Good Mental Health Likely Means Good Adherence to HIV Meds

April 20, 2015

Good Mental Health Likely Means Good Adherence to HIV Meds

Psychological wellbeing emerged as the only factor that predicted good adherence to HIV antiretrovirals (ARVs) in a recent study, aidsmap reports. Publishing their findings in the Journal of Acquired Immune Deficiency Syndromes, researchers from the HPTN 052 study (which famously demonstrated that taking ARVs was linked to a 96 percent reduction in risk of transmitting the virus) recruited 1,763 mixed-HIV-status heterosexual couples in nine countries and randomized the HIV-positive partners to begin treatment early (when their CD4 levels were between 350 and 550), or on a delay.

After controlling for various factors, the researchers found that the only variable linked with optimum adherence, defined as taking 95 percent of ARV doses according to counts of remaining pills at clinic visits as well as self report, was good mental health.

The only element that predicted whether someone had a fully suppressed viral load was optimum adherence.

To read the aidsmap story, click here.

To read the journal abstract, click here.

Search: Mental health, adherence, HIV, Journal of Acquired Immune Deficiency Syndromes, HPTN 052.

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HIV Ages Immune Cell DNA by 14 Years

April 22, 2015

HIV Ages Immune Cell DNA by 14 Years

Untreated HIV causes changes to cellular DNA that are akin to 14 years of aging, which may partially explain the early onset of age-related diseases among people living with the virus. Publishing their findings in PLOS ONE, researchers compared DNA extracted from stored white blood cells of treatment-naive HIV-positive men between 20 and 56 years old with that of age-matched HIV-negative men, for a total of 96 samples.

The researchers compared changes to cellular DNA that are strongly linked with aging to changes that take place during HIV disease, and used the overlap to estimate the age of the HIV-positive individuals who gave samples. They found that, according to their cellular DNA, these men seemed to be 14 years older than their chronological age.

“This number is in line with both anecdotal and published data suggesting that treated HIV-infected adults can develop the diseases of aging mentioned above, approximately a decade earlier than their uninfected peers,” Beth Jamieson, PhD, a professor of medicine in the division of hematology and oncology at the David Geffen School of Medicine at UCLA and one of the study’s senior authors, said in a press release.

The researchers could not determine if antiretroviral therapy reverses such genetic changes, nor could they tell whether HIV treatment itself contributes to these changes.

To read the press release, click here.

To read the study, click here.

Search: HIV, cellular aging, PLOS ONE, Beth Jamieson.

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Your Gut and HIV

Even With Early HIV Meds, Signs of Gut-Damaging Inflammation Are High

By Julie "JD" Davids

March 20, 2015

Even if people with HIV start antiretroviral therapy soon after infection, there are still signs of increased inflammatory activity and damage to the gut, both during and after the acute infection period, according to a study presented at CROI 2015, in Seattle, Washington.

The study, presented by Netanya Sandler Utay, M.D., followed 78 people living with HIV and 109 HIV-negative people for nearly two years. About 92% of the HIV-positive individuals were male and their median age was 28. Like the HIV-positive group, the HIV-negative control group was primarily male and around the same age. The study was conducted in Thailand.

The people with HIV in the study were very newly infected -- the median time from infection to diagnosis was 16 days -- and they started on antiretroviral therapy within an average of three days after diagnosis.

The researchers looked at changes associated with inflammation, microbial translocation (gut damage that allows intestinal bacteria to leak into systemic circulation), blood clotting and fibrosis (the thickening and scarring of connective tissue), as it is known that these factors can affect the lives, and even the lifespans, of people with HIV.

The researchers found that the markers for these factors were all much higher in these acutely infected patients at the time of diagnosis, compared to the HIV-negative individuals. However, their levels were lower than the levels in people who did not start treatment until later in their HIV infection (known as chronic infection).

With one exception, the markers for inflammation remained high in the HIV-positive patients, even though they started treatment during acute HIV infection.

What's the bottom line? "The inflammatory damage caused by HIV may not be completely prevented by starting [antiretroviral therapy] during acute HIV infection," the authors stated.

Want to learn more? You can watch the full study presentation here.

Julie "JD" Davids is the managing editor for TheBody.com and TheBodyPRO.com.

Follow JD on Twitter: @JDAtTheBody.

Learn more about the Belly and HIV here:

Your Gut and HIV

Copyright © 2015 Remedy Health Media, LLC. All rights reserved.

Life Expectancy After an HIV Diagnosis

Some Notes From an HIV Doctor on Life Expectancy After an HIV Diagnosis

By Mathew RodriguezFrom TheBody.com

April 20, 2015

Joel Gallant, M.D., M.P.H.

One question that comes up often after an HIV diagnosis is "How long do I have to live?" Of course, the first thing you should hear from your doctor is that, with proper treatment and care, you don't have to expect a shorter life because of HIV. On his personal tumblr, Joel Gallant, M.D., M.P.H., an HIV doctor at Southwest CARE Center in Santa Fe, New Mexico, answers questions from people living with HIV who are concerned about a number of issues, including HIV diagnoses.

On Sept. 21, 2014, an anonymous user asked:

It has been well established that HIV accelerates the aging process by 10 to 20 years, even with treatment. My question then is what about those infected later in life, say 50s and 60s when their normal life expectancy is already within that range. Can they expect a greater or some sort of ratio in this acceleration in aging than say someone in their 30s-40s?

