World Hepatitis Day: steps towards elimination World Hepatitis Day takes place every year on 28 July. News highlights from this year include:
- Elimination of viral hepatitis by 2030 is a
global health target endorsed by the World Health Assembly. World
Health Organization (WHO) data on 28 countries representing 70% of the global burden
of viral hepatitis show that more than 86% of countries reviewed have set
national hepatitis elimination targets and more than 70% have begun to develop
national hepatitis plans to enable access to effective prevention, diagnosis,
treatment and care services. Furthermore, nearly half of the countries surveyed
are aiming for elimination through providing universal access to hepatitis
treatment.
Drug prices: time to shift from talking about high prices to low production costs Dzintars Gotham presenting at IAS 2017. Image credit: Enzo Poultreniez / http://aides.org Protests
against the high cost of hepatitis C drugs may be having the paradoxical effect
of discouraging access to treatment rather than promoting access, one of
Australia’s leading researchers on hepatitis C told last month’s 9th
International AIDS Society Conference on HIV Science (IAS 2017) in Paris.
"One of the
most important things we have to do is re-frame [the debate about hepatitis C
drug prices]. The focus on $1000 a pill has done us a disservice with donors. We
need to be talking about a $150 course of treatment," said Professor
Margaret Hellard, Deputy Director of the Burnet Institute, Melbourne.
In fact, research presented at the conference shows
that a course of treatment for hepatitis C could be delivered for $47 in countries where generic versions of
hepatitis C drugs can be used. Using data on the costs of the raw materials
used to manufacture direct-acting antivirals, and on the costs of production,
researchers calculated that even including a 10% profit margin, generic
manufacturers could make sofosbuvir/daclatasvir available for $47 and
sofosbuvir/ledipasvir for $79. Hepatitis B treatment with entecavir would cost
$82 a year. What’s missing is funding for treatment and awareness among
governments and donors of how affordable treatment for hepatitis C could be.
Awareness of
the costs of production might also encourage governments in upper-middle income
and higher income countries to adopt a tougher stance in price negotiations and
start thinking in terms of their strategic aims for public health, several
panellists at a conference symposium on drug costs argued.
"One of the
jobs of government should be negotiating hard for the best price and not just
accepting the price offered," said Margaret Hellard. "We need our governments
to make strong and brave decisions on behalf of their people."
Hepatitis C: DAA treatment and mortality For the first time, a large study has demonstrated that
sustained virologic response with direct-acting antivirals (DAAs) significantly
reduces mortality rates among people with hepatitis C virus (HCV)
monoinfection.
The study – published in Clinical Infectious Diseases
– matched people who received therapy with all-DAA regimens with a control group of people not receiving therapy. Mortality rates in the first 18 months were
significantly lower among people who received DAAs. After controlling for other
factors, treatment with DAAs was associated with a 57% reduction in the risk of
death. Among those who were treated, cure was associated with a 43% reduction
in the risk of death. (Although these figures give the impression that
treatment had a greater impact than cure, they are not comparable because they
refer to a reduction in risk in two different populations, all people with
hepatitis C and all people treated.)
The study appeared shortly after the
publication of a systematic review by the Cochrane Collaboration which
concluded that there was no evidence that DAA treatment reduced the risk of
death or serious illness. That review was strongly criticised by the European
Association for the Study of the Liver (EASL) and the American
Association for the Study of Liver Diseases (AASLD).
A second
study, published recently in the journal Gut,
found that the risk of several non-liver complications associated with chronic HCV infection is reduced after interferon-based treatment
that achieves a sustained virological response.
The study found that curing hepatitis C with
interferon-based treatment significantly reduced the risk of developing
non-Hodgkin lymphoma, mixed
cryoglobulinaemia, glomerulonephritis, porphyria cutanea tarda and type
2 diabetes, and of suffering a stroke.
Treatment was only protective against the risk of
glomerulonephritis and stroke if started within one or two years of infection
with HCV. Treatment was only beneficial in reducing the risk of non-Hodgkin
lymphoma if started within a year of infection.
Vosevi approved in the European Union and United States On 18 July the US Food and Drug Administration approved Gilead
Sciences' Vosevi, a new once-daily combination pill containing sofosbuvir,
velpatasvir, and voxilaprevir. Vosevi was approved as "salvage
therapy" for people with all hepatitis C virus (HCV) genotypes who were
not previously cured with prior direct-acting antiviral (DAA) therapy.
On 28 July the European Commission approved Vosevi for the treatment of adults with genotype
1 to 6 chronic HCV infection.
Vosevi was
authorised for marketing in the European Union as:
- An 8-week
regimen for previously untreated people without cirrhosis.
- An 8-week
regimen for previously untreated people with compensated cirrhosis.
- A 12-week
regimen for people with any genotype of chronic HCV infection, without
cirrhosis or with compensated cirrhosis (Child-Pugh class A), who have
previously experienced treatment failure with a DAA-containing
regimen.
Maviret approved in the European Union and United States The European Commission and the
US Food and Drug Administration last month approved AbbVie's new
combination pill for people with hepatitis C virus (HCV) genotypes 1 to 6, to
be marketed as Maviret in the European Union and as Mavyret in
the United States.
Maviret is a fixed-dose co-formulation
containing the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor
pibrentasvir; both drugs are being approved for the first time.
