Ritonavir, also known as Norvir, is a type of medicine called a protease inhibitor (PI). PIs act by blocking protease, a protein that HIV needs to make more copies of itself. Ritonavir was approved by the FDA on March 1, 1996, for use with other antiretroviral agents in the treatment of HIV infection in adults and children 2 years of age or older. Ritonavir is now approved with other anti-HIV drugs in the treatment of HIV-1 infection in children in individuals over 1 month in age. Studies have shown that ritonavir works as a booster for some other PIs. Taking ritonavir makes it possible to take a lower dose of the other PIs. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced the launch of My SPRYCEL (dasatinib) Support, a useful resource to assist adult patients with chronic myeloid leukemia (CML) who are taking SPRYCEL.
Tobira Therapeutics Inc., a biopharmaceutical company focused on developing and commercializing innovative antiviral compounds to treat HIV disease, today announced the completion of a $31 million Series B financing. New investor Novo A/S is leading the round, joined by original investors, Domain Associates, L.L.C., Frazier Healthcare Ventures, Montreux Equity Partners and Canaan Partners.
Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.
Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).
Nevirapine is widely used to help prevent mother-to-child transmission of the HIV virus. In cases where the infants are nonetheless infected with HIV virus at birth, the standard treatment is to use protease inhibitors (PI) to reduce the amount of virus in their bloodstream. A new study involving 195 infants in South Africa found that children who were treated with PI and then switched to nevirapine were more likely to maintain virus below the detection threshold of the test than infants who continued to receive PI.
HIV infected children in South Africa who were exposed to the drug nevirapine at birth (used to help prevent mother to child HIV transmission) and then received a protease inhibitor (PI) for viral suppression achieved lower rates of viremia (virus in the blood stream) if they were switched to nevirapine, compared to children who continued on the PI-based regimen, according to a study in the September 8 issue of JAMA.
Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.
There are a handful of drugs effective in treating HIV/AIDS. However new research shows that some of these drugs can increase the risk of heart attacks. The results come from a Garvan Institute of Medical Research study involving 20 people, 10 taking the drug Ritonavir and 10 others the drug Raltegravir for one month.
InterMune, Inc. today announced results from operations for the second quarter and six months ended June 30, 2010. InterMune also highlighted its recent clinical development and business activities, and provided forward-looking financial guidance for 2010.
Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.
Bristol-Myers Squibb Company and AstraZeneca today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement (as measured by glycosylated hemoglobin level (HbA1c)) in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone.
Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.
Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).
Preliminary findings from a unique study with sunitinib suggest that it might be possible to tweak the dosage of chemotherapy drugs used to treat HIV-positive cancer patients to achieve therapeutic benefit. Given the type of drug cocktail patients use to treat their HIV, much more or considerably less chemotherapy may be warranted, say the researchers, part of the NCI-supported AIDS Malignancy Consortium (AMC). The trial design is being presented at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO).
Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.
Sanofi-aventis announced today the initiation of a multinational, randomized double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq(R) (dronedarone) in over 10, 000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardiovascular events. The announcement was made during Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions.
Dendreon Corporation today announced that the U.S. Food and Drug Administration has approved PROVENGE (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer.
EndoChoice, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its BONASTENT® Fully Covered Esophageal Stent for the treatment of malignant esophageal obstructions, and its BONASTENT Uncovered Biliary Stent for the treatment of malignant biliary obstructions.
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