Gallant answered:

In fact, it has not been well established that HIV accelerates the aging process or reduces life expectancy even with treatment. In fact this is a subject of enormous controversy. There are a number of problems with studies that suggest this acceleration in aging. One is the use of inappropriate comparisons. For example, many studies compare data from inner city HIV clinics -- which may include poor minorities, HCV-coinfected people, and injection drug users -- with the general population. If the HIV-positive people die earlier, is it really because HIV is making them age faster, or is it because of other factors that have nothing to do with HIV?
An interesting study that does not suffer from this bias is a recent Kaiser study looking at the difference in risk of heart attack between HIV-positive and HIV-negative patients over time. They found that, while historically there had been an increased risk of heart attack in HIV-positive people, that difference has been shrinking over time and has now disappeared. The assumption is that we are using more "heart friendly" drugs to treat HIV infection and that we're being more aggressive at treating other conditions that could increase the risk. The fact that this study comes from Kaiser means that there's greater homogeneity than in some of the other comparison studies. In other words, the HIV-positive people are fairly similar to the HIV-negative people from a socioeconomic standpoint -- they all have jobs that allow them to enroll in Kaiser for insurance. This homogeneity makes the comparison much more meaningful.
There's no question that people with well-controlled HIV infection have somewhat higher levels of inflammation and immune activation than HIV-negative people, but their levels are still just a small fraction of what they would be if their viral loads weren't suppressed. There's a lot of discussion and debate about how much this ongoing inflammation and immune activation will affect longevity and quality of life during the aging process, but there's no evidence at all that it will reduce life expectancy by 10-20 years. In fact, there have been a number of studies from various countries that estimate that the life expectancy of an HIV-positive person with an undetectable viral load and a CD4 count about 500 is approximately the same as that of the general population.

Joel Gallant, M.D., M.P.H., is the associate medical director of specialty services at Southwest CARE Center in New Mexico. You can ask him a question directly on his Tumblr page, Ask Dr. Joel.

Mathew Rodriguez is the community editor for TheBody.com and TheBodyPRO.com. You can follow him on Twitter at @mathewrodriguez, like his Facebook page or visit him on his personal website.

You can read more articles from Mathew Rodriquez here: http://www.thebody.com/

No HIV Transmissions Between Gay Couples When Viral Load Is Undetectable: Preliminary Results

No HIV Transmissions Between Gay Couples When Viral Load Is Undetectable: Preliminary Results

By Simon Collins

From HIV i-Base

March 24, 2015

Preliminary results from a prospective observational study in serodifferent gay couples reported no linked HIV transmissions when the HIV positive partner had an undetectable viral load, even when not using condoms.¹

This was from an interim prespecified analysis, but the findings are important for adding to those from the European PARTNER study that were presented at CROI last year.²

By December 2014, the Opposites Attract study had enrolled 234 couples in Australia (n=135), Bangkok (n=52) and Rio de Janeiro (n=47) who were already not using condoms. As with the PARTNER study, phylogenetic analysis is used to determine whether any new infections are linked to the HIV positive partner.

Only limited results were included in the poster on baseline characteristics of participants, but mean age was 36 (no SD given), and couples had been together for <12 months (39%), 1-5 years (33%) and >5 years (28%).

This analysis contained results from 150 couple years of follow up (CYFU) with only 91/150 from when condoms were not used. 152 couples contributed to follow-up 43% of which (n=65) were open relationships and 88/150 who had condomless sex. Unlike the PARTNER study, not all HIV positive people were on treatment: only 84.2% were on treatment at baseline and overall viral load was undetectable (<200 copies/mL) in 82.9%. Also at baseline, STI prevalence (details not given) was 11% and 6% in the positive and negative partners respectively.

No linked HIV transmissions were reported from 5905 times in 88 couples when condoms were not used (based on reports from the negative partner), with upper limit of 95% confidence intervals of the annual HIV incidence rates ranging from 2.46 to 6.46 per 100 couple years of follow up (CYFU). By comparison this upper limit was 184.31 when viral load was detectable at >200 copies/mL.

 See Table 1.

Table 1: HIV Incidence in Interim Analysis of Opposites Attract
Type of condomless (CL) anal sex	New linked trans-missions	Couple years of follow up (CYFU)	No. of acts	Incidence rate (95% CI)
Overall	0	150	5905	0 (0 to 2.46)
Any CL	0	91	5905	0 (0 to 4.06)
Insertive	0	78	3569	0 (0 to 4.74)
Receptive	0	57	2337	0 (0 to 6.46)
Any when VL <200 c/mL	0	89	5656	0 (0 to 4.16)
Any when VL >200 c/mL	0	2	237	0 (0 to 184.31)

Comment

This is good news, even though it is from a very short follow-up time.

Based on the limited data so far, the Opposites Attract study is reporting that although there were no linked transmissions, there is 95% confidence that the real risk is that 0 to 6.5/100 men could become HIV positive over a year. This is from being the receptive partner and based on having sex without condoms an average of 67 times a year. However, using a one-side confidence interval, there is also a 5% (1 in 20) chance that the real risk is above 6.5/100 men per year.

