By Enid Vázquez @ENIDVAZQUEZPA

New version of Stribild

Gilead Sciences filed a New Drug Application with the Food and Drug Administration (FDA) for what amounts to its Stribild single tablet regimen (STR), except that it contains tenofovir alafenamide (TAF) instead of tenofovir DF (TDF). If approved, this would be the first time that TAF is on the market. It has been shown to be kinder to the kidneys and bones than TDF, currently on the market under the brand name Viread (also found in Truvada and other HIV medications). The rest of the new medication remains the same: elvitegravir (brand name Vitekta), cobicistat (brand name Tybost), and emtricitabine (brand name Emtriva).

Tests miss some HIV infections

According to a report by I. Chen and colleagues in the December 1, 2014 issue of JAIDS, two men with recently acquired HIV infection came up HIV-negative repeatedly using both rapid testing and viral load measurements. Reported Abigail Zuger, MD in the NEJM Journal Watch HIV/AIDS, “Most new HIV infections are easily diagnosed using the standard algorithms. A few, however, are difficult to pin down, possibly reflecting an early natural viral suppression that may ultimately turn into elite control.” The infections were confirmed with a third-generation enzyme immunoassay, a fourth-generation antigen/antibody combination assay, and Western blot testing.

All oral Olysio and Sovaldi

In November, Olysio (simeprevir) and Sovaldi (sofosbuvir) were FDA-approved as an all-oral, interferon- and ribavirin-free therapy for the treatment of genotype 1 chronic hepatitis C virus (HCV). Approval was based in part on the results of the COSMOS study, which included people with and without previous HCV treatment, some also given ribavirin (but none had HIV). Recommended treatment is 12 or 24 weeks (the longer duration is for people with cirrhosis). Read more at prn.to/10oHJ3k. For more hepatitis C news see Andrew Reynolds’ report from AASLD beginning on page 46.

WHO recommends expanded naloxone access

In November, the World Health Organization issued new guidelines which “aim to reduce the number of opioid-related deaths globally. The guidelines recommend countries expand naloxone access to people likely to witness an overdose in their community, such as friends, family members, partners of people who use drugs, and social workers.”  WHO noted that such expansion would save 20,000 lives a year in the United States alone. For more, go to who.int/features/2014/naloxone/en/.

HIV therapy lowers risk of stroke

A study from F.C. Chow and colleagues in the November 13, 2014 issue of AIDS found that for one San Francisco clinic’s HIV patients, undetectable viral load significantly decreased the risk of a stroke. In a review from the NEJM Journal Watch HIV/AIDS, Charles B. Hicks, MD commented that, “The mechanism by which ongoing HIV replication increases risk for ischemic stroke is unclear, but persistent HIV-related inflammation and immune activation likely play a major role. The strong association of ischemic stroke with hypertension and dyslipidemia in this population reminds us of the importance of aggressively managing these conditions in all HIV-infected patients.”

OI guidelines updated

U.S. guidelines for the treatment of HIV opportunistic infections were updated in November. Read “What’s New in the Guidelines” at aidsinfo.nih.gov/guidelines/html/4/adult-and-adolescent-oi-prevention-and-treatment-guidelines/0.

Three drugs better than one to prevent mother-to-child transmission

The National Institutes of Health (NIH) announced that, “For HIV-infected women in good immune health, taking a three-drug regimen during pregnancy prevents mother-to-child HIV transmission more effectively than taking one drug during pregnancy, another during labor, and two more after giving birth, an international clinical trial has found.” The NIH-sponsored PROMISE (Promoting Maternal-Infant Survival Everywhere) study offers further support for World Health Organization guidelines for preventing mother-to-child transmission, the agency noted. Read more at nih.gov/news/health/nov2014/niaid-17.htm.

Heart disease missed; HAART and aging

See outstanding reports from treatment advocate Theo Smart via TheBodyPro.com, “Cardiovascular Disease Risk Missed in Many HIV-Positive Veterans Despite Better Risk-Assessment Tool” from the 54th ICAAC meeting (bit.ly/11m5jhT) and “Comparing Older and Younger Patients Starting HIV Treatment” (bit.ly/1xzsQsz), looking at a study from Thailand presented at IDWeek 2014. “The number of people living with HIV aged 50 and older is increasing,” wrote Smart. “It has been estimated that by 2015 more than half of the people living with HIV in the U.S. will be over the age of 50—and their clinical management may be more complicated. In the days before antiretroviral therapy, the progression of HIV disease had been observed to be much more rapid in older patients, and this has remained the case in the era of antiretroviral therapy.”

