Briefly Jul+Aug 2016

MSM rates of HIV

“A new report in JMIR Public Health and Surveillance, authored by researchers at Emory University’s Rollins School of Public Health, provides state, city, and county estimates of the rate of MSM [men who have sex with men] living with HIV,” states a press release from the university. Overall, the HIV prevalence in MSM in 2012 was 15% (15 in 100 MSM were living with HIV), but the rate varies drastically by geography.

For example, the highest rate was 39.49% in the Jackson, Mississippi region. Six states with more than 15% prevalence in MSM were all in the South and 21 of the 25 metropolitan statistical areas with the highest levels of HIV-positive MSM were in southern states. Seven out of 10 new HIV diagnoses in the U.S. occur in MSM, although they represent about 2% of the population. Read the report at publichealth.jmir.org/2016/1/e22/.

Perinatal, OI guidelines 

Updates to the U.S. HIV perinatal guidelines and guidelines on opportunistic infections (OIs) in people living with HIV were released in May. The section on toxicity and pharmacokinetic (PK) data on the use of HIV medications in pregnancy was updated (see Table 7 in the guidelines). In the OI guidelines, the bacterial enteric infections section was updated to include new information on “the growing issue of antibiotic resistance among enteric bacteria, as well as updated information on the treatment of enteric infections, including in pregnant women.” Go to aidsinfo.nih.gov.

Updated CDC nPEP guidelines

In April, the CDC updated its guidelines for HIV non-occupational PEP (post-exposure prophylaxis, or nPEP), in which antiviral medications are used for 28 days following exposure to the virus, in order to prevent infection. All PEP should be started within 72 hours of exposure. According to the guidelines, these updates—the first since 2005—“provide additional evidence regarding use of [nPEP] from animal studies, human observational studies, and consideration of new antiretroviral medications that were approved since the 2005 guidelines, some of which have improved tolerability.” “Nonoccupational” refers primarily to sexual contact, including rape.

According to expert opinion, the best HIV meds to use after an exposure to prevent infection is a triple drug combination of Truvada plus Isentress or Tivicay. Certain restrictions apply, and other regimens are recommended, depending on such things as a patient’s age and kidney function. There are also suggestions for putting patients on PrEP (pre-exposure prophylaxis) following PEP. See cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf.

Billing codes for PrEP

A provider’s guide to billing and reimbursement for HIV and STI prevention services was published in April by the National Association of State and Territorial AIDS Directors (NASTAD). See nastad.org/resource/billing-coding-guide-hiv-prevention.

Black lives and PrEP

The report “Black Lives Matter—What’s PrEP Got to Do With It?” was published by the Black AIDS Institute in April. Among the key messages: “PrEP can help end the AIDS epidemic in Black America;“ “Black America needs PrEP the most;“ and “When it comes to PrEP, Black America is being left behind.” Read the report and its recommendations at blackaids.org/reports/black-lives-matter-whats-prep-got-to-do-with-it.

Vitekta to be taken off the market

The single-tablet regimens (STRs) Genvoya and Stribild contain elvitegravir, sold separately as Vitekta. Now Gilead Sciences is taking Vitekta off the market, since the powerhouse med is rarely used outside of those two STRs. Vitekta is scheduled to come off the market in February 2017.

Less cancer care in HIV

It’s known that people living with HIV are less likely to receive cancer treatment than others, reported Gita Suneja, MD, MSHP, of the University of Utah School of Medicine, and her colleagues. They looked to see whether insurance and comorbidities (other illnesses that a person has) affect this disparity. Not quite. “In the United States, HIV-infected patients with cancer appear to be less likely to receive cancer treatment regardless of insurance and comorbidities,” they concluded in their study, published in Cancer online in May. Still, they also found that “black race and a lack of private insurance” was a predictor of non-treatment. The study looked at data from more than 10,000 people with HIV and more than two million individuals without the virus.

