Content about HIV

January 19, 2012

Gilead receives FDA approval for lower-dose HIV drug in children

The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.

January 16, 2012

FDA issues alert about sharing of insulin pens

The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

SILVER SPRING, Md. — The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

But the agency said it knew of two undisclosed hospitals that it said had reused the cartridge components of insulin pens in administering insulin to more than 2,000 patients, though the hospitals reportedly changed the pens themselves.

January 3, 2012

FDA accepts application for Gilead HIV drug

The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

Gilead said the FDA planned to review the application for the Quad by Aug. 27.

The Quad combines four Gilead drugs — Truvada (emtricitabine and tenofovir disoproxil fumarate), cobicistat and elvitegravir — into one pill. The last drug was licensed from Japan Tobacco.

December 21, 2011

Merck's Isentress approved for children, adolescents

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.

December 20, 2011

WHO approves Mylan generic HIV drugs for use in developing world

The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

PITTSBURGH — The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

December 16, 2011

STDs becoming more prevalent across baby boomer demographic

According to an article in the November/December issue of the journal Medical-Surgical Nursing, rates of HIV/AIDS, herpes, syphilis, human papilloma virus and other STDs are climbing steadily across men and women older than 50 years.

PITMAN, N.J. — According to an article in the November/December issue of the journal Medical-Surgical Nursing, rates of HIV/AIDS, herpes, syphilis, human papilloma virus and other STDs are climbing steadily across men and women older than 50 years.

December 15, 2011

FDA to review patch for HIV-related pain

A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

SAM MATEO, Calif. — A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

NeurogesX said Thursday that the FDA Anesthetic and Analgesic Drug Products Advisory Committee would meet on Feb. 9, 2012, to review the patch drug Qutenza (capsaicin) as a treatment for pain associated with HIV-associated peripheral neuropathy, or HIV-PN.

The drug currently is approved for treating pain associated with postherpetic neuralgia.

December 5, 2011

On the brink of Clinics 2.0

Since the inception of retail-based health clinics in 2000, the concept has grown to more than 1,300 locations throughout the United States. The real question now: Are we on the brink of clinics version 2.0? 

Since the inception of retail-based health clinics in 2000, the concept has grown to more than 1,300 locations throughout the United States and, in more recent months, has celebrated several significant milestones that prove clinics are not only an integral part of the U.S. healthcare system but also are a viable model for retailers when handled correctly. The real question now: Are we on the brink of clinics version 2.0? 

November 11, 2011

Study: Retail-based clinics a viable business for Walmart, other retailers, if managed correctly

Retail-based health clinics represent a viable business for retailers who locate and correctly manage them, according to Kalorama Information.

NEW YORK — Retail-based health clinics represent a viable business for retailers who locate and correctly manage them, according to Kalorama Information.

The healthcare market research publisher, which is a division of MarketResearch.com, made its assessment based on the recent news that Walmart may dramatically expand its retail clinics offering.

November 10, 2011

Walgreens fields 500-plus HIV Centers of Excellence pharmacies

Walgreens now has certified more than 500 of its pharmacies as HIV Centers of Excellence in communities highly impacted by HIV, as identified by the Centers for Disease Control and Prevention, the pharmacy operator announced Thursday at the U.S. Conference on AIDS.

CHICAGO — Walgreens now has certified more than 500 of its pharmacies as HIV Centers of Excellence in communities highly impacted by HIV, as identified by the Centers for Disease Control and Prevention, the pharmacy operator announced Thursday at the U.S. Conference on AIDS.

November 8, 2011

FDA develops Web resource outlining proper sharps disposal

The Food and Drug Administration on Tuesday launched a website for patients and caregivers on the safe disposal of needles and other “sharps” that are used at home, at work and while traveling.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday launched a website for patients and caregivers on the safe disposal of needles and other “sharps” that are used at home, at work and while traveling.

November 7, 2011

Walgreens joins Magic Johnson Foundation on Point Forward Day

The Magic Johnson Foundation on Monday initiated Point Forward Day, marking 20 years to the date that Johnson announced his HIV status and subsequent retirement from the National Basketball Association.

LOS ANGELES — The Magic Johnson Foundation on Monday initiated Point Forward Day, marking 20 years to the date that Johnson announced his HIV status and subsequent retirement from the National Basketball Association.

In partnership with AIDS Healthcare Foundation, MJF will host free confidential testing events at retailers, including Walgreens in Chicago. At select locations, testing will include participation from government officials, dignitaries and athletes who will lead their communities by getting tested first at on site mobile units.

October 27, 2011

Bristol-Myers Squibb, Gilead Sciences to develop, commercialize HIV combo treatment

Drug makers Bristol-Myers Squibb and Gilead Sciences announced an agreement to develop and commercialize a fixed-dose combination treatment for patients with HIV.

FOSTER CITY, Calif. — Drug makers Bristol-Myers Squibb and Gilead Sciences announced an agreement to develop and commercialize a fixed-dose combination treatment for patients with HIV.

