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Treats HIV infection and hepatitis B virus (HBV). HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

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Comparison of the efficacy of tenofovir and adefovir in the treatment of chronic hepatitis B: a systematic review

Chronic viral hepatitis B remains a global public health concern. Currently, several drugs, such as tenofovir and adefovir, are recommended for treatment of patients with chronic hepatitis B. tenofovir is a nucleoside analog with selective activity against hepatitis b virus and has been shown to be more potent in vitro than adefovir. But the results of trials comparing tenofovir and adefovir in the treatment of chronic hepatitis B were inconsistent. However, there was no systematic review on the comparison of the efficacy of tenofovir and adefovir in the treatment of chronic hepatitis B. To evaluate the comparison of the efficacy of tenofovir and adefovir in the treatment of chronic hepatitis B we conducted a systematic review and meta-analysis of clinical trials. We searched PUBMED, Web of Science, EMBASE, CNKI, VIP database, WANFANG database, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Review. Finally six studies were left for analysis which involved 910 patients in total, of whom 576 were included in tenofovir groups and 334 were included in adefovir groups. At the end of 48-week treatment, tenofovir was superior to adefovir at the HBV-DNA suppression in patients[RR = 2.59; 95%CI(1.01-6.67), P = 0.05]. While there was no significant difference in the ALT normalization[RR = 1.15; 95%CI(0.96-1.37), P = 0.14], HBeAg seroconversion[RR = 1.32; 95%CI(1.00-1.75), P = 0.05] and HBsAg loss rate[RR = 1.19; 95%CI(0.74-1.91), P = 0.48]. More high-quality, well-designed, randomized controlled, multi-center trails are clearly needed to guide evolving standards of care for chronic hepatitis B.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2011

Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients

BACKGROUND: The efficacy of tenofovir disoproxil fumarate (TDF) as part of combination antiretroviral treatment (ART) has been demonstrated in several randomized, controlled trials. However, an increasing number of case reports suggest that TDF use may be associated with significant nephrotoxicity. Our objective was to determine the renal safety of TDF-containing ART regimens for HIV-infected individuals.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

Tenofovir and entecavir are the most effective antiviral agents for chronic hepatitis B: a systematic review and Bayesian meta-analyses

The authors concluded that over a one year period, tenofovir and entecavir were the most potent oral antiviral agents for HBeAg-positive chronic hepatitis B patients and tenofovir for HBeAg-negative patients. Potential for language bias, uncertain study quality, a small number of studies available for comparisons and limitations inherent with network analysis mean the authors’ conclusions should be interpreted with caution.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

Safety of tenofovir during pregnancy for the mother and fetus: a systematic review

Tenofovir disoproxil fumarate (TDF) safety during pregnancy has important public health implications. This review summarizes TDF safety during pregnancy, focusing on pregnancy outcomes, congenital anomaly risk, and other potential toxicities on neonates. Although information is limited, TDF appears to be safe during pregnancy. In 6 studies of human immunodeficiency virus type 1 (and/or hepatitis B virus)-infected women receiving TDF during pregnancy, adverse events were mild to moderate; none were considered to be TDF-related. Five studies that followed in utero TDF-exposed infants showed no increased risk of growth or bone abnormalities. One study showed slightly lower infant height at age 1 year, but the significance is unclear. The Antiretroviral Pregnancy Registry database, with 1800 pregnancies exposed to TDF in the first trimester, does not indicate increased congenital anomaly risk with TDF exposure. More evidence collected prospectively, ideally with bone density measurements and randomized trial design, will be optimal to determine the effects of antenatal TDF exposure on children's health.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Comparing initial antiretroviral regimens tenofovir or zidovudine as part of three‐drug combinations for treatment of HIV infection

The introduction of highly active antiretroviral therapy (ART) as treatment for HIV infection has greatly improved mortality and morbidity for adults and adolescents living with HIV around the world. Deciding which treatment regimen to begin for first‐line treatment in ART‐naïve patients, however, remains a significant challenge. Two commonly used medications are tenofovir (TDF) and zidovudine (AZT). The purpose of this review was to assess which of these two medications was the best for initial treatment for people living with HIV, and through our search we identified two randomised controlled trials. We did not find any critical difference between the two medications in regards to serious adverse events or virologic response, but did find that TDF is superior to AZT in terms of immunologic response and adherence and more frequent emergence of resistance. However, these two studies are not directly comparable because they used two related different drugs in addition to TDF and AZT. Future studies and recommendations should focus on specific toxicities and tolerability when comparing these two medications.

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

Version: 2011

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

Management of Chronic Hepatitis B

Synthesize evidence of the natural history of chronic hepatitis B (CHB) and effects and harms of antiviral drugs on clinical, virological, histological, and biochemical outcomes.

