hepatitis C is inflammation of the liver caused by an infection with the hepatitis C virus. It is transmitted when an infected person's blood enters the bloodstream of an uninfected person. The Centers for Disease Control (CDC) estimates that approximately 2.7 million people have chronic HCV infection in the U.S. There are six major HCV genotypes (GT1-6), with genotype 1 (GT1) as the most prevalent form in the U.S. It is estimated that of people infected with chronic HCV, about 5 to 20 percent will go on to develop cirrhosis over a period of 20–30 years, and with HCV-related liver transplants on the rise, HCV is a critical public health issue. Presently, there is no vaccine for HCV infection.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Wedemeyer H. Hepatitis C. Chapter 80: In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease. Vol 2. 10th ed. Philadelphia, PA: Saunders Elsevier; 2016.
2 Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for health professionals. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#section1. Accessed June 9, 2016.
3 AbbVie 2016 Impact by the Numbers. http://www.abbvie.com/responsibility/home.html

Pricey drugs overwhelm Medicare safeguard

Pricey drugs overwhelm Medicare safeguard
July 25, 2016 by Ricardo Alonso-Zaldivar

A safeguard for Medicare beneficiaries has become a way for drugmakers to get paid billions of dollars for pricey medications at taxpayer expense, government numbers show.
The cost of Medicare's "catastrophic" prescription coverage jumped by 85 percent in three years, from $27.7 billion in 2013 to $51.3 billion in 2015, according to the program's number-crunching Office of the Actuary.
Out of some 2,750 drugs covered by Medicare's Part D benefit, two pills for hepatitis C infection—Harvoni and Sovaldi—accounted for nearly $7.5 billion in catastrophic drug costs in 2015.

Continue reading....


CHMP Grants Positive Opinion for 12 weeks of Viekirax for Geno 4 with compensated cirrhosis

  • Posted by HCV New Drugs
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CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A)

- The CHMP opinion represents a positive advance toward approval of the 12-week regimen of VIEKIRAX with ribavirin for genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with or without compensated cirrhosis

AbbVie's EMA label expansion application supported by 97 percent SVR(12) rate (n=57/59) in a dedicated Phase 3 AGATE-I study of patients with GT4 HCV with compensated cirrhosis(1)

- In Europe, where nine million people are infected with HCV,(2) GT4 is becoming increasingly prevalent in several countries including Italy, France, Greece and Spain(3)   



NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the use of 12 weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) in genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with compensated cirrhosis (Child-Pugh A). VIEKIRAX with RBV is currently approved in the European Union for GT4 patients with compensated cirrhosis for 24 weeks.

"Through optimizing the use of VIEKIRAX, AbbVie strives to meet the needs of patients and physicians, including a shortened treatment duration," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone is progress toward an approval that would allow us to provide the opportunity for a cure with just 12 weeks of our regimen to genotype 4 patients with or without compensated cirrhosis in Europe."  

Chronic HCV affects more than 160 million people worldwide,4 with 34 million people living with GT4 HCV infection.3 In Europe, where nine million people are infected with HCV,2 GT4 is becoming increasingly prevalent in several countries including Italy, France, Greece and Spain, where prevalence rates from 10 to 24 percent have been reported.3

The CHMP positive opinion is supported by data from a dedicated Phase 3 AGATE-I study of GT4 HCV infected patients with compensated cirrhosis. The randomized, open-label study evaluated the safety and efficacy of VIEKIRAX and RBV for 12 and 16 weeks. Results from the study showed that with 12 weeks of treatment with VIEKIRAX and RBV, 97 percent (n=57/59) of patients achieved sustained virologic response at 12 weeks post-treatment (SVR12 ).1

"Until recently people living with genotype 4 chronic hepatitis C had limited treatment options," said Tarik Asselah, M.D., lead study author and professor at Université Paris Diderot. "If approved, this 12-week treatment would mark another step forward in the cure for GT4 patients, allowing difficult-to-cure patients with compensated cirrhosis to be treated in half the time with VIEKIRAX, representing a significant benefit for both them and their physicians."

Results from the AGATE-I study also showed that patients treated with 16 weeks of VIEKIRAX and RBV achieved 98 percent (n=60/61) SVR12 rates. The most commonly reported adverse events (≥20 percent) in the 12-week arm were asthenia, fatigue and headache (18 percent, 17 percent and 23 percent respectively); and for the 16 week arm were fatigue, asthenia, headache, anemia, nausea, and pruritus (33 percent, 32 percent, 23 percent, 23 percent and 20 percent respectively).1 One patient in the 12-week group experienced virologic breakthrough and one discontinued prematurely after the first day of treatment. One patient missed the post-treatment week 12 visit in the 16-week group.1 The full study results were published online in The Lancet in June 2016.

About VIEKIRAX® VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection. VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily.
Currently, in GT4 HCV infected patients VIEKIRAX with RBV is taken for 12 weeks, except in patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.

Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.


