News

FDA issues Complete Response Letters for elvitegravir and cobicistat (Gilead Sciences)

Gilead Sciences, Inc. has announced that the company has received Complete Response Letters from the FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.

In its communications,the FDA states that it cannot approve the applications in their current forms. The letters state that during recent inspections, deficiencies in ...

CHMP recommends Stribild (Gilead Sciences) for the treatment of HIV

Gilead Sciences, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP), has adopted a positive opinion on the company's Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of ...

Phase III SAILING study of dolutegravir(ViiV) success in HIV-1

ViiV Healthcare has announced 24-week data from the Phase III SAILING (ING111762) study evaluating the investigational integrase inhibitor dolutegravir in patients with HIV-1 who are failing on current therapy, but had not been treated with an integrase inhibitor.

At 24 weeks, 79% of study participants receiving the once-daily dolutegravir regimen were virologically suppressed (HIV-1 RNA <50 c/mL) vs. ...

Phase IV study of Livalo (Eli Lilly/Kowa Pharmaceuticals) meets end point in patients with Dyslipidemia

Results of a Phase IV study evaluating the efficacy of Livalo (pitavastatin), from Eli Lilly/Kowa Pharmaceuticals, compared with pravastatin in reducing low-density lipoprotein cholesterol (LDL-C) in HIV-infected adults with Dyslipidemia has met its end point. Results showed that, after 12 weeks of therapy, pitavastatin had a significantly greater decrease in LDL-C compared with pravastatin (pitavastatin -49.4 mg/dL and pravastatin -33.6 ...

VOICE study of Truvada gel (Gilead Sciences) unsuccessful in HIV prevention

Anti retroviral therapy was applied in the VOICE study which used a vaginal gel containing tenofovir (Viread as a pill) and tenofovir-emtricitabine (Truvada) from Gilead Sciences. None of the treatments was effective in the VOICE study, mostly because patients failed to use the product daily. 315 out of 5029 women in the study were infected by HIV (5.7%).

Investigators ...

EC approve new strength Prezista (J&J Janssen Cilag) for AIDS patients

The European Commission has approved a new Prezista (darunavir) 800mg tablet, from J&J Janssen Cilag, allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in treatment-experienced and treatment-naive patients with no darunavir resistance-associated mutations. This new tablet strength has been developed to ...

FDA approves Fulyzaq (Salix Pharmaceuticals) for Diarrhoea in HIV/AIDS

The FDA has approved Fulyzaq (crofelemer 125 mg delayed-release) tablets, from Salix Pharmaceuticals, for the symptomatic relief of Diarrhoea in patients with HIV/ AIDS. Approval is based on a randomized, double-blind, placebo-controlled and placebo-free, multi-center study of 374 HIV-positive patients on antiretroviral therapy (ART), with a history of Diarrhoea for one month or more. The primary efficacy endpoint was the ...

ViiV healthCare files dolutegravir for HIV treatment in EU, US and Canada

ViiV Healthcare has announced the submission of regulatory applications in the European Union , United States and Canada for the investigational integrase inhibitor dolutegravir (S/GSK1349572) for the treatment of HIV infection in adults and adolescents, specifically: -A Marketing Authorisation Application to the European Medicines Agency for dolutegravir for the treatment of HIV infection in adults and children aged 12 ...

FDA updates prescribing information for Edurant (Tibotec) for AIDS patients

The FDA has approved a prescribing information update for Edurant (rilpivirine) tablets, from Tibotec, to include 96-week pooled data from the Phase III ECHO and THRIVE studies, which evaluated the efficacy and safety of Edurant for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) in antiretroviral treatment-naive adults. In addition to the inclusion of the 96-week data in the ...

CHMP recommends extension of Isentress indication for HIV

The CHMP has recommended a change to the indication for Isentress (raltegravir), from Merck., which is now indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 2 years....

FDA approves Stribild ( Gilead Sciences) for treatment of HIV-1 Infection

Gilead Sciences,announced that the FDA has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults. Stribild, referred to as “Quad” prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil ...

Vacc-4x (Bionor Pharma) in Phase III trial with Revlimid(Celgene)for HIV treatment

Bionor Pharma announced that the clinical trial application for the placebo-controlled study with Vacc-4x in combination with Celgene`s Revlimid has been approved by the German health regulatory authorities. The study will be conducted at four different clinics in Germany, and will include HIV patients who do not recover a normal CD4 T-cell count (measurement of the immune system) despite receiving ...