By comparison, the results from the PARTNER study, reported a much smaller upper risk of 2.7/100 men based on receptive sex (with ejaculation, slightly lower without) over the same time period. The lower estimate is because the PARTNER study contains a much larger number of years of observation of men having condomless sex. Because PARTNER uses a two-sided confidence interval there is a 2.5% (1 in 40) chance that the real rate could be higher than the upper confidence limit of 1.7/100 men per year.

This detail is important for explaining why the headline result of finding zero linked transmissions means very different things in each study.

Continued follow up is important in both studies for defining a similar level of confidence in the level of risk for gay men as the PARTNER study already reported for heterosexual couples. Of interest, the Opposites Attract study includes a sub study looking at viral load in semen.³

In Europe, this follow-up continues in the PARTNER 2 study, which is currently looking to enrol an additional 530 gay couples from 2014-2017. Support from doctors and researchers to help this enrolment is important and new patient materials, including leaflets and posters, are now available.⁴

References

1. Grulich AE et al. HIV transmission in male serodiscordant couples in Australia, Thailand and Brazil. 2015 Conference on Retroviruses and Opportunistic Infections (CROI 2015), 23-26 February 2015, Seattle. Late breaker poster 1019 LB.
2. Rodger A et al. HIV transmission risk through condomless sex if HIV+ partner on suppressive ART: PARTNER Study. 21st CROI, 3-6 March 2014, Boston. Oral late breaker abstract 153LB.
   See report in HTB March 2014 for details of exposure risks and confidence intervals.
3. Opposites Attract study website.
4. PARTNER 2 study website.

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The First Year of HIV Infection: A Window of Opportunity

April 2015

The First Year of HIV Infection: A Window of Opportunity

by Benjamin Ryan

People who start HIV treatment within a year of contracting the virus appear to have a better chance of refurbishing their immune systems than those whose treatment is delayed past that point. Researchers studied 1,119 people living with HIV whose records indicated an estimated date when they became HIV positive. They compared this group with a population of HIV-negative people, whose median CD4 count of about 900 led the researchers to establish 800 CD4s as the “normal” threshold.

Thirty-eight percent of the HIV-positive people who started antiretrovirals (ARVs) within a year of contracting the virus saw their CD4 cells rise to normal levels, while 28 percent of those who started treatment later reached such a high CD4 count.

When compared with the rest of the participants in the study, the HIV-positive individuals who began the study with more than 500 CD4s were twice as likely to develop a normal level of CD4s, and four times as likely to do so if they started ARVs with CD4s above 500. Notably, among the participants who had more than 500 CD4 cells upon entering the study and who began ARVs when their CD4s were still that high, those who started treatment after being infected for a year were 80 percent less likely to reach normal CD4 levels than those who went on ARVs during their first year of infection.
Also, people who started ARVs within 12 months of contracting the virus had a 7.8 percent risk of developing AIDS, compared with 15.3 percent among those who started treatment after 12 months.

The study’s lead author, Sunil K. Ahuja, MD, director of the Veterans Administration Center for Personalized Medicine in San Antonio, Texas, acknowledges that it is certainly worthy to weigh the potential cost of spending more of a lifetime on ARVs—since those drugs have toxicities—against the apparent benefits of earlier therapy. Nevertheless, he says, “If I had a choice, I would like to get my patients back to a state where I could say they are immunologically similar to HIV-uninfected people. Now, that may seem like an audacious goal, but that is the goal.”

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PAPs and Co-Pay Programs : Help Paying for Meds

