Transcript DHHS Guidelines (2011) Recommended First

HIV Guidelines for the Management
and Prevention of HIV Infection
DHHS, IAS-USA, EACS, WHO and CDC
Mark E Higgins M.D.
Wellspring Medical Group
San Francisco, Ca
DHHS = Department of Health and Human Services
IAS-USA = International Antiviral Society – USA
EACS = European AIDS Clinical Society
CDC = Centers for Disease Control and Prevention
WHO = World Health Organization
1
Disclaimer
These non-promotional slides are intended to
be used as educational material only in
response to an unsolicited question or request.
The double-dagger (‡) symbol indicates that
these slides may contain information that is not
within FDA approved product labeling and has
not otherwise been approved by the FDA.
2
HIV Guidelines Overview
• HIV testing recommendations
• Key HIV treatment recommendations from DHHS, IAS-USA and
EACS regarding:
– When to Start
– What to Start
– Regimen Simplification
– Special Populations
• Pregnant Women
• Older Patients
• HBV/HCV Coinfection
• CDC Interim Guidance for Pre-Exposure Prophylaxis
– MSM, IDUs, and Heterosexually Active Adults
• US Public Health Service 2013 PEP Guidelines
3
HIV Testing Recommendations
• U.S. Preventive Services Task Force
• CDC
4
U.S. Preventive Services Task Force (USPSTF) Recommendations
Routine HIV Testing
• USPSTF recommends that clinicians screen adolescents and
adults 15-65 years and all pregnant women for HIV infection
(Grade A)*
– Younger adolescents and older adults who are at increased risk
should also be screened
– Repeat screening should be considered for those known to be at
risk for HIV infection
• Rationale for updated recommendations:
– ART reduces progression to AIDS, AIDS-related events and death
and substantially reduces transmission of HIV
– Data support earlier initiation of ART, and routine testing helps
identify patients earlier
*Grade A: the USPSTF recommends the service. There is a high certainty that the net benefit is substantial
Moyer VA. on behalf of the USPSTF. Ann Intern Med. 2013;159(1):51-60
5
U.S. Preventive Services Task Force (USPSTF) Recommendations
Repeat HIV Screening
• Repeat screening should be considered for those known
to be at risk for HIV infection, actively engaged in risky
behaviors, or who live or receive medical care in a highprevalence setting
– Based on prevalence data, MSM and IVDUs are considered
to be at very high risk for new HIV infection
– Other behavioral risk factors for HIV infection include:
• Having unprotected vaginal or anal intercourse
• Having sexual partners who are HIV-infected, bisexual, or
injection drug users
• Exchanging sex for drugs or money
– Other persons at high risk include those who have acquired
or request testing for other STIs
Moyer VA. on behalf of the USPSTF. Ann Intern Med. 2013;159(1):51-60.
6
CDC Recommendations
Routine HIV Testing
• HIV1
– Routine voluntary testing for patients 13-64 years in healthcare
settings
– Opt-out testing - not based on patient risk and no separate consent
– Pre-test counseling not required
– Repeat HIV testing based on patient risk, and annually for high risk:
• IDUs
• Sex for money or drugs
• Sex partners of HIV+ persons
• >1 sex partner since last HIV test
1. CDC. MMWR 2006;55(RR-14):1-24
2. CDC. MMWR 2006;55(RR-07):1-23
3. CDC. MMWR 2006;55(RR-16):1-25
7
When to Start
Recommendations for Treatment-Naïve
Adult Patients Initiating ART
• DHHS
• IAS-USA
8
Structure of HIV
History of DHHS Recommendations
Evolution to Initiating Treatment Early to Improve Outcomes
1987
1998
2001
FACTOR
AIDS
CD4
Viral
Load
Other
Factors
2002
2004
2008
2009/2011
2012/2013
RECOMMENDATION FOR TREATMENT
Treat
All
Treat
<500
>20,000
Treat
Treat
Treat
• Recommended at <200
• Offer at <350
• Individualize decision at
>350
>55,000
>100,000
Treat
Treat
Treat
• Recommended
<350
• Risks/Benefits
>350
• Recommended
<500
• Favor/Optional
>500
• Recommended
for all CD4 cell
counts
No specific viral load
No specific viral
load
Pregnant women
HBV co-infected
HIVAN
ART is also
recommended for
HIV-infected
individuals for the
prevention of HIV
transmission
DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013 & other
years as noted. Available at: http://www.aidsinfo.nih.gov
10
DHHS 2013 & IAS-USA 2012 Guidelines
When to Initiate ART for Treatment-Naïve Adult Patients
DHHS Recommends1
IAS-USA Recommends2
ART is recommended for all
HIV-infected individuals to reduce the risk of
disease progression and for the
prevention of HIV transmission
ART is recommended for all
HIV-infected individuals
Strength of recommendation increases as CD4 cell
count decreases.