Evidence Reports/Technology Assessments - Agency for Healthcare Research and Quality (US).

Version: October 2008
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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

Virological efficacy of abacavir: systematic review and meta-analysis

OBJECTIVES: The efficacy of abacavir/lamivudine has been reported to be inferior to tenofovir/emtricitabine. Several randomized clinical trials (RCTs) investigated the effectiveness and safety of abacavir/lamivudine and tenofovir/emtricitabine combined antiretroviral treatment (cART) and we have reviewed the available evidence.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Comparative efficacy of oral nucleoside or nucleotide analog monotherapy used in chronic hepatitis B: a mixed-treatment comparison meta-analysis

STUDY OBJECTIVE: To compare the efficacy of nucleoside or nucleotide analog monotherapy for the treatment of chronic hepatitis virus B (HBV) with adefovir dipivoxil, entecavir, lamivudine, telbivudine, and tenofovir disoproxil fumarate.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Topical microbicides for prevention of sexually transmitted infections

Microbicide research has had disappointing outcomes during the last two decades as most microbicides have not shown evidence that they can prevent acquisition of sexually transmitted infections (STIs), including human immunodeficiency virus (HIV). However, a recent small preliminary study suggests that microbicides containing the antiretroviral drug tenofovir may prevent acquisition of HIV and herpes simplex virus infection in women; but further research is needed to assess the generalisability of these findings. Therefore, there is not enough evidence to recommend topical microbicides for HIV or STI prevention at present.

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

Version: 2012

Relative risk of renal disease among people living with HIV: a systematic review and meta-analysis

BACKGROUND: Antiretroviral therapy (ART) has substantially decreased mortality and HIV-related morbidity. However, other morbidities appear to be more common among PLHIV than in the general population. This study aimed to estimate the relative risk of renal disease among people living with HIV (PLHIV) compared to the HIV-uninfected population.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

The importance of baseline viral load when assessing relative efficacy in treatment-naive HBeAg-positive chronic hepatitis B: a systematic review and network meta-analysis

BACKGROUND: To date no network meta-analysis (NMA) has accounted for baseline variations in viral load when assessing the relative efficacy of interventions for chronic hepatitis B (CHB). We undertook baseline-adjusted and unadjusted analyses using the same data to explore the impact of baseline viral load (BVL) on CHB treatment response.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Meta-analysis: oral anti-viral agents in adults with decompensated hepatitis B virus cirrhosis

BACKGROUND: The optimal oral anti-viral agent to use in patients with decompensated HBV cirrhosis remains unclear.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Comparative efficacy of nucleoside/nucleotide reverse transcriptase inhibitors in combination with efavirenz: results of a systematic overview

BACKGROUND: Many trials of antiretroviral therapy in treatment-naïve subjects have investigated the relative efficacy of the third drug in a treatment regimen. However, the nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) components may also affect efficacy.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2007

ACIDFORM: a review of the evidence

OBJECTIVE: ACIDFORM is a candidate microbicide with spermicidal properties. A large Phase 3 trial is underway, and it is anticipated that this product will be approved for contraceptive use and marketed soon in the United States. The goal of this article is to critically review the evidence supporting the properties, safety profile and different uses of ACIDFORM gel.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Effects of first-line use of nucleoside analogues, efavirenz, and ritonavir-boosted protease inhibitors on lipid levels

This review found that there was a wide range of lipid elevations during 48 weeks of ritonavir-boosted protease inhibitors or efavirenz in antiretroviral-naive patients, depending on the type of antiretrovirals used. The reliability of the conclusions is unclear due to a lack of reporting of the review process, lack of validity assessment, and unclear suitability of the data synthesis methods.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

Comparative efficacy of Lamivudine and emtricitabine: a systematic review and meta-analysis of randomized trials

INTRODUCTION: Lamivudine and emtricitabine are considered equivalent by several guidelines, but evidence of comparable efficacy is conflicting.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Systematic review of antiretroviral-associated lipodystrophy: lipoatrophy, but not central fat gain, is an antiretroviral adverse drug reaction

BACKGROUND: Lipoatrophy and/or central fat gain are observed frequently in patients on antiretroviral therapy (ART). Both are assumed to be antiretroviral adverse drug reactions.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

The importance of baseline viral load when assessing relative efficacy in treatment-naive HBeAg-positive chronic hepatitis B: a systematic review and network meta-analysis

This review's conclusions emphasised the importance of adjusting for baseline viral load when assessing the relative efficacy of chronic hepatitis B treatments in achieving an undetectable viral load. These conclusions are likely to be reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

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