Introduction Are you uninsured? If you do have health coverage, are your prescription co-pays or other co-insurance costs prohibitively expensive? Or does your health plan come with high medication deductibles that you can't afford? Help may be available from pharmaceutical companies in the form of patient assistance programs (PAPs) and co-pay programs. In recent years, the Fair Pricing Coalition (FPC) has been working closely with the pharmaceutical industry to streamline access to co-pay programs and PAPs for people living with viral hepatitis. The FPC has negotiated co-pay programs with virtually every major hepatitis drug manufacturer. Below is a list of co-pay and patient assistance programs for HIV medications as well as meds for hepatitis B and C, including contact information for these programs. This page will be updated as new treatments are released and in the event that these programs evolve over time. Different pharmaceutical company programs have different eligibility criteria based on the federal poverty level (FPL). Eligibility for this year is based on last year's income. The figure is adjusted based on family or household size. A complete table is available here. Unless otherwise stated, companies ask for verification of income, usually in the form of a federal income tax return. Companies also generally consider household income, meaning that a married couple that files joint taxes will be judged on their combined income. People who file individual income tax returns will only have their individual income considered. If you are told you are ineligible for assistance, this does not mean there is still no chance for you; you can always appeal to have the decision reversed. PROGRAMS FOR HIV Co-Pay Programs These programs offer assistance to people with private health insurance for the co-payments required to obtain HIV drugs at the pharmacy. Some companies offer co-pay assistance for all of their drugs, including non-HIV drugs. AbbVie (formerly Abbott) Drugs covered: Kaletra, Norvir Contact Information: 800-222-6885, or go to the product websites (e.g. www.kaletra.com) Program Details: The co-pay assistance covers the first $200 per Kaletra prescription per month, and the first $50 per Norvir prescription per month. Currently, a person must reapply for the program each year. The program is accessible online or through healthcare providers. Bristol-Myers Squibb Drugs covered: Atripla, Reyataz and Sustiva Contact Information: 888-281-8981 for Sustiva and Reyataz or Atripla or go to the product websites (e.g.www.sustiva.com) Program Details: The program covers the first $200 per-month of your co-payment for Reyataz and Sustiva, and the first $400 for Atripla. Currently, a person must reapply for the program each year.  The program is accessible online or through healthcare providers. Genentech/Roche HIV Drugs covered: Fuzeon Contact Information: 866-422-2377, or go to www.genentech-access.com Program Details: Makes contributions to non-profit programs that will cover co-pays for both private insurance patients and Medicare Part D patients. Gilead Sciences Drugs covered: Atripla, Complera, Emtriva, Stribild, Truvada, Tybost, Viread Contact Information: 877-505-6986, or go to product websites (e.g. www.truvada.com) Program Details: The program covers the first $6,000 per year of your co-payment for Atripla, Complera, and Stribild; the first $300 per month/$3,600 per year of your co-payment for Emtriva, Truvada and Viread; and the first $50 per month/$600 per year of your co-payment for Tybost. The program automatically renews annually for enrolled patients. The program is accessible through healthcare providers, community based organizations and pharmacies. Janssen Therapeutics (formerly Tibotec Therapeutics) Drugs covered: Edurant, Intelence, Prezista Contact Information: 866-961-7169 for Edurant, Intelence or Prezista, or go to product websites (e.g.www.prezista.com). You can also get all of the relevant information or forms including an instant savings card at www.janssentherapeutics.com. Program Details: After paying the first $5 of your co-payment, there is no limit on the amount of the remaining co-pay Janssen will cover. Currently, you must reapply for the program each year.  The program is accessible online or through healthcare providers. Merck & Co. Drugs covered: Isentress Contact Information: 855-834-3467 or www.isentress.com or www.activatethecard.com/6919/ Program Details: The program covers the first $400 of your co-payment for Isentress for each of 12 eligible prescriptions. Currently, a person must reapply for the program after 12 prescriptions have been filled. The program is accessible online. ViiV Healthcare Drugs covered: Combivir, Epivir, Epzicom, Lexiva, Rescriptor, Retrovir, Selzentry, Tivicay, Triumeq, Trizivir,Viracept and Ziagen Contact Information: 877-844-8872. You can get the card from your provider or print out the card online atwww.mysupportcard.com, or call the number above. To activate the new card, call 855-208-3317 or go towww.activatethecard.com/gsk. Program Details: The program covers the first $200 per-month of your co-payment on Combivir, Epivir, Epzicom, Lexiva, Rescriptor, Retrovir, Selzentry, Trizivir, Viracept and Ziagen and the first $400 per-month of your co-payment for Tivicay and Triumeq. Patient Assistance Programs (PAP’s), CPAPA and HarborPath for HIV Patient Assistance Programs (PAPs) offer free HIV drugs to people who do not qualify for assistance programs such as Medicaid, Medicare, or AIDS Drug Assistance Programs (ADAPs). Different company programs have different eligibility criteria based on the Federal Poverty Level (FPL) Eligibility for this year is based on last year's income. The figure is adjusted based on family or household size. A complete table isavailable here. A complete table is available here. Unless otherwise stated, companies ask for verification of income, usually in the form of a federal income tax return. Companies also generally consider household income, meaning that a married couple that files joint taxes would be judged on their combined income. People who file individual income tax returns would only have their individual income considered. Always apply for an exception if told you are not eligible. Two other recent developments that will potentially ease access to PAPs are the Common PAP Application (CPAPA) and HarborPath. The Department of Health and Human Services (DHHS), along with seven pharmaceutical companies, the National Alliance of State and Territorial AIDS Directors (NASTAD), and community stakeholders developed a common patient assistance program application that can be used by both providers and patients. Before, patients and advocates had to fill out different sets of paperwork for each company; the new application should help simplify this process, however the form still has to be sent to each company program you are applying to for assistance. Click here for the form. HarborPath is a non-profit organization that helps uninsured individuals living with HIV/AIDS gain access to brand-name prescription medicines at no cost, by providing case managers with a single "one-stop shopping" online portal for PAP applications and medication fulfillment through a mail-order pharmacy. Currently in its pilot phase in six states with most HIV pharmaceutical companies on board for ADAP waiting list clients, there are plans for expansion, including adding medicines for hepatitis C. (Merck participates with its HCV drug Victrelis.) Go to harborpath.org for more information. Please note: Most companies are using HarborPath for ADAP waiting list patients. Boehringer Ingelheim and Genentech are covering ADAP waiting list patients only through their own PAPs. Other companies are covering ADAP waiting list patients through both HarborPath and their own PAPs. Some companies are also covering ADAP disenrolled clients