Other considerations:
• ART recommended in patients >50 years,
regardless of CD4 cell count
• ART should be considered for HIV/HCV
coinfected patients, regardless of CD4 cell count
Strength of recommendation increases as CD4
cell count decreases and in the presence of the
following conditions:
• Pregnancy
• Chronic HBV coinfection
• HCV coinfection (if CD4 >500, may delay ART
until completion of HCV treatment)
• Age >60 years
• HIV-associated nephropathy
• Acute phase of primary HIV infection,
regardless of symptoms
• Opportunistic infections (within 2 weeks)
1. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013.
Available at: http://www.aidsinfo.nih.gov/Guidelines
2. Thompson MA, et al. JAMA 2012;308:387-402
11
DHHS 2013 & IAS-USA 2012 Guidelines
Benefits and Challenges of Early Therapy
Benefits
• Reduction in deaths1,2
• Reduction in AIDS-related illnesses1,2
• Reduction in non-AIDS conditions:1,2
– Heart disease1,2
– Kidney disease1,2
Potential Challenges/Concerns
• Impact of adverse effects on quality
of life and adherence1
• Impact of non-adherence on efficacy1
• Impact of resistance development on
future therapeutic options1
– Non-AIDS cancers1,2
• Cost associated with therapy1, and
financial/workforce resources2
– Neurological diseases1
• Need for broader testing2
– Liver disease1,2
• Better CD4 cell improvement in
younger patients1
• Preservation of immunologic function2
• Reduction in risk of HIV transmission1,2
1. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013.
Available at: http://www.aidsinfo.nih.gov/Guidelines
2. Thompson MA, et al. JAMA 2012;308:387-402
12
What to Start
Recommendations for Treatment-Naïve
Adult Patients Initiating ART
• DHHS
• IAS-USA
• EACS
13
‡
DHHS 2013 Guidelines
Recommended First-line ARV Regimens in Adultsa
ALTERNATIVEb
PREFERREDb
NNRTI
EFV/FTCc/TDF (AI)
Integrase
RAL (BID)
Inhibitor
Boosted
PI
+
FTCc/TDF
(AI)
ATV + RTV + FTCc/TDF (AI)
DRV + RTV + FTCc/TDF (AI)
RPV/FTCc/TDF (BI)d
EFV
+
RPVd
+
3TCc/ABCe (BI)
3TCc/ABCe (BIII)
EVG/COBI/FTCc/TDF (BI)f
RAL (BID)
+
3TCc/ABCe (BIII)
ATV + RTV
+
3TCc/ABCe (BI)
DRV + RTV
+
3TCc/ABCe (BIII)
FPV + RTV + FTCc/TDF or 3TCc/ABCe (BI)
LPV/r
+ FTCc/TDF or 3TCc/ABCe (BI)
Rating: A= Strong; B = Moderate; I = Data from randomized controlled trials; III = Expert opinion
a For non-pregnant women. When designing a regimen for a pregnant woman, consult the current DHHS Perinatal Guidelines
b Preferred regimens have optimal and durable efficacy, favorable tolerability and toxicity profile, and ease of use. Alternative regimens are effective and tolerable, but
have potential disadvantages compared with preferred regimens. An alternative regimen may be the preferred regimen for some patients.