Addiction and recovery survey

University of Southern California researchers are conducting an anonymous, online survey of how people resolved problems with alcohol and other drugs. “We’re interested in hearing about people’s experiences in addiction and recovery,” the researchers wrote. “If you are aged 18 or older, believe you have ever been addicted to drugs, alcohol, or another substance, and you have substantially reduced or entirely stopped use at any point, you are eligible to participate in our study.” Author William L. White, a longtime leader and trainer in addiction work and recovery, promoted the study in his blog, noting that there is a “need for research on the prevalence, pathways, styles, and stages of long-term personal and family recovery.” The survey should take 10 to 20 minutes to complete. Go to usc.qualtrics.com/SE/?SID=SV_bPC9XJshl4MBatL.

Medicaid and hep C treatment

In June, after negotiations to avoid a federal class action lawsuit, officials for the state of Delaware lifted some of its Medicaid restrictions on the treatment of hepatitis C virus (HCV). “It is unimaginable that an insurance provider would tell someone with cancer, ‘We need to wait until you get really sick before we treat you.’ But that’s what patients in Delaware with HCV were being told, and what patients in other states are still being told,” said Anna Haac of the law firm Tycko & Zavareei LLP in a press release.

Declining condom use among gay men

The CDC reported that gay men’s use of condoms here in the United States has been falling for a decade. This was true regardless of serosorting (having sex with men of their own HIV status), seropositioning (strategies for prevention based on HIV status; for example, where the HIV-positive partner bottoms to lessen the risk of infection to an uninfected partner), or the use of PrEP (for prevention). Read a report on the finding at aidsmap.com/American-gay-mens-use-of-condoms-has-been-falling-for-a-decade-regardless-of-sero-sorting-or-PrEP/page/3058699/.

BY ANDREW REYNOLDS, PROJECT INFORM

HCV in semen of HIV-positive MSM

Researchers from the Icahn School of Medicine at Mt. Sinai in New York and the University of California, San Diego have reported on the presence of HCV in semen from some men living with HIV. Published in the journal Open Forum Infectious Diseases, the researchers found infectious levels of HCV in the semen of 11 of the 33 study participants (33%). There were no clear associations between HIV viral load in the blood, and the presence of HCV in semen, but men with higher levels of HCV in the blood did appear to have higher levels of HCV in their semen. It also does not appear that the presence of other STIs were needed to increase the level of HCV in semen. The authors conclude that condomless receptive anal sex with an HCV-infected partner can lead to HCV infection, and recommend the use of condoms to prevent said infection. You can read the study at bit.ly/1U9mHxw.

Harm Reduction Coalition releases report on safe injection facilities

With increased awareness of injection-related HIV and HCV outbreaks, as well as increased attention to the opioid epidemic and suffering that has resulted from overdose deaths, there has been much public discussion about new alternatives for reducing these harms. One such alternative has long been in use abroad: Safe injection facilities, or SIFs. SIFs, also called drug consumption rooms or safe injection sites, are “protected places for the hygienic consumption of pre-obtained drugs in a non-judgmental environment and under the supervision of trained staff. SIFs represent a public health intervention operating as part of a wider network of services for people who use drugs, woven into local networks of coordinated strategies to address the individual risks and community impact of drug use. These programs aim to reach underserved and marginalized populations, address health inequities, and resolve public health and safety tensions related to public injecting,” according to a report from the Harm Reduction Coalition.

To further the discussion of the role of SIFs in the United States, the coalition convened a meeting of international law enforcement, substance use, and public health experts to discuss their experience and lessons learned with a group of advocates and public health officials. The report from this meeting concludes that:

• People who use SIFs take better care of themselves, reduce or eliminate their needle sharing, use their drugs more safely, and ultimately reduce their drug use;
• SIF participants gain access to other medical and social services and entry into drug treatment;
• There has not been a single overdose death in any of these programs over many years of operation and many thousands of supervised injections; and
• SIFs do not increase drug use in the area, nor do they encourage young people to initiate drug use;
• Crime and public nuisance decrease in the areas around these programs.