through their own PAP programs and some are not. If an ADAP patient has been disenrolled because the state has lowered FPL eligibility, the drug company FPL may also be too low to cover them. Check the individual company PAP criteria; and always apply for an exception if you are told you are not eligible. In some instances, Medicare Part D clients, as well as the underinsured who have co-insurance, deductibles, caps or co-pays they cannot afford, are covered 100% by the PAP; eligibility is based on both projected out of pocket drug/medical expenses and income. Both underinsured and people with no insurance who are initially denied coverage through the PAP should always ask for an exception or an appeal. AbbVie (formerly Abbott) Drugs covered: Kaletra, Norvir Contact Information: 800-222-6885 or go to product specific websites (e.g. www.kaletra.com). Program Details: The PAP is for people who do not qualify for other assistance. AbbVie’s program covers people with incomes up to 500 percent of the FPL. AbbVie does not request income verification and they only consider the income of the individual. In some instances, Medicare Part D clients, as well as the underinsured who have co-insurance, deductibles, caps or co-pays they cannot afford, are covered 100% by the PAP; eligibility is based on both projected out of pocket drug/medical expenses and income. Both the underinsured and people with no insurance who are initially denied coverage through the PAP should always ask for an exception or an appeal. AbbVie currently participates in the HarborPath ADAP waiting list program. Boehringer Ingelheim Drugs covered: Aptivus, Viramune XR Contact Information: 800-556-8317 or www.rxhope.com or www.pparx.org. Program Details: The PAP is for people who do not qualify for other assistance. BI’s program covers people with incomes up to 500 percent of the FPL. In some instances, Medicare Part D clients, as well as the underinsured who have co-insurance, deductibles, caps or co-pays they cannot afford, are covered 100% by the PAP; eligibility is based on both projected out of pocket drug/medical expenses and income. Both underinsured and people with no insurance who are initially denied coverage through the PAP should always ask for an exception or an appeal. BI currently does not participate in the HarborPath ADAP waiting list program. Bristol-Myers Squibb Drugs covered: Atripla, Reyataz and Sustiva Contact Information: 888-281-8981 or www.bms.com or go to product websites (e.g. www.sustiva.com). The Atripla PAP is handled separately at 866-290-4767 or go to www.atripla.com. Program Details: The PAP is for people who do not qualify for other assistance. The BMS program covers people with incomes up to 500 percent of the FPL. In some instances, Medicare Part D clients, as well as the underinsured who have co-insurance, deductibles, caps or co-pays they cannot afford, are covered 100% by the PAP; eligibility is based on both projected out of pocket drug/medical expenses and income. Both underinsured and people with no insurance who are initially denied coverage through the PAP should always ask for an exception or an appeal. BMS makes exceptions to their income eligibility criteria.BMS currently participates in the HarborPath ADAP waiting list program. Genentech/Roche HIV Drugs covered: Fuzeon Contact Information: 877-757-6243 Program Details: The PAP is for people who do not qualify for other assistance .Genentech’s program covers people with incomes up to 950 percent of the FPL. Genentech does not currently participate in the HarborPath ADAP waiting list program. Genentech will also assist Medicare Part D clients, as well as the underinsured who have co-insurance, deductibles, caps or co-pays they cannot afford, by referring them to non-profit foundations that may be able to assist them; eligibility is based on both projected out of pocket drug/medical expenses and income. Gilead Sciences Drugs covered: Atripla, Complera, Emtriva, Stribild, Truvada, Tybost, Viread Contact Information: 800-226-2056 or go to www.gilead.com/us_advancing_access. The Atripla PAP is handled separately at 866-290-4767 or go to www.atripla.com. Program Details: The PAP is for people who do not qualify for other assistance. Gilead’s program covers people with incomes up to 500 percent of FPL. In some instances, Medicare Part D clients, as well as the underinsured who have co-insurance, deductibles, caps or co-pays they cannot afford, are covered 100% by the PAP; eligibility is based on both projected out of pocket drug/medical expenses and income. Both underinsured and people with no insurance who are initially denied coverage through the PAP should always ask for an exception or an appeal. Gilead currently participates in the HarborPath ADAP waiting list program. Janssen Therapeutics (formerly Tibotec Therapeutics) Drugs covered: Edurant, Intelence, Prezista Contact Information: 800-652-6227 or www.jjpaf.org or product-specific website (e.g. www.prezista.com). Program Details: The PAP is for people who do not qualify for other assistance. Janssen’s program covers people with incomes up to 200 percent of FPL, but makes exceptions to their FPL eligibility criteria. In some instances, Medicare Part D clients, as well as the underinsured who have co-insurance, deductibles, caps or co-pays they cannot afford, are covered 100% by the PAP; eligibility is based on both projected out of pocket drug/medical expenses and income. Both underinsured and people with no insurance who are initially denied coverage through the PAP should always ask for an exception or an appeal. Janssen currently participates in the HarborPath ADAP waiting list program. Merck & Co. Drugs covered: Crixivan, Isentress Contact Information: 800-850-3430 or www.isentress.com Program Details: The PAP is for people who do not qualify for other assistance. Merck’s program covers people with incomes up to 500 percent of the FPL. In some instances, Medicare Part D clients, as well as the underinsured who have co-insurance, deductibles, caps or co-pays they cannot afford, are covered 100% by the PAP; eligibility is based on both projected out of pocket drug/medical expenses and income. Both underinsured and people with no insurance who are initially denied coverage through the PAP should always ask for an exception or an appeal. Merck currently participates in the HarborPath ADAP waiting list program. ViiV Healthcare Drugs covered: Combivir, Epivir, Epzicom, Lexiva, Rescriptor, Retrovir, Selzentry, Tivicay, Triumeq, Trizivir,Viracept and Ziagen Contact Information: 877-784-4842 or www.viivhealthcareforyou.com. Program Details: The PAP is for people who do not qualify for other ViiV’s program covers people with incomes up to 500 percent of the FPL. In some instances, Medicare Part D clients are covered 100% by the PAP after $600 out of pocket patient expenses. People initially denied coverage through the PAP should always ask for an exception or an appeal. ViiV currently participates in the HarborPath ADAP waiting list program. PROGRAMS FOR VIRAL HEPATITIS Co-Pay Programs These programs offer assistance to people with private insurance for the co-payments required to obtain hepatitis B and/or hepatitis C drugs at the pharmacy. Hepatitis B Virus (HBV) Bristol-Myers Squibb Drugs covered: Baraclude Contact Information: 855-898-0267 or www.baraclude.com/all-in-one-access-program.aspx. Ask the operator to speak to someone about the Baraclude Co-pay Benefits Program and ask for a card to be mailed to you. Program Details: The program covers up to $400 per co-pay. Provides up to $400 per prescription for eligible patients without prescription benefits. Gilead Sciences Drugs covered: Viread Contact Information: 877-627-0415 or www.viread.com/en/my_access.aspx Program Details: This program is for patients who are uninsured or who pay their prescription costs in full. Depending on