Weekend Reading: Coffee can play a role in reducing risks of cancer and diabetes

Coffee can play a role in reducing risks of cancer and diabetes

Good day folks, in this issue of "Weekend Reading" we point you to a podcast over at ABC Radio on the many health benefits of drinking coffee, hosted by Dr. Kruszelnicki.

Topics covered in the two part program include the effect of caffeine on; liver cancer, type II diabetes, prostate cancer, oral cancer, and heart disease.

But what about the side effects of drinking coffee, good or bad?

There is a body of evidence that some of the side effects of coffee may actually be good for you, and they appear to have nothing to do with caffeine. But Dr Karl Kruszelnicki's grind is the observational studies that make up the 'statistics' behind the health benefits.

Listen to the podcast or read the transcript;

Coffee is now good for us—or is it?
Part One - Listen here
July 12 2016
Yes, it is a drug, and so we should remember the words of Paracelsus, 'all drugs are poisons, what matters is the dose.' Based on the fact that coffee has been used widely for over a millennium, we would expect its bad side-effects would be fairly minimal—so long as we don't take too much.
Read the transcript

Part Two - Listen here
July 19,2016
Coffee can play a role in reducing risks of cancer and diabetes
It seems that beside caffeine, there are other natural chemicals in coffee that can help with medical conditions. With regard to liver cancer, two chemicals, kahweol and cafestrol, have direct cancer protection and anti-inflammatory properties. They seem to 'upregulate biochemical pathways in the liver that protect the body from toxins, including aflatoxin and other carcinogenic compounds'.
Read the transcript

Cheers!

Behind the Headlines - Alcohol 'a direct cause of seven types of cancer'

Behind The Headlines: Analysis by Bazian edited by NHS Choices

What is Behind the Headlines?
Each day the NHS Choices team selects health stories that are making headlines. These, along with the scientific articles behind the stories, are sent to Bazian, a leading provider of evidence-based healthcare information. Bazian's clinicians and scientists analyse the research and produce impartial evidence-based assessments, which are edited and published by NHS Choices.

Alcohol 'a direct cause of seven types of cancer'
Friday July 22 2016
Several studies looking at whether alcohol causes cancer were looked at during the research

Alcohol can increase your cancer risk
"Even one glass of wine a day raises the risk of cancer: Alarming study reveals booze is linked to at least seven forms of the disease," reports the Mail Online.

The news comes from a review that aimed to summarise data from a range of previous studies to evaluate the strength of evidence that alcohol causes cancer.

The main finding was that existing evidence supports the link between alcohol consumption and cancer at seven sites, including the throat, gullet, liver, colon, rectum and female breast.

The links were said to be strongest for heavy drinking, but this study suggested that even low or moderate drinking may contribute to a significant proportion of cancer cases because of how common this level of drinking is. The study also suggests there's no evidence of a "safe" level of drinking with respect to cancer.

However, it's important to be aware that this review doesn't state how the author identified and assessed the research they've drawn upon. We don't know whether all relevant research has been considered and the conclusions must be considered largely the opinion of this single author.

Nevertheless, the main finding of the link between alcohol and these seven cancers is already well recognised.  Recently updated government recommendations state there's no safe level of alcohol consumption, and men and women are advised not to regularly drink more than 14 units a week. This review further supports this advice.

Where did the story come from?
The study was published in the peer-reviewed scientific journal Addiction. It is available on an open-access basis and is free to read online.

The study was published in the peer-reviewed scientific journal Addiction. It is available on an open-access basis and is free to read online.

Generally the media coverage of this topic was accurate, although the tone of the reporting tended to suggest this was a new discovery, when the link between alcohol and certain types of cancer is well established.

What kind of research was this?
This was a review which aimed to summarise data from published biological and epidemiological research, and meta-analyses that have pooled data, to evaluate the strength of evidence that alcohol causes cancer.

Alcoholic drinks have been considered potentially carcinogenic (cancer causing) for a while, but there are still concerns about the validity of some observational studies finding links with cancer, and uncertainty about precisely how alcohol causes cancer.

A systematic review is the best way of gathering and summarising the available research around a particular topic area. But in this case the exact methods are not described in the paper and it's not possible to say whether they were systematic.

There's a possibility that some relevant research may have been missed and that this review is giving an incomplete picture of the issue

What did the research involve?
The author of this review reports drawing upon biological and epidemiological research as well as meta-analyses conducted in the last 10 years by a number of institutions, including the World Cancer Research Fund and American Institute for Cancer Research, the International Agency for Research on Cancer and the Global Burden of Disease Alcohol Group.

The majority of epidemiological research seemed to come from cohort and observational studies.
The research was reviewed and summarised in a narrative format which explored the evidence that alcohol causes cancer, while contrasting this with the notion that alcohol consumption may offer some form of protection from cardiovascular disease.

No methods are provided and the author does not describe how they identified the research, as you would expect from a systematic review.  For example, they do not give the literature databases searched, the search dates, search terms, study inclusion or exclusion criteria, or descriptions of how studies were quality assessed.  