Positive results from Phase III study of Isentress (Merck Inc) for HIV-1 patients

Final results from the STARTMRK study, a Phase III trial evaluating Isentress (raltegravir), from Merck Inc, in combination therapy in previously untreated adult HIV-1 patients, indicate that virologic efficacy was better than the efavirenz-based regimen at 240 weeks. In the study, 563 previously untreated HIV-1 infected adult patients with HIV-1 RNA greater than 5000 copies/mL received either 400 mg Isentress ...

Selzentry/Celsentri(ViiV) in trial for HIV Prevention

The first clinical trial to test whether drug regimens containing Selzentry/Celsentri (maraviroc) from Viiv HealthCare, are also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection. The eventual goal is to see if the drug regimens can reduce the risk of infection. The trial involves a strategy known as pre-exposure prophylaxis, or ...

FDA approves Truvada(Gilead Sciences) for HIV Prevention

The FDA has approved Truvada (emtricitabine/tenofovir disoproxil fumarate) from Gilead Sciences, the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices ...

Success in Phase III SINGLE trial of Dolutegravir

Interim results from the Phase III SINGLE study involving dolutegravir from Shionogi-Viiv HealthCare,demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla. At 48 weeks, 88% of study participants on the dolutegravir regimen were virologically suppressed (<50 copies/mL) vs. 81% of participants on the single tablet regimen Atripla: The difference in the primary endpoint was statistically significant. ...

Final results from trial of Truvada (Gilead Sciences) for HIV Prevention

Final results from the FEM-PrEP HIV-prevention trial of Truvada (emtricitabine/tenofovir disoproxil fumarate), from Gilead Sciences, reinforce the key role of adherence in HIV Prevention studies and the need to determine better approaches to support adherence in future pre-exposure prophylaxis (PrEP) programs. Despite targeted counseling and support, adherence to the drug regimen was low, suggesting that women in the clinical trial ...

Gilead Sciences files cobicistat"booster" for AIDS drugs

Gilead Sciences, announced it has submitted a New Drug Application (NDA) to the FDA for marketing approval of cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing. Cobicistat is also a component of the Quad once-daily single tablet regimen for HIV, which is ...

FDA approves the Cobas TaqMan HIV-1 Test (Roche)

The FDA has approved the Cobas TaqMan HIV-1 Test, from Roche, which will be available in the US later this year. The test utilizes the FDA-approved High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 Analyzer for automated amplification and detection. This one targets two highly conserved regions of the HIV-1 genome and ...

Elvitegravir (Gilead Sciences) is filed at FDA for HIV-1 Infection in treatment-experienced adults

Elvitegravir,from Gilead Sciences, an integrase inhibitor for treatment for HIV-1 infection in treatment-experienced adults is filed at the FDA. The submission is supported by 96-week data from a pivotal Phase III 145 study, in which the drug dosed once daily at 150mg or 85mg was non-inferior to the integrase inhibitor raltegravir 400mg dosed twice daily – each administered with a ...

Study shows Viramune/Viramune XR (Boehringer) halves risk of HIV infection in newborns

Adding the drug Viramune/Viramune XR (nevirapine), from Boehringer, to the regimen given to newborns of women diagnosed with HIV shortly before or during labour halves the newborns’ risk of contracting the virus. Researchers led by Karin Nielsen-Saines of the University of California, Los Angeles, School of Medicine, found that the rate of mother-to-child HIV transmission around the time of delivery ...

EMA accepts application for elvitegravir(Gilead Sciences) for HIV-1 treatment

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients,from Gilead Sciences. The filing for elvitegravir was supported by 96-week data from a pivotal Phase III study (Study 145) in which the product (150mg or 85mg) dosed once daily was shown to be non-inferior ...

Cobicistat (Gilead Sciences) "booster" for AIDS drugs is filed at EMA

The marketing authorisation application (MAA) for the HIV drug "boosting" agent cobicistat from Gilead Sciences had been validated by the European Medicines Agency (EMA). cobicistat is a pharmaco-enhancing agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir (Bristol-Myers Squibb's Reyataz) and darunavir (Janssen's Prezista), to enable once-daily dosing....

New formulation of Viread (Gilead Sciences) makes gel safer for rectal use against HIV

New results show that a change in the formulation of Viread (tenofovir gel), from Gilead Sciences, developed for vaginal use to protect against HIV may make it safer to use in the rectum. The rectal epithelium is much thinner than the vaginal lining, so the gel may not be safe or effective to use rectally. To make Viread safe and ...