eligibility, this program may pay up to the entire amount of the co-pay for HBV treatment using Viread. Hepatitis C Virus (HCV) AbbVie Inc. Drugs covered: Viekira Pak (ombitasvir + paritaprevir + ritonavir) + (dasabuvir), Moderiba (ribavirin) Contact Information: For Viekira, 844-277-6233 or www.viekira.com/proceed-program. For Moderiba, 844-663-3742 or www.moderiba.com/patient-support/financial. Program Details: For Viekira, contact company to determine eligibility and amount of coverage. For Moderiba, $5 out-of-pocket co-pay card may be printed from website (for those who are eligible). Genentech/Roche Drugs covered: Pegasys and Copegus Contact Information: 888-202-9939 or www.activatethecard.com/pegasys/welcome.html Program Details: After you pay $25, the card pays 80 percent of co-pays up to $1,500 to $2,400 a year, depending on your income. Call or enroll in the co-pay card program online. Gilead Sciences Drugs covered: Harvoni (sofosbuvir + ledipasvir), Sovaldi (sofosbuvir) Contact Information: 855-7MY-PATH (855-769-7284) or www.MySupportPath.com Program Details: The Co-pay Coupon Program reduces co-pays to $5 in most cases for those who qualify. Financial aid for as much as $16,000 is also available to go toward prescription deductibles and coinsurance obligations. The program is open to those with a maximum household income of $100,000 for up to a family of three, and 500 percent of federal poverty level for families with four or more members. Kadmon Pharmaceuticals Drugs covered: Ribasphere (ribavirin) Contact Information: 800-364-4767 orwww.hcvadvocate.org/community/community_pdf/Riba_CoPay_Cards.pdf Program Details: The Ribasphere Ribapak CoPay Savings Card assists those who qualify by reducing their co-pays or coinsurance for Ribasphere to no more than $5 a month. Complete the form on the website, print, and take with Ribasphere prescription and insurance card to your pharmacist. Janssen/Johnson & Johnson Drugs covered: Olysio (simeprevir) Contact Information: 855-5-OLYSIO (855-565-9746) or www.olysio.com Program Details: The Janssen Therapeutics Patient Savings program assists those who qualify by reducing their co-pays or coinsurance for Olysio to as little as $5 per fill. The maximum financial assistance is $50,000 for the 12-month period after you qualify. To qualify, your household income must be under 500 percent of federal poverty level, although you can appeal for total coverage if your income is higher. Merck & Co. Drugs covered: PegIntron and Victrelis Contact Information: 866-939-4372 or www.victrelis.com and www.pegintron.com Program Details: Victrelis: People can print out a card at www.victrelis.com which offers eligible patients savings of up to 20 percent of the total cost of each Victrelis prescription, on up to 12 prescriptions (which would be a full 44 weeks of treatment for those who need it for that duration). PegIntron: People can print out a card at www.pegintron.com which offers eligible patients up to $200 savings on their co-payment for each Pegintron prescription up to 12 prescriptions. PAP Programs These programs offer free hepatitis B or C drugs to lower-income people with who are uninsured or underinsured and who do not qualify for insurance programs such as Medicaid or Medicare. Hepatitis B Virus (HBV) Bristol-Myers Squibb Drugs covered: Baraclude Contact Information: 855-898-0267 or visit www.baraclude.com/all-in-one-access-program.aspx Program Details: The PAP is for people who do not qualify for other assistance or health insurance programs and is limited by income. Most programs have limits based on the total household income compared to established FPL percentages. Generally, programs will accept appeals for special circumstances if a person does not initially qualify and is turned down. Gilead Sciences Drugs covered: Hepsera, Viread Contact Information: 800-226-2056 or visit www.gilead.com/us_advancing_access Program Details: The PAP is for people who do not qualify for other assistance or health insurance programs and is limited by income. Most programs have limits based on the total household income compared to established FPL percentages. Generally, programs will accept appeals for special circumstances if a person does not initially qualify and is turned down. GlaxoSmithKline (GSK) Drugs covered: Epivir Contact Information: 866-728-4368 or www.bridgestoaccess.com; 866-518-4357 or www.gsk-access.com Program Details: GSK's Bridges to Access program is for people who do not qualify for other assistance or health insurance programs and is limited by income. Most programs have limits based on the total household income compared to established FPL percentages. Generally, programs will accept appeals for special circumstances if a person does not initially qualify and is turned down. The GSK Access program offers medication at no cost for qualified patients who are enrolled in a Medicare Part D prescription drug plan. Hepatitis C Virus (HCV) AbbVie Inc. Drugs covered: Viekira Pak (ombitasvir + paritaprevir + ritonavir) + (dasabuvir), Moderiba (ribavirin) Contact Information: 844-776-2333 or www.viekira.com Program Details: Contact company to determine eligibility and amount of coverage. Genentech/Roche Drugs covered: Pegasys and Copegus Contact Information: 888-941-3331 or www.pegasysaccesssolutions.com Program Details: The PAP is for people who do not qualify for other assistance or health insurance programs and is limited by income. Most programs have limits based on the total household income compared to established federal poverty levels. Generally, programs will accept appeals for special circumstances if a person does not initially qualify and is turned down. Gilead Sciences Drugs covered: Harvoni (sofosbuvir + ledipasvir), Sovaldi (sofosbuvir) Contact Information: 855-769-7284 or www.MySupportPath.com Program Details: Called Support Path, Gilead's program may provide Harvoni or Sovaldi coverage for free to those with a maximum household income of $100,000 for up to a family of three, and 500 percent of federal poverty level for families with four or more members. You can also contact Support Path for assistance finding other sources of health coverage, such as through Medicaid, Medicare or the Affordable Care Act. Janssen/Johnson & Johnson Drugs covered: Olysio (simeprevir), Procrit* Contact Information: Olysio 855-5-OLYSIO (855-565-9747) or www.olysio.com/hcp/experience; Procrit 800-652-6227 or www.jjpaf.org Program Details: The Johnson & Johnson Patient Assistance Foundation will provide free coverage of Olysio to those who qualify. The income limit is 500 percent of the federal poverty level, although you can appeal if your income is higher than that. For Procrit, the income cap is 400 percent FPL. *Procrit is a treatment that may be prescribed off-label for anemia that may occur when ribavirin is used in the hepatitis C treatment regimen. Merck & Co. Drugs covered: Pegintron and Victrelis Contact Information: 866-363-6379 or www.merckhelps.com Program Details: The ACT Program can help you answer questions related to insurance coverage and reimbursement. Program specialists can also help you apply for the PAP. The PAP is for people who do not qualify for other assistance or health insurance programs and is limited by income. Most programs have limits based on the total household income compared to established federal poverty levels. Generally the program will accept appeals for special circumstances if a person does not initially qualify and is turned down, provided they fall within the 500 percent FPL income eligibility requirement. The information on this page is based on a document originally produced by the Fair Pricing Coalition, an ad hoc group of activists who advocate with the pharmaceutical industry regarding the price and patient access to HIV and viral hepatitis drugs. For more information, please visit www.fairpricingcoalition.org.