APLA starts new PrEP program

AIDS Project Los Angeles (APLA) announced a new PrEP (pre-exposure prophylaxis) program at the Gleicher/Chen Health Center in Baldwin Hills. According to an APLA press release, “The Pendleton/Goldman PrEP program [began] serving patients November 17, and will focus on HIV-negative gay and bisexual men, as well as transgender women—a population that the Centers for Disease Control and Prevention (CDC) says is statistically at higher risk for HIV. … It educates eligible HIV-negative patients about and offers them access to Truvada—currently the only drug approved for use as PrEP—which is highly effective in preventing sexual transmission of HIV.” To make an appointment, call (323) 329-9900, or go to aplahw.org.

Gay dating apps team up with AIDS organizations

“For the first time ever,” reported the San Francisco AIDS Foundation (SFAF), “representatives from seven of the largest gay dating and hook-up websites and apps came together with HIV and STI prevention leaders from around the country to discuss how to create healthier online communities for gay and bisexual men.” Read about the October 2014 meeting in a report at sfaf.org/hiv-info/hot-topics/from-the-experts/hivstd-prevention-online-survey-results.html.

Hep C guidelines updated

The Department of Health and Human Services (DHHS) in November updated the hep C/HIV co-infection section of its HIV treatment guidelines, which now “emphasizes considerations for use of antiretroviral (ARV) drugs in patients who also receive treatment for HCV infection. The section includes a new table (Table 12) that provides clinicians with guidance on the concomitant use of HCV drugs and ARV drugs with a focus on potential pharmacokinetic drug interactions.” Read the section at aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/26/hiv-hcv.

Chicago man arrested for not disclosing status to sex partner

HIV activists were outraged after a young Chicago man was arrested at his job for allegedly not disclosing that he had HIV to a sex partner. The AIDS Foundation of Chicago (AFC) charged mainstream media with driving stigma instead of facts. Read the organization’s statement, along with links to other reports, including an HIV Plus magazine article detailing potential legal problems with the arrest, at aidschicago.org/inside-story/954-media-driven-stigma-continues-with-new-hiv-criminalization-case.

Illinois to offer PrEP drug assistance program

In December the Illinois Department of Public Health (IDPH) announced that it plans to offer financial assistance for PrEP (pre-exposure prophylaxis), beginning in January. Called PrEP4Illinois, this will make it only the second state in the country to have a program like this, the first being Washington state, which rolled out its PrEP Drug Assistance Program in early 2014. IDPH HIV/AIDS Section Chief Mildred Williamson told the Windy City Times, “We’re incorporating PrEP content into our fundamentals training for organizations that we fund who do HIV testing and counseling. We’re also sending a ‘dear colleague’ letter to medical providers around the state encouraging them to prescribe [Truvada] to high-risk persons they serve.” IDPH is also creating a statewide PrEP provider referral list for counselors and their clients.

New HIV documentary points out It’s Not Over

It’s Not Over, a new feature-length documentary from MTV star and award-winning filmmaker Andrew Jenks, was released in October, and will be distributed globally by Netflix, SnagFilms, and Pivot TV. Made possible by the MAC AIDS Fund, It’s Not Over follows the lives of three young people from around the world, including a college girl from the U.S. who was born with HIV. Watch the trailer at itsnotoverfilm.com.

Legal woes unfold for origami condom inventor

The Washington Free Beacon reported that, “Origami condom inventor Daniel Resnic will now have to find a third lawyer to take up his case against accusations that he wasted millions of taxpayer dollars by using grant money for plastic surgery, lavish vacations, parties at the Playboy Mansion, a Cadillac, and a condo in Provincetown, Massachusetts. The law firm representing Resnic, who received over $2.4 million from the National Institutes of Health (NIH) to develop so-called origami condoms, was granted a motion to be removed as his counsel on Oct. 28 in the Superior Court of Los Angeles.” Read the report at freebeacon.com/issues/origami-condom-inventor-dropped-by-second-lawyer/.