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Dolutegravir / abacavir / lamivudine fixed combination (Triumeq) for HIV: Dolutegravir / abacavir / lamivudine for initial treatment in adults with HIV infection

In 2014 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assessed which advantages and disadvantages dolutegravir / abacavir / lamivudine has compared with previous standard therapies in people who are having initial treatment for HIV. A study looking at efavirenz provided results which were used for a comparison of the two drugs. The patient group that was treated using efavirenz also received the fixed combination tenofovir / emtricitabine.A total of 844 people participated in the study, with one half of them receiving dolutegravir / abacavir / lamivudine and the other half efavirenz / tenofovir / emtricitabine. All data was analyzed after 20 months.The following results apply to people who have not yet taken any other medication to treat HIV.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: January 2, 2015

Dolutegravir (Tivicay) for HIV infection: Dolutegravir for additional treatment in adults with HIV infection

In the spring of 2014 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assessed which advantages and disadvantages dolutegravir has compared with previous standard therapies in people who have already had medical treatment for HIV. One study was available to IQWiG for the purpose of this assessment. This study involved adults with HIV who had already had HIV therapy and were resistant to at least two HIV drugs.Participants in the study were divided into two groups. One group used dolutegravir, and the other was given the drug raltegravir. Both groups also received two additional drugs to treat HIV which were selected based on individual needs. A total of 724 people participated in this study and all data was analyzed after 48 weeks.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: May 15, 2014

Dolutegravir (Tivicay) for HIV infection: Dolutegravir for first treatment in adults with HIV infection

In the spring of 2014 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assessed which advantages and disadvantages dolutegravir has compared with previous standard therapies in people who are having initial treatment for HIV. The assessment was based on two relevant studies comparing dolutegravir with efavirenz. One study compared two groups who took both dolutegravir and a fixed combination of either abacavir / lamivudin or tenofovir / emtricitabin. In the other study, one group used dolutegravir with the fixed combination of abacavir / lamivudin, while the other group was given the fixed combination of efavirenz / tenofovir / emtricitabin.The first study included 103 people in its analysis, and the second study involved 844 participants. The study data were analyzed after 96 weeks.The following results apply to people who have not yet taken any other medication to treat HIV.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: May 15, 2014

When is the best time to start antiretroviral therapy in people with HIV, who also have cryptococcal disease infection of the brain and spinal cord?

Antiretroviral therapy (ART) has been shown to be effective in slowing down the progression of AIDS and in reducing HIV‐related illnesses and death. Currently, this therapy is given based on a patient’s CD4 cell count (the body's defense system). An HIV‐infected individual whose meninges (the membranes covering the brain and spinal cord) are also infected by a fungus called Cryptococcus neoformans is considered very sick with his/her immune system severely weakened, and therefore will require ART.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Antifungal interventions for the primary prevention of cryptococcal disease in adults with HIV

Infection with the human immunodeficiency virus (HIV) leads to progressive destruction and weakening of the body's immune system. Patients with advanced HIV disease are vulnerable to various diseases, called opportunistic infections (OIs), which most people with normal immune systems are protected against. One of these OIs, a fungal disease called cryptococcosis, causes meningitis (an inflammation of the membrane surrounding the brain) and pneumonia and is lethal when untreated. This study looked at two medications, itraconazole and fluconazole, which could be taken by patients with advanced HIV disease, to prevent this fungal infection from ever occurring. This study found that both were effective drugs for preventing cryptococcal disease. However, these drugs were not found to be effective in decreasing the overall death rates from HIV. More studies of these medications are needed to further evaluate their cost‐effectiveness and benefits in decreasing death rates in groups of patients with HIV.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Muscle stimulation for weakness in adults with advanced disease

Individual studies suggest that the use of neuromuscular electrical stimulation, or NMES, may help improve muscle weakness which occurs as a consequence of a progressive disease. NMES uses a lightweight stimulator unit and skin electrodes to produce a muscle contraction. Being a passive form of exercise, it allows patients to exercise their leg muscles at home and unsupervised. This may be particularly helpful for patients who are unable to take part in existing forms of exercise, for example, because of breathlessness or fatigue.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Sargramostim (GM‐CSF) for induction of remission in Crohn's disease

Crohn's disease is a chronic inflammatory condition of the gut. New theories regarding the cause of this inflammation has led some investigators to think it is a weak immune system, rather than an overactive one, that leads to this condition. They tested this idea using a drug called sargramostim, which boosts the immune system, in patients with Crohn's disease. This review of three studies did not show any difference in effectiveness between sargramostim and placebo (fake drug) for induction of remission or clinical improvement in patients with active Crohn's disease. Side effects associated with sargramostim treatment included bone pain, musculoskeletal chest pain, and dyspnea (shortness of breath). Due to the fact that there were only a small number of trials in this area and some of them give opposite results, the authors concluded that while sargramostim does not appear to be more effective than placebo more research is needed to determine if this drug provides a benefit for the treatment of active Crohn's disease.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Therapies for BCG induced disease in children