Viramune (Boehringer) patent expires on 22 May 2012

Zhejiang Huahai Pharmaceutical has agreed with Breckenridge Pharmaceutical to market, in the USA, a generic version of Viramune (nevirapine) currently marketed by Boehringer Ingelheim for HIV treatment. The US patent for Viramune expires on 22 May 2012....

FDFA Advisory Committee recommends QUAD (Gilead) for HIV treatment

The FDA Antiviral Drugs Advisory Committee voted 13-1 that Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) from Gilead Sciences, is a safe and effective drug for HIV patients who have not received prior treatment for the disease.The FDA is expected to take action on the application for Quad by August 27....

FDA Advisory Committee recommends Truvada(Gilead) for HIV Prophylaxis

The FDA Antiviral Drugs Advisory Committee voted to recommend the use of Truvada (emtricitabine/tenofovir disoproxil fumarate) from Gilead Sciences ,as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection among uninfected adults. The panellists voted 19-3 that the application supported a favourable risk-benefit assessment adequate to approve Truvada for PrEP in HIV-uninfected men who have sex with ...

Truvada (Gilead Sciences) given to men at high risk for HIV would be cost-effective prophylaxis

Giving a daily Truvada (emtricitabine/tenofovir disoproxil fumarate) pill to help prevent HIV infection could significantly reduce the spread of AIDS, but only makes economic sense if used in select, high-risk groups, Stanford University researchers conclude. The researchers investigated whether it would be cost-effective to prescribe the pill daily in large populations, a prevention technique known as pre-exposure prophylaxis, or PrEP. ...

Phase II study underway of Shok-Pak (Inflammagen Therapeutics) for patients with Shock

A 200-patient Phase II pilot study has begun to examine the efficacy and safety of the Shok-Pak, from InflammaGen Therapeutics, as a potential treatment for critically ill patients suffering from Multiple Organ Dysfunction Syndrome (MODS), formally known as multiple organ failure. Conditions expected to qualify for the study include new-onset sepsis and septic shock, post-operative complications and new-onset gastrointestinal bleeding. ...

Vacc-4x(Bionor Pharma) success in Phase IIb trial for HIV/AIDS

Bionor Pharma announced a final review of phase IIb data for its vaccine, Vacc-4x, which confirms a statistically significant 64% reduction of viral load “set point” (average of the last two viral load measurements before the end of the study) in patients receiving Vacc-4x compared to those given placebo. The HIV viral load set point in patients given Vacc-4x was ...

Viread(Gilead Sciences) and Kidney Disease risk

Viread (tenofovir) from Gilead Sciences one of the most commonly prescribed antiretroviral medications for HIV/AIDS, is associated with a significant risk of kidney damage and chronic kidney disease that increases over time, according to a study of more than 10,000 patients led by researchers at the San Francisco VA Medical Center (SFVAMC) and the University of California, San Francisco . ...

OraQuick Advance Rapid HIV-112 (OraSure) compares to conventional blood test for HIV

The OraQuick Advance Rapid HIV-112 Antibody Test, from OraSure, is comparable in accuracy to the traditional blood test, according to a new study. The meta-analysis, which compared studies worldwide, showed that the OraQuick test had the same accuracy as the blood test for high-risk populations. The test sensitivity was slightly reduced for low risk populations. The findings showed that the ...

Isentress (Merck) shows promise in treating young patients with HIV

An update on a Phase II clinical trial of Isentress (raltegravir), from Merck, sponsored by the National Institute of Health’s National Institute of Allergy and Infectious Diseases, shows the drug has an excellent efficacy profile in children with HIV who have failed other regimens. All of the 96 patients enrolled had previously been treated with a regimen of other HIV ...

Truvada filed at FDA for reduction in HIV Risk

Gilead Sciences has submitted a supplemental new drug application to the FDA seeking approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection among uninfected adults. The application is based on the iPrEx trial where Truvada reduced HIV risk in men by 44% versus placebo and up to 73% for ...

Cobicistat (Gilead Sciences) success in Study 114 as "booster" in AIDS treatment

Study 114 of Cobicistat from Gilead Sciences reported a primary endpoint analysis that indicated that after 48 weeks of treatment, 85 percent of patients taking a regimen of cobicistat-boosted atazanavir (a protease inhibitor) plus Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) achieved HIV RNA (viral load) of less than 50 copies/mL, compared to 87 percent of patients taking ritonavir-boosted atazanavir plus ...

