The FDA in December 2014 approved Viekira Pak for the treatment of hepatitis C virus (HCV), genotype 1, including patients who have cirrhosis. Viekira Pak consists of three new hep C drugs (ombitasvir, paritaprevir, and dasabuvir) along with the older medication ritonavir, used to boost blood levels of the paritaprevir. The treatment can be taken with or without ribavirin, but is not recommended for those whose liver doesn’t function properly (decompensated cirrhosis). In studies, 91% of the participants taking it were cured at week 12 (experienced a sustained virologic response, or SVR). The dose is one dasabuvir tablet twice daily plus two tablets once daily that contain the three other meds in them. The most common side effects in research were itching, nausea, trouble sleeping, lack of energy, and feeling tired or weak.
On April 7, Gilead Sciences applied for a New Drug Application from the FDA for a new version of its bestselling Truvada. Instead of using the tenofovir DF (TDF) found in Truvada, the new fixed-dose pill combines tenofovir alafenamide (TAF) with the other medication in Truvada, emtricitabine. The new drug will come in two doses: 200 mg of emtricitabine with either 10 mg TAF or 25 mg TAF. TAF has shown high efficacy at a smaller dose than TDF, and with less bone and renal toxicity. The smaller 10 mg dose is for use with protease inhibitors or regimens containing ritonavir (Norvir, also found in Kaletra) or cobicistat (Tybost, also found in EvoTaz, Prexcobix, and Stribild). Read more about TAF on page 30.
The hepatitis C medication sofosbuvir appears to have a negative interaction with the heart medication amiodarone (brand name Cordarone). Some patients developed abnormally slow heartbeats and one died of cardiac arrest. Three patients needed to have a pacemaker inserted. The others recovered after discontinuing medication.
According to the FDA, anyone combining these medications should seek immediate medical attention if they experience fainting or near fainting; dizziness or light-headedness; malaise (general ill feeling); weakness; excessive tiredness; shortness of breath; chest pains; or confusion or memory problems.
“The U.S. Food and Drug Administration (FDA) is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone [Cordarone] is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct-acting antiviral for the treatment of hepatitis C infection [such as Olysio or daclatasvir],” the agency reported in March. “We are adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels.”
The FDA also reported that, “Health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, we recommend heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.”
“How effective are condoms for gay men?” Read the informative report on a recently published CDC study at thebodypro.com. While condoms used consistently during anal sex can reduce the risk of HIV by 70%, “Notably, the study observed low rates of consistent condom use. Only 16% of participants reported ‘always’ using condoms during anal sex with male partners (of any HIV status) throughout the entire study period, despite having received sustained behavioral interventions.” Read the report here.
On April 8, the Department of Health and Human Services (DHHS) updated its HIV treatment guidelines. Atripla is no longer on the “recommended” list, but considered an “alternative” drug, based on a high rate of central nervous system (CNS) side effects and a possible association with suicidality. Reyataz, with a Norvir booster dose plus Truvada, is also no longer recommended but alternative, based on a higher discontinuation rate due to side effects in one large study comparing it to two other recommended regimens. The Reyataz side effect was not harmful to health, but cosmetic (yellowing of the eyes and skin).
Three other regimens were downgraded from “recommended” to “alternative”: Complera; Sustiva plus Epzicom; and boosted Reyataz plus Epzicom. A caveat remains—that they be used only in people with less than 100,000 viral load and more than 200 T-cells.
For patients who cannot take either abacavir (Ziagen, found in Epzicom) or tenofovir DF (Viread, found in Truvada, Atripla, Stribild, and Complera), there are now two regimens listed as “other”: Kaletra plus Epivir and Prezista boosted by Norvir or Tybost (Prezista/Tybost is also available in the fixed-dose tablet Prezcobix) plus Isentress.
Five regimens remain recommended for people taking HIV meds for the first time: the protease inhibitor drug Prezista boosted by Norvir plus Truvada and four integrase inhibitors (INIs)-based regimens—Stribild, Triumeq, Isentress/Truvada, and Tivicay/Epzicom.
There is also new information and clinician guidance on such topics as HIV-2, drug interactions, treatment of people with hepatitis C virus, persistently low T-cells, and initial therapy in various clinical scenarios. Go to aidsinfo.nih.gov.
The 2005 version of “Clinical Practice Guideline for the Management of Chronic Kidney Disease in Patients Infected with HIV” has been updated. “These guidelines recommend ART for all HIV-infected patients with kidney disease—a group that is frequently undertreated because of uncertainties regarding appropriate drug selection and dosing,” according to Meghan E. Sise, MD, MS, and Rajesh T. Gandhi, MD, writing for the NEJM Journal Watch/Infectious Diseases. The HIV Medicine Association (HIVMA) and Infectious Diseases Society of America (IDSA) produce the guidance.
Anal cancer is more prevalent in HIV-positive people whether gay or straight, male or female, with or without having anal sex. Yet doctors still don’t know the best way to screen, prevent, or treat problems that can progress to cancer. An important new study is set to help change that.