Bacillus Calmette‐Guérin (BCG) is a widely used tuberculosis vaccine derived from a non‐infectious strain of the bovine tuberculosis bacillus (Mycobacterium bovis) and mainly given to young children. Usually, the only adverse reaction to the vaccine is an ulcer at the site of injection, which may leave a small scar.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Fixed‐dose combination therapy for the prevention of cardiovascular disease

Cardiovascular diseases (CVD), including heart attacks and strokes, are the leading cause of death and disability worldwide. Drug therapy with blood pressure and cholesterol lowering medications, particularly statins, have been proven to reduce the likelihood that individuals will experience a fatal or non‐fatal cardiovascular event. Aspirin has also been proven to prevent heart attacks, certain types of strokes, and death in people with prior cardiovascular disease. The concept of fixed‐dose combination therapy is to combine mulitple medications in a single pill as this has been shown to improve adherence in patients with high blood pressure and human immunodeficiency virus (HIV). There have been recent randomised controlled clinical trials to evaluate the effect of fixed‐dose combination therapy for CVD prevention. The aim of this systematic review was to determine the effects of fixed‐dose combination therapy on all‐cause mortality, fatal and non‐fatal CVD events, adverse events, blood pressure, lipids, discontinuation rates, quality of life, and costs for CVD prevention.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Primary CNS Lymphoma Treatment (PDQ®): Patient Version

Expert-reviewed information summary about the treatment of primary CNS lymphoma.

PDQ Cancer Information Summaries [Internet] - National Cancer Institute (US).

Version: February 20, 2015

Testing Treatments: Better Research for Better Healthcare. 2nd edition

How do we know whether a particular treatment really works? How reliable is the evidence? And how do we ensure that research into medical treatments best meets the needs of patients? These are just a few of the questions addressed in a lively and informative way in Testing Treatments. Brimming with vivid examples, Testing Treatments will inspire both patients and professionals.

Pinter & Martin.

Version: 2011
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Interventions for treating HIV‐associated nephropathy

HIV‐associated nephropathy (HIVAN) is a kidney disease common among HIV positive patients, especially patients of African origin. The condition rapidly deteriorates if left untreated. Various treatment options exist, but the benefit of each is unknown. These include: antiretroviral therapy, steroids, angiotensin‐converting enzyme inhibitors (ACEi) and cyclosporin. The aim of this review was to determine the benefits and harms of each treatment option. No completed randomised control trials (RCT) of any interventions for HIVAN were found and so the effects of the treatment options could not be evaluated. However, the results of observational studies identified showed that steroids and ACEI were beneficial in improving the kidney functions of patients. We await the results of three ongoing studies, however more RCTs are needed.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Managing weight loss and fatigue in advanced illness

Fatigue and unintentional weight loss are two of the commonest symptoms experienced by people with advanced progressive illness and can be of great concern to those affected and of even greater concern to formal and informal caregivers. No robust information currently exists on optimal interventions to manage fatigue and/or weight loss in any advanced progressive illness. This overview presents what we know from research held within Cochrane systematic reviews on treatments to manage these symptoms in non curative illnesses such as advanced cancer, heart failure, lung failure, cystic fibrosis, multiple sclerosis, motor neuron disease, Parkinson's disease, dementia and acquired immune deficiency syndrome (AIDS).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Treatment for leiomyosarcoma and leiomyoma in children with HIV infection

There is a lack of reliable evidence on interventions for treating leiomyosarcoma and leiomyoma in children with HIV/AIDS. Smooth muscle tumour (SMT) is a type of cancer composed of leiomyoma and leiomyosarcoma. Although there are many more cases among adults with HIV infection than with children, an increasing number of SMTs have been described in HIV‐infected children. Leiomyosarcoma has become the second most frequent malignancy in children with HIV infection or other immunodeficiency diseases in the United States; however, there is a lack of uniform and effective therapies and their efficacy and safety still are unknown. No randomised controlled trials and clinical controlled trials of interventions for leiomyosarcoma and leiomyoma in children with AIDS were found that rigorously evaluated effectiveness.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2010