BY ANDREW REYNOLDS

Experts on hepatitis C and other liver diseases from all around the world gathered in Barcelona April 13-17, 2016 for the European Association for the Study of the Liver’s International Liver Congress (EASL 2016). There were a number of reports related to hepatitis C epidemiology, prevention, and treatment. The following is a selection of relevant presentations.

Sofosbuvir/velpatasvir/GS-9857: High cure rates in GT 1 treatment-experienced patients

Epclusa, the fixed-dose combination of sofosbuvir and velpatasvir, was FDA approved on June 28, 2016. The next regimen developed by Gilead will be this combination with a new protease inhibitor, GS-9857, included with it. Eric Lawitz and colleagues reported results from a Phase 2 study looking at this combination with treatment-experienced patients. This study had a treatment arm without ribavirin and one with it: 100% (24/24) of those without ribavirin and 96% (24/25) of those with it achieved an SVR12 (sustained virologic response at week 12, aka, cure), for an overall SVR12 rate of 98% (48/49). The one patient who was not cured had a viral relapse after completing therapy. The treatment was very well tolerated, with no one stopping the treatment because of them. It’s worth noting the side effects were even fewer and better tolerated in the ribavirin-free group. This regimen was not impacted by the presence of drug resistance, and it’s currently in a Phase 3 study to further test its effectiveness for treating and curing treatment-experienced patients who have fewer treatment options currently available.

ABT-493 and ABT-530: 100% SVR12 rates in treatment-naïve GT 3 patients with cirrhosis

Hepatitis C genotype (GT) 3 leads to a faster progression to cirrhosis, higher rates of steatosis (fatty liver), and higher rates of liver cancer. It can be challenging to cure, especially in those living with cirrhosis. In a study looking at the effectiveness of AbbVie’s next generation of hepatitis C treatments—ABT-493 and ABT-530—Paul Kwo and colleagues showed 100% SVR12 among 24 treatment-naïve patients with GT3 and cirrhosis. It’s worth noting that a comparison arm of ABT-493 + ABT-530 + ribavirin also achieved a 100% SVR12 among its 24 participants. Given the same cure rates, a ribavirin-free option for treating this patient population appears possible. The treatment was very well tolerated, with mild side effects reported and no one quitting the regimen as a result of them. Additionally, the regimen appears to overcome drug resistance. This is a small, Phase 2 study, and more evidence will be collected in Phase 3, but these results are very exciting and this treatment can play a key role in treating this difficult to cure patient population.

ABT-493 and ABT-530: 96% SVR12 rates in GT 1 patients with cirrhosis

Ed Gane and colleagues presented results from the SURVEYOR-I Study, a Phase 2 study looking at treating GT 1 patients with compensated cirrhosis given ABT-493 and ABT-530. In the study, 26 of 27, or 96%, of participants achieved an SVR12. Side effects included headaches and fatigue, but all were considered mild to moderate, and no one stopped treatment because of them. Drug resistance did not appear to impact SVR rates. This treatment will be further studied in a Phase 3 study, but these early results look very promising for the treatment of GT 1 in patients with cirrhosis with or without drug resistance.

High cure rates for GT 1 and 2 patients with 8 weeks of ABT-493 and ABT-530

Over the past five years we’ve seen hepatitis C (HCV) treatment duration shorten from as many as 48 weeks down to 12 weeks, with very effective and well-tolerated medications. The next step in the development of HCV treatments is to further shorten the length of treatment. Fred Poordad and colleagues reported results from a study that looked at curing HCV GT1 and GT2 with 8 weeks of ABT-493 and ABT-530. Among the participants of this study, 97% (33/34) GT1 and 98% (53/54) GT2 achieved a cure. The cure rates were not impacted by viral load, treatment experience, or presence of drug resistance. The treatments were very well-tolerated with only one person stopping treatment due to side effects. Most significantly, there were no virologic failures among the participants. Further research with larger numbers of patients is needed, but this is a promising start for a shorter treatment to cure hepatitis C.