FDA Approves Truvada Which Claims to Reduce Risk of HIV Infection: VIDEO

The FDA today approved  Gilead Sciences' pill Truvada as a preventive measure for people who are at high risk of acquiring HIV through sexual activity, the AP reports:

Public health advocates say the approval could help slow the spread of HIV, which has held steady at about 50,000 new infections per year for the past 15 years.

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. An estimated 240,000 HIV carriers remain unaware of their status.

Gilead Sciences has marketed Truvada, which can cost up to $14,000 a year, since 2004 as a treatment for people who are already infected with the virus.

Writes the FDA in a press release:

As part of PrEP, HIV-uninfected individuals who are at high risk will need to take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. Again, PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.

As a part of this action, FDA is strengthening Truvada's Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use to reduce the risk of development of resistant HIV-1 variants. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status.

Watch Dr. Anthony Fauci of the National Institute of Allergies and Infectious Diseases discuss the drug with PBS Newshour's Ray Suarez, AFTER THE JUMP...

Medicare Steps Up Enforcement of Visitation and Representation Rights for Gay Partners in Hospitals

Medicare has stepped up enforcement of rules finalized last year regarding visitation and representation rights for same-sex partners in hospitals.

From the Department of Health and Human Services (HHS):

Today, the Department of Health and Human Services (HHS) announced new guidance to support enforcement of rules that protect hospital patients’ right to choose their own visitors during a hospital stay, including a visitor who is a same-sex domestic partner. These rules, finalized by the Centers for Medicare & Medicaid Services (CMS) in November, apply to all hospitals that participate in Medicare and Medicaid.  The guidance also supports enforcement of the right of patients to designate the person of their choice, including a same-sex partner, to make medical decisions on their behalf should they become incapacitated.

The rules updated the Conditions of Participation (CoPs), which are the health and safety standards all Medicare- and Medicaid-participating hospitals and critical access hospitals must meet, and apply to all patients of those hospitals even if they are not on Medicare or Medicaid.  Among other things, the CoPs require hospitals to explain to all patients their right to choose who may visit them during their inpatient stay, regardless of whether the visitor is a family member, a spouse, a domestic partner (including a same-sex domestic partner), or another type of visitor, as well as their right to withdraw such consent to visitation at any time. 

Existing CoPs also protect the rights of hospital patients to have representatives who can act on their behalf.  HHS has updated the guidance for these rules to emphasize that hospitals should give deference to patients’ wishes concerning their representatives, whether expressed in writing, orally, or through other evidence, unless prohibited by state law.  The guidance issued today is intended to make it easier for family members, including a same-sex domestic partner, to make informed care decisions for loved ones who have become incapacitated.

According to HHS, a letter was sent to State Survey Agencies, which conduct on-site inspections of hospitals on behalf of CMS, directing them to be aware of the guidance.

Said HHS Secretary Kathleen Sebelius: "Couples take a vow to be with each other in sickness and in health and it is unacceptable that, in the past, some same-sex partners were denied the right to visit their loved ones in times of need. We are releasing guidance for enforcing new rules that give all patients, including those with same-sex partners, the right to choose who can visit them in the hospital as well as enhancing existing guidance regarding the right to choose who will help make medical decisions on their behalf.”