Last Revised: 1/12/15

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Herpes Simplex Virus (oral & genital herpes)

What are the symptoms, & how is it diagnosed?

The symptoms of herpes depends on the site of disease:

• Oral herpes (cold sores): Sores around the mouth and nostrils. They may itch or be painful. They might look like the sore in this picture:

• Genital herpes: Sores on the penis in males or near or in the vagina in women. Genital herpes can also cause sores near the anus, including the area between the anus and the genitals (the perineum). Sometimes, genital herpes can cause pain when urinating or defecation. They might look like the sores in this picture:

How is herpes diagnosed?

Oral and genital herpes are well-known diseases. Most doctors and other health-care providers know herpes when they see it. In turn, both types of herpes can often be diagnosed—and treatment recommended— simply by examining the sores. However, guidelines published by the Centers for Disease Control and Prevention (CDC) recommends that mouth sores in particular be confirmed by laboratory testing as oral herpes can sometimes be more difficult to diagnose in people with HIV.

When in doubt, a small sample of the sore is sent to a lab for testing. If the virus is found in the sample, a confirmed diagnosis can be made.

Because a large number of people are infected with HSV-1 and/or HSV-2, there is no value in having blood samples tested for the presence of antibodies to either virus. Being infected with the virus does not necessarily mean that herpes sores will occur.

How is Herpes treated?

Herpes cannot be cured. Once either virus is inside the body and settles itself into the nerve cells, it cannot be eliminated. However, herpes sores can be treated. Treatment can speed up healing time, reduce pain, and delay or prevent additional flare ups. Typically, treatment is used only during a flare up. This is called "episodic therapy." In people with compromised immune systems, flare-ups can be frequent and may require long-term therapy to prevent recurrences. This is called "suppressive therapy." Some people can tell when they are about to have a flare up, usually because of tingling at the site where a sore will appear. This is called the "prodrome" stage.