c 3TC may substitute for FTC or vice versa
d RPV is not recommended in patients with pretreatment HIV RNA >100,000 copies/mL; higher rate of virologic failure with pre-ART CD4 cell count <200 cells/mm 3
e ABC should not be used in HLA-B*5701 positive patients; use with caution in pts with known high risk of CVD or with pre-ART HIV RNA >100,000 copies/mL
f EVG/COBI/FTC/TDF should not be started in patients with CrCL <70 mL/min
g RPV/FTC/TDF must be taken with a meal; neither EFV/FTC/TDF nor RPV/FTC/TDF should be used in patients with CrCL <50 mL/min; EVG/COBI/TDF/FTC must be
taken with food and should not be used in patients with CrCL <70 mL/min
“The fixed-dose combinations of EFV/FTC/TDF, RPV/FTC/TDF, and
EVG/COBI/FTC/TDF are administered as one tablet, once daily and
are designed to improve adherence”g
DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013. Available at: http://www.aidsinfo.nih.gov/Guidelines
14
‡
DHHS 2013 Guidelines
Alternate ARV Regimens in Adultsa
Regimens that May be Selected for Some Patients but are Less Satisfactory
than Preferred or Alternative Regimens
3TC b/ZDV (BID)
3TCb/ZDV (BID)
3TC b/ZDV (BID)
NNRTI
EFV +
NVP +
RPV +
Integrase
Inhibitor
RAL (BID)
3TC*/ABC (QD)
or
Boosted PI
ATV
+
ATV + RTV
+
DRV + RTV
+
FPV + RTV
+
LPV/r
+
b
SQV + RTV + FTC /TDF (QD)
or 3TCb/ABC (QD)
or
3TCb/ZDV (BID)
3TC b/ZDV (BID)
3TC b/ZDV (BID)
3TCb/ZDV (BID)
3TC b/ZDV (BID)
3TCb/ZDV (BID)
MVC (BID) + FTCb/TDF (QD)
or 3TCb/ABC (QD)
or
3TCb/ZDV (BID)
CCR5
Antagonist
a
b
FTCb/TDF (QD)
or 3TCb/ABC (QD)
or
3TC b/ZDV (BID)
+
For non-pregnant women. When designing a regimen for a pregnant woman, consult the current DHHS Perinatal Guidelines
3TC may substitute for FTC or vice versa
DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013. Available at: 15
http://www.aidsinfo.nih.gov/Guidelines
IAS-USA 2012 Guidelines
‡
Recommended and Alternative Initial ART in Adults
NNRTI
RECOMMENDEDa
ALTERNATIVEa
EFV + FTC/TDF (AIa)
EFV + 3TC/ABC (AIa)b,c in HLA-B*5701-negative
RPV/FTC/TDF (BIa)
RPV + 3TC/ABC (BIa)b,c
NVP + FTC/TDF or 3TC/ABC (BIa)b,c
patients with HIV-1 RNA <100,000 c/mL
Integrase
Inhibitor
Boosted
PI
RAL (BID) + FTC/TDF (AIa)
DRV + RTV + FTC/TDF (AIa)
ATV + RTV + FTC/TDF (AIa)
ATV + RTV + 3TC/ABC (AIa)b,c in HLA-B*5701-
EVG/COBI/FTC/TDF (BIb)d
RAL (BID) + 3TC/ABC (BIIa)b,c
DRV + RTV + 3TC/ABC (BIII)b,c
LPV/r + FTC/TDF or 3TC/ABC (BIa)b,c
negative patients with HIV-1 RNA <100,000 c/mL
Rating: A= Strong support; B = Moderate support; Quality of evidence: Ia = Evidence from 1+ RCTs published in peer-reviewed literature; Ib = Evidence from 1+ RCTs
presented in abstract form at peer reviewed scientific meetings; IIa = Evidence from nonrandomized CTs/cohort/case-control studies published in peer-reviewed
literature; III = panel analysis of available evidence
a FDCs are recommended when available and appropriate
b HLA-B*5701 screening is recommended before ABC administration to reduce the risk of hypersensitivity reaction
c Avoiding the use of ABC or LPV/r might be considered for patients with or at high risk of cardiovascular disease
d New Drug Application for this combined formulation has been filed with regulatory authorities. Approval decisions pending. Note – EVG/COBI/FTC/TDF was FDA
approved in August, 2012
“Fixed-dose formulations and once-daily regimens are generally preferred”
EFV/FTC/TDF “has become the standard-of-care comparator
regimen in most clinical trials”
16
Thompson MA, et al. JAMA 2012;308:387-402
IAS-USA 2012 Guidelines
‡