The two companies said the drug will combine Bristol's Reyataz (atazanavir sulfate) and Gilead's boosting agent cobicistat, which is designed to increase blood levels of certain HIV medicines to potentially allow for one-pill, once-daily dosing. Gilead is currently studying Reyataz and cobicistat in phase-2 and phase-3 trials.

September 22, 2011

J&J HIV drug shows fewer side effects in trial data analysis

A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.

CHICAGO — A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.

September 20, 2011

Under PEPFAR, Matrix granted tentative approval for novel co-packaged HIV/AIDS treatment

Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

PITTSBURGH — Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

September 19, 2011

Merck drug for HIV effective, tolerated, study results show

A drug made by Merck for treating HIV infection was effective and tolerated in patients regardless of their gender or race, according to results of a late-stage clinical trial announced Monday.

CHICAGO — A drug made by Merck for treating HIV infection was effective and tolerated in patients regardless of their gender or race, according to results of a late-stage clinical trial announced Monday.

August 24, 2011

Q&A: A new twist  on specialty Rx

Specialty pharmacy is expanding beyond its traditional base as a central-fill and mail-order distribution model for patients. A new, community-driven model is emerging, led by a fast-growing network of integrated,  community-based specialty providers based in Drexel Hill, Pa.

August 16, 2011

Events to raise awareness of AIDS, healthcare initiatives

The Community Education Group and the Urban Coalition for HIV/AIDS Prevention Services will sponsor a series of community mobilizing events around the country in the time leading up to the International AIDS Conference in Washington next July.

WASHINGTON — The Community Education Group and the Urban Coalition for HIV/AIDS Prevention Services will sponsor a series of community mobilizing events around the country in the time leading up to the International AIDS Conference in Washington next July.

August 11, 2011

FDA approves single-pill HIV drug

The Food and Drug Administration has approved a new single-pill treatment for HIV made by Gilead Sciences and Johnson & Johnson, Gilead said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a new single-pill treatment for HIV made by Gilead Sciences and Johnson & Johnson, Gilead said.

Gilead announced the approval of Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate). The drug combines Gilead's Truvada with J&J's Edurant.

August 8, 2011

Pharmacy professor to assist in review of ReachRx protocols and initiatives for Armada

Specialty pharmacy services company Armada Health Care has enlisted a New York pharmacy professor to assist in the review of developed clinical protocols and medication assessment tools, Armada said Monday.

FLORHAM PARK, N.J. — Specialty pharmacy services company Armada Health Care has enlisted a New York pharmacy professor to assist in the review of developed clinical protocols and medication assessment tools, Armada said Monday.

July 19, 2011

Matrix expands licensing agreement with Gilead for HIV/AIDS therapies

Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.

PITTSBURGH — Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.

Under the new terms, Mylan said that Matrix has the rights to produce and market generic versions of three Gilead HIV/AIDS therapies — elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “quad,” a once-daily, single-tablet combination of four separate Gilead medicines — if and when the drugs receive regulatory approval.

July 19, 2011

Ranbaxy to produce, market antiretrovirals under licensing agreement with Gilead

Ranbaxy will produce and market three HIV/AIDS drugs that currently are in late-stage clinical development by Gilead under a new licensing agreement between the drug makers.

GURGAON, India — Ranbaxy will produce and market three HIV/AIDS drugs that currently are in late-stage clinical development by Gilead under a new licensing agreement between the drug makers.

July 18, 2011

Minimal drug interaction found between Livalo, HIV drugs

A statin made by Eli Lilly and Kowa Pharmaceuticals America appears to work well with drugs used to treat HIV, according to a study presented at the sixth International AIDS Society conference on HIV Pathogenesis, Treatment and Prevention in Rome.

INDIANAPOLIS — A statin made by Eli Lilly and Kowa Pharmaceuticals America appears to work well with drugs used to treat HIV, according to a study presented at the sixth International AIDS Society conference on HIV Pathogenesis, Treatment and Prevention in Rome.

The study was designed to investigate potential interactions between Livalo (pitavastatin) and Abbott’s antiretroviral protease inhibitor Kaletra (lopinavir and ritonavir). The study found that each drug had only a minimal effect on the other.

July 14, 2011

Merck partners with universities to research ways to eradicate HIV

A team comprised of scientists from drug maker Merck and several U.S. universities will look for ways to eradicate HIV, Merck said.

WHITEHOUSE STATION, N.J. — A team comprised of scientists from drug maker Merck and several U.S. universities will look for ways to eradicate HIV, Merck said.

July 13, 2011

Studies find HIV drug treatments may reduce infection risk among heterosexual couples

Taking drugs for treating HIV might reduce the risk of infection among heterosexual couples, according to two new studies conducted in Africa.

NEW YORK — Taking drugs for treating HIV might reduce the risk of infection among heterosexual couples, according to two new studies conducted in Africa.

One study, funded by the Bill & Melinda Gates Foundation and conducted among 4,758 couples in Kenya and Uganda, found that when taken daily, Gilead’s Viread (tenofovir) reduced the rates of infection by at least 62% compared with placebo. Truvada (tenofovir and emtricitabine), another drug made by Gilead, reduced infection risk by 73%.