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Chronic hepatitis B describes a spectrum of disease usually characterised by the presence of detectable hepatitis B surface antigen (HBsAg) in the blood or serum for longer than 6 months. In some people, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC). The progression of liver disease is associated with hepatitis B virus (HBV) DNA levels in the blood. Without antiviral treatment, the 5-year cumulative incidence of cirrhosis ranges from 8 to 20%. People with cirrhosis face a significant risk of decompensated liver disease if they remain untreated. Five-year survival rates among people with untreated decompensated cirrhosis can be as low as 15%. Chronic hepatitis B can be divided into e antigen- (HBeAg) positive or HBeAg-negative disease based on the presence or absence of e antigen. The presence of HBeAg is typically associated with higher rates of viral replication and therefore increased infectivity.

NICE Clinical Guidelines - National Clinical Guideline Centre (UK).

Version: June 2013

The aim of this report is to assess the added benefit of rilpivirine compared to efavirenz as appropriate comparator therapy (ACT) for the “treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/mL”. The assessment was carried out in comparison with efavirenz as ACT with respect to patient-relevant outcomes. This deviates from the specification of the Federal Joint Committee, because the latter designates efavirenz in combination with two nucleoside reverse transcriptase inhibitors (NRTIs; tenofovir / emtricitabine or abacavir / lamivudine) as ACT. However, in the Institute’s view, it is not necessary to specify the particular backbone therapy of efavirenz for this assessment. The resulting wider consideration of backbone therapies does not contravene the approval status of rilpivirine. Only randomized controlled trials (RCTs) with a direct comparator were included in the assessment.

Institute for Quality and Efficiency in Health Care (IQWiG).

Version: April 12, 2012

The aim of this report is to assess the added benefit of EVG / COBI / FTC / TDF compared with the appropriate comparator therapy (ACT) in adults infected with human immunodeficiency virus type 1 (HIV-1).

Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 12, 2013

In 2004, the U.S. Preventive Services Task Force (USPSTF) recommended against screening asymptomatic persons in the general population for hepatitis B virus (HBV).

Evidence Syntheses - Agency for Healthcare Research and Quality (US).

Version: May 2014

In this new consolidated guidelines document on HIV prevention, diagnosis, treatment and care for key populations, the World Health Organization brings together all existing guidance relevant to five key populations – men who have sex with men, people who inject drugs, people in prisons and other closed settings, sex workers and transgender people – and updates selected guidance and recommendations.

World Health Organization.

Version: 2016

This early-release guideline makes available two key recommendations that were developed during the revision process in 2015. First, antiretroviral therapy (ART) should be initiated in everyone living with HIV at any CD4 cell count. Second, the use of daily oral pre-exposure prophylaxis (PrEP) is recommended as a prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches. The first of these recommendations is based on evidence from clinical trials and observational studies released since 2013 showing that earlier use of ART results in better clinical outcomes for people living with HIV compared with delayed treatment. The second recommendation is based on clinical trial results confirming the efficacy of the ARV drug tenofovir for use as PrEP to prevent people from acquiring HIV in a wide variety of settings and populations.

World Health Organization.

Version: September 2015

The study found that treating all patients with chronic hepatitis C without a prior non-invasive liver test (NILT) is cost-effective; however, recently approved interferon-free regimens were not included. For hepatitis B e antigen (HBeAg)-negative patients, this strategy is cost-effective only if the higher cost-effectiveness threshold is appropriate. For HBeAg-positive patients, two NILTs applied sequentially were cost-effective but highly uncertain. No conclusive results could be obtained for alcoholic and non-alcoholic fatty liver disease. Most studies evaluating non-invasive fibrosis tests had a high risk of bias.

Health Technology Assessment - NIHR Journals Library.

Version: January 2015

In April 2013 NHS England became responsible for commissioning all health services for people in prison in England. Healthcare in prison has a very important role in identifying significant health needs, maintaining health and detecting chronic conditions. This guideline supports equivalence of healthcare in prisons, a principle whereby health services for people in prisons are provided to the same standard, quality and to the same specification as for patients in the wider NHS. Providing equivalence of care will aim to address health need, reduce health inequalities, prevent deterioration, reduce deaths due to natural causes and subsequently assist rehabilitation and reduce re offending. This approach takes into account the differences in client groups to support improved take up of services and contribute to health improvement of people in prison.

NICE Guideline - National Guideline Centre (UK).