Initial ART Regimens for Special Circumstances in Adults
CCR5 Antagonist-Based and NRTI-Sparing Regimens to Consider Only in Special Circumstances
Regimens
CCR5 Antagonist
plus NRTIs
MVC + FTC/TDF or 3TC/ABC (CIII)a,b
Protease Inhibitor
plus Integrase
Inhibitor
DRV + RTV + RAL (BIIa)a,b
LPV/r + RAL (BIa)a,b
Rating: B = Moderate support; C = Limited support; Quality of evidence: Ia = Evidence from 1+ RCTs published in peer-reviewed literature; IIa = Evidence from
nonrandomized CTs/cohort/case-control studies published in peer-reviewed literature; III = panel analysis of available evidence
a Tropism assay to confirm R5 virus should be done before prescribing MVC
b Data emerging for these regimens. Clinical trial evidence needed before formal recommendation can be made
“Sufficient evidence is lacking to recommend [NRTI-sparing regimens]
as initial regimens”
17
Thompson MA, et al. JAMA 2012;308:387-402
‡
EACS 2012 Guidelines
Recommended Components of Initial ART in Adults
RECOMMENDED
Column A
Column B
Remarks
EFVa
RPVb
FTC/TDF or
3TC/ABC
EFV/FTC/TDF, RPV/FTC/TDF, FTC/TDF and
3TC/ABC co-formulated
NVP
FTC/TDF
FTC/TDF co-formulated
Boosted PI
ATV + RTV
DRV + RTV
LPV/r
FTC/TDF or
3TC/ABC
ATV + RTV: 300 + 100 mg QD
DRV + RTV: 800 + 100 mg QD
LPV/r: 400/100 mg BID or 800/200 mg QD
InSTI
RAL
FTC/TDF
RAL: 400 mg BID
(combine a drug from Column A
with those listed in Column B)
NNRTI
ALTERNATIVE
Remarks
Boosted PI
SQV + RTV
or FPV + RTV
1000 + 100 mg BID
700/100 mg BID or 1400/200 mg QD
NRTI
TDF + 3TC, ZDV/3TC, ddI + 3TC
or ddI + FTC
ZDV/3TC co-formulated
CCR5
MVC
Only if CCR5 tropic HIV
aNot
recommended in pregnancy; EFV/FTC/TDF STR is indicated for treatment of HIV-1 infected adults with virologic suppression levels of HIV-1 RNA
<50 c/mL on current combination therapy for > 3 months
bOnly if HIV-1 RNA <100,000 c/mL; FTC/RPV/TDF STR is indicated for treatment of HIV-1 infected treatment-naive adults with HIV-1 RNA ≤100,000 c/mL
“Generic HIV drugs are becoming more available and can be used as long as they
replace the same drug and do not break recommended fixed dose combinations”
Adapted from EACS Guidelines for the Clinical Management and Treatment of HIV Infected Adults in Europe, November 2012. Available at
http://www.europeanaidsclinicalsociety.org/guidelines.asp
18
Regimen Simplification
• DHHS
• IAS-USA
19
DHHS 2013 Guidelines
‡
Regimen Simplification
•
Fixed-dose combinations and single-tablet regimens reduce the number of
pills and dosing frequency
– Associated with higher adherence1-3 and increased patient satisfaction4
•
The major rationale for regimen simplification5
– Improve quality of life
– Maintain long-term medication adherence
– Avoid long-term toxicities
– Reduce risk of virologic failure
For a patient who has no history of viral resistance on an NRTI-containing
Regimen, “other NRTIs may be substituted to create a regimen with lower dosing
frequency (e.g., once-daily) that takes advantage of coformulated agents…”5
“Patients on regimens initiated earlier in the era of potent combination ART
with drugs that pose a high pill burden and/or frequent dosing requirements
are often good candidates for regimen simplification”5
1. Claxton AJ, et al. Clin Ther 2001;23:1296-310
4. Stone VE, et al. J Acquir Immune Defic Syndr 2004;36:808-16
2. Molina JM, et al. AIDS Res Hum Retroviruses 2007;23:1505-14 5. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1
3. Gallant JE, et al. N Engl J Med 2006;354:251-60
Infected Adults and Adolescents. February 12, 2013.