There are four treatments available for the treatment of herpes:

• Acyclovir (Zovirax): Acyclovir has been studied and used for many years as a treatment for oral and genital herpes. It has been studied specifically in people with HIV and herpes and has been shown to be safe and effective. Acyclovir is available in a topical cream, pills, and an intravenous formulation. Most experts agree that the cream is not very effective and that pills are best for mild to moderate flare-ups or long-term suppressive therapy. Intravenous acyclovir is used to treat serious flare-ups or outbreaks that effect internal organs (especially HSV infection of the central nervous system). The oral dose used to treat flare-ups is 400 mg taken either three or four times a day, usually for five to ten days. Treatment will work best if it is started within 24 hours of the first sign of symptoms or the prodrome stage. For this reason, people with more frequent outbreaks not on suppressive therapy may wish to keep acyclovir on hand in case of a flare up. The dose can be doubled if the herpes sores fail to respond. Taking 400 mg of the drug three-times daily or 800 mg of the drug twice a day for a prolonged period of time can help prevent flare-ups from recurring. However, this is usually recommended only for patients who have a history of frequent recurrences.
• Valacyclovir (Valtrex): Valacyclovir is a "pro-drug" of acyclovir and has been approved specifically for the treatment of herpes in HIV-positive people. Unlike acyclovir, valacyclovir needs to be broken down by the body before its active ingredient— acyclovir—can begin controlling the disease. This allows for higher amounts of acyclovir to remain in the body, thus requiring a lower dose of the drug to be taken by mouth. For mild to moderate herpes flare ups the dose of valacyclovir in people with HIV is 500 mg twice daily. For episodic therapy, valacyclovir is taken for five to ten days. However, the drug can be taken every day for a prolonged period of time using half the dose needed to treat flare-ups (500 mg every day). Treatment will work best if it is started within 24 hours of the first sign of symptoms or the prodrome stage. For this reason, people with more frequent outbreaks not on suppressive therapy may wish to keep valacyclovir on hand in case of a flare up. Like acyclovir, valacyclovir rarely causes side effects.
• Famciclovir (Famvir): Famciclovir is the pill form of a topical cream called penciclovir (Denavir). Usually, 500 mg of the drug is taken by mouth, twice daily, for five to ten days. Treatment will work best if it is started within 24 hours of the first sign of symptoms or the prodrome stage. A dose of 500 mg twice daily, taken for a prolonged period of time, is considered to be a safe and effective preventative therapy for recurrent herpes flare-ups.
• Trifluridine (Viroptic):Trifluridine drops are used to treat HSV infection of the eye(s). One drop is placed in the affected eye, every two hours, for up to 21 days. It cannot be used to treat or prevent HSV disease of other parts of the body.

In some cases, herpes flare-ups do not respond to acyclovir, valacyclovir, or famciclovir, probably due to the emergence of drug-resistant forms of HSV-1 and HSV-2. HIV-positive patients with suppressed immune systems —usually a CD4 cell count less that 100—who have been receiving long-term acyclovir for the treatment and prevention of recurrent herpes flare-ups have been known to develop drug-resistant herpes. Because acyclovir is similar to both valacyclovir and famciclovir, simply switching to these two drugs is not usually effective.

At the present time, foscarnet (Foscavir) is the most common treatment for acyclovir-resistant herpes. The drug must be administered via an intravenous (IV) line, usually three times a day, often in a hospital or under the close supervision of an in-home nurse.

Some healthy tips

• During a flare up, it is important to keep the sores and the area around the sores as clean and dry as possible. This will help your natural healing processes. Some doctors recommend warm showers in order to cleanse the infected area. Afterwards, towel dry gently, or dry the area with a hair dryer on a low or cool setting. To prevent chaffing, some people also find it helpful to avoid tight-fitting undergarments. Most creams and lotions do no good and may even irritate the area.
• The amino acids lysine and arginine have been shown to play a role in herpes flare-ups. According to some new research, lysine can help control herpes flare-ups. Arginine, on the other hand, can actually make flare-ups worse. In turn, foods that are rich in lysine— but low in arginine—can help control both oral and genital herpes. Fish, chicken, beef, lamb, milk, cheese, beans, brewer's yeast, mung bean sprouts and most fruits and vegetables have more lysine than arginine, except for peas. Gelatin, chocolate, carob, coconut, oats, whole wheat and white flour, peanuts, soybeans, and wheat germ have more arginine than lysine.

Can Herpes be prevented?

Vaccines to prevent herpes virus infections are currently being studied and it is felt that an effective vaccine may be available in three to five years. Vaccines will only function to prevent the infection from occurring in the first place—they won't likely help control flare-ups in patients who are already infected.
People who are infected with herpes can transmit the virus during periods where the virus is shedding, but there are no symptoms. Because of this, the Centers for Disease Control and Prevention (CDC) recommends that people with herpes who have a regular sex partner who is not infected with herpes may want to take suppressive treatment as an added precaution, in addition to consistent and correct condom use.

Are there any experimental treatments?
Some researchers are studying new therapies for the treatment of herpes, including a topical foscarnet cream and a topical gel of the anti-CMV drug cidofovir. Another topical drug being studied for oral and genital herpes is trifluridine, a drug already approved for the treatment of herpes infection of the eye.

If you would like to find out more about these studies, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email contactus@aidsinfo.nih.gov.

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