The Food and Drug Administration ( FDA ), on Nov. 5, announced that it had approved the drug Genvoya, manufactured by Foster City, California-based Gilead Sciences, Inc., for use in treating HIV-1.
The drug contains the components elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, and is intended as a single-pill, daily medication for individuals who are previously untreated, as well as those whose viral load is suppressed.
The form of tenofovir utilized in Genvoya is effective in smaller doses than versions appearing in other medications and should pose fewer risks for side-effects, especially loss of bone density and renal impairment, in combination with other antiretroviral agents, according to a Gilead statement. Tenofovir is also used in Gilead's Truvada, a medication taken both as treatment for HIV as well as for pre-exposure prophylaxis ( PrEP ). Among Genvoya's possible severe side-effects are buildup of lactic acid in the bloodstream and liver problems.
"Today's approval of a fixed dose combination containing a new form of tenofovir provides another effective, once-daily complete regimen for patients with HIV-1 infection," said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a statement.
ABC News reported that the annual list price of Genvoya will be $31,362. Gilead offers assistance to patients unable to afford its medications, but has faced criticism from HIV/AIDS advocates for its high prices.
Reform group passes
By Matt Simonette
The Union for Reform Judaism ( URJ ), on Nov. 5, passed a resolution calling on synagogues to embrace transgender individuals, according to Jewish Forward.
The resolution, which passed in a voice vote at the URJ's biennial conference in Orlando, Florida, gave specific suggestions as to how transgender persons could be welcomed, including having cultural training for staff, making gender-neutral restrooms available, and presenting sermons about transgender issues.
While other mainstream religious bodies have similarly affirmed their transgender members, the URJ vote is significant in that included those suggestions for specific actions.
"It's a big deal, but at the same time it's not controversial for [URJ] at all," said Michael Toumayan of Human Rights Campaign.
URJ, with some 1.5 million members, is the largest Jewish movement in the U.S.
Jewish Forward's article is at http://bit.ly/1Pt4J7o.
Mormons ban children
couples from joining
By Matt Simonette
Children raised by same-sex couples will be barred from joining the Church of Jesus Christ of Latter-day Saints until they turn 18, according to a new policy. They must also move out of their parents' home, disavow all same-sex relationships and receive special approval from church leadership, New York Times reported.
The rules were published Nov. 5 in a handbook sent to lay leaders. The regulations also stipulate that persons in same-sex marriages would be considered apostates and subject to excommunication. Bishops and congregational leaders previously had more discretion in addressing the issue locally.
"The church has long been on record as opposing same-sex marriages," said church spokesman Eric Hawkins in a statement. "While it respects the law of the land, and acknowledges the right of others to think and act differently, it does not perform or accept same-sex marriage within its membership."
The New York Times' article is at nyti.ms/1S3ug6i .