20
Available at: http://www.aidsinfo.nih.gov/Guidelines
IAS-USA 2012 Guidelines
Regimen Simplification
IAS-USA
• Support switching an equally effective regimen for one
with fewer drugs or lower pill burden
“Fixed-dose formulations and once-daily regimens are
generally preferred for initial therapy”
21
Thompson MA, et al. JAMA 2012;308:387-402
Recommendations for
Special Populations
• Pregnant women
• Older patients
• HBV/HCV coinfection
22
Special Populations
‡
Pregnant Women
DHHS1
• ART is recommended for all HIV-infected individuals, including
pregnant women
• Consult the DHHS Perinatal Guidelines when choosing a regimen
• EFV can be continued in pregnant women who present for care in
the first trimester, provided the regimen provides virologic
suppression
IAS-USA2
• Initiation of ART is recommended for all pregnant women to prevent
HIV transmission and for the mother’s health
• Women who conceive while already taking ART, including EFV or
TDF, should continue the same therapy unless there is a need for
change due to failure or intolerance
1. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013.
Available at: http://www.aidsinfo.nih.gov/Guidelines
2. Thompson MA, et al. JAMA 2012;308:387-402
23
‡
DHHS 2012 Perinatal Recommendations
Recommended ART for Perinatal Use*
PIs
NNRTIs
NRTIs
Other
Preferred
ATV + RTV
LPV/r
RTVa
NVP
3TC
ZDV
--
Alternative
DRV + RTV
SQV
--
FTC
TDF
ABC
--
Use in Special
Circumstances
IDV + RTVb
NFVc
EFVd
d4Tb
ddIb
RALb
Insufficient Data
to Recommend
FPV + RTV
TPV
RPV
ETR
--
MVC
T20
* There are no clinical studies in pregnant women. The known benefits and known/unknown risk of ARV use during pregnancy should be discussed
a As a booster
b When preferred and alternative agents cannot be used
c For prophylaxis of transmission when women would not other be indicated and when alternative agents are not tolerated
d EFV may be continued in pregnant women who present for care in the first trimester, provided there is virologic suppression
Reproductive Options for Serodiscordant Couples
• Initiation of ART for the HIV-infected partner is recommended
• Periconception administration of PrEP for HIV-uninfected partners may offer an additional tool to reduce the risk of
sexual transmission. The utility of PrEP of the uninfected partner when the infected partner is receiving antiretroviral
therapy has not been studied
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. July 31, 2012. Available at:
http://www.aidsinfo.nih.gov/Guidelines
24
‡
Special Populations
Pregnancy Categories for All Antiretrovirals
Category B
Category C
Category D
EVG/COBI/FTC/TDF
FTC/RPV/TDF
--
EFV/FTC/TDF
NRTIs
FTC
TDF
ddI
3TC
ABC
d4T
ZDV
--
NNRTIs
RPV
ETR
NVP
DLV
EFV
PIs
ATV
NFV
RTV
SQV
DRV
FPV
IDV
LPV/r
TPV
--
--
RAL
--
MVC
T-20
--
--
Single Tablet
Regimens
Integrase Inhibitor
Entry Inhibitors
There are no Pregnancy Category A or X antiretrovirals for HIV treatment
Data obtained from individual Prescribing Information on February 19, 2013
25
Special Populations
Older Patients
DHHS1
•
•
ART is recommended for all individuals with emphasis in those >50
years, regardless of CD4 cell count
The risk of non-AIDS related complications may increase and the
immunologic response to ART may be reduced in older HIV-infected
patients
IAS-USA2
•
•
Treatment is recommended for all patients, with emphasis in those >60 years,
regardless of CD4 cell count
Older age is associated with higher risk of AIDS and non-AIDS-related deaths
1. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013. Available at:
http://www.aidsinfo.nih.gov/Guidelines
26
2. Thompson MA, et al. JAMA 2012;308:387-402
Special Populations
‡
HBV Coinfection
DHHS1
•
•
•
