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Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study.

BACKGROUND: Dolutegravir (S/GSK1349572) is a once-daily HIV integrase inhibitor with potent antiviral activity and a favourable safety profi … ir (50 mg once daily) or raltegravir (400 mg twice daily). Study drugs were given with coformulated tenofovir/emtricitabine or abacavir/lamivudine. Randomisation was stratified by screening HIV-1 RNA (≤ 100,000 copies per mL or >100,000 copies per mL) and nucleoside reverse transcriptase inhibitor backbone. Investigators were not masked to HIV-1 RNA results …

Progressive disseminated histoplasmosis with concomitant disseminated nontuberculous mycobacterial infection in a patient with AIDS from a nonendemic region (California).

BACKGROUND: Opportunistic infections, while well studied in the AIDS population, continue to have variable and surprising presentations. Here, we present a case of disseminated histoplasmosis with disseminated nontuberculous mycobacterial infection in a 50 year old man with long standing AIDS living in a non-endemic area. CASE PRESENTATION: Patient presented with a constellation of symptoms, and imaging of the chest showed a pulmonary mass with cavitation, multiple nodules, and ground glass opacities. Further investigations revealed granulomatous lung nodules and fungemia consistent with Hist

Introduction of a nomogram for predicting adverse pregnancy outcomes based on maternal serum markers in the quad screen test.

PURPOSE: The aim of this study was to develop a nomogram that can calculate a total score, derived from each serum marker in the quad screen test, for systematically predicting adverse pregnancy outcomes (APOs). METHODS: We retrospectively reviewed 3684 singleton pregnant women who underwent a quad screen test and gave birth at a single medical centre from January 2005 to December 2010. The serum marker data from the quad screen test and pregnancy outcomes were used to construct logistic regression models for predicting the risks of APOs. APO was defined as the presence of at least one of the

Extensive brain masses and cavitary lung lesions associated with toxoplasmosis and acquired immunodeficiency syndrome.

Toxoplasmosis is an important cause of enhancing brain lesions in patients with acquired immunodeficiency syndrome (AIDS), and it is typically associated with low CD4-lymphocyte counts. Extensive toxoplasma encephalitis when the CD4-lymphocyte count is above 100 cells/µl is unusual. Cavitary lung lesions are also not typically associated with toxoplasmosis. Here, we present a case of toxoplasmosis associated with extensive brain masses and cavitary lung lesions, both of which improved with directed toxoplasmosis therapy, in an AIDS patient with a CD4 cell count of 120 cells/µl.

Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial.

BACKGROUND: HIV antiretroviral therapy (ART) is often managed without routine laboratory monitoring in Africa; however, the effect of this approach is unknown. This trial investigated whether routine toxicity and efficacy monitoring of HIV-infected patients receiving ART had an important long-term effect on clinical outcomes in Africa. METHODS: In this open, non-inferiority trial in three centres in Uganda and one in Zimbabwe, 3321 symptomatic, ART-naive, HIV-infected adults with CD4 counts less than 200 cells per microL starting ART were randomly assigned to laboratory and clinical monitorin

Fanconi syndrome induced by adefovir dipivoxil: a case report and clinical review.

More than 150 cases of Fanconi syndrome (FS) or hypophosphatemia osteomalacia induced by low-dose adefovir dipivoxil (ADV) have been reported since 2002, when ADV was introduced for the long-term treatment of hepatitis B virus (HBV) infection. Because the life expectancy of HBV-infected individuals has increased, the adverse effects of long-term treatment with antiviral therapies are increasingly observed, and nephrotoxicity is one of the most severe adverse effects of ADV. Therefore, the number of cases may be far higher than reported. Moreover, ADV-induced FS is often misdiagnosed or diagnos

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… Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial . … Lancet Gastroenterol Hepatol 2016 ; 1 : E2 . 10.1016/S2468-1253(16)30107-8 28404092 50 Agarwal K Fung S Seto WK , et al A phase 3 study comparing tenofovir alafenamide (TAF) to tenofovir disoproxil fumarate (TDF) in patients with HBeAg-positive, chronic hepatitis B (CHB): efficacy and safety results …

COVID-19 in people living with HIV: Clinical implications of dynamics of the immune response to SARS-CoV-2.

Little evidence on coronavirus disease 2019 (COVID-19) in people living with HIV (PLWH) is currently available. We reported clinical and viroimmunological data of all HIV-positive patients admitted to our center with COVID-19 from March 1 to May 12, 2020. Overall, five patients were included: all were virologically-suppressed on antiretroviral therapy and CD4+ count was greater than 350 cell/mm3 in all but two patients. Although all patients had evidence of pneumonia on admission, only one developed respiratory failure. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA was never

Long-term follow-up of HBsAg-positive patients in Germany.