Maviret is indicated for previously untreated people,
or those treated with prior interferon-based therapy, who have HCV genotypes 1,
2, 3, 4, 5 or 6 and who either do not have liver cirrhosis or have compensated
cirrhosis (Child-Pugh class A).
In the European indication, Maviret is not
recommended for retreatment of people who previously used NS3A/4A protease
inhibitors or NS5A polymerase inhibitors. In the US indication, it is approved
for adults with HCV genotype 1 who were previously treated with either an
NS3/4A inhibitor or an NS5A inhibitor, but not both. This means that Maviret/Mavyret should not be used after
Harvoni or Epclusa.
Maviret is not recommended for people with
significant liver function impairment (Child-Pugh class B), and it is
contraindicated for those with decompensated cirrhosis (Child-Pugh class C).
In the United States AbbVie
has announced that the price of Mavyret
will be set at $26,400 for an 8-week course of the drug. This price is
lower than the best price negotiated for sofosbuvir/ledipasvir (Harvoni) by one of the largest
healthcare payers in the United States, the Veterans Affairs Administration and
is likely to stimulate demands by insurers for cuts in the prices of other
drugs. Prices for Maviret have not
been announced yet for European Union countries.
Epclusa use expanded to people with HIV co-infection in the United States The US
Food and Drug Administration (FDA) announced on 1 August that the indication for
use of Epclusa now includes use in people with HIV and genotype 1 to 6
chronic hepatitis C virus co-infection without cirrhosis or with compensated cirrhosis, or with
decompensated cirrhosis in combination with ribavirin.
Harvoni licence extended to adolescents aged 12-18 years in European Union The indication
for Harvoni in the European Union
has been extended to include the treatment of chronic hepatitis C virus genotype 1, 3, 4, 5
and 6 infection in adolescents aged 12 to < 18 years.
Hepatitis C treatment in Africa Karine Lacombe of Saint-Antoine Hospital, Paris, at IAS 2017. Photo by Liz Highleyman, hivandhepatitis.com Treatment for hepatitis C in sub-Saharan Africa can produce
cure rates as high as those seen in industrialised countries, with high
adherence and minimal side-effects, according to a
presentation last month at the 9th International AIDS Society Conference on HIV
Science (IAS 2017) in Paris, France.
The TAC ANRS 12311 trial,
sponsored by the French National Agency for Research on AIDS and Viral
Hepatitis (ANRS), assessed the feasibility, efficacy and safety of interferon-free
direct-acting antiviral treatment in Cameroon and Ivory Coast. Starting in October 2015, this
open-label study enrolled 120 adults who had not previously been treated for
hepatitis C.
After 12 weeks of post-treatment follow-up, 89% achieved
sustained virological response (SVR12), or continued undetectable hepatitis C virus (HCV) RNA,
considered a cure. Cure rates were 88% for genotype 1, 90% for genotype 2 and
89% for genotype 4. The SVR12 rate was a bit lower for those with cirrhosis, at
78%. HIV co-infection had no impact on efficacy, adherence or safety.
Based on these findings, "It is time to scale up HCV screening and advocate for treatment access for those in need in resource-limited countries, to make global HCV elimination a reality for all," the researchers concluded.
Non-alcoholic fatty liver disease in people living with HIV Liver disease is now a leading
cause of serious illness and death in people with HIV. Until now, much of the
liver disease occurring in people living with HIV has been associated with
co-infection with hepatitis B or C, but non-alcoholic fatty liver disease
(NAFLD) is emerging as a new concern in the management of individuals with HIV
infection who do not have hepatitis B or C co-infection.
The condition is defined by the
accumulation of fat in the liver and the presence of triglycerides in liver
cells in the absence of a cause such as excess alcohol consumption. NAFLD may
progress to non-alcoholic steatohepatitis (NASH), in which the liver becomes inflamed and liver cells are
damaged, and possibly to fibrosis and cirrhosis (death of liver tissue and
scarring) or to liver cancer. NAFLD also increases the risk of developing
cardiovascular disease.
Numerous pharmaceutical
treatments for NASH are being investigated in clinical trials but it is far
from clear which types of drugs are likely to prove effective, and if treatment
of NASH will have any long-term impact on mortality and serious illness due to
liver disease or cardiovascular disease.
In HIV-negative individuals,
NAFLD is usually associated with metabolic syndrome including obesity, insulin
resistance and elevated lipids. Global prevalence of NAFLD is estimated at 25%,
with prevalence higher in people with type 2 diabetes.
Over
a third of people with HIV have NAFLD in the absence of hepatitis B or C,
according to a new study published last month in the journal AIDS.
Metabolic disorders including high body mass index (BMI), diabetes and elevated
lipids were key risk factors. The study also revealed high prevalences of NASH and liver fibrosis, possible outcomes of
NAFLD, with metabolic disorders once again shown as the most important factors.
The researchers conclude that:
- NAFLD is common in people
with HIV, but more studies with good-quality biopsy data are needed to
give a clearer idea of its prevalence.
- People with features of
metabolic syndrome should be thoroughly investigated for NAFLD.
- Lifestyle changes are the
mainstay of treatment for NAFLD, but few people manage to achieve the
changes needed to remedy the disorder. People with HIV should, therefore,
be allowed to participate in clinical studies investigating experimental
drug therapies for the condition.
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