ART is recommended for all individuals regardless of CD4 cell count, including
those with HBV
HIV/HBV coinfection increases the urgency for therapy
Preferred ART consists of TDF + FTC or TDF + 3TC as NRTI backbone
– Discontinuation of agents with anti-HBV activity can result in reactivation of HBV
– If ART needs to be modified due to HIV virologic failure and the patient has
adequate HBV suppression, the ARVs active against HBV should be continued
along with other suitable ARV agents to achieve HIV suppression
IAS-USA2
•
•
•
HIV increases the risk of liver-related mortality in HBV-coinfected patients
ART should be initiated regardless of CD4 cell count in patients with chronic HBV
coinfection
The optimal ART regimen for HIV/HBV coinfected patients should include TDF +
FTC (or 3TC)
1. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013. Available at:
http://www.aidsinfo.nih.gov/Guidelines
27
2. Thompson MA, et al. JAMA 2012;308:387-402
Special Populations
HCV Coinfection
DHHS1
•
•
•
•
•
ART is recommended for all individuals regardless of CD4 cell count, including
those with HCV
HIV/HCV coinfection increases the urgency for therapy
ART may slow the progression of liver disease
Initial ART regimens for most HIV/HCV confected patients are the same as those
for individuals without HCV infection
In patients with lower CD4 cell counts (<200 cells/mm3), it may be preferable to
initiate ART and delay HCV therapy until CD4 counts increase
IAS-USA2
•
•
Infection with HIV increases the risk of liver-related morbidity and mortality in
persons coinfected with HCV
ART should be initiated regardless of CD4 cell count in patients with chronic
HCV coinfection
– ART initiation may be delayed until completion of HCV treatment when CD4 cell
count is >500 cells/mm3
1. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013. Available at:
http://www.aidsinfo.nih.gov/Guidelines
28
2. Thompson MA, et al. JAMA 2012;308:387-402
‡
CDC Interim Guidance: PrEP for the
Prevention of HIV Infection in MSM,
IDUs*, and Heterosexually Active
Adults
MSM = men who have sex with men
IDU = Injection Drug User
*Risk reduction via IDU exposure is not in the TVD label
29
‡
CDC Interim Guidance
Summary of PrEP Efficacy Trials
Study
iPrEx1
mITTa
% Reduction in HIV
Incidence (95% CI)
Population
MSM
44% (15-63%)
Overall
Men
Women
Combined SelfReport & Pill-Count
Medication
Adherence (95% CI)
Pill-Count
Medication
Adherence
(95% CI)
TFV Blood
Detectionb
(95% CI)
>50%:c 50%
(18-70%)
>90%:c 73%
(41-88%)
NR
92%
(40-99%)
NR
100%d
(87-100%)
90%
(58-98%)
Partners
PrEP1
Heterosexual
discordant
couples
75%
(55-87%)
84%
(54-95%)
66%
(28-84%)
TDF21
Heterosexual
men &
women
62%
(22-83%)
80%
(25-97%)
49%
(-21 to
81%, NS)
NR
NR
84%
(-62 to
98%, NS)
FEMPrEP1
Heterosexual
women
NS
NS
NS
NR
NR
NR
VOICE2
Heterosexual
women
NS
NS
NS
NR
NR
NR
aExcluded
only those enrolled patients later found to be infected at randomization and those with no follow-up visit or HIV test
percentage of reduction in HIV incidence among those with TFV detected in blood, compared with those without detectable TFV
cThe percentage of reduction in HIV incidence, compared with placebo, is presented for 2 groups: those with 50% medication adherence & those with 90% medication adherence
dIn a substudy of participants who provided counts via home-based unannounced pill counts with supplementary adherence counseling if the counts were <80%
bThe
1. CDC. MMWR 2012;61:586-589
2. Marrazzo JM, et al. CROI 2013; Atlanta, GA. Oral #26LB
30
CDC PrEP Interim Guidance for the Prevention of HIV
Infection in MSM, IDUs, and Heterosexually Active Adults
NOTE: Truvada use to prevent parenteral HIV acquisition in those without sexual acquisition risk is currently an "off-label" use.