“No one knew that cervical cancer was preventable before the use of Pap smears became widespread in the 1960s and cut the incidence of disease by 80%,” said Joel Palefsky, MD, principal investigator of the ANCHOR study.
According to the study’s website, “Anal cancer rates are rising among people living with HIV. The goal of the ANCHOR study is to find the best way to prevent anal cancer among HIV-positive men and women. During a screening visit, you will be screened for pre-cancerous anal lesions. If lesions are found, you will be enrolled and randomized to either have the lesions treated or monitored every six months. Both groups will be followed for a minimum of five years. You will be compensated $100 for the screening visit.”
Screening consists of an anal Pap smear, a swipe with a medical cotton swab. Despite the growing risk of anal cancer, the procedure is not yet widely practiced in medical care.
For more details, go to anchorstudy.org. There are 12 sites throughout the country, including Chicago, at the Anal Dysplasia Clinic Midwest, headed by Gary Bucher, MD, a longtime specialist in the disease.
The Core Center (2020 W. Harrison St., in the Medical District) has opened a PrEP clinic for the prevention of HIV in anyone at risk of infection, age 18 and up. People can be seen whether or not they have insurance, and the clinic will help patients obtain benefits such as co-pay assistance or free medicine. Research opportunities are also available (free medicine and care). Clinic hours are currently being held on the first and third Friday afternoon of the month; appointments must be made. Call (312) 572-4500. Walk-ins, however, can be seen for screening and preliminary labs Mondays through Thursdays; ask for a Health Educator. Adolescents younger than 18 will be referred to a different clinic nearby. Read more about PrEP on page 28.
Kaiser Permanente has found a decline in heart attacks in its HIV-positive patients. “Our findings lend support to the concept that increased heart attack risk for HIV patients is largely reversible with continued emphasis on primary prevention in combination with early initiation of anti-retroviral therapy to preserve immune function,” said lead study author Daniel B. Klein, MD, in a press release. Read the press release here.
New data on the sexual transmission of the hepatitis C virus (HCV) have emerged since our article on the topic (“Can hepatitis C be sexually transmitted?” in the November+December 2014 issue). In the March 1st issue of the Journal of Infectious Diseases (JID), researchers reported finding HCV in the semen of gay males and other men who have sex with men (MSM) whether they were HIV-positive or -negative, or had acute (recent) or chronic HCV. They reported that this could affect sexual transmission of HCV, “but other factors, including high-risk behaviors, may be the main drivers for HCV transmission in HIV-infected individuals.” In the February 18 online edition of Clinical Infectious Diseases, Kaiser Permanente reported on two PrEP patients who remained HIV-negative, but had acquired HCV.
Neither of the two men reported any injection drug use, tattoos or occupational exposures to blood while taking PrEP, but both were diagnosed and treated with multiple rectal STIs and condomless receptive anal sex with partners whose HCV status they did not know. This is a small sample—two out of 485 PrEP patients—but still significant enough to monitor. And at this year’s CROI (see page 28), there was a poster presentation from MOSAIC, the largest case-control study focusing on transmission of HCV in HIV-positive MSM. Risk factors associated with HCV transmission in HIV-positive MSM included receptive anal sex without a condom, ulcerative STIs, unprotected (no gloves) fisting, and shared sex toys. Additional non-sexual factors include sharing of straws for snorting drugs and having a lower CD4 cell count. In contrast to past results, there was no relationship with the number of sex partners, group sex participation, or rectal bleeding. These are still worth considering as potential risk factors going forward. Additionally the authors called for further research on the role of CD4 count as a potential driver for HCV infection.
These results further support the recommendation that sexually active MSM and those who do not use injection drugs should be routinely screened for HCV as a component of their sexual health and wellness. —Andrew Reynolds, Project Inform
The second annual National HIV/AIDS Long-Term Survivors Awareness Day (NHALTSAD) is Friday, June 5th. The organization Let’s Kick ASS (AIDS Survival Syndrome) created the awareness day last year to recognize and honor those living longest with HIV. According to a press release, this year’s event “spotlights the present-day intricacies of survival while aging with HIV. It also stresses the importance of keeping those older adults without HIV from acquiring it.
The Illinois ADAP (AIDS Drugs Assistance Program) list of drugs issued on February 3rd shows an astounding growth in coverage. The formulary not only includes a new HIV medication approved by the FDA in January, Prezcobix, but for the first time also includes psychotropic medications, such as the antidepressants Cymbalta, Paxil, and Wellbutrin, along with other drugs not specifically for HIV but frequently used by people living with the virus, including testosterone.
Julie Scofield, executive director of the National Alliance of State and Territorial AIDS Directors (NASTAD), has stepped down after 22 years. In a blog Scofield noted that, “The decision to step down feels right for the organization at this time and for me. ...The good news is that I am passing the baton to an extraordinary leader who is eager to lead the organization into the future and the challenges we all know are ahead.” Deputy executive director Murray Penner, an expert in the treatment of both HIV and hepatitis C who joined NASTAD in 2001, stepped up into the executive director’s job in April.