BACKGROUND: Little is known about the prognosis and complications of chronic hepatitis B in countries with low disease prevalence including Germany. MATERIALS AND METHODS: This retrospective/prospective study analyzes the course of 608 HBsAg-positive patients between 2002 and 2012 in Germany. The follow-up duration was 5.2±2.9 years (mean±SD) and the age of the patients was 40.4±13.8 years. Of the total cohort, 59.9% were men; 34.9% had been born in Germany, 30.4% in Turkey, and 34.7% in other countries. RESULTS: In 78.3% of women, diagnosis was made during pregnancy screening, which is the

Hypophosphatemic Osteomalacia Induced by Low-Dose Adefovir-Related Fanconi Syndrome.

Adefovir dipivoxil (ADV), an antiviral agent for chronic hepatitis B virus infection, has been associated with nephrotoxicity, particularly Fanconi syndrome, even at low doses (10 mg/day). Fanconi syndrome is a generalized proximal tubular dysfunction leading to phosphate wasting and hypophosphatemic osteomalacia. Here, the author reports a case of a 58-year-old man with a 2-year history of bone pain involving the left foot, upper back, and left scapula, later extending to the right foot and chest wall, without antecedent trauma. Magnetic resonance imaging revealed insufficiency fractures in b

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… Reported prevalence ranges from 20% to 53%, with fracture rates up to 11%, particularly higher among those treated with tenofovir disoproxil fumarate (TDF), another antiviral agent for chronic HBV infection. … Current guidelines recommend tenofovir alafenamide fumarate as a preferred option, given its potent antiviral activity and favorable renal and bone safety profile [ 12 , 18 , 19 ]. …

HIV-1 infection and the kidney: an evolving challenge in HIV medicine.

With the advent of highly active antiretroviral therapy (HAART), the incidence of opportunistic infections has declined substantially, and cardiovascular, liver, and renal diseases have emerged as major causes of morbidity and mortality in individuals with human immunodeficiency virus (HIV). Acute renal failure is common in HIV-infected patients and is associated with acute infection and medication-related nephrotoxicity. HIV-associated nephropathy is the most common cause of chronic kidney disease in HIV-positive African American populations and may respond to HAART. Other important HIV-assoc

Vitamin D Insufficiency/Deficiency in HIV-Infected Inner City Youth.

BACKGROUND: High prevalence of vitamin D deficiency among HIV-infected individuals has been reported in many studies. Increasing evidence fo … 9.47% ± 11.62%). The HIV plasma RNA was similar in all the groups. Our patients who were prescribed tenofovir (TDF) and/or efavirenz (EFV) did not have different vitamin D levels than patients who were prescribed other antiretroviral (ARV) medications. Only 60 (39.5%) of the 152 patients who received vitamin D supplement showed improvement in vitamin D leve …

Bone Disease in HIV: Need for Early Diagnosis and Prevention.

The transformation of HIV into a manageable chronic condition has unveiled new clinical challenges associated with aging-related pathologies, including bone disease. This review explores the intricate relationship between HIV, antiretroviral therapy (ART), and bone disease, highlighting the necessity of early diagnosis and preventative strategies to mitigate the increased risk of osteopenia, osteoporosis, and fractures in people living with HIV (PLWHIV). It synthesizes the current literature to elucidate the multifactorial etiology of bone pathology in this population, that includes direct vir

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… Fanconi syndrome due to tenofovir disoproxil fumarate reversed by switching to tenofovir alafenamide fumarate in an HIV-infected patient. Ther. Adv. Infect. Dis. 2018;5:91–95. doi: 10.1177/2049936118785497. 34. … Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: A randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect. …

Doravirine versus dolutegravir-based regimen in antiretroviral treatment-naive people living with HIV-1 (ANRS0392s ELDORADO): protocol for an international, open-label, randomised, non-inferiority, phase III trial.

INTRODUCTION: Increasing evidence suggests that dolutegravir (DTG), endorsed by the WHO since 2018 for first-line antiretroviral therapy (AR … pants will be randomised in a 1:1 ratio to receive either DOR 100 mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300 mg daily) plus lamivudine (3TC) (300 mg daily) or DTG (50 mg daily) in combination with TDF (300 mg once daily) plus either emtricitabine (FTC) (200 mg daily) or 3TC (300 mg daily). Randomisation will be stratified by …

Safety and efficacy of GST-HG141, a novel HBV capsid assembly modulator, for the treatment of chronic hepatitis B patients with low-level viremia: a randomized, double-blind, placebo-controlled, multicenter phase II study.

BACKGROUND: Chronic hepatitis B (CHB) remains a major global health challenge with no curative therapies. Approximately 15-40% of patients treated with current standard-of-care antiviral therapies such as nucleos(t)ide analogs (NUCs), including entecavir (ETV) and tenofovir (TDF/TAF), fail to fully suppress serum HBV DNA, resulting in persistent low-level viremia (LLV), which is associated with increased risks of cirrhosis, liver failure, and hepatocellular carcinoma. GST-HG141, a novel HBV capsid assembly modulator, previously demonstrated favorable safety and antiviral activity in a Phase Ib…

Efficacy, Convenience, Safety and Durability of DTG-Based Antiretroviral Therapies: Evidence from a Prospective Study by the Italian MaSTER Cohort.

