WHO Guidelines for the screening, care and
treatment of persons with hepatitis C infection
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· Treatment duration of telaprevir/PEG-IFN/RBV for treatment-naive patients
is 24-48 weeks depending on the response to treatment (telaprevir is given
for 12 weeks only).
· Treatment duration of boceprevir/PEG-IFN/RBV in treatment-naive patients
is 28-48 weeks depending on the response to treatment.
· Treatment duration in previously treated patients varies by previous response
· Simprevir in combination with PEG-IFN/RBV is given for 12 weeks followed by
an additional 12 weeks of PEG-INF/RBV for a total of 24 weeks treatment for
all treatment-naive and prior relapsed patients (including those with cirrhosis).
· Prior non-responder patients (including partial or null-responders) should undergo
an additional 36 weeks of PEG-INF/RBV for a total of 48 weeks of treatment.
· HCV RNA should be monitored and treatment discontinued if it is >25 IU/
mL at weeks 4, 12 or 24.
For the medicine to be used in other countries, it must be registered with the
national drug regulatory agency. This process can take 1-2 years. It will be
important for national and international agencies, civil society organizations and
pharmaceutical companies to work together to assure rapid approval of this
medicine and that it is available at an affordable price.
· For infection with HCV genotypes 1 and 4, sofosbuvir/RBV/PEG-IFN may be
given for 12 weeks.
· In persons with genotype 1 infection who are IFN intolerant, sofosbuvir/RBV
may be given for 24 weeks, but this regimen will result in substantially lower
SVR rates than a PEG-IFN-containing regimen.
· For infection with HCV genotype 2, sofosbuvir/RBV may be given for 12
· For infection with HCV genotype 3, sofosbuvir/RBV may be given for 24
weeks or PEG-IFN/RBV/sofosbuvir may be given for 12 weeks.
TABLE 8.1 Contraindications to PEG-IFN/RBV therapy
· Uncontrolled depression or psychosis
· Uncontrolled epilepsy
· Uncontrolled autoimmune disease
· Decompensated cirrhosis (Child-Pugh ≥B7 or B6 in HCV/HIV coinfection)
· Pregnancy or unwillingness to use contraception
· Breastfeeding women
· Severe concurrent medical disease including severe infections
· Poorly controlled hypertension
· Poorly controlled cardiac failure
· Poorly controlled diabetes
· Solid organ transplant (except liver transplant recipients)
· Chronic obstructive pulmonary disease
· Age less than 2 years
· Hypersensitivity to drugs used to treat HCV
· Abnormal haematological indices:
-- Hb <13 g/dL in men or <12 g/dL in women
-- Neutrophil count <1.5x109/L
-- Platelet count <90x109/L
· Serum creatinine >1.5 mg/dL
· Haemoglobinopathies (sickle cell disease or thalassaemia)
· Significant coronary artery disease
WHO issues its first hepatitis C treatment guidelines
9 April 2014 | London, United Kingdom - WHO has issued its first guidance for the treatment of hepatitis C, a chronic infection that affects an estimated 130 million to 150 million people and results in 350 000 to 500 000 deaths a year.
The publication of the "WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection" coincides with the availability of more effective and safer oral hepatitis medicines, along with the promise of even more new medicines in the next few years.
"The WHO recommendations are based on a thorough review of the best and latest scientific evidence," says Dr Stefan Wiktor, who leads WHO's Global Hepatitis Programme. "The new guidance aims to help countries to improve treatment and care for hepatitis and thereby reduce deaths from liver cancer and cirrhosis."
WHO will be working with countries to introduce the guidelines as part of their national treatment programmes. WHO support will include assistance to make the new treatments available and consideration of all possible avenues to make them affordable for all. WHO will also assess the quality of hepatitis laboratory tests and generic forms of hepatitis medicines.
"Hepatitis C treatment is currently unaffordable to most patients in need. The challenge now is to ensure that everyone who needs these drugs can access them," says Dr Peter Beyer, Senior Advisor for the Essential Medicines and Health Products Department at WHO. "Experience has shown that a multi-pronged strategy is required to improve access to treatment, including creating demand for treatment. The development of WHO guidelines is a key step in this process."
Nine key recommendations
The new guidelines make nine key recommendations. These include approaches to increase the number of people screened for hepatitis C infection, advice as to how to mitigate liver damage for those who are infected and how to select and provide appropriate treatments for chronic hepatitis C infection.
WHO recommends a screening test for those considered at high risk of infection, followed by another test for those who screen positive, to establish whether they have chronic hepatitis C infection.
Mitigating liver damage
Since alcohol use can accelerate liver damage caused by hepatitis C, WHO now advises that people with chronic hepatitis C infection receive an alcohol assessment. The Organization also recommends providing counseling to reduce alcohol intake for people with moderate or high alcohol use. In addition, the guidelines provide advice on the selection of the most appropriate test to assess the degree of liver damage in those with chronic hepatitis C infection.
The guidelines provide recommendations on existing treatments based on interferon injections as well as the new regimens that use only oral medicines. WHO will update recommendations on drug treatments periodically as additional antiviral medicines are registered on the market and new evidence emerges.
The 2014 recommendations also summarize for policy makers and health care workers interventions that should be put in place to prevent transmission of hepatitis C, including measures to assure the safety of medical procedures and injections in health care settings and among persons who inject drugs. Rates of new hepatitis C infections remain unacceptably high in many countries because of the reuse of injection equipment and lack of screening of blood transfusions.
"Many people remain unaware - sometimes for decades - that they are infected with hepatitis C," says Dr Andrew Ball, Senior Advisor for Policy, Strategy and Equity for WHO's HIV/AIDS Department where the Global Hepatitis Programme is housed. "Today's launch highlights the need for more awareness and education on hepatitis for the general public. Greater awareness on the risks associated with hepatitis C should lead to a demand for services and expansion of laboratory capacity and clinical services so that more people can be tested, treated and cured."
There are five main hepatitis viruses, referred to as types A, B, C, D and E. Hepatitis B and C have the greatest public health impact because they cause chronic infection which can progress to cirrhosis and liver cancer. Hepatitis A and E, spread though unsafe water and contaminated food, have the potential to cause outbreaks in certain populations.
Hepatitis C virus is most commonly transmitted through exposure to contaminated blood. Those at risk include people undergoing invasive medical procedures and therapeutic injections where there is poor infection control. Also at risk are those exposed to contaminated injecting and skin piercing equipment, including through injecting drug use, tattooing and body piercing.
The WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection were launched on the eve of the opening of the 2014 International Liver Congress, attended by around 10 000 delegates in London.
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