PrEP has the potential to contribute to effective and safe HIV
prevention for MSM, IDUs, and heterosexually active adults,
when:
1.
2.
3.
4.
5.
6.
PrEP is targeted to persons at high risk for HIV acquisition, especially persons
whose regular sexual partners are known to be HIV+
Importance of adherence to daily medication and its influence on efficacy is
clearly discussed
Couples understand that although no adverse effects have been found among
infants exposed to TDF/FTC during pregnancy and breastfeeding, these data
are incomplete for women in HIV-discordant couples using TDF/FTC to prevent
acquisition of HIV
Delivered as a part of a comprehensive set of prevention services, including
risk-reduction, PrEP medication adherence counseling, and ready access to
condoms
STI treatment is provided when indicated by screening tests conducted at least
every 6 months
Accompanied by monitoring of HIV status, pregnancy status, side effects,
adherence, and risk behaviors at each quarterly follow-up visit
1. CDC. MMWR 2011;60:65-69 2. CDC. MMWR 2012;61:586-589
3. CDC. MMWR 2013; (62(23):463-465.
31
US Public Health Service 2013 Guidelines
HIV Post Exposure Prophylaxis (PEP)
for Occupational Blood Exposure
32
US Public Health Service 2013 Guidelines
HIV Post Exposure Prophylaxis (PEP)
for Occupational Blood Exposure*
1. PEP is recommended when occupational exposures to HIV occur
2. The HIV status of the exposure source patient should be determined, if possible, to guide
need for HIV PEP
3. PEP medication regimens should be started as soon as possible after occupational
exposure to HIV, and they should be continued for a 4-week duration
4. New recommendation: PEP medication regimens should contain 3 (or more) antiretroviral
drugs
5. Expert consultation is recommended for any occupational exposures to HIV
6. Close follow-up should be provided that includes counseling, baseline and follow-up HIV
testing, and monitoring for drug toxicity. Follow-up appointments should begin within 72
hours of an HIV exposure; and
7. New recommendation: If a newer fourth-generation combination HIV p24 antigen–HIV
antibody test is utilized for follow-up HIV testing, HIV testing may be concluded 4 months
after exposure. If a newer testing platform is not available, follow-up HIV testing is
typically concluded 6 months after an HIV exposure.
* Post-exposure prophylaxis is recommended within 72 hours after non-occupational exposure to blood, genital
secretions, or other potentially infectious body fluids of an HIV-infected individual.1,2
Infection Control and Hospital Epidemiology, Vol. 34, No. 9 (September 2013), pp. 875- 892
US Public Health Service 2013 Guidelines
Recommended PEP Regimens
•
•
•
The PHS no longer
recommends that the
severity of exposure be
used to determine the
number of drugs to be
offered in an HIV PEP
regimen.
A regimen containing 3 (or
more) antiretroviral drugs is
now recommended.
Recommended PEP
regimens include those
consisting of a
•
dual NRTI backbone plus
•
an INSTI,a PI (boosted with
ritonavir), or a NNRTI
Preferred HIV PEP Regimen
TDF/FTC RAL
Alternative Regimen
Stribild
(1 drug from each column)
TDF/FTC RAL
TDF + 3TC DRV/r
AZT/3TC (bid) ETR
AZT+FTC ATV/r
RPV
LPV/r
Infection Control and Hospital Epidemiology, Vol. 34, No. 9 (September 2013), pp. 875-892
Conclusions
• Routine HIV testing is recommended by the USPSTF and CDC
• HIV treatment guidelines support earlier treatment initiation
– ART is recommended by DHHS and IAS-USA guidelines for all HIV-1
infected adult patients
• Preferred regimens are identified based on improved efficacy and
reduced toxicity profiles
– Alternative regimens may be the preferred regimen for some patients
• Regimen simplification is supported by DHHS and IAS-USA Guidelines
– Simplification can improve quality of life, reduce toxicity and risk of virologic
failure, and improve adherence
• Additional recommendations exist for special patient groups and
should be considered
35