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Gilead Applies For FDA Approval Of New Once-Daily Combination Antiretroviral Pill – Gilead Sciences announced last week that it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for a new once-daily combination antiretroviral pill for the treatment of HIV. The pill will contain Truvada (emtricitabine/tenofovir), which is a combination of two antiretrovirals, plus the new antiretroviral rilpivirine (TMC278), which is made by Tibotec Pharmaceuticals. Tibotec applied for FDA approval of rilpivirine in July. Rilpivirine and the once-daily pill have also been submitted for approval in Europe. If approved, the new combination treatment would be the second once-daily combination pill that contains a complete HIV drug regimen; the first is Atripla (efavirenz/emtricitabine/tenofovir), also marketed by Gilead. For more information, please see the Gilead Sciences press release.

Vertex Applies For FDA Approval Of New Hepatitis C Drug – Vertex Pharmaceuticals, a pharmaceutical company based in Cambridge, MA, announced that it has filed a new drug application with the FDA for its investigational hepatitis C antiviral drug telaprevir. Vertex requested a priority review of its application, which shortens the review period from 10 months to 6 months. The application is based on clinical trial data showing that 75 percent of study participants who took telaprevir in combination with Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin) were cured of hepatitis C, versus 44 percent who received only Pegasys and Copegus. A majority of study participants were also able to cut their treatment time in half, to 24 weeks. Hepatitis C coinfection is common in people with HIV and is usually more serious than in people who do not have HIV, with disease progression and liver damage occurring more rapidly. For more information, please see the Vertex Pharmaceuticals press release.

Indian Embassies And Consulates To Drop HIV Test Requirement For Visa Entry – India’s Ministry for External Affairs has sent a notice to its embassies and consulates worldwide that HIV test requirements should be dropped from visa applications for visiting foreigners. Prior to the announcement, many embassies and consulates required proof of a negative HIV test before granting a visa. The health ministry had recommended the requirement be dropped in 2002, but many embassies and consulates had not enforced the recommendation. The new policy officially states that there are no travel or residency restrictions on people with HIV who wish to travel to India. The move follows similar lifts on travel restrictions for people with HIV in the U.S. and China earlier this year. For more information, please see the article in the Times of India.

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Tibotec Pharmaceuticals And Gilead Sciences Submit European Marketing Applications For New HIV Drugs – Tibotec Pharmaceuticals has submitted a European Marketing Authorization Application (MAA) for the new HIV drug rilpivirine (TMC278), a new non-nucleoside reverse transcriptase inhibitor. In addition, Gilead Sciences has submitted an MAA for a once-daily tablet combining rilpivirine with Gilead’s Truvada (emtricitabine/tenofovir). If the MAAs are approved, Tibotec and Gilead would be allowed to market the drugs in all 27 European Union member states. A decision on the MAAs will likely be made in approximately 9 to 12 months. Tibotec filed for approval of rilpivirine in July with the U.S. Food and Drug Administration. For more information, please see the Tibotec and Gilead press releases.

PUBPAT Challenges Abbott Laboratories’ Patents For HIV Drug Norvir – The Public Patent Foundation (PUBPAT), a New York City public interest group, has requested that the U.S. Patent and Trademark Office review eight of Abbott Laboratories’ patents for the HIV drug Norvir (ritonavir). PUBPAT argues that the patents are invalid and should not have been granted. Norvir is widely used as a protease inhibitor booster and is a key component in many HIV/AIDS treatment regimens. If the U.S. Patent Office decides the patents are invalid, other drug companies would be able to produce generic versions of Norvir. For more information, please see the PUBPAT website.

Legal Groups Accuse California Of Violating HIV Privacy Laws – The American Civil Liberties Union of Northern California, Lambda Legal, and the AIDS Legal Services Alliance have accused the California Department of Health Services (CDHS) of violating patient confidentiality laws by releasing the names of HIV-positive welfare recipients to the AIDS Healthcare Foundation, a Los Angeles-based advocacy and treatment organization. CDHS and the AIDS Healthcare Foundation deny that privacy laws were breached and argue they were trying to help patients by notifying them of additional services for which they were eligible. California state law makes it illegal to share a person’s HIV status without permission except as provided by law for public health purposes. For more information, please see MercuryNews.com.

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New Jersey Restores Drug Funds For Low-Income HIV/AIDS Patients – New Jersey residents with HIV/AIDS who were excluded from the New Jersey AIDS Drug Distribution Program will now be enrolled in a new drug benefit program, the Temporary AIDS Supplemental Rebate and Federal Assistance Program. The new program will cover the cost of antiretroviral medications to individuals making between 300 percent ($32,490) and 500 percent ($54,150) of the federal poverty level per year. Funding for the new program comes from pharmaceutical company rebates and newly available federal AIDS grants. Program participants will be able to use the same eligibility number that they are currently using to fill prescriptions. For more information, please see the New Jersey Department of Health and Senior Services website.

Tibotec Pharmaceuticals Submits New Drug Application For Rilpivirine To Treat HIV – Tibotec Pharmaceuticals has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for rilpivirine (TMC278), a new non-nucleoside reverse transcriptase inhibitor. Rilpivirine is being studied for once-daily use with other antiretroviral drugs in treatment-naive HIV-positive adults. The application is based on the results of two Phase 3 clinical trials evaluating rilpivirine plus Truvada (emtricitabine/tenofovir) versus Sustiva (efavirenz). Tibotec has also agreed to collaborate with Gilead Sciences to develop a once-daily combination pill of rilpivirine and Truvada. For more information, please see the Tibotec Pharmaceuticals website and press release.

FDA Warns Consumers Of Serious Harm From Drinking Miracle Mineral Solution – The FDA is warning consumers not to drink Miracle Mineral Solution, also known as Miracle Mineral Supplement (MMS). MMS is sold online and falsely claims to treat multiple diseases, including HIV/AIDS, hepatitis, and cancer. The supplement contains an industrial bleach that can cause serious illness or injury, including severe nausea, vomiting, and life-threatening low blood pressure caused by dehydration. The FDA has warned consumers who have MMS to stop using it immediately and throw it away. For more information, please see the FDA website.

Some Dietary Supplements For People With HIV May Be Contaminated And Unsafe – The September issue of Consumer Reports identifies 12 dietary supplements that consumers should avoid because of possible health risks to the heart, liver, and kidneys. The list includes supplements such as colloidal silver (also known as ionic silver, native silver, or silver in suspending agent) and germanium (also known as Ge, Ge-132, or germanium-132) that are commonly used by people with HIV. Supplement manufacturers are not required to demonstrate the safety and efficacy of their products, which can be contaminated with heavy metals, pesticides, or prescription drugs. Consumer Reports developed the harmful ingredient list with the Natural Medicines Comprehensive Database, an organization that researches and evaluates the safety and effectiveness of dietary supplements. For more information, please see the Consumer Reports website.