Background: Dolutegravir (DTG) is recommended by international guidelines as a main component of an optimal initial regimen of cART (combina … ors for poor performance of DTG-containing-regimens were found to be: a backbone regimen containing tenofovir, being cART naïve, having detectable HIV RNA at baseline, FIB-4 score above 3.25 and having a cancer diagnosis. By contrast, protective factors were found to be: higher CD4+ T-cell counts and higher CD4/CD8 ratio at baseline. Conclusion: DTG-based r …

Current landscape of innovative drug development and regulatory support in China.

The global pharmaceutical landscape remains dynamic and competitive, shaped by advancements in first-in-class therapies and breakthrough technologies. The United States has maintained its leadership in first-in-class therapies and breakthrough technologies, driven by advanced regulatory pathways, significant multinational corporation investments, a robust Research and Development (R&D) workforce, and continuous technological innovation. Additionally, global impact of the Food and Drug Administration (FDA) is further amplified through collaborations like Project Orbis, which facilitates simulta

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… Among them, Coblopasvir Hydrochloride Capsules 269 – 272 is the first domestically developed broad-spectrum anti-HCV drug, Tenofovir Amibufenamide Tablets 273 – 280 is the first domestically developed small-molecule anti-HBV drug, and Ainuovirine 281 – 288 is the first domestically developed novel anti-HIV …

What is the treatment of tracheal lesions associated with traditional thyroidectomy? Case report and systematic review.

INTRODUCTION: Novel plant DING proteins (full-length 38 kDa p38SJ, and 27 kDa p27SJ) exhibit phosphatase activity and modulate HIV-1 gene tr … esses HIV-1 infection. DING protein improved inhibitory effects of the known anti-retroviral drugs, Tenofovir (TFV) and Emtricitabine (FTS) on HIV-1, since in the combination with these drugs; the suppression of HIV-1 by DNG was significantly higher when it was in combination with these drugs, compared to controls or cases without DING. Thus, our data suppo …

Geographic and temporal trends in the molecular epidemiology and genetic mechanisms of transmitted HIV-1 drug resistance: an individual-patient- and sequence-level meta-analysis.

BACKGROUND: Regional and subtype-specific mutational patterns of HIV-1 transmitted drug resistance (TDR) are essential for informing first-l … hereas only 27% of NRTI SDRMs were associated with high-level resistance to zidovudine, lamivudine, tenofovir, or abacavir. Of 763 viruses with TDR in SSA and SSEA, 725 (95%) were genetically dissimilar; 38 (5%) formed 19 sequence pairs. Inherent limitations of this study are that some cohorts may not represent the broader regional population and that studi …

Profile of elderly patients receiving antiretroviral therapy at Newlands Clinic in 2020: A cross-sectional study.

BACKGROUND: People living with HIV (PLWH) face new challenges such as accelerated ageing and higher rates of comorbidities including cardiovascular, renal and metabolic diseases as they age. OBJECTIVES: To profile the demographic and clinical characteristics of elderly patients receiving HIV care at Newlands Clinic (NC), Harare, Zimbabwe, as of 01 October 2019. METHODS: A cross-sectional analysis was conducted using clinic data. All patients who were 50 years and older on 01 October 2019 were enrolled. Descriptive statistics (medians, interquartile ranges [IQRs] and proportions) were used to

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… Most patients (64.1%) received the fixed dose ART combination of tenofovir, lamivudine and dolutegravir. TABLE 1 Demographic and clinical characteristics of elderly patients receiving antiretroviral therapy at Newlands Clinic in March 2020, by sex. … /ritonovir; DTG, dolutegravir. † , Either nevirapine or efavirenz. ‡ , Tenofovir, lamivudine and dolutegravir. § , Atazanavir/ritonavir. ¶ , Lopinavir/ritonavir. †† , Dolutegravir. …

HBV Reactivation During the Treatment of Non-Hodgkin Lymphoma and Management Strategies.

Hepatitis B virus reactivation (HBV-R), which can lead to HBV-related morbidity and mortality, is a common and well-known complication that occurs during the treatment of non-Hodgkin lymphoma (NHL) patients with current or past exposure to HBV infection. HBV-R is thought to be closely associated with chemotherapeutic or immunosuppressive therapies. However, immunosuppressive agents such as anti-CD20 antibodies (e.g., rituximab and ofatumumab), glucocorticoids, and hematopoietic stem cell transplantation (HSCT) administered to NHL patients during treatment can cause deep immunodepression and pl

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… Entecavir and Tenofovir ETV and tenofovir disoproxil fumarate are new-generation NAs that have a high barrier to drug resistance and superior viral suppressive capability ( 23 , 86 – 88 ). … In a study conducted to evaluate the effectiveness of tenofovir for the treatment of HBV-R in patients undergoing immunosuppressive treatment, 25 of 38 patients were given tenofovir as prophylaxis, and 13 were administered the drug as pre-emptive therapy. …