What were the basic results?
There were several findings from this study, the main one being that existing evidence supports the link between alcohol consumption and cancer at seven sites: oropharynx (mouth and throat), larynx (voice box), oesophagus (gullet), liver, colon (bowel), rectum and female breast.

The strength of the association differed by the site of the cancer. It was strongest for the mouth, throat and oesophagus, with the review suggesting that someone who drinks more than 50g of alcohol a day is four to seven times more likely to develop these types of cancer compared to someone who doesn't drink. As the author says, the interaction of smoking with alcohol is also believed to contribute to the risk of these cancers.

The link was comparatively weaker for colorectal, liver and breast cancer. The review suggests someone who drinks more than 50g of alcohol a day is 1.5 times more likely to develop these types of cancer compared to someone who doesn't drink.

For all of these associations there was a dose-response relationship, where increased consumption was linked with an increase in cancer risk. This applied to all types of alcoholic drinks. The highest risks were associated with heavier drinking. There was also some suggestion that the level of risk goes down over time when alcohol consumption stops.

Recent large studies have found uncertain evidence whether low to moderate consumption has a significant effect on total cancer risk. But given that this level of consumption is common in the general population, the author considers that it could still contribute to a significant number of cases.

Furthermore, they say there is no clear threshold of what constitutes a harmful level of alcohol consumption, and therefore no safe level of drinking with respect to cancer.

The author also suggests that confounding factors may be responsible for the protective effect between alcohol consumption and cardiovascular disease that has been found in previous studies. For example, this may be due to the potential bias caused by misclassification of former drinkers as abstainers.

The research went on to report that alcohol is estimated to be responsible for approximately half a million deaths from cancer in 2012 and 5.8% of cancer deaths worldwide, deeming it to be a significant public health burden.

How did the researchers interpret the results?
The author concluded: "There is strong evidence that alcohol causes cancer at seven sites, and probably others. The measured associations exhibit gradients of effect that are biologically plausible, and there is some evidence of reversibility of risk in laryngeal, pharyngeal and liver cancers when consumption ceases."

"The highest risks are associated with the heaviest drinking, but a considerable burden is experienced by drinkers with low to moderate consumption, due to the distribution of drinking in the population."

Conclusion
This narrative review aimed to summarise data from published biological and epidemiological research to discuss the strength of evidence that alcohol causes cancer.

The author gives their main finding as a link between alcohol consumption and cancer at seven sites, and also that the highest risks seem to be associated with heavier drinking. However, they state there's no "safe" drinking threshold and that low to moderate consumption still contributes to a significant number of cancer cases.

The biggest limitation of this review is that it doesn't appear to be systematic. The author provided no methods for how they identified and appraised the research they drew on. Despite referencing a number of large studies and reviews, this study and its conclusions have to be considered largely the opinion of the author following their appraisal of the evidence.

We don't know whether the review has considered all research relevant to the topic and is able to reliably quantify the risks of cancer – overall or at specific sites – associated with alcohol consumption.

An additional limitation to keep in mind is that this data mainly appeared to be from observational studies. These cannot prove cause and effect. The individual studies will likely have varied considerably in the additional health and lifestyle factors they took account of when looking at the links with alcohol. For example, smoking, diet and physical activity are all factors likely to be associated both with level of alcohol consumption and cancer risk.

As the author notes in particular, confounding factors may be responsible for the observed protective effect between alcohol consumption and cardiovascular disease.

Another limitation is that alcohol consumption is likely to be self-reported in the studies analysed, which may be inaccurate and lead to misclassification. For example, a potential bias that the author notes is classifying former drinkers as abstainers.

The author does consider the limitations of these observational findings, saying: "The limitations of cohort studies mean that the true effects may be somewhat weaker or stronger than estimated currently, but are unlikely to be qualitatively different."

But despite the methodological limitations of this review, it does support current understanding around this topic. Cancer Research UK also reports that alcohol can increase risk of these seven cancers and that there is no "safe" alcohol limit.

While we can't give a safe limit to drink when it comes to cancer, people are advised to follow current alcohol recommendations, which are to drink no more than 14 units per week and to spread your drinking over three days or more if you drink as much as 14 units a week.

Analysis by Bazian
Edited by NHS Choices

Links to the headlines
Even one glass of wine a day raises the risk of cancer: Alarming study reveals booze is linked to at least seven forms of the disease. Mail Online, July 22 2016
Alcohol is a direct cause of seven ​​forms of cancer, finds study. The Guardian, July 22 2016
Alcohol linked to at least seven types of cancer, study says, while 'health benefits are irrelevant'. The Telegraph, July 22 2016
Alcohol raises risk of seven different cancers, experts warn – even just one glass. Daily Mirror, July 22 2016
Alcohol causes seven types of cancer – and probably others, study finds. The Independent, July 22 2016

Links to the science

Connor J. Alcohol consumption as a cause of cancer. Addiction. Published online July 21 2016