Version: November 2016

The guideline covers the identification and assessment of suspected cirrhosis, monitoring to detect complications and management of complications such as ascites and hepatorenal syndrome and referral for tertiary care.

NICE Guideline - National Guideline Centre (UK).

Version: July 2016

This guideline makes recommendations on the prevention, diagnosis and management of latent and active tuberculosis (TB), including both drug susceptible and drug resistant forms of the disease. It covers the organisation of relevant TB services. It relates to activities undertaken in any setting in which NHS or public health services for TB are received, provided or commissioned in the public, private and voluntary sectors.

NICE Guideline - Internal Clinical Guidelines Team (UK).

Version: January 2016

To assess the benefits and harms of serologic screening and preventive interventions for genital herpes simplex virus (HSV) infection in asymptomatic adults, adolescents, and pregnant women.

Evidence Syntheses - Agency for Healthcare Research and Quality (US).

Version: December 2016

The objective of this systematic review was to assess the comparative efficacy and safety of currently available and emerging regimens for the treatment of chronic hepatitis C (CHC) infection (genotypes 1 to 6).

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: January 2016

Testing and diagnosis of hepatitis B (HBV) and C (HCV) infection is the gateway for access to both prevention and treatment services, and is a crucial component of an effective response to the hepatitis epidemic. Early identification of persons with chronic HBV or HCV infection enables them to receive the necessary care and treatment to prevent or delay progression of liver disease. Testing also provides an opportunity to link people to interventions to reduce transmission, through counselling on risk behaviours and provision of prevention commodities (such as sterile needles and syringes) and hepatitis B vaccination.

World Health Organization.

Version: February 2017

The field of HCV therapeutics continues to evolve rapidly and, since the World Health Organization (WHO) issued its first Guidelines for the screening, care and treatment of persons with hepatitis C infection in 2014, several new medicines have been approved by at least one stringent regulatory authority. These medicines, called direct-acting antivirals (DAAs), are transforming the treatment of HCV, enabling regimens that can be administered orally, are of shorter duration (as short as eight weeks), result in cure rates higher than 90%, and are associated with fewer serious adverse events than the previous interferon- containing regimens. WHO is updating its hepatitis C treatment guidelines to provide recommendations for the use of these new medicines.

World Health Organization.

Version: April 2016

This document is part of the process for improving the quality of care in family planning. Medical eligibility criteria for contraceptive use (MEC), the first edition of which was published in 1996, presents current WHO guidance on the safety of various contraceptive methods for use in the context of specific health conditions and characteristics. This is the fifth edition of the MEC – the latest in the series of periodic updates.

World Health Organization.

Version: 2015

Approximately 242,000 Canadians are infected with the hepatitis C virus (HCV), although there are believed to be a number of infected individuals who are unaware that they have HCV. Of those infected, approximately 25% clear infection spontaneously (range 15% to 45%) and the remainder develop chronic hepatitis C (CHC). There are six genotypes and treatment strategy tends to differ depending on genotype.

Rapid Response Report: Summary with Critical Appraisal - Canadian Agency for Drugs and Technologies in Health.

Version: June 23, 2014

A 2005 U.S. Preventive Services Task Force (USPSTF) review found good evidence that HIV screening tests are accurate and that identification of undiagnosed HIV infection and treatment of immunologically advanced disease is associated with substantial clinical benefits. However, it found insufficient evidence to estimate effects of diagnosis and subsequent interventions on transmission risks, or to estimate clinical benefits of antiretroviral treatment in patients with less immunologically advanced disease.

Evidence Syntheses - Agency for Healthcare Research and Quality (US).

Version: November 2012

A 2005 U.S. Preventive Services Task Force (USPSTF) review found good evidence that prenatal HIV screening is accurate and can lead to interventions that reduce the risk of mother-to-child transmission.

Evidence Syntheses - Agency for Healthcare Research and Quality (US).

Version: November 2012

Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice (3rd edition) (PCPNC), has been updated to include recommendations from recently approved WHO guidelines relevant to maternal and perinatal health. These include pre-eclampsia & eclampsia; postpartum haemorrhage; postnatal care for the mother and baby; newborn resuscitation; prevention of mother-to- child transmission of HIV; HIV and infant feeding; malaria in pregnancy, interventions to improve preterm birth outcomes, tobacco use and second-hand exposure in pregnancy, post-partum depression, post-partum family planning and post abortion care.

World Health Organization.

Version: 2015

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health.

National Academies Press (US).

Version: April 20, 2015

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