Interventions for untreated patients with AIDS‐associated non‐Hodgkin's lymphoma

Lymphoma is a cancer of the lymphatic system. There are two general types: Hodgkin's disease (HD) and non‐Hodgkin's lymphoma (NHL). Non‐Hodgkin's lymphoma is the most common AIDS‐defining malignancy in HIV‐infected patients. The most frequent clinical presentations of NHL during AIDS are systemic illness with the compromise of the primary central nervous system and with primary effusion. In people with HIV infection, most lymphomas have originated in an aggressive B‐cell precursor and have a high‐to‐intermediate histology grade. Randomised controlled trials (RCTs) of different interventions for treating AIDS‐associated NHL found unclear evidence for efficacy and safety.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

A daily low dose of cotrimoxazole for preventing opportunistic infections in adults with HIV

Cotrimoxazole helps to prevent infections in adults who are HIV‐infected but may increase resistance to the drug and more trials are needed.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Interventions for the prevention of mycobacterium avium complex in adults and children with HIV

Mycobacterium avium complex (MAC) infection is a common complication of advanced acquired immunodeficiency syndrome (AIDS) disease and can shorten the survival of these patients. We sought to examine effectiveness of all drugs for preventing MAC infection in adults and children with HIV infection. This review included eight trials conducted in the USA and Europe, published between 1993 and 2003.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

The role of chemotherapy additional to high‐dose methotrexate for treatment of patients with primary central nervous system lymphoma

Primary central nervous system lymphoma (PCNSL) is a malignant disease of the lymphatic system that accounts for about 2% to 5% of all primary intracranial tumours in immunocompetent patients. It is a form of extranodal non‐Hodgkin lymphoma (NHL) and appears at a median age of 62 years. PCNSL is a rare disease with an incidence of 2.7 cases per million population per year, but since the 1990s the occurrence of it has increased in immunocompetent as well as immunocompromised (mostly human immunodeficiency virus (HIV)‐infection related) populations. Symptoms of PCNSL can present manifold though the usual signs are neurological deficits, neuropsychiatric symptoms and raised intracranial pressure. Despite improved treatment strategies, overall survival is still poor and a standard of care for PCNSL patients has not been defined yet. However, high‐dose methotrexate (HD‐MTX) with additional chemotherapy is considered to increase overall survival although the value of additional chemotherapy remains unclear, as there is evidence of a higher risk of adverse events. In this systematic review we summarised and analysed the evidence from randomised controlled trials (RCTs) on efficacy and safety of methotrexate combined with additional chemotherapy in the treatment of adult, immunocompetent PCNSL patients regarding overall survival, progression‐free survival, response rate, adverse events, treatment‐related mortality and quality of life. We searched several important medical databases such as CENTRAL and MEDLINE and found one RCT with 79 patients that fulfilled our inclusion criteria. As a result, this review shows that patients treated with methotrexate plus cytarabine compared to high‐dose methotrexate alone have a statistically significant improvement in progression‐free survival and response rate. No statistically significant difference is shown for overall survival. Adverse events, especially infections, hepatotoxicity and haematological toxicities are more common in patients undergoing therapy with methotrexate plus cytarabine, although there are no differences in terms of treatment‐related mortality. Owing to the small number of included trials and patients, the findings in this review remain uncertain and more RCTs with enlarged numbers of patients and longer follow‐up periods are needed. However, the one analysed study demonstrated that RCTs are feasible on patients with this rare disease and should concentrate on overall survival.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

PRO 140 for treatment of people with HIV infection

PRO 140 (a humanized form of the PA14 antibody, a monoclonal CCR5 antibody) is a laboratory made antibody that blocks the CCR5 receptor on CD4 cells. By blocking CCR5, PRO 140 prevents the HIV virus from infecting healthy cells. PRO 140 may be an effective new treatment drug because it has the potential to address the limitations of currently available therapies for HIV‐infected patients. PRO 140 has emerged as an important new therapy and has entered testing.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Immunoglobulins (human serum immune gamma globulins) seem effective for prevention of hepatitis A

Hepatitis A is a common, contagious viral disease in low‐income countries. Hepatitis A is transmitted primarily by faecal‐oral spread from person to person. Passive immunoprophylaxis for hepatitis A using immunoglobulin preparations were essential for prevention before development of specific hepatitis A vaccine (active immunisation). This review concludes that immunoglobulins seem effective for preventing hepatitis A in both children and adults. However, the evidence, on which the conclusion is based, is not strong as the included trials appear to have risk of bias and their number is insufficient. Because there is a potential risk of blood‐borne diseases from immunoglobulins preparations, such as human immunodeficiency virus, and because of the availability of hepatitis A vaccine, the use of immunoglobulins has become limited. However, their use is still required in some specific populations, such as persons with compromised immune function, children under one year of age, or persons who have not developed a full response to vaccine immunisation. Future clinical trials should address the benefit and harm of immunoglobulins in these populations.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2010

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