Viread (Gilead Sciences) dropped from HIV prevention trial

Viread gel (tenofovir disoproxil fumarate), from Gilead Sciences, has been dropped from the VOICE trial. The decision to discontinue use of the anti-retroviral (ARV) gel was made after a routine review of study data concluded Viread was not effective in preventing HIV in the women enrolled in the trial. VOICE is evaluating two ARV-based approaches for preventing the sexual transmission ...

FDA approve a labelling update for Reyataz (BMS) for HIV-infected pregnant women

The FDA has approved an update to the labeling for Reyataz (atazanavir sulfate), from BMS, to include dose recommendations in HIV-infected pregnant women. In HIV combination therapy, treatment with the recommended adult dose of Reyataz 300 mg, boosted with 100 mg of ritonavir, achieved minimum plasma concentrations (24 hours post-dose) during the third trimester of pregnancy comparable to that observed ...

Eviplera triple therapy ( Gilead Sciences) is EU approved for HIV-1 infection

The EMA has granted marketing authorisation for the combination drug Eviplera, from Gilead Sciences, for HIV-1 infection.Eviplera is a once-daily single-tablet that combines Truvada (tenofovir/emtricitabine) from Gilead Sciences and Edurant(rilpivirine) from Tibotec, a Johnson & Johnson company.The combination has been approved by the FDA as Complera....

Napo Pharma terminates agreement wit Salix Pharma for crofelemer for Chronic Diarrhoea in AIDS patients

Napo Pharma has terminated its agreement with Salix Pharma for failure of Salix Pharma to proceed with an application to the FDA for crofelemer for chronic diarrhoea in people living with HIV/AIDS, despite a successful Phase III result. Napo has filed a lawsuit against Salix seeking $150 million for breach of contract....

Transdermal IQP-0410 patch shows promise for HIV patients

Studies of IQP-0410, from ImQuest Biosciences, a promising HIV therapeutic, demonstrate that it can be applied to the skin of patients with HIV as transdermal patches which are capable of releasing more than 96 percent of the HIV medication over the course of seven days. The results were presented at the 2011 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting ...

Why Viread acts against both HIV and HVS

New research published in the journal Cell Host and Microbe reveals why giving anti-HIV drug Viread (tenofovir disoproxil fumarate) from Gilead Sciences, as a gel results in dual protection against both HIV and Herpes Simplex Virus. Infection with HSV is known to facilitate the risk of HIV infection and impacts the clinical course of the disease. It is also known ...

Raltegravir shows benefits in adult HIV-1 patients

A new analysis reveals that Isentress (raltegravir), from Merck, used in combination therapy shows better efficacy compared to efavirenz-based therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients. The analysis of the STARTMRK Phase III study at 192 weeks of treatment showed that the percentage of patients maintaining undetectable virus levels (less than 50 copies/mL) was 76.2 percent (n=214/281) for Isentress ...

CHMP recommends Edurant for HIV-1 infection

The CHMP has adopted a positive opinion recommending the approval of Edurant (rilpivirine), a 25 mg tablet from Tibotec Pharma, as a once-daily treatment in combination with other antiretroviral agents 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. Edurant is a non-nucleoside reverse ...

CHMP recommends Eviplera triple therapy for HIV-1 infection

The CHMP has adopted a positive opinion for the once-daily single-tablet regimen, Eviplera, combining Gilead's Truvada (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine (as hydrochloride)) from Gilead, for the treatment of HIV-1 infection in antiretroviral-naive adults with a viral load less than or equal to 100,000 HIV-1 RNA copies. The combination is ...

Viramine XR once a day is EU approved for HIV treatment

Once-daily Viramune (nevirapine) prolonged-release tablet from Boehringer Ingelheim has been approved for use in EU in combination with other antiretroviral medications for the treatment of HIV-1 infection. The EU approval is for the use of one 400mg tablet once daily for adults and adolescents and for 50mg and 100mg strengths for once-daily treatment of children. The Viramune XR single 400mg ...

QUAD HIV drug more effective than other therapies

New results from a pivotal Phase III trial of QUAD (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate), from Gilead Sciences, for HIV-1 infection in treatment-naïve patients, has met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada. The primary endpoint analysis of Study 103 indicated that 90 percent of patients in the QUAD arm ...

No sex difference in HIV patients with boosted Reyataz

A retrospective study, which included 1,294 antiretroviral (ARV)-experienced patients, demonstrated no difference in time to virologic failure in women compared to men taking Reyataz (atazanavir sulphate), from BMS, (ATV/ritonavir)-based regimens, over a follow-up period of up to five years. The results revealed no gender-based differences in time to virological failure, defined as two consecutive HIV